(84 days)
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 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the S.I.N. Instrument Kits.
Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Manual Cleaning Validation (FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling) | Validate cleaning instructions and ensure sterilization cycle effectiveness. | 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 (For both assays) |
| Bacterial Endotoxin Testing (USP <85>) | Validate cleaning instructions and ensure BET level meets FDA expectation (≤ 20 EU/device). | Endotoxin results ≤ 20 EU/device. | Pass |
| Sterilization Validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2) | Validate sterilization instructions and ensure appropriate sterilization of 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 of 10^-6 is achieved if the Instructions for Use are followed. | Pass |
| Dry Time (Referenced from K201688) | Validate that 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 (FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling) | 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 - ANSI/AAMI/ISO 10993-5, ANSI/AAMI/ISO 10993-12) | 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 |
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions "3 consecutive half-cycles performed for each of 3 sizes of trays" for Sterilization Validation. For Biocompatibility, it states "L-929 cells exposed to extract of device." The exact number of units or iterations per test beyond what is explicitly stated (e.g., how many trays were tested for cleaning, how many units for biocompatibility extract) is not explicitly detailed in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only lists the standards followed (e.g., FDA Guidance, USP, ANSI/AAMI/ISO).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The tests performed are laboratory-based and follow established standards, implying no human expert consensus was required to establish ground truth for these specific performance criteria.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable as the tests are non-clinical, objective validations against predetermined criteria, not assessments requiring expert adjudication of subjective findings.
-
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:
- No MRMC comparative effectiveness study was done. This device (S.I.N. Instrument Kits, which are instrument sterilization trays) is a physical medical device, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone (algorithm-only) performance study was done. As mentioned above, this is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for these non-clinical tests is based on objective measurements and adherence to established regulatory standards and protocols (e.g., protein residue levels, endotoxin levels, sterility assurance level (SAL), weight change, visual inspection, dimensional verification, cell viability).
-
The sample size for the training set:
- There is no training set as this is a physical medical device validation, not a machine learning model.
-
How the ground truth for the training set was established:
- This question is not applicable as there is no training set.
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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
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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, 1100São Paulo, São Paulo03340-000 BrazilTelephone +55-11-21693000 ext 3236 |
|---|---|
| Official Contact | Denise Domiciano, Quality and Regulatory Manager |
| Representative/Consultant | Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone +1 858-792-1235Fax +1 858-792-1236Email kthomas@paxmed.comflarson@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 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 FDAGuidanceReprocessing Medical Devices inHealth Care Settings: ValidationMethods and Labeling(issued March 2015)Referenced from K201688 | The purpose of this test is tovalidate that the cleaninginstructions provided in theInstructions for Use appropriatelyclean the tray, and to ensure thesterilization cycle will be effective. | Protein assay Acceptance criterion:No color change = absence of proteinresidueSensitivity = 1 µg protein residueTotal 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 |
Summary of Nonclinical Testing Table
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| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| 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/AAMI/ISO 10993-5ANSI/AAMI/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 |
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 – K222005S.I.N. Instrument KitsS.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 steuse 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 steuse 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 steuse 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 – K201688S.I.N. Instrument KitsS.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 allowthe 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 allowthe 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 allowthe 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 allowthe 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 allowthe 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 allowthe 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 allowthe 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 allowthe 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 allowthe 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 allowthe 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 KitsS.I.N. - Sistema de Implante Nacional S.A. | K201688S.I.N. Instrument KitsS.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 SterilizationMethod | 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 | ||||
| DimensionsandVent 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, sterilizedVisual inspectionComponent dimensional fit verificationFunctional closure (lid-base latch) verification | Disassembled, cleaned, assembled, sterilizedVisual inspectionComponent dimensional fit verificationFunctional 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 |
§ 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).