(93 days)
Not Found
No
The device description and intended use focus on physical instrument trays for sterilization, with no mention of software, data processing, or AI/ML capabilities.
No
The device is described as an instrument kit designed to enclose and protect other medical devices during sterilization, not to treat or diagnose patients.
No
The device is described as an instrument kit/container used to enclose other medical devices for sterilization, organize, and protect them. It does not perform any diagnostic function.
No
The device description clearly states it includes physical components like instrument trays, bases, lids, and holders made of polysulfone and silicone. It is a reusable rigid container system, not software.
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 device is used to "enclose other medical devices that are to be sterilized" and "allow sterilization of the enclosed medical devices." This describes a device used in the process of sterilizing medical instruments, not for performing diagnostic tests on biological samples.
- Device Description: The description details reusable rigid containers designed to hold and protect instruments during sterilization. It mentions materials like polysulfone and silicone, and features like perforations for sterilant penetration. This aligns with a sterilization accessory, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis.
- Performance Studies: The performance studies focus on sterilization validation, cleaning validation, and biocompatibility, which are relevant to a sterilization accessory, not an IVD.
Therefore, the S.I.N. Instrument Kits are a medical device used in the sterilization process, not 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 ℃ 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 Epikut Kit and the associated instruments is 154 grams.
The weight of the empty Safe Drill Epikut Kit is 138 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 ℃ 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 620 grams.
The weight of the empty Unitite Surgical Kit is 520 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 ℃ 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 605 grams.
The weight of the empty Epikut Surgical Kit is 520 grams.
Indications for Use for Epikut 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 ℃ 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 Guided Kit and the associated instruments is 808 grams.
The weight of the empty Epikut Surgical Guided Kit is 650 grams.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The subject device includes a total of 4 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 3 sizes (same lid, base, and enclosed volume), and a total of 4 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 was performed for Manual Cleaning Validation, Bacterial Endotoxin Testing, Sterilization Validation (including sterilant penetration and dry time validation), Dry time, Life Cycle / Simulated Use Life Validation, and Biocompatibility of Subject Device (Cytotoxicity testing). All tests met their acceptance criteria, demonstrating that the device is safe and effective and performs as well as or better than the predicate device. No clinical data were included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
November 2, 2021
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: K212404
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: August 2, 2021 Received: August 2, 2021
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 and Part 809); 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,
Clarence W. Murray, III, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K212404
Device Name
S.I.N. Instrument Kits
Indications for Use (Describe)
Indications for Use for Safe Drill Epikut 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 Epikut Kit and the associated instruments is 154 grams.
The weight of the empty Safe Drill Epikut Kit is 138 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
3
510(k) Number (if known) K212404
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 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 Unitite Surgical Kit and the associated instruments is 620 grams.
The weight of the empty Unitite Surgical Kit is 520 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
4
510(k) Number (if known) K212404
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 ℃ 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 605 grams.
The weight of the empty Epikut Surgical Kit is 520 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
5
510(k) Number (if known) K212404
Device Name
S.I.N. Instrument Kits
Indications for Use (Describe)
Indications for Use for Epikut 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 ℃ 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 Guided Kit and the associated instruments is 808 grams.
The weight of the empty Epikut Surgical Guided Kit is 650 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 G) |
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
6
510(k) Summary
K212404
S.I.N. – Sistema de Implante Nacional S.A.
S.I.N. Instrument Kits
October 21, 2021
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 | ||
| 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: K201688, S.I.N. Instrument Kits, S.I.N. - Sistema de Implante Nacional S.A.
7
SUBJECT DEVICE INDICATIONS FOR USE STATEMENTS
Indications for Use for Safe Drill Epikut 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 Epikut Kit and the associated instruments is 154 grams. The weight of the empty Safe Drill Epikut Kit is 138 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 620 grams. The weight of the empty Unitite Surgical Kit is 520 grams.
The weight of the empty Unlite Surgical Kit is 320 grain.
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 605 grams.
The weight of the empty Epikut Surgical Kit is 520 grams.
