(58 days)
S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated 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 PTG Surgical Kit and associated instruments is 632 grams.
The weight of the empty Epikut PTG Surgical Kit is 353 grams.
The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray, and a lid (cover). The subject device tray is 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 tray is perforated to allow for penetration of the sterilant, is to be used with moist heat (steam) and requires 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 provided text is a 510(k) Premarket Notification for a medical device (S.I.N. Instrument Kits, an instrument sterilization tray). This document describes the nonclinical testing and acceptance criteria for mechanical and sterilization performance of the device itself, rather than the performance of an AI/ML algorithm.
Therefore, the specific information requested in your prompt regarding acceptance criteria and study design for an AI/ML device (e.g., sample sizes, expert ground truth, MRMC studies, standalone algorithm performance, training set details) cannot be extracted from this document. This document describes a traditional medical device, not an AI/ML enabled one.
However, I can extract the acceptance criteria and performance data for the device itself based on the provided "Summary of Nonclinical Testing" table.
Acceptance Criteria and Device Performance (Non-AI/ML)
The S.I.N. Instrument Kits are sterilization trays. The studies performed are to ensure the trays can be properly cleaned, sterilized, and maintain their integrity over a specified lifespan.
1. Table of acceptance criteria and the reported device performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Manual Cleaning Validation | To validate that the cleaning instructions appropriately clean the tray, and to ensure the sterilization cycle will be effective. | Protein assay: No color change = absence of protein residue (Sensitivity = 1 µg protein residue) Total organic carbon assay: results < limit of quantification = 0.1 ppm; Assay limit of detection = 0.015 ppm | Pass |
| Bacterial Endotoxin Testing, USP <85> | To validate that the cleaning instructions appropriately clean the tray, and to ensure the BET level meets FDA expectation (≤ 20 EU/device). | Endotoxin results: ≤ 20 EU/device | Pass |
| Sterilization Validation (including sterilant penetration and dry time validation) | To validate that the sterilization instructions appropriately sterilize the tray and contents. | 3 consecutive half-cycles performed for each of 3 sizes of trays demonstrate complete inactivation of all biologic indicators. A minimum SAL (Sterility Assurance Level) of 10^-6 is achieved if the Instructions for Use are followed. | Pass |
| Dry Time | To validate that the sterilization instructions appropriately dry the wrapped tray for storage. | Using pre-cycle and post-cycle weights, the weight gain after drying will be ≤ 3%. | Pass |
| Life Cycle / Simulated Use-life Validation | To validate the service life of the trays as stated in the Instructions for Use. | Visual inspection, component dimensional fit verification, functional closure/latch verification for 250 use cycles. | Pass |
| Biocompatibility of Subject Device (Cytotoxicity testing) | To evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay. | Non-cytotoxic if: ≤ 50% of L-929 cells exposed to extract of device show rounding and lysis. | Pass |
Since this document does not pertain to an AI/ML device, the following points typical for AI/ML device evaluations are not applicable and thus, no information can be extracted for them:
- 2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML study.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not applicable (for AI/ML, but for a physical device, the "ground truth" is established through standardized testing procedures and specified acceptance criteria, as shown in the table).
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
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July 12, 2024
S.I.N. - Sistema de Implante Nacional S.A. Denise Domiciano Quality and Regulatory Manager Rua Soldado Ocimar Guimarães da Silva, 421 São Paulo, São Paulo 03348-060 Brazil
Re: K241378
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: May 15, 2024 Received: May 15, 2024
Dear Denise Domiciano:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Digitally signed by Stephen Stephen A. A. Anisko -S Date: 2024.07.12 19:48:56 Anisko -S -04'00' for: Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
OHT4: Office of Surgical
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and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241378
Device Name S.I.N. Instrument Kits
Indications for Use (Describe)
Indications for Use for Epikut PTG Surgical Kit
S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterlized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated 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 PTG Surgical Kit and associated instruments is 632 grams.
The weight of the empty Epikut PTG Surgical Kit is 353 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)
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510(k) Summary K241378
S.I.N. - Sistema de Implante Nacional S.A. S.I.N. Instrument Kits
JUNE 25, 2024
ADMINISTRATIVE INFORMATION
| Manufacturer Name | S.I.N. - Sistema de Implante Nacional S.A. |
|---|---|
| Rua Soldado Ocimar Guimarães da Silva, | |
| 421 São Paulo, São Paulo | |
| 03348-060 BRAZIL | |
| Telephone | +55 -11-21693000 ext 3236 |
| Official Contact | Denise Domiciano, Quality and Regulatory Manager |
| Email denise.domiciano@sinimplantsystem.com |
Representative
Floyd G. Larson, MS, MBA PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 + 858 792- 1235 Telephone Fax + 858 792-1236 Email 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.
