(393 days)
PolyVac's delivery systems consist of perforated trays with lids, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device is maintained until used. PolyVac's delivery systems are to be sterilized in one of the following cycles: Prevacuum Steam : 132°C - 4 minutes minimum; Gravity Steam: 132°C - 30 minutes minimum; Gravity Steam: 121°C - 55 minutes minimum
PolyVac Delivery Systems consist of different sizes of the same basic configuration. All systems consist of a minimum of a plastic or metal base and lid. All lids can be fastened to the base by means of assembled hardware or by a locking tab, designed as part of the lid. Accessories may be used with systems to organize or separate contents to be placed in them for use. The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and lid has an evenly distributed hole pattern in relation to its size.
The PolyVac Surgical Instrument Delivery System is intended to protect medical device instrumentation and facilitate the sterilization process. The acceptance criteria and the study proving the device meets these criteria are detailed below. It's important to note that this document outlines safety and biocompatibility tests and sterilization efficacy, rather than performance in the sense of accuracy, sensitivity, or specificity, as seen in diagnostic AI.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Acute Systemic Toxicity (USP) | No significantly greater systemic reaction than blank extractant. | Extracts of the test article injected into mice did not produce a significantly greater systemic reaction than the blank extractant. |
| Intracutaneous Toxicity (USP) | No significantly greater tissue reaction than blank extractant. | Extracts of the test article injected intracutaneously into rabbits did not produce a significantly greater tissue reaction than the blank extractant. | |
| Implantation Test (USP) | Macroscopic reaction not significant compared to USP negative control plastic. | The macroscopic reaction of the test article implanted for 7 days was not significant as compared to the USP negative control plastic. | |
| Sterilization Efficacy | Prevacuum Steam Sterilization (132°C, 4 min) | Six-log reduction of spores; excellent steam penetration. | Successfully sterilized with a six-log reduction of all spore strips and inoculated devices. Thermocouple data indicated excellent steam penetration within wrapped packages. |
| Gravity Air Displacement Steam Sterilization (132°C, 30 min) | Six-log reduction of spores; excellent steam penetration. | Successfully sterilized with a six-log reduction of all spore strips and inoculated devices. Thermocouple data indicated excellent steam penetration within wrapped packages. | |
| Gravity Air Displacement Steam Sterilization (121°C, 55 min) | Six-log reduction of spores; excellent steam penetration. | Successfully sterilized with a six-log reduction of all spore strips and inoculated devices. Thermocouple data indicated excellent steam penetration within wrapped packages. |
2. Sample Size Used for the Test Set and Data Provenance
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Biocompatibility Tests: The exact number of mice and rabbits used for the Acute Systemic Toxicity and Intracutaneous Toxicity tests, respectively, is not specified. For the Implantation Test, the number of implanted test articles is not specified. The provenance of the data is not explicitly stated (e.g., country of origin, specific lab), but these are standard USP (United States Pharmacopeia) tests, implying a controlled laboratory setting. The tests were likely conducted prospectively.
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Sterilization Qualification: The document refers to "test articles" that were inoculated with a biological indicator organism. The exact number of test articles (PolyVac Delivery Systems) used for each sterilization cycle is not specified. This testing would have been conducted prospectively in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device and testing does not typically involve "experts" in the sense of clinical specialists like radiologists establishing ground truth. The "ground truth" for these tests is based on objective, quantifiable biological and physical measurements:
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Biocompatibility: The assessment of systemic and tissue reactions, and macroscopic reactions, would be performed by trained laboratory personnel (e.g., toxicologists, histopathologists) following USP protocols. The document does not specify the number or qualifications of these individuals but implies adherence to established scientific standards.
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Sterilization Qualification: The "ground truth" for sterilization efficacy is the demonstrable six-log reduction of biological indicator spores and successful steam penetration, as measured by thermocouples. This is determined empirically by laboratory technicians following validated sterilization protocols. The "experts" in this context are those who design, execute, and interpret the microbiology and engineering aspects of sterilization studies, whose qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessments by multiple human readers (e.g., in medical image analysis). For the objective tests described here:
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Biocompatibility: The results (e.g., presence/absence of significant reaction) are based on direct observation and measurement by trained laboratory personnel, often against a control. Any ambiguous findings would typically be resolved by internal laboratory procedures or re-testing, rather than an "adjudication" process in the diagnostic sense.
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Sterilization Qualification: The outcomes (six-log reduction, steam penetration) are determined by quantitative laboratory methods. The results are binary (pass/fail) based on predefined criteria. No expert adjudication method is relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to compare the performance of different diagnostic methods or to assess the impact of AI assistance on human reader performance. The PolyVac Surgical Instrument Delivery System is a medical device for sterilization and protection of instruments, not a diagnostic tool or AI system that involves human interpretation. Therefore, this type of study is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this question is not applicable. The PolyVac Delivery System is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply.
7. The Type of Ground Truth Used
The ground truth used for these studies is empirical and objective:
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Biocompatibility: The ground truth is based on biological response (e.g., observed systemic reactions in mice, tissue reactions in rabbits, macroscopic reactions in implant sites) against established USP standards and control samples.
