Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define the device as reusable rigid containers for organizing and sterilizing medical instruments. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies focus on sterilization validation and material properties, not algorithmic performance.

Therapeutic

No
The device is described as instrument kits/trays intended to enclose other medical devices for sterilization, organize, and protect instruments. Its function is related to the sterilization process and organization of instruments, not directly for treating or diagnosing a medical condition.

Diagnostic

No
The device is described as an "Instrument Kit" intended to enclose other medical devices for sterilization, and to organize and protect instruments. There is no mention of it being used to diagnose diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it includes physical components such as instrument trays, bases, lids, and holders made from polysulfone and silicone. It is a reusable rigid container system for sterilization, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for enclosing other medical devices for sterilization by a healthcare provider. It facilitates the sterilization process and maintains sterility when used with a cleared wrap. This is a function related to the preparation and handling of medical instruments, not the diagnosis of diseases or conditions based on in vitro examination of specimens.
Device Description: The description details a reusable rigid container system for organizing and protecting instruments during sterilization. This aligns with the intended use and does not involve any components or processes related to analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Reagents or assays

The device's function is purely related to the sterilization and organization of medical instruments used in healthcare settings.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

S.I.N. Instrument Kits are intended to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

Product codes (comma separated list FDA assigned to the subject device)

KCT

Device Description

The subject device includes a total of 14 instrument trays. The subject device trays are reusable rigid containers, comprising a base (bottom), one or more removable inner trays, and a lid (cover). The subject device trays are to be used to organize and protect the instruments that are sterilized by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior components during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone (PSU), and holders of various geometries to position instrument in the kits are manufactured from silicone. The subject device includes a total of 5 sizes (same lid, base, and enclosed volume), and a total of 14 tray configurations.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care provider

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing was performed to demonstrate the subject devices met the acceptance criteria of the standard. Tests included:

Manual Cleaning Validation against FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 2015). Acceptance criteria: No color change (absence of protein residue), Sensitivity = 1 µg protein residue; Total organic carbon assay results . Acceptance criterion: Endotoxin results

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 21, 2020

S.I.N. - Sistema de Implante Nacional S.A. % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International. LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K201688

Trade/Device Name: S.I.N. Instrument Kits Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 15, 2020 Received: September 17, 2020

Dear Kevin Thomas:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CAPT Elizabeth F. Claverie, MS Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Safe Drill Unitite Kit

S.I.N. Instrument Kits are intended to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Safe Drill Unitite Kit and the associated instruments is 304 grams.

The weight of the empty Safe Drill Unitite Kit is 150 grams.

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Paperwork Reduction Act (PRA) Staff

PRAStaff @fda.hhs.gov

3

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Safe Drill SW Kit

S.I.N. Instrument Kits are intended to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Safe Drill SW Kit and the associated instruments is 278 grams.

The weight of the empty Safe Drill SW Kit is 138 grams.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Offic

Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov

4

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Prosthetic Kit

S.I.N. Instrument Kits are intended to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Prosthetic Kit and the associated instruments is 332 grams.

The weight of the empty Prosthetic Kit is 160 grams.

Type of Use (Select one or both, as applicable)	X Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)	X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov

5

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Rotatory Expanding Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Rotatory Expanding Kit and the associated instruments is 276 grams.

The weight of the empty Rotatory Expanding Kit is 133 grams.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

PRAStaff @fda.hhs.gov

6

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Bone Expander Kit

S.I.N. Instrument Kits are intended to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Bone Expander Kit and the associated instruments is 974 grams.

The weight of the empty Bone Expander Kit is 367 grams.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of

information unless it displays a currently valid OMB number."

7

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Sinus Lift Kit

S.I.N. Instrument Kits are intended to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Sinus Lift Kit and the associated instruments is 808 grams.

The weight of the empty Sinus Lift Kit is 370 grams.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov

8

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Osteotome Kit

S.I.N. Instrument Kits are intended to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Osteotome Kit and the associated instruments is 957 grams.

