(84 days)
No
The device description and intended use clearly define the device as reusable rigid containers for 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 "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is a reusable rigid container intended for the sterilization of other medical devices, not for diagnosing, treating, or preventing disease in a patient.
No
The device is an instrument kit designed to enclose and facilitate the sterilization of other medical devices, not to diagnose medical conditions.
No
The device description explicitly states it includes physical components such as instrument trays, bases, lids, and holders made from polysulfone and silicone. It is a hardware device used for sterilization.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the S.I.N. Instrument Kits are used to enclose other medical devices for sterilization by a healthcare provider. They facilitate the sterilization process and maintain 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 reusable rigid containers designed to organize and protect instruments during sterilization. The materials and design are focused on withstanding sterilization cycles and allowing sterilant penetration. This aligns with a device used in a clinical setting for instrument management, not for laboratory testing of biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used with biological specimens (blood, urine, tissue, etc.), performing tests on these specimens, or providing diagnostic information. The focus is entirely on the physical process of sterilization and instrument handling.
Therefore, the S.I.N. Instrument Kits fall under the category of devices used in the sterilization and handling of medical instruments, not as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 Epikut Long Surgical Kit and the associated instruments is 440 grams.
The weight of the empty Epikut Long Surgical Kit is 310 grams.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The subject device includes a total of three (3) 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 instruments in the kits are manufactured from silicone. The subject device includes two (2) sizes (lid, base, and enclosed volume), and a total of three (3) 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)
Nonclinical Testing:
Test Methodology: Manual Cleaning Validation FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015) Referenced from K201688
Purpose: 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.
Acceptance Criteria: Protein assay Acceptance criterion: No color change = absence of protein residue; Sensitivity = 1 µg protein residue; Total organic carbon assay Acceptance criterion: results Referenced from K201688
Purpose: 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 (
§ 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).
0
September 29, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
S.I.N. - Sistema De Implante Nacional S.A. % Kevin Thomas Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 EL Camino Real. Suite 400 San Diego, California 92130
Re: K222005
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: July 6, 2022 Received: July 7, 2022
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222005
Device Name
S.I.N. Instrument Kits
Indications for Use (Describe)
Indications for Use for Epikut Long 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 Epikut Long Surgical Kit and the associated instruments is 440 grams.
The weight of the empty Epikut Long Surgical Kit is 310 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
"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."
3
Indications for Use
510(k) Number (if known) K222005
Device Name
S.I.N. Instrument Kits
Indications for Use (Describe)
Indications for Use for Epikut 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 Epikut Surgical Kit and the associated instruments is 612 grams.
The weight of the empty Epikut Surgical Kit is 554 grams.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☒ Residential Use (Part 21 CFR 601 Subpart D) □ Over-The-Counter Use (21 CFR 201.66) | ☒ Residential Use (Part 21 CFR 601 Subpart D) | □ Over-The-Counter Use (21 CFR 201.66) |
| ☒ Residential Use (Part 21 CFR 601 Subpart D) | □ Over-The-Counter Use (21 CFR 201.66) |
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
"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."
4
Indications for Use
510(k) Number (if known) K222005
Device Name
S.I.N. Instrument Kits
Indications for Use (Describe)
Indications for Use for Orthodontic 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 Orthodontic Kit and the associated instruments is 430 grams.
The weight of the empty Orthodontic Kit is 310 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
"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."
5
510(k) Summary K222005 S.I.N. - Sistema de Implante Nacional S.A. S.I.N. Instrument Kits
August 19, 2022
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
Primary predicate device is: K201688, S.I.N. Instrument Kits, S.I.N. - Sistema de Implante Nacional S.A. Reference device: K212404, S.I.N. Instrument Kits, S.I.N. – Sistema de Implante Nacional S.A.
6
SUBJECT DEVICE INDICATIONS FOR USE STATEMENTS
Indications for Use for Epikut Long 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 Epikut Long Surgical Kit and the associated instruments is 440 grams.
The weight of the empty Epikut Long Surgical Kit is 310 grams.
Indications for Use for Orthodontic 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 Orthodontic Kit and the associated instruments is 430 grams.
The weight of the empty Orthodontic Kit is 310 grams.
Indications for Use for Epikut 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 Epikut Surgical Kit and the associated instruments is 612 grams. The empty Epikut Surgical Kit is 554 grams.