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SUBJECT DEVICE INDICATION FOR USE STATEMENT
Indications for Use for Epikut PTG Surgical Kit
S.I.N. Instruments Kits are intended to be used to enclose other medical devices that are to be sterlized by a health care provider.
S.I.N. Instruments Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instruments 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°C for 30 minutes and 30 minutes dry time.
S.I.N. Instruments Kits are intended for sterilization of non-porous loads.
S.I.N. Instruments Kits are recommended not to be stacked during sterilization.
The combined weight of the Epikut PTG Surgical Kit and the associated instruments is 632 grams. The weight of the empty Epikut PTG Surgical Kit is 353 grams.
SUBJECT DEVICE DESCRIPTION
The subject device is a reusable rigid container, comprising a base (bottom), a removable inner tray, and a lid (cover). The subject device tray is 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 tray is perforated to allow for penetration of the sterilant, is to be used with moist heat (steam) and requires 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.
TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE
The comparison of the Indications for Use Statements and technological characteristics for the subject device, the predicate device, and the reference device are provided at the end of this summary on pages 5-8.
The subject device is provided in one (1) size and one (1) configuration; 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.
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SUMMARY OF NONCLINICAL TESTING
Provided below are the nonclinical test methodologies performed to demonstrate the subject device meets the acceptance criteria of the standard.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Manual Cleaning Validation FDAGuidanceReprocessing Medical Devices inHealth Care Settings: ValidationMethods and Labeling(issued March 2015Referenced from K201688 | The purpose of this test is tovalidate that the cleaninginstructions provided in theInstructions for Use appropriatelyclean the tray, and to ensure the | Protein assay Acceptance criterion:No color change = absence of proteinresidueSensitivity = 1 µg protein residue | Pass |
| sterilization cycle will be effective. | Total organic carbon assay Acceptancecriterion:results < limit of quantification = 0.1 ppm;Assay limit of detection = 0.015 ppm | Pass | |
| Bacterial Endotoxin Testing, USP<85>Referenced from K201688 | The purpose of this test is tovalidate that the cleaninginstructions provided in theInstructions for Use appropriatelyclean the tray, and to ensure theBET level meets FDA expectation(≤ 20 EU/device) | Acceptance criterion:Endotoxin results : ≤ 20 EU/device | Pass |
| Sterilization Validationincluding sterilant penetration anddry time validationANSI/AAMI/ISO 17665-1ANSI/AAMI/ISO 17665-2Referenced from K201688 | The purpose of this test is tovalidate that the sterilizationinstructions listed in theInstructions for Use appropriatelysterilize the tray and contents. | Acceptance criterion:3 consecutive half-cycles performed foreach of 3 sizes of trays demonstratecomplete inactivation of all biologicindicators.A minimum SAL of 10-6 is achieved if theInstructions for Use are followed | Pass |
| Dry timeReferenced from K201688 | The purpose of this test is tovalidate that the sterilizationinstructions listed in theInstructions for Use appropriatelydry the wrapped tray for storage. | Acceptance criterion:Using pre-cycle and post-cycle weights, theweight gain after drying will be ≤ 3% | Pass |
| Life Cycle / Simulated Use-lifeValidation FDA GuidanceReprocessing Medical Devices inHealth Care Settings: ValidationMethods and Labeling(issued March 2015)Referenced from K201688 | The purpose of this test is tovalidate the service life of the traysas stated in the Instructions for Use. | Acceptance criteria:Visual inspection, component dimensionalfit verification, functional closure/latchverification for 250 use cycles | Pass |
| Biocompatibility of SubjectDeviceCytotoxicity testingANSI/AAM.T/.ISO 10993-5ANSI/AAM.T/ ISO 10993- 12Referenced from K201688and K212404 | The purpose of this test is toevaluate the cytotoxicity potentialof the test article using an in vitrocell culture assay. | Acceptance criterion:Non-cytotoxic if :≤ 50% of L-929 cellsexposed to extract of device show roundingand lysis | Pass |
Summary of Nonclinical Testing Table
In summary, the nonclinical testing provided for the subject device met the acceptance criteria for each standard and test methodology used to evaluate the subject device as shown in the table above.