Indications for Use for Epikut 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 Epikut Surgical Guided Kit and the associated instruments is 808 grams.
The weight of the empty Epikut Surgical Guided Kit is 650 grams.
8
SUBJECT DEVICE DESCRIPTION
The subject device includes a total of 4 instrument trays. The subject device trays are reusable rigid containers, comprising a base (bottom), one or more removable inner travs, 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 3 sizes (same lid, base, and enclosed volume), and a total of 4 tray configurations.
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 6-8.
The subject device is provided in 3 sizes and 4 configurations; the 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.
9
| Summary of Nonclinical Testing Table | |
|---|---|
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Manual Cleaning Validation | |||
| FDA Guidance | |||
| Reprocessing Medical Devices in | |||
| Health Care Settings: Validation | |||
| Methods and Labeling | 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 | Protein assay Acceptance criterion: | ||
| No color change = absence of protein | |||
| residue | |||
| Sensitivity = 1 µg protein residue | Pass | ||
| (issued March 2015) | |||
| Referenced from K201688 | sterilization cycle will be | ||
| effective. | 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 | ||
| 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 | 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.
10
CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the subject device in 510(k) submission K212404, S.I.N. Instrument Kits, is as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K201688.
11
Indications for Use Statements
| Indications for Use Statements | |
|---|---|
| Subject Device | |
| K212404 | |
| S.I.N. Instrument Kits | |
| S.I.N. - Sistema de Implante Nacional S.A. | Indications for Use for Safe Drill Epikut 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. | |
| 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 Epikut Kit and the associated instruments is 154 grams. | |
| The weight of the empty Safe Drill Epikut Kit is 138 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. | |
| 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 620 grams. | |
| The weight of the empty Unitite Surgical Kit is 520 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. | |
| 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 605 grams. | |
| The weight of the empty Epikut Surgical Kit is 520 grams. | |
| Indications for Use for Epikut 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. | |
| 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 Guided Kit and the associated instruments is 808 grams. | |
| The weight of the empty Epikut Surgical Guided Kit is 650 grams. | |
| Predicate Device | |
| K201688 | |
| S.I.N. Instrument Kits | |
| S.I.N. - Sistema de Implante Nacional S.A. | 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. |
| 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. | |
| Safe Drill Unitite Kit | 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 | 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 | 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 | 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 | 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 Statements | |
| Sinus Lift Kit | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
ization of the enclosed medical devices. S.I.N. Instrument Kits require the
ization of the enclosed medical devices. S.I.N. Instrument Kits require the
ization of the enclosed medical devices. S.I.N. Instrument Kits require the
ization of the enclosed medical devices. S.I.N. Instrument Kits require the
