(69 days)
No
The device is a rigid container for sterilizing instruments and the description focuses on materials, dimensions, and sterilization validation, with no mention of AI or ML.
No
The device is a rigid container used for sterilizing other medical devices, not for directly treating a patient.
No.
The device is a reusable rigid container intended to hold other medical devices during sterilization, not to diagnose any medical condition.
No
The device is a reusable rigid container made of physical materials (polysulfone and silicone) intended to enclose other medical devices for sterilization. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "enclose other medical devices that are to be sterilized by a health care provider" and to "allow sterilization of the enclosed medical devices." This describes a device used in the process of preparing other medical devices for use, not a device used to perform a diagnostic test on a biological sample.
- Device Description: The description details a "reusable rigid container" designed to organize and protect instruments during sterilization. This aligns with the intended use and does not suggest any diagnostic function.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or calibrators
The device is a sterilization accessory, falling under the category of medical devices used in the sterilization process of other medical devices.
N/A
Intended Use / Indications for Use
S.I.N. Instrument Kits are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. S.I.N. Instrument Kits are intended to allow sterilization of the enclosed medical devices. S.I.N. Instrument Kits require the use of a wrap that is FDA cleared to maintain the sterility of the enclosed devices.
The kits are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycles, and moist heat (steam) sterilized using the following cycle:
Gravity displacement – Exposure at 121 °C for 30 minutes and 30 minutes dry time.
S.I.N. Instrument Kits are intended for sterilization of non-porous loads.
S.I.N. Instrument Kits are recommended not to be stacked during sterilization.
The combined weight of the Epikut Long Surgical Kit and the associated instruments is 422 grams. The weight of the empty Epikut Long Surgical Kit is 310 grams.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The subject device 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 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.
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.
Test Methodology: Manual Cleaning Validation FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015) Referenced from K201688
Purpose: The purpose of this test is to validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the sterilization cycle will be effective.
Results: Pass
Test Methodology: Bacterial Endotoxin Testing, USP Referenced from K201688
Purpose: The purpose of this test is to validate that the cleaning instructions provided in the Instructions for Use appropriately clean the tray, and to ensure the BET level meets FDA expectation (≤ 20 EU/device)
Results: Pass
Test Methodology: Sterilization Validation including sterilant penetration and dry time validation ANSI/AAMI/ISO 17665-1 ANSI/AAMI/ISO 17665-2 Referenced from K201688
Purpose: The purpose of this test is to validate that the sterilization instructions listed in the Instructions for Use appropriately sterilize the tray and contents.
Results: Pass
Test Methodology: Dry time Referenced from K201688
Purpose: 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.
Results: Pass
Test Methodology: 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
Purpose: The purpose of this test is to validate the service life of the trays as stated in the Instructions for Use.
Results: Pass
Test Methodology: Biocompatibility of Subject Device Cytotoxicity testing ANSI/AAMI/ISO 10993-5 ANSI/AAMI/ISO 10993-12 Referenced from K201688 and K212404
Purpose: The purpose of this test is to evaluate the cytotoxicity potential of the test article using an in vitro cell culture assay.
Results: Pass
No clinical data were included in this submission.
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.
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
October 27, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "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: K222514
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 19, 2022 Received: August 19, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222514
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 422 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)
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3
510(k) Summary K222514 S.I.N. – Sistema de Implante Nacional S.A. S.I.N. Instrument Kits
October 25, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | S.I.N. – Sistema de Implante Nacional S.A. | |
|---|---|---|
| Avenida Vereador Abel Ferreira, 1100 | ||
| São Paulo, São Paulo | ||
| 03340-000 Brazil | ||
| Telephone | +55-11-21693000 ext 3236 | |
| Official Contact | Denise Domiciano, Quality and Regulatory Manager | |
| Representative/Consultant | Kevin A. Thomas, PhD | |
| Floyd G. Larson, MS, MBA | ||
| PaxMed International, LLC | ||
| 12264 El Camino Real, Suite 400 | ||
| San Diego, CA 92130 | ||
| Telephone | +1 858-792-1235 | |
| Fax | +1 858-792-1236 | |
| 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 |
| Regulatory Class | Class II |
| Product Code | KCT |
| Classification Panel | General Hospital |
| Reviewing Office | Office of Health Technology 6 (OHT 6: Orthopedic Devices) |
| Reviewing Division | Division of Health Technology 6 B (Spinal Devices) |
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.
4
SUBJECT DEVICE INDICATIONS FOR USE STATEMENT
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 422 grams. The weight of the empty Epikut Long Surgical Kit is 310 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.
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.
5
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 | Results |
|---|---|---|
| Manual Cleaning Validation FDA Guidance | ||
| Reprocessing Medical Devices in Health Care | ||
| Settings: Validation Methods and Labeling | ||
| (issued March 2015) | ||
| Referenced from K201688 | The purpose of this test is to validate that the | |
| cleaning instructions provided in the Instructions | ||
| for Use appropriately clean the tray, and to ensure | ||
| the sterilization cycle will be effective. | Pass | |
| Bacterial Endotoxin Testing, USP | ||
| 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) | 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. | 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. | 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. | Pass | |
| Biocompatibility of Subject Device | ||
| Cytotoxicity testing | ||
| ANSI/AAMI/ISO 10993-5 | ||
| ANSI/AAMI/ISO 10993-12 | ||
| Referenced from K201688 and K212404 | The purpose of this test is to evaluate the | |
| cytotoxicity potential of the test article using an in | ||
| vitro cell culture assay. | Pass |
Summary of Nonclinical Testing Table
In summary, the nonclinical testing provided for these devices met the acceptance criteria for each standard and test methodology used to evaluate the devices as shown in the table above.
No clinical data were included in this submission.
CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the subject 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.