No clinical data was included in this submission.
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CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the subject device in this 510(k) submission, K241378, S.I.N. Instrument Kit, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201688.
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Indications for Use Statements
| Indications for Use Statements | |
|---|---|
| Subject Device – K241378S.I.N. Instrument KitsS.I.N.- Sistema de Implante Nacional S.A.Epikut PTG Surgical Kit | S.I.N. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow steruse 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. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments Kits are recommended not to be stacked during sterilization.The combined weight of the Epikut PTG Surgical Kit and the associated instruments is 632grams.The weight of the empty Epikut PTG Surgical Kit is 353 grams. |
| Primary Predicate Device – K201688S.I.N. Instrument KitsS.I.N. – Sistema de Implant Nacional S.A.Safe Drill Unitite Kit | S.I.N. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow steriuse 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. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow steriuse 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. Instruments Kits are intended for sterilization of non-porous loads. S.I.Ν.Instruments 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. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow steriuse 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. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow steriuse 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. Instruments Kits are intended for sterilization of non-porous loads.S.I.N. Instruments 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. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow steriuse 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. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow sterilizeuse 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow sterilizeuse 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow sterilizeuse 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments Kits are recommended not to be stacked during sterilization.The combined weight of the Unitite Surgical Kit and the associated instruments is 1126grams. The weight of the empty Unitite Surgical Kit is 515grams. |
| Strong SW Surgical Kit | S.I.N. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow sterilizeuse 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow sterilizeuse 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow sterilizeuse 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow sterilizeuse 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow steruse 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow sterof 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. |
| Reference Device – K212404S.I.N. Instrument KitsS.I.N. – Sistema de Implante Nacional S.A. | |
| Safe Drill Epikut Kit | S.I.N. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow sterof 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. |
| Unitite Surgical Kit | S.I.N. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow sterof 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. |
| Epikut Surgical Kit | S.I.N. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow sterof 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. |
| Epikut Surgical Guided Kit | S.I.N. Instruments Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instruments Kits are intended to allow sterof 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 °C for 30 minutes and 30 minutes dry time.S.I.N. Instruments Kits are intended for sterilization of non-porous loads. S.I.N.Instruments 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. |
zation of the enclosed medical devices. S.I.N. Instruments Kits require the
ization of the enclosed medical devices. S.I.N. Instruments Kits require the
zation of the enclosed medical devices. S.I.N. Instruments Kits require the
zation of the enclosed medical devices. S.I.N. Instruments Kits require the
zation of the enclosed medical devices. S.I.N. Instruments Kits require the
zation of the enclosed medical devices. S.I.N. Instruments Kits require the
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zation of the enclosed medical devices. S.I.N. Instruments Kits require the
zation of the enclosed medical devices. S.I.N. Instruments Kits require the
zation of the enclosed medical devices. S.I.N. Instruments Kits require the