The weight of the empty Osteotome Kit is 350 grams.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

9

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Unitite Surgical Kit

S.I.N. Instrument Kits are intended to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Unitite Surgical Kit and the associated instruments is 1126 grams.

The weight of the empty Unitite Surgical Kit is 515 grams.

Type of Use (Select one or both, as applicable)	X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)	X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Paperwork Reduction Act (PRA) Staff

PRAStaff @fda.hhs.gov

10

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Strong SW Surgical Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Strong SW Surgical Kit and the associated instruments is 698 grams.

The weight of the empty Strong SW Surgical Kit is 130 grams.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff @fda.hhs.gov

11

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Tryon Surgical Kit KCHE 03

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Tryon Surgical Kit KCHE 03 and the associated instruments is 1127 grams.

The weight of the empty Tryon Surgical Kit KCHE 03 is 520 grams.

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
-------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

12

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Tryon Surgical Kit KCHE 04

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Tryon Surgical Kit KCHE 04 and the associated instruments is 1138 grams.

The weight of the empty Tryon Surgical Kit KCHE 04 is 523 grams.

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

13

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Unitite Surgical Guided Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Unitite Surgical Guided Kit and the associated instruments is 1434 grams.

The weight of the empty Unitite Surgical Guided Kit is 650 grams.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov	Department of Health and Human Services

14

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Strong SW Surgical Guided Kit

Tyne of Use /Select one or hoth as annlicable /

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Strong SW Surgical Guided Kit and the associated instruments is 1399 grams.

The weight of the empty Strong SW Surgical Guided Kit is 647 grams.

1 ype of Oos (Ourout One of Wom, us upplivable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Food and Druq Administration
Office of Chief Information Officer	Department of Health and Human Services
Paperwork Reduction Act (PRA) Staff

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

PRAStaff @fda.hhs.gov

15

510(k) Number (if known)

K201688

Device Name

S.I.N. Instrument Kits

Indications for Use (Describe)

Indications for Use for Zygomatic Surgical Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated vycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Zygomatic Surgical Kit and the associated instruments is 1150 grams.

The weight of the empty Zygomatic Surgical Kit is 464 grams.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

16

510(k) Summary

K201688

S.I.N. - Sistema de Implante Nacional S.A.

S.I.N Instrument Kits

October 14, 2020

ADMINISTRATIVE INFORMATION

Manufacturer Name	S.I.N. – Sistema de Implante Nacional S.A.
	Avenida Vereador Abel Ferreira, 1100
	São Paulo, São Paulo
	03340-000 Brazil
	Telephone +55-11-21693000 ext 3236
Official Contact	Denise Domiciano, Quality and Regulatory Manager
Representative/Consultant	Kevin A. Thomas, PhD
	Floyd G. Larson, MS, MBA
	PaxMed International, LLC 12264
	El Camino Real, Suite 400 San
	Diego, CA 92130
	Telephone +1 858-792-1235
	Fax +1 858-792-1236
	Email kthomas@paxmed.com
	flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	S.I.N. Instrument Kits
Common Name	Instrument sterilization trays
Regulation Number	21 CFR 880.6850
Regulation Name	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulatory Class	Class II
Product Code	KCT
Classification Panel	General Hospital
Reviewing Office	Office of Surgical and Infection Control Devices (OHT4) Reviewing
Division	Division of Infection Control and Plastic Surgery Devices (DHT4B)

PREDICATE DEVICE INFORMATION The primary predicate device is: K182865, Neodent Instrument Kits, JJGC Indústria e Comércio de Materiais Dentários S.A.

17

SUBJECT DEVICE INDICATIONS FOR USE STATEMENTS

Indications for Use for Safe Drill Unitite Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 ℃ for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Safe Drill Unitite Kit and the associated instruments is 304 grams. The weight of the empty Safe Drill Unitite Kit is 150 grams.

Indications for Use for Safe Drill SW Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Safe Drill SW Kit and the associated instruments is 278 grams.

The weight of the empty Safe Drill SW Kit is 138 grams.

Indications for Use for Prosthetic Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement – Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Prosthetic Kit and the associated instruments is 332 grams.