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Sterilization Qualification: The ground truth is based on microbiological sterility (demonstrated by a six-log reduction of biological indicator spores) and physical parameters (successful steam penetration confirmed by thermocouple data) according to validated sterilization cycle parameters.
8. The Sample Size for the Training Set
No training set is applicable. This device is not an AI algorithm or a diagnostic model that requires a training set. The tests conducted are empirical performance validations of a physical product.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of device.
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AUG 0 2 2002
K@12/05
510(k) Summary Pursuant to 21 CFR 807.92
| 1. Submitted By: | PolyVac Inc.253 Abby RoadManchester, New Hampshire 03103 |
|---|---|
| 2. Contact: | D. Darin Martin, Official Correspondent for PolyVac Inc. at:Symmetry Medical Inc.220 West Market StreetWarsaw, Indiana 46582 |
| 3. Product: | PolyVac Surgical Instrument Delivery System880.6850 Sterilization WrapClass IIPack, Sterilization Wrapper, Bag and Accessories80 KCT |
| 4. Common Names: | Minitainer Modultainer IVInstrument Cassettes OpitainerStandard Modultainer UniversalModultainer II Modultainer IIIModultainer II Hybrid VaultLapCare / Arthrocare |
Description:
PolyVac Delivery Systems consist of different sizes of the same basic configuration. All systems consist of a minimum of a plastic or metal base and lid. All lids can be fastened to the base by means of assembled hardware or by a locking tab, designed as part of the lid. Accessories may be used with systems to organize or separate contents to be placed in them for use.
The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and lid has an evenly distributed hole pattern in relation to its size.
{1}------------------------------------------------
Intended Use:
PolyVac's delivery systems are intended to protect medical device instrumentation and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device is maintained until used.
PolyVac's delivery systems are to be sterilized in one of the following cvcles:
Prevacuum Steam : 132°C - 4 minutes minimum Dry for 20 - 40 minutes as needed
132°C - 30 minutes minimum-Gravity Steam: Gravity Steam: 121°C - 55 minutes minimum -Dry for 20 - 50 minutes as needed
Technological Characteristics:
The PolyVac Delivery System does not incorporate any new technological characteristics or material as compared to legally marketed devices.
Performance Data:
A summary of the following testing is provided to support the premarket notification:
Acute Systemic Toxicity USP: Extracts of test article injected into mice did not produce a significantly greater systemic reaction than the blank extractant.
Intracutaneous Toxicity USP: Extracts of test article injected intracutaneously into rabbits did not produce a significantly greater tissue reaction than the blank extractant.
Implantation Test USP: The macroscopic reaction of the test article implanted 7 days was not significant as compared to the USP negative control plastic.
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Sterilization Qualification: The test articles were inoculated with a biological indicator organism, and thermocouples were placed. They were then wrapped in a double layer of approved sterilization wrap and placed into the sterilizer for processing. The system was successfully sterilized in a Prevacuum Cycle at 132ºC for a 2 minutes (4 minute ½ cycle), a Gravity air Displacement Cycle at 132 ℃ for 15 minutes (30 minute ½ cycle), and a Gravity air Displacement Cycle at 121 ℃ for 27,5 minutes (55 minute ½ cycle). The sterilization tests demonstrated a six log reduction of all spores strips and inoculated devices. Thermocouple data indicated excellent steam penetration within the wrapped packages.
Substantial Equivalence:
The Delivery Systems offered by PolyVac are comparable in design to sterilization cases and trays manufactured by Riley Medical #K944025 (primary predicate).
Additionally, sterilization cases and trays are also offered by:
| Tuttnauer USA | #K990761 |
|---|---|
| C/T Medical Systems | #K980065 |
Conclusions:
The studies conducted on PolyVac's Delivery Systems demonstrate that the device is substantially equivalent to other sterilization cases and trays currently in commercial distribution. Additionally, it provides a reliable means of packaging, transporting, and storing instruments for sterilization.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines that resemble a bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 02 2002
Mr. D. Darin Martin Vice President, Quality Assurance & Regulatory Affairs Symmetry Medical, Incorporated 220 West Market Warsaw, Indiana 46580
Re: K012105
Trade/Device Name: PolyVac Surgical Instrument Delivery System Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: June 4, 2002 Received: June 5, 2002
Dear Mr. Martin:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Martin
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Pusaro
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number: | K012105 |
|---|---|
| Device Name: | PolyVac Surgical Instrument Delivery System |
| Intended Use: | PolyVac's delivery systems consist of perforated trays with lids, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device is maintained until used. |
| PolyVac's delivery systems are to be sterilized in one of the following cycles: | |
| Prevacuum Steam : 132°C - 4 minutes minimumGravity Steam: 132°C - 30 minutes minimumGravity Steam: 121°C - 55 minutes minimum |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per CFR 801.109) or
Over-the-counter use
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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
51680 Number 210 510() Number _
§ 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).