ization of the enclosed medical devices. S.I.N. Instruments Kits require the
zation of the enclosed medical devices. S.I.N. Instruments Kits require the
zation of the enclosed medical devices. S.I.N. Instruments Kits require the
zation of the enclosed medical devices. S.I.N. Instruments Kits require the
{10}------------------------------------------------
ization of the enclosed medical devices. S.I.N. Instruments Kits require the
ization of the enclosed medical devices. S.I.N. Instruments Kitsrequire the use
ization of the enclosed medical devices. S.I.N. Instruments Kitsrequire the use
ization of the enclosed medical devices. S.I.N. Instruments Kitsrequire the use
ization of the enclosed medical devices. S.I.N. Instruments Kitsrequire the use
ization of the enclosed medical devices. S.I.N. Instruments Kitsrequire the use
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Technological Characteristics
| Subject Device | Primary Predicate Device | Reference Device | Comparison | ||||
|---|---|---|---|---|---|---|---|
| Attribute | K241378S.I.N. Instrument KitsS.I.N. - Sistema de Implante Nacional S.A. | K206188S.I.N. Instrument KitsS.I.N. - Sistema de Implante Nacional S.A. | K212404S.I.N. Instrument KitsS.I.N. - Sistema de Implante Nacional S.A. | ||||
| Product Code | KCT | KCT | KCT | Same | |||
| Design | Rigid polymer base, lid, and removable inner tray | 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) | Polysulfone (base, tray, lid); Medical grade silicone (grommets) | Same | |||
| Materials Compatible with SterilizationMethod | Yes | Yes | Yes | Same | |||
| Perforated | Yes; allows moist heat (steam) penetration to achieve sterilization | Yes, allows moist heat (steam) penetration to achieve sterilization | Yes, allows moist heat (steam) penetration to achieve sterilization | Same | |||
| Reusable | Yes | Yes | Yes | Same | |||
| Number of Sizes/Configurations | 1 size, 1 configuration | K201688 - 5 sizes, 14 configurations | K201688 - 5 sizes, 14 configurations | Similar | |||
| DimensionsandVent to Volume Ratio | Subject Device Tray | Length x Width x Height, mm | Vent to Volume Ratio | Trays in K201688 | Length x Width x Height, mm | Vent to Volume Ratio | Similar |
| COSEP 01, Epikut PTG Surgical Tray | 215 x 100 x 35.5 | 0.0087 cm²/cm³ | COUSD 02, Safe Drill Unitite Tray | 113.7 x 75.7 x 29.5 | 0.0089cm²/cm³ | ||
| COWSD 02, Safe Drill SW Tray | 113.7 x 75.7 x 29.5 | 0.0089cm²/cm³ | |||||
| COTMEC, Prosthetic Tray | 113.7 x 75.7 x 29.5 | 0.0089cm²/cm³ | |||||
| COER, Rotatory Expanding Tray | 113.7 x 75.7 x 29.5 | 0.0089cm²/cm³ | |||||
| COEXP, Bone Expander Tray | 113.7 x 75.7 x 29.5 | 0.0100cm²/cm³ | |||||
| COLEV, Sinus Lift Tray | 215 x 100 x 33.5 | 0.0100 cm²/cm³ | |||||
| COOST, Osteotome Tray | 113.7 x 75.7 x 29.5 | 0.0100cm²/cm³ | |||||
| COSU 03, Unitite Surgical Tray | 165 x 190 x 55 | 0.0086cm²/cm³ | |||||
| COSW 02, Strong SW Surgical Tray | 165 x 190 x 55 | 0.0086cm²/cm³ | |||||
| COHE 03, Tryon Surgical Tray KCHE 03 | 165 x 190 x 55 | 0.0086cm²/cm³ | |||||
| COHE 04, Tryon Surgical Tray KCHE 04 | 165 x 190 x 55 | 0.0086cm²/cm³ | |||||
| COSUG 02, Unitite Surgical Guided Tray | 142 x 206 x 72 | 0.0083 cm²/cm³ | |||||
| COSWG 02, Strong SW Surgical Guided Tray | 165 x 190 x 55 | 0.0083 cm²/cm³ | |||||
| COKZ, Zygomatic Surgical Tray | 113.7 x 75.7 x 29.5 | 0.0131 cm²/cm³ | |||||
| Trays in K212404 | |||||||
| COESD 02, Safe Drill Epikut Tray | 118 x 78.25 x 29.2 | 0.0083 cm²/cm³ | |||||
| COSU 04, Unitite Surgical Tray | 165x190 x 55 | 0.0086cm²/cm³ | |||||
| COSE 01, Epikut Surgical Tray | 165 x190 x 55 | 0.0086cm²/cm³ | |||||
| COSEG 01I, Epikut Surgical Guided Tray | 142x 206 x 72 | 0.0083 cm²/cm³ | |||||
| Reusable | Reusable up to 250 cycles | Reusable up to 250 cycles | Reusable up to 250 cycles | Same | |||
| Use-life Testing | Disassembled, cleaned, assembled, sterilizedVisual inspection.Component dimensional fit verificationFunctional closure (lid-base latch) verification | Disassembled, cleaned, assembled, sterilizedVisual inspectionComponent dimensional fit verificationFunctional closure (lid-base latch) verification | Same | ||||
| Sterilization Method | |||||||
| Sterilant | Moist heat (steam) | Moist heat (steam) | Same | ||||
| Cycles | Gravity displacement - Exposure at 121°C °C for 30 minutes and 30 minutes dry time. | Gravity displacement - Exposure at 121°C °C for 30 minutes and 30 minutes dry time | Same | ||||
| Sterile Barrier | Sterilization wrap, FDA cleared for indicated method and cycle | Sterilization wrap, FDA cleared for indicated method and cycle | Same |
§ 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).