The weight of the empty Prosthetic Kit is 160 grams.

Indications for Use for Rotatory Expanding Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement – Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Rotatory Expanding Kit and the associated instruments is 276 grams.

The weight of the empty Rotatory Expanding Kit is 133 grams.

18

Indications for Use for Bone Expander Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Bone Expander Kit and the associated instruments is 974 grams.

The weight of the empty Bone Expander Kit is 367 grams.

Indications for Use for Sinus Lift Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Sinus Lift Kit and the associated instruments is 808 grams.

The weight of the empty Sinus Lift Kit is 370 grams.

Indications for Use for Osteotome Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 ℃ for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Osteotome Kit and the associated instruments is 957 grams.

The weight of the empty Osteotome Kit is 350 grams.

Indications for Use for Unitite Surgical Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Unitite Surgical Kit and the associated instruments is 1126 grams.

The weight of the empty Unitite Surgical Kit is 515 grams.

Indications for Use for Strong SW Surgical Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.

19

The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Strong SW Surgical Kit and the associated instruments is 698 grams.

The weight of the empty Strong SW Surgical Kit is 130 grams.

Indications for Use for Tryon Surgical Kit KCHE 03

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement – Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Tryon Surgical Kit KCHE 03 and the associated instruments is 1127 grams.

The weight of the empty Tryon Surgical Kit KCHE 03 is 520 grams.

Indications for Use for Tryon Surgical Kit KCHE 04

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Tryon Surgical Kit KCHE 04 and the associated instruments is 1138 grams. The weight of the empty Tryon Surgical Kit KCHE 04 is 523 grams.

Indications for Use for Unitite Surgical Guided Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Unitite Surgical Guided Kit and the associated instruments is 1434 grams.

The weight of the empty Unitite Surgical Guided Kit is 650 grams.

Indications for Use for Strong SW Surgical Guided Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

20

The combined weight of the Strong SW Surgical Guided Kit and the associated instruments is 1399 grams. The weight of the empty Strong SW Surgical Guided Kit is 647 grams.

Indications for Use for Zygomatic Surgical Kit

S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices. The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:

Gravity displacement – Exposure at 121 °C for 30 minutes and 30 minutes dry time.

S.I.N. Instrument Kits are intended for sterilization of non-porous loads.

S.I.N. Instrument Kits are recommended not to be stacked during sterilization.

The combined weight of the Zygomatic Surgical Kit and the associated instruments is 1150 grams.

The weight of the empty Zygomatic Surgical Kit is 464 grams.

SUBJECT DEVICE DESCRIPTION

The subject device includes a total of 14 instrument trays. The subject device trays are reusable rigid containers, comprising a base (bottom), one or more removable inner trays, and a lid (cover). The subject device trays are to be used to organize and protect the instruments that are sterilized by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior components during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polysulfone (PSU), and holders of various geometries to position instrument in the kits are manufactured from silicone. The subject device includes a total of 5 sizes (same lid, base, and enclosed volume), and a total of 14 tray configurations.

TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE

The comparison of the Technological characteristics for the subject devices and the predicate device are provided at the end of the 510k summary on pages 7 - 10.

The subject device is provided in 5 sizes and 14 configurations; the predicate device K182865 is provided in 4 sizes and 4 configurations. The subject device and the predicate device have similar overall dimensions, enclose similar volumes, and have similar vent to volume ratios. Differences in the dimensions and vent to volume ratios between the subject device and the predicate device are mitigated by the sterilization validation performed.

SUMMARY OF NONCLINICAL TESTING

Provided below are the non-clinical test methodologies performed to demonstrate the subject devices met the acceptance criteria of the standard.

