The APTIMAX™ Instrument Trays are designed to encase surgical instruments for sterilization in steam, ethylene oxide and STERRAD Sterilization Systems.

The APTIMAX™ Instrument Trays and accessories are designed to encase surgical instruments for sterilization.

The APTIMAX™ Instrument Trays and accessories were previously indicated for use only with the Sterrad® Sterilization Systems. This Premarket Notification expands the Indications for Use for the APTIMAX™ Instrument Trays and accessories to also include their use in prevacuum steam and ethylene oxide sterilization cycles.

Device Description

The APTIMAX™ Instrument Tray, Instrument Tray Mat and Instrument Tray Holder are intended to encase surgical instruments for sterilization in steam (with the exception of gravity displacement cycles), ethylene oxide and STERRAD® Sterilization Systems.

The instrument tray, available in various sizes, is injection molded with a Liguid Crystal Polymer, which is compatible with various sterilization systems such as the STERRAD® Sterilization System, steam sterilizers and ethylene oxide sterilizers.

The tray is designed with a high perforation area on the lid. base and side panels to enhance diffusion of sterilant during sterilization. The hole size and spacing is the same in all trays to enable the use of a common design instrument tray mats and holders.

Prior to sterilization, the tray is over-packaged with a microbial barrier, such as polypropylene CSR wrap or pouch, which is compatible with the sterilization method for maintaining sterility after sterilization.

Accessories for the APTIMAX™ Instrument Tray include the Instrument Tray Holder and the Instrument Tray Mat. The holder and mat are designed to secure and provide protection of delicate endoscopic and microsurgical instruments in the APTIMAX™ Instrument Tray.

The instrument holder and mat, available in various sizes, are manufactured from a silicone material. which is compatible with various sterilization systems such as the STERRAD® Sterilization system, steam sterilizers and ethylene oxide sterilizers.

AI/ML Overview

The provided text describes validation testing for a medical device (APTIMAX™ Instrument Tray and Accessories) to demonstrate its efficacy and material compatibility with various sterilization methods. It does not contain information about an AI/ML powered medical device, therefore many of the requested fields cannot be filled.

Here's an analysis of the provided text based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
Efficacy Testing (Sterility Assurance)
Ethylene Oxide: Achieve 6-log spore reduction after a half-cycle exposure.	All test samples were found to be sterile, demonstrating a 6-log spore reduction after half-cycle exposure (using B. globigii endospores, >10^6).
Prevacuum & Flash Steam (Tray & Mat): Lethality achieved at minimum temperature and half cycle with maximum load.	Lethality was achieved with a 1.5 minute half-cycle (at 131.7 °C) for both prevacuum and flash cycles. No growth was observed at half cycle for three consecutive runs (using B. stearothermophilus endospores, >10^6).
Prevacuum & Flash Steam (Tray Holder): Lethality achieved at minimum temperature and half cycle with maximum load.	Lethality was achieved with a 1.5 minute half-cycle (at 131.7 °C) for both prevacuum and flash cycles. No growth was observed at half cycle for three consecutive runs (using B. stearothermophilus endospores, >10^6).
STERRAD 100 System: Achieve minimum Sterility Assurance Level (SAL) of 10^-6 at half-cycle with minimum injection volume.	Complete inactivation of challenge biological indicators was achieved for three consecutive runs at half-cycle with minimum injection volume. Results demonstrated a minimum SAL of 10^-6 (using B. stearothermophilus endospores, >10^6).
STERRAD 100S System: Achieve minimum Sterility Assurance Level (SAL) of 10^-6 at half-cycle with minimum injection volume.	Complete inactivation of challenge biological indicators was achieved for three consecutive runs at half-cycle with minimum injection volume. Results demonstrated a minimum SAL of 10^-6 (using B. stearothermophilus endospores, >10^6).
STERRAD 50 System: Achieve minimum Sterility Assurance Level (SAL) of 10^-6 at half-cycle with minimum injection volume.	Complete inactivation of challenge biological indicators was achieved for three consecutive runs at half-cycle with minimum injection volume. Results demonstrated a minimum SAL of 10^-6 (using B. stearothermophilus endospores, >10^6).
Material Compatibility (Ethylene Oxide): Residuals below limits proposed in the Federal Register of June 23, 1978.	Residual results for Ethylene Oxide, Ethylene Chlorohydrin, and Ethylene Glycol were far below the proposed limits.
Material Compatibility (Steam Sterilization): No change in surface characteristics and physical properties (tensile strength) within acceptable limits after 50 cycles.	No change in surface characteristics observed after 50 cycles. Physical properties (tensile strength) had changes within acceptable limits.
Material Compatibility (STERRAD 100 System): No change in surface characteristics and physical properties (tensile strength) within acceptable limits (<10%) after 100 cycles.	No change in surface characteristics observed after 100 cycles. Physical properties (tensile strength) changes were within acceptable limits (<10%) for trays. All but one tensile bar were within limits; the one outlier was tested for hardness change, and the result was not significant.

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

The sample sizes for "test sets" in this context refer to the number of sterilization cycles and biological indicators/spore carriers used.

Ethylene Oxide Efficacy: "All test samples" (number not explicitly stated as a single value, but implies multiple BI carriers per run). Three consecutive runs were performed.
Prevacuum & Flash Steam Efficacy (Tray & Mat): Not explicitly stated how many coupons were used per run, but tested over "three consecutive runs."
Prevacuum & Flash Steam Efficacy (Tray Holder): Not explicitly stated how many coupons were used per run, but tested over "three consecutive runs."
STERRAD 100, 100S, 50 Efficacy: One stainless steel coupon inoculated with B. stearothermophilus endospores (>10^6) per worst-case location, and one glass substrate spore carrier for STERRAD 50, tested over "three consecutive runs."
Ethylene Oxide Residuals: Tensile bars (representative of tray and mat-holder