(263 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and sterilization efficacy of the delivery systems, with no mention of AI or ML technologies.
No.
Explanation: The device is a delivery system designed to enclose and protect medical device instrumentation and facilitate sterilization, not to provide therapeutic treatment or diagnosis.
No
Explanation: The device is described as a delivery system (trays with lids) for medical device instrumentation, designed to facilitate the sterilization process. It does not perform any diagnostic function.
No
The device description clearly states it consists of physical components (plastic or metal base and lid) and is intended for enclosing and protecting medical device instrumentation during sterilization, which is a hardware function.
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 for enclosing and protecting medical device instrumentation and facilitating the sterilization process. This is a function related to the preparation and handling of medical devices, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical characteristics of the trays and lids, their materials, and their compatibility with sterilization methods. There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD-specific information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims or interpretations
- Performance metrics like sensitivity, specificity, etc., in a diagnostic context.
The device is a sterilization container, which is a type of medical device used in the healthcare setting, but it does not fit the definition of an In Vitro Diagnostic device.
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, PolyVac's delivery systems are to be sterilized in one of the following cycles: Prevacuum Steam : 132°C - 4 minutes minimum Dry for 20 - 40 minutes as needed 132°C - 30 minutes minimum Gravity Steam: Gravity Steam: Dry for 20 - 50 minutes as needed Ethylene Oxide
PolyVac's delivery systems consist of perforated trays with llds, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing sterilant penetration and air removal, When used In conjunction with an approved sterilization wrap.
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 or Ethylene Oxide 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)
Ethylene Oxide Qualification: The test articles were inoculated with spore strips and biological indicator organisms, and chemical indicators were placed. They were then wrapped in a double layer of approved sterilization wrap and placed into the ethylene oxide sterilizer for processing. The system was successfully sterilized in a 60 minute ETO half cycle. The sterilization tests demonstrate a six log reduction capability of all spores strips and inoculated devices.
Ethylene Oxide Residual Evaluation: Radel-R materials were exposed to full Ethylene Oxide Cycles and aerated for 11 hr. and 35 min. Residual concentrations of EO, ECH, and EGly, were all within acceptable limits.
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.
Not Found
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
Ko4022}
510(k) Summary Pursuant to 21 CFR 807.92
- Symmetry Medical Inc. 1. Submitted By: 220 West Market Street Warsaw. Indiana 46582
D. Darin Martin 2. Contact: Symmetry Medical Inc. 220 West Market Street Warsaw, Indiana 46582
Poly Vac Surgical Instrument Delivery System 880.6850 Sterilization Wrap Class II Pack, Sterilization Wrapper, Bag and Accessories 80 KCT
-
- Common Names: Minitainer Instrument Cassettes Standard Modultainer Modultainer II Modultainer II Hybrid LapCare / Arthrocare
Modultainer IV Opitainer Universal Modultainer III . Vault
- Common Names: Minitainer Instrument Cassettes Standard Modultainer Modultainer II Modultainer II Hybrid LapCare / Arthrocare
Description:
- Product:
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 or Ethylene Oxide sterilization methods. Each tray and lid has an evenly distributed hole pattern in relation to its size.
1
urgical Instrument Delivery System
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,
PolyVac's delivery systems are to be sterilized in one of the following cycles:
Prevacuum Steam : 132°C - 4 minutes minimum Dry for 20 - 40 minutes as needed
132°C - 30 minutes minimum Gravity Steam: Gravity Steam: Dry for 20 - 50 minutes as needed
Ethylene Oxide
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 for the new Ethylene Oxide indication:
Ethylene Oxide Qualification: The test articles were inoculated with spore strips and biological indicator organisms, and chemical indicators were placed. They were then wrapped in a double layer of approved sterilization wrap and placed into the ethylene oxide sterilizer for processing. The system was successfully sterilized in a 60 minute ETO half cycle. The sterilization tests demonstrate a six log reduction capability of all spores strips and inoculated devices.
Ethylene Oxide Residual Evaluation: Radel-R materials were exposed to full Ethylene Oxide Cycles and aerated for 11 hr. and 35 min. Residual concentrations of EO, ECH, and EGly, were all within acceptable limits.
2
Substantial Equivalence:
The Delivery Systems offered by Poly Vac are of the same design as The Delivery Bystems Circs manufactured by PolyVac under a previously stermzanon cases and any mix devices are substantially equivalent to other sterilization cases cleared for use with Ethylene Oxide: Aptimax -Sterifization cases etc. Sterilization Products, and Metapak - K993535, Riley Medical, Inc.
Conclusions:
The studies conducted on PolyVac's Delivery Systems demonstrate that the The stubles occantially 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing another, with three lines representing the arms and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2004
Symmetry Medical, Incorporated C/O Mr. David C. Furr Official Correspondent FDC Services 7822 Ladue Glen Fort Wayne, Indiana 46804
Re: K040223
Ro40223 Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: August 5, 2004 Received: August 6, 2004
Dear Mr. Furr:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined 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 interstate conmiseree prior to that have been reclassified in accordance with the provisions of Amendinens, of to devroes and nove of the (Act) that do not require approval of a premarket the Federal 1 000; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or 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 If your device is classified (oos as a vitional controls. Existing major regulations affecting (1 Mr.), it may of each of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Furr
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that I Dri 3 issuaired on that your device complies with other requirements Incall that I DX nas made a decembers and regulations administered by other Federal agencies. of the Act of ally I oderal bake and squirements, including, but not limited to: registration You must comply with an the Piore ong (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in are quality 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) I his letter will anow you to began mail as a substantial equivalence of your device to a premarket notification. - The PD Fridation 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), If you desire specific act 100 for Joinner at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain outer generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin. Ph 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: | K040223 |
|---|---|
| Device Name: | PolyVac Surgical Instrument Delivery System |
| Intended Use: | PolyVac's delivery systems consist of perforated trays with llds, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing sterilant penetration and air removal, When used In conjunction with an approved sterilization wrap. |
| Sterilization Method: | Ethylene Oxide |
| Prescription Use (Per CFR 801.109) | or |
| Over-the-counter use | X |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Janette Y. Michael C.M.S.
FOR DR. CHIU LIN
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthoontal Devices
510(k) Number: K040223