21

Test Methodology	Purpose	Acceptance Criteria
Manual Cleaning Validation FDA
Guidance
Reprocessing Medical Devices in
Health Care Settings: Validation
Methods and Labeling
(issued March 2015)	The purpose of this test is to
validate that the cleaning
instructions provided in the
Instructions for Use appropriately
clean the tray, and to ensure the
sterilization cycle will be
effective.	Protein assay
Acceptance criterion:
No color change = absence of protein
residue
Sensitivity = 1 µg protein residue	Pass
		Total organic carbon assay
Acceptance criterion:
results	The purpose of this test is to
validate that the cleaning
instructions provided in the
Instructions for Use appropriately
clean the tray, and to ensure the
BET level meets FDA expectation
(≤ 20 EU/device)	Acceptance criterion:
Endotoxin results ≤ 20 EU/device	Pass
Sterilization Validation
including sterilant penetration and
dry time validation
ANSI/AAMI/ISO 17665-1
ANSI/AAMI/ISO 17665-2	The purpose of this test is to
validate that the sterilization
instructions listed in the
Instructions for Use appropriately
sterilize the tray and contents.	Acceptance criterion:
3 consecutive half-cycles performed for
each of 3 sizes of trays demonstrate
complete inactivation of all biologic
indicators;
A minimum SAL of 10-6 is achieved if the
Instructions for Use are followed	Pass
Dry time	The purpose of this test is to
validate that the sterilization
instructions listed in the
Instructions for Use appropriately
dry the wrapped tray for storage.	Acceptance criterion:
Using pre-cycle and post-cycle weights,
the weight gain after drying will be ≤ 3%	Pass
Life Cycle / Simulated Use Life
Validation FDA Guidance
Reprocessing Medical Devices in
Health Care Settings: Validation
Methods and Labeling
(issued March 2015)	The purpose of this test is to
validate the service life of the
trays as stated in the Instructions
for Use.	Acceptance criteria:
Visual inspection, component dimensional
fit verification, functional closure/latch
verification for 250 use cycles	Pass
Biocompatibility of Subject
Device (by cytotoxicity testing)
ANSI/AAMI/ISO 10993-5
ANSI/AAMI/ISO 10993-12	The purpose of this test is to
evaluate the cytotoxicity potential
of the test article using an in vitro
cell culture assay.	Acceptance criterion:
Non-cytotoxic if ≤ 50% of L-929 cells
exposed to extract of device show
rounding and lysis	Pass

Summary of Nonclinical Testing Table

In summary, the nonclinical testing provided for these devices met the acceptance criteria for each standard and test methodology used to evaluate the devices as shown in the table above.

No clinical data were included in this submission.

CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the subject devices are as safe, as effective, and performs as well as or better than the legally marketed predicate device.

