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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the PolyVac Surgical Instrument Delivery System's acceptance criteria and the supporting study:

The provided text describes a 510(k) premarket notification for the "PolyVac Surgical Instrument Delivery System" seeking to add Ethylene Oxide (EO) sterilization as an approved method.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes a performance study aimed at demonstrating equivalence and efficacy for the new sterilization method. The implicit acceptance criterion is that the device successfully achieves sterilization in the specified Ethylene Oxide process.

Acceptance Criterion (Implicit)	Reported Device Performance
Ethylene Oxide Sterilization Efficacy: Achieve a six-log reduction in microbial load (sterility assurance).	Ethylene Oxide Qualification: "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: Residual concentrations of EO, ECH, and EGly must be within acceptable limits after aeration.	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." (Note: The document does not specify what these acceptable limits are, only that they were met).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the number of PolyVac Delivery Systems (or individual materials/components) used for the Ethylene Oxide Qualification and Residual Evaluation tests. It refers to "test articles" and "Radel-R materials."
Data Provenance: The data is likely prospective, generated specifically for this 510(k) submission to demonstrate the new sterilization method. The country of origin of the data is not specified, but given the company's location (Warsaw, Indiana) and submission to the FDA, it's presumed to be from the USA or a recognized testing facility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of study does not involve experts establishing ground truth in the way a diagnostic AI study would (e.g., radiologists reviewing images). Instead, the "ground truth" is established by validated biological and chemical indicators.

Ethylene Oxide Qualification: The "ground truth" for sterilization efficacy is the sterility of the devices, determined by the absence of growth from spore strips and biological indicator organisms after processing. This is an objective, laboratory-based assessment, not reliant on expert review.
Ethylene Oxide Residual Evaluation: The "ground truth" for chemical residuals is determined by analytical chemistry techniques, measured against predefined acceptable limits.

Therefore, the concept of "number of experts" and "qualifications of those experts" for ground truth establishment does not apply in this context.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are relevant for studies where multiple human readers interpret data, and discrepancies need to be resolved for ground truth. This is not applicable here as the "ground truth" is determined by objective laboratory assays (biological indicator tests, chemical analyses).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic devices involving human interpretation (e.g., comparing human performance with and without AI assistance). The PolyVac system is a surgical instrument delivery system, and its performance is evaluated through material compatibility and sterilization efficacy, not diagnostic interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. The PolyVac system is a physical medical device, not a software algorithm. Its performance is inherent in its physical and material properties and its interaction with the sterilization process, not through an algorithm.

7. The Type of Ground Truth Used

Ethylene Oxide Qualification: The ground truth is biological indicator sterility (absence of microbial growth) corroborated by chemical indicators. This is an objective, laboratory-based measurement of sterilization efficacy.
Ethylene Oxide Residual Evaluation: The ground truth is objective chemical concentration measurements (EO, ECH, EGly) compared against predefined safety limits.

8. The Sample Size for the Training Set

The concept of a "training set" is applicable to machine learning algorithms. The PolyVac system is a physical device, not an AI, so there is no training set. Its performance relies on its physical design and materials, which are validated through specific testing.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this physical device, this question is not applicable.

Summary

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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

1. Common Names: Minitainer Instrument Cassettes Standard Modultainer Modultainer II Modultainer II Hybrid LapCare / Arthrocare
  Modultainer IV Opitainer Universal Modultainer III . Vault

Description:

Product:

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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.

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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.

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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.

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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

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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

Regulation Number and Section

§ 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).