rilization of the enclosed medical devices. S.I.N. Instrument Kits require
12
510(k) Summary Page 7 of 8
S.I.N Dental Implant System K212404
13
Technological Characteristics
| Subject Device | Primary Predicate Device | Comparison | |
|---|---|---|---|
| Attribute | K212404 | ||
| 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 | 3 | 5 | Similar |
| Total Number of Configurations | 4 | 14 | Similar |
| Dimensions and | |||
| Vent to Volume Ratio | Tray | Tray | Similar |
| COESD 02, Safe Drill Epikut Tray | |||
| Length x Width x Height, mm | |||
| 118.0 x 78.25 x 29.2 | |||
| Vent to Volume Ratio | |||
| 0.0083 cm²/cm³ | COUSD 02, Safe Drill Unitite Tray | ||
| Length x Width x Height, mm | |||
| 113.7 x 75.7 x 29.5 | |||
| Vent to Volume Ratio | |||
| 0.0089 cm²/cm³ | |||
| COSU 04, Unitite Surgical Tray | |||
| Length x Width x Height, mm | |||
| 165 x 190 x 55 | |||
| Vent to Volume Ratio | |||
| 0.0086 cm²/cm³ | COWSD 02, Safe Drill SW Tray | ||
| Length x Width x Height, mm | |||
| 113.7 x 75.7 x 29.5 | |||
| Vent to Volume Ratio | |||
| 0.0089 cm²/cm³ | |||
| COSE 01, Epikut Surgical Tray | |||
| Length x Width x Height, mm | |||
| 165 x 190 x 55 | |||
| Vent to Volume Ratio | |||
| 0.0086 cm²/cm³ | COTMEC, Prosthetic Tray | ||
| Length x Width x Height, mm | |||
| 113.7 x 75.7 x 29.5 | |||
| Vent to Volume Ratio | |||
| 0.0089 cm²/cm³ | |||
| COSEG 01I, Epikut Surgical Guided Tray | |||
| Length x Width x Height, mm | |||
| 142 x 206 x 72 | |||
| Vent to Volume Ratio | |||
| 0.0083 cm²/cm³ | COER, Rotatory Expanding Tray | ||
| Length x Width x Height, mm | |||
| 113.7 x 75.7 x 29.5 | |||
| Vent to Volume Ratio | |||
| 0.0089 cm²/cm³ | |||
| COEXP, Bone Expander Tray | |||
| Length x Width x Height, mm | |||
| 113.7 x 75.7 x 29.5 | |||
| Vent to Volume Ratio | |||
| 0.0100 cm²/cm³ | |||
| COLEV, Sinus Lift Tray | |||
| Length x Width x Height, mm | |||
| 215 x 100 x 33.5 | |||
| Vent to Volume Ratio | |||
| 0.0100 cm²/cm³ | |||
| COOST, Osteotome Tray | |||
| Length x Width x Height, mm | |||
| 113.7 x 75.7 x 29.5 | |||
| Vent to Volume Ratio | |||
| 0.0100 cm²/cm³ | |||
| COSU 03, Unitite Surgical Tray | |||
| Length x Width x Height, mm | |||
| 165 x 190 x 55 | |||
| Vent to Volume Ratio | |||
| 0.0086 cm²/cm³ | |||
| COSW 02, Strong SW Surgical Tray | |||
| Length x Width x Height, mm | |||
| 165 x 190 x 55 | |||
| Vent to Volume Ratio | |||
| 0.0086 cm²/cm³ | |||
| COHE 03, Tryon Surgical Tray KCHE 03 | |||
| Length x Width x Height, mm | |||
| 165 x 190 x 55 | |||
| Vent to Volume Ratio | |||
| 0.0086 cm²/cm³ | |||
| COHE 04, Tryon Surgical Tray KCHE 04 | |||
| Length x Width x Height, mm | |||
| 165 x 190 x 55 | |||
| Vent to Volume Ratio | |||
| 0.0086 cm²/cm³ | |||
| COSUG 02, Unitite Surgical Guided Tray | |||
| Length x Width x Height, mm | |||
| 142 x 206 x 72 | |||
| Vent to Volume Ratio | |||
| 0.0083 cm²/cm³ | |||
| COSWG 02, Strong SW Surgical Guided Tray | |||
| Length x Width x Height, mm | |||
| 165 x 190 x 55 | |||
| Vent to Volume Ratio | |||
| 0.0083 cm²/cm³ | |||
| COKZ, Zygomatic Surgical Tray | |||
| Length x Width x Height, mm | |||
| 113.7 x 75.7 x 29.5 | |||
| Vent to Volume Ratio | |||
| 0.0131 cm²/cm³ | |||
| Reusable | Yes | ||
| Reusable up to 250 cycles | Yes | ||
| 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 | |||
| Sterilant | Moist heat (steam) | Moist heat (steam) | Same |
| Cycles | Wrapped in a sterilizable wrap that is FDA cleared for the indicated cycle | ||
| Gravity displacement | |||
| 30 minute exposure at 121 °C (250 °F) | |||
| 30 minute drying time | Gravity displacement | Same | |
| Sterile Barrier | Sterilization wrap, FDA cleared for indicated method and cycle | Sterilization wrap, FDA cleared for indicated method and cycle | Same |