SUBJECT DEVICE DESCRIPTION
The subject device includes a total of three (3) 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 instruments in the kits are manufactured from silicone. The subject device includes two (2) sizes (lid, base, and enclosed volume), and a total of three (3) tray configurations.
7
TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE
The comparison of the technological characteristics and Indications for Use Statements for the subject devices and the predicate device are provided at the end of this summary on pages 5-8.
The subject device is provided in 2 sizes and 3 configurations; the primary predicate device K201688 is provided in 5 sizes and 14 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 nonclinical test methodologies performed to demonstrate the subject devices met the acceptance criteria of the standard.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Manual Cleaning Validation FDA | |||
| Guidance | |||
| Reprocessing Medical Devices in | |||
| Health Care Settings: Validation | |||
| Methods and Labeling | |||
| (issued March 2015) |
Referenced from K201688 | 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
Total organic carbon assay Acceptance
criterion:
results
Referenced from K201688 | 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
Referenced from K201688 | 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
Referenced from K201688 | 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 |
Summary of Nonclinical Testing Table
8
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Life Cycle / Simulated Use Life | |||
| Validation FDA Guidance | |||
| Reprocessing Medical Devices in | |||
| Health Care Settings: Validation | |||
| Methods and Labeling | |||
| (issued March 2015) | |||
| Referenced from K201688 | 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 | |||
| Cytotoxicity testing | |||
| ANSI/AAMI/ISO 10993-5 | |||
| ANSI/AAMI/ISO 10993-12 | |||
| Referenced from K201688 | |||
| and K212404 | 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 |
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 device in this 510(k) submission, S.I.N. Instrument Kits, is as safe, as effective, and perform as well as or better than the legally marketed predicate devices cleared under K201688 and K212404.
9
Indications for Use Statements
| Indications for Use Statements | |
|---|---|
| Subject Device – K222005 | |
| S.I.N. Instrument Kits | |
| S.I.N. - Sistema de Implante Nacional S.A. | |
| Epikut Long 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 ste |
| 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 Epikut Long Surgical Kit and the associated instruments is 440 grams. | |
| The weight of the empty Epikut Long Surgical Kit is 310 grams. | |
| Orthodontic 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 ste |
| 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 Orthodontic Kit and the associated instruments is 430 grams. | |
| The weight of the empty Orthodontic Kit is 310 grams. | |
| Epikut 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 ste |
| 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 Epikut Surgical Kit and the associated instruments is 612 grams. | |
| The weight of the empty Epikut Surgical Kit is 554 grams. | |
| Primary Predicate Device – K201688 | |
| 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 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 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 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 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 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 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 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 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 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 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 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 Sinus Lift Kit and the associated instruments is 808 grams. | |
| The weight of the empty Sinus Lift Kit is 370 grams. | |
| 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 |
| 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 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 |
| 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. | |
| 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 |
| 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 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 |
| 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. | |
| 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 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. |
| 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 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. |
