(393 days)
No
The 510(k) summary describes a medical device delivery system (trays and lids) for sterilization and protection of instruments. There is no mention of AI or ML in the intended use, device description, or performance studies. The device's function is purely mechanical and related to sterilization processes.
No.
The device is described as a delivery system for medical device instrumentation, intended to enclose, protect, and facilitate sterilization, not to provide therapy.
No
This device, PolyVac's delivery systems, is intended to enclose medical device instrumentation and facilitate sterilization, maintaining sterility of the enclosed medical device until used. It is not designed to diagnose any condition or disease.
No
The device description clearly states it consists of physical components like plastic or metal bases and lids, and accessories. It is a hardware device for sterilization.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for enclosing and protecting medical device instrumentation and facilitating sterilization. It does not mention any use in the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics of the trays and lids, their materials, and their design for sterilization. It does not describe any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies described relate to biocompatibility (toxicity, implantation) and sterilization efficacy. These are relevant to devices used in a clinical setting but not specifically to IVDs.
IVDs are devices used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. This device's function is entirely focused on the handling and sterilization of other medical devices, not on the analysis of biological specimens.
N/A
Intended Use / Indications for 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
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
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device 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.
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
Not Found
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)
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.
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.
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.
Riley Medical #K944025
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.
Tuttnauer USA #K990761, C/T Medical Systems #K980065
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
AUG 0 2 2002
K@12/05
510(k) Summary Pursuant to 21 CFR 807.92
| 1. Submitted By: | PolyVac Inc.
253 Abby Road
Manchester, New Hampshire 03103 |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact: | D. Darin Martin, Official Correspondent for PolyVac Inc. at:
Symmetry Medical Inc.
220 West Market Street
Warsaw, Indiana 46582 |
| 3. Product: | PolyVac Surgical Instrument Delivery System
880.6850 Sterilization Wrap
Class II
Pack, Sterilization Wrapper, Bag and Accessories
80 KCT |
| 4. Common Names: | Minitainer Modultainer IV
Instrument Cassettes Opitainer
Standard Modultainer Universal
Modultainer II Modultainer III
Modultainer II Hybrid Vault
LapCare / 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.
2
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.
3
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.
4
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
5
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 _