22

	Indications for Use Statements
K201688 Subject Device
S.I.N. Instrument Kits
S.I.N. - Sistema de Implante Nacional S.A.
Safe Drill Unitite Kit	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to all
the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Safe Drill Unitite Kit and the associated instruments is 304 grams.
The weight of the empty Safe Drill Unitite Kit is 150 grams.
Safe Drill SW Kit	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to all
the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Safe Drill SW Kit and the associated instruments is 278 grams.
The weight of the empty Safe Drill SW Kit is 138 grams.
Prosthetic Kit	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to all
the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Prosthetic Kit and the associated instruments is 332 grams.
The weight of the empty Prosthetic Kit is 160 grams.
Rotatory Expanding Kit	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to all
the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Rotatory Expanding Kit and the associated instruments is 276 grams.
The weight of the empty Rotatory Expanding Kit is 133 grams.
Bone Expander Kit	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to all
the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Bone Expander Kit and the associated instruments is 974 grams.
The weight of the empty Bone Expander Kit is 367 grams.
Sinus Lift Kit	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to all
the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Sinus Lift Kit and the associated instruments is 808 grams.
The weight of the empty Sinus Lift Kit is 370 grams.
	Indications for Use Statements
Osteotome Kit	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed
FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Gravity displacement –
Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Osteotome Kit and the associated instruments is 957 grams. The weight of the empty
Osteotome Kit is 350 grams.
Unitite Surgical Kit	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed
FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Gravity displacement -
Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Unitite Surgical Kit and the associated instruments is 1126 grams. The weight of the empty
Unitite Surgical Kit is 515 grams.
Strong SW Surgical Kit	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed
FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Gravity displacement -
Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Strong SW Surgical Kit and the associated instruments is 698 grams. The weight of the empty
Strong SW Surgical Kit is 130 grams.
Tryon Surgical Kit KCHE
03	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed
FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Gravity displacement -
Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Tryon Surgical Kit KCHE 03 and the associated instruments is 1127 grams. The weight of the empty
Tryon Surgical Kit KCHE 03 is 520 grams.
Tryon Surgical Kit KCHE
04	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed
FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Gravity displacement -
Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Tryon Surgical Kit KCHE 04 and the associated instruments is 1138 grams. The weight of the empty
Tryon Surgical Kit KCHE 04 is 523 grams.
Unitite Surgical Guided Kit	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed
FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Gravity displacement -
Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Unitite Surgical Guided Kit and the associated instruments is 1434 grams. The weight of the empty
Unitite Surgical Guided Kit is 650 grams.
Strong SW Surgical Guided
Kit	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed
FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle: Gravity displacement -
Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Strong SW Surgical Guided Kit and the associated instruments is 1399 grams. The weight of the empty
	Indications for Use Statements
Zygomatic Surgical Kit	S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow
the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
Gravity displacement - Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Zygomatic Surgical Kit and the associated instruments is 1150 grams.
The weight of the empty Zygomatic Surgical Kit is 464 grams.
Predicate Device
K182865
Neodent Instrument Kits
JJGC Indústria e Comércio de Materiais Dentários S.A.	Indications for Use for GM/WS Surgical Kit Case:
Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to all
require the use of FDA cleared wrap to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20 minute dry time
Gravity displacement - Exposure at 132 °C for 15 minutes, 20 minute dry time
Neodent Instrument Kits are intended for sterilization of non-porous loads.
The combined weight of the GM/WS Surgical Kit Case and the associated instruments is 674.5 g. The weight of the empty Kit Case is 507 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
Indications for Use for GM Prosthetic Kit Case:
Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to all
require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry time
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Neodent Instrument Kits are intended for sterilization of non-porous loads.
The combined weight of the GM Prosthetic Kit Case and the associated instruments is 250.5 g. The weight of the empty Kit Case is 210 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
Indications for Use for GM Try-In Kit Case:
Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits require the use of
The kits are to be enclosed in a sterilizable wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum) – Exposure at 132 °C for 4 minutes, 20-minute dry time.
Gravity displacement - Exposure at 132 °C for 15 minutes, 20-minute dry time.
Neodent Instrument Kits are intended for sterilization of non-porous loads.
The combined weight of the GM Try-In Kit Case and the associated instruments is 212.6 g. The weight of the empty Kit Case is 195 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.
Indications for Use for GM Guided Surgery Kit Case:
Neodent Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. Neodent Instrument Kits are intended to all
require the use of FDA-cleared wrap to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA-cleared for the indicated cycles, and moist heat (steam) sterilized using one of the following cycles:
Fractionated vacuum (pre-vacuum) - Exposure at 132 °C for 4 minutes, 20-minute dry time
Gravity displacement - Exposure at 132 °C for 15 minutes, 40-minute dry time.
Neodent Instrument Kits are intended for sterilization of non-porous loads.
The combined weight of the GM Guided Surgery Surgical Kit Case and the associated instruments is 728.4 g. The weight of the empty Kit Case is 567 grams.
Neodent Instrument Kits are recommended not to be stacked during sterilization.

w sterilization of the enclosed medical devices. S.I.N. Instrument Kits require

23

nedical devices. S.I.N. Instrument Kits require the use of a wrap that is

24

sterilization of the enclosed medical devices. S.I.N. Instrument Kits require

w sterilization of the enclosed medical devices. Neodent Instrument Kits

FDA-cleared wrap to maintain the sterility of the enclosed devices.