| 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 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 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. |
| 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. |
lization of the enclosed medical devices. S.I.N. Instrument Kits require the
lization of the enclosed medical devices. S.I.N. Instrument Kits require the
lization of the enclosed medical devices. S.I.N. Instrument Kits require the
erilization of the enclosed medical devices. S.I.N. Instrument Kits require
erilization of the enclosed medical devices. S.I.N. Instrument Kits require
erilization of the enclosed medical devices. S.I.N. Instrument Kits require
10
terilization of the enclosed medical devices. S.I.N. Instrument Kits require
terilization of the enclosed medical devices. S.I.N. Instrument Kits require
terilization of the enclosed medical devices. S.I.N. Instrument Kits require
terilization of the enclosed medical devices. S.I.N. Instrument Kits require
terilization of the enclosed medical devices. S.I.N. Instrument Kits require
terilization of the enclosed medical devices. S.I.N. Instrument Kits require
terilization of the enclosed medical devices. S.I.N. Instrument Kits require
11
510(k) Summary Page 7 of 8
erilization of the enclosed medical devices. S.I.N. Instrument Kits require
erilization of the enclosed medical devices. S.I.N. Instrument Kits require
erilization of the enclosed medical devices. S.I.N. Instrument Kits require
erilization of the enclosed medical devices. S.I.N. Instrument Kits require
12
Technological Characteristics
| Subject Device | Primary Predicate Device | Comparison | |||||
|---|---|---|---|---|---|---|---|
| Attribute | S.I.N. Instrument Kits | ||||||
| S.I.N. - Sistema de Implante Nacional S.A. | K201688 | ||||||
| S.I.N. Instrument Kits | |||||||
| S.I.N. - Sistema de Implante Nacional 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); Medical grade silicone (grommets) | Polysulfone (base, tray, lid); Medical grade silicone (grommets) | Same | ||||
| Materials Compatible with Sterilization | |||||||
| Method | 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 Sizes/Configurations | 2 sizes, 3 configurations | 5 sizes, 14 configurations | Similar | ||||
| Dimensions | |||||||
| and | |||||||
| Vent to Volume Ratio | Tray | Length x Width x Height, | |||||
| mm | Vent to Volume Ratio | Tray | Length x Width x Height, mm | Vent to Volume Ratio | Similar | ||
| COSEL 01, Epikut Long Surgical Tray | 215 x 100 x 35.5 | $0.0100 cm^2 / cm^3$ | COUSD 02, Safe Drill Unitite Tray | 113.7 x 75.7 x 29.5 | $0.0089 cm^2 / cm^3$ | ||
| COOR, Orthodontic Tray | 215 x 100 x 35.5 | $0.0100 cm^2 / cm^3$ | COWSD 02, Safe Drill SW Tray | 113.7 x 75.7 x 29.5 | $0.0089 cm^2 / cm^3$ | ||
| COSE 02, Epikut Surgical Tray | 165 x 190 x 55 | $0.0086 cm^2 / cm^3$ | COTMEC, Prosthetic Tray | 113.7 x 75.7 x 29.5 | $0.0089 cm^2 / cm^3$ | ||
| COER, Rotatory Expanding Tray | 113.7 x 75.7 x 29.5 | $0.0089 cm^2 / cm^3$ | |||||
| COEXP, Bone Expander Tray | 113.7 x 75.7 x 29.5 | $0.0100 cm^2 / cm^3$ | |||||
| COLEV, Sinus Lift Tray | 215 x 100 x 33.5 | $0.0100 cm^2 / cm^3$ | |||||
| COOST, Osteotome Tray | 113.7 x 75.7 x 29.5 | $0.0100 cm^2 / cm^3$ | |||||
| COSU 03, Unitite Surgical Tray | 165 x 190 x 55 | $0.0086 cm^2 / cm^3$ | |||||
| COSW 02, Strong SW Surgical Tray | 165 x 190 x 55 | $0.0086 cm^2 / cm^3$ | |||||
| COHE 03, Tryon Surgical Tray KCHE 03 | 165 x 190 x 55 | $0.0086 cm^2 / cm^3$ | |||||
| COHE 04, Tryon Surgical Tray KCHE 04 | 165 x 190 x 55 | $0.0086 cm^2 / cm^3$ | |||||
| COSUG 02, Unitite Surgical Guided Tray | 142 x 206 x 72 | $0.0083 cm^2 / cm^3$ | |||||
| COSWG 02, Strong SW Surgical Guided Tray | 165 x 190 x 55 | $0.0083 cm^2 / cm^3$ | |||||
| COKZ, Zygomatic Surgical Tray | 113.7 x 75.7 x 29.5 | $0.0131 cm^2 / cm^3$ | |||||
| Reusable | Reusable up to 250 cycles | Reusable up to 250 cycles | Same | ||||
| Use Life Testing | Disassembled, cleaned, assembled, sterilized | ||||||
| Visual inspection | |||||||
| Component dimensional fit verification | |||||||
| Functional closure (lid-base latch) verification | Disassembled, cleaned, assembled, sterilized | ||||||
| Visual inspection | |||||||
| Component dimensional fit verification | |||||||
| Functional closure (lid-base latch) verification | Same | ||||||
| Sterilization Method | Moist heat (steam) | Moist heat (steam) | Same | ||||
| Sterilant | Moist heat (steam) | Moist heat (steam) | Same | ||||
| Cycles | Gravity displacement | Gravity displacement | Same | ||||
| Sterile Barrier | Sterilization wrap, FDA cleared for indicated method and cycle | Sterilization wrap, FDA cleared for indicated method and cycle | Same |