w sterilization of the enclosed medical devices. Neodent Instrument Kits

25

Technological Characteristics

	Subject Device			Primary Predicate Device			Comparison
Attribute	K201688			K182865
	S.I.N. Instrument Kits			Neodent Instrument Kits
	S.I.N. - Sistema de Implante Nacional S.A.			JJGC Indústria e Comércio de Materiais Dentários S.A.
Product Code	KCT			KCT			Same
Design	Rigid polymer base, lid, and removable inner tray			Rigid polymer base, lid, and removable inner tray			Same
Materials	Polysulfone (base, tray, lid)			Polysulfone (base, tray)			Similar
	Medical grade silicone (grommets)			Polyphenylsulfone (Radel R5000) (lid)
				Medical grade silicone (grommets)
Titanium alloy (retention fixtures)
Materials Compatible with
Sterilization Method described below.	Yes			Yes			Same
Perforated	Yes; allows moist heat (steam) penetration to achieve sterilization			Yes; allows moist heat (steam) penetration to achieve sterilization			Same
Reusable	Yes			Yes			Same
Number of Overall Tray Dimensions	5			4			Similar
Total Number of Configurations	14			4			Similar
Dimension
s and
Vent to Volume Ratio	Tray	Length x Width x Height, mm	Vent to Volume Ratio	Set	Length x Width x Height, mm	Vent to Volume Ratio	Similar
	COUSD 02, Safe Drill Unitite Tray	113.7 x 75.7 x 29.5	0.0089 cm²/cm³	Set 110.287	264 x 163 x 54	0.0102 cm²/cm³
	COWSD 02, Safe Drill SW Tray	113.7 x 75.7 x 29.5	0.0089 cm²/cm³	Set 110.294	195 x 90 x 54	0.0191 cm²/cm³
	COTMEC, Prosthetic Tray	113.7 x 75.7 x 29.5	0.0089 cm²/cm³	Set 110.295	195 x 90 x 44	0.0247 cm²/cm³
	COER, Rotatory Expanding Tray	113.7 x 75.7 x 29.5	0.0089 cm²/cm³	Set 110.296	264 x 163 x 58	0.0093 cm²/cm³
	COEXP, Bone Expander Tray	113.7 x 75.7 x 29.5	0.0100 cm²/cm³
	COLEV, Sinus Lift Tray	215 x 100 x 33.5	0.0100 cm²/cm³
	COOST, Osteotome Tray	113.7 x 75.7 x 29.5	0.0100 cm²/cm³
	COSU 03, Unitite Surgical Tray	165 x 190 x 55	0.0086 cm²/cm³
	COSW 02, Strong SW Surgical Tray	165 x 190 x 55	0.0086 cm²/cm³
	COHE 03, Tryon Surgical Tray KCHE 03	165 x 190 x 55	0.0086 cm²/cm³
	COHE 04, Tryon Surgical Tray KCHE 04	165 x 190 x 55	0.0086 cm²/cm³
	COSUG 02, Unitite Surgical Guided Tray	142 x 206 x 72	0.0083 cm²/cm³
	COSWG 02, Strong SW Surgical Guided Tray	165 x 190 x 55	0.0083 cm²/cm³
	COKZ, Zygomatic Surgical Tray	113.7 x 75.7 x 29.5	0.0131 cm²/cm³
Reusable	Yes			Yes			Same
Use Life Testing	Reusable up to 250 cycles
Disassembled, cleaned, assembled,
sterilized Visual inspection
Component dimensional fit verification
Functional closure (lid-base latch)
verification			Reusable up to 100 cycles
Assembled/disassembled, cleaned,
sterilized Visual inspection
Component dimensional fit verification
Functional closure (lid-base latch)
verification			Similar
Sterilization Method
Sterilant	Moist heat (steam)			Moist heat (steam)			Same
Cycles	Gravity displacement			Gravity displacement			Same (SAL)
	30 minute exposure at 121 oC (250 oF), with a 30 minute drying time; results in SAL of 10-6			15 minute exposure at 132 oC (250 oF), with a 20 minute drying time
	(No other cycle validated)			Fractionated vacuum (pre-vacuum)			Not
applicable
				4 minute exposure at 132 oC (250 oF), with a 20 minute drying time
Sterile Barrier	Sterilization wrap, FDA cleared for indicated method and cycles			Sterilization wrap, FDA cleared for indicated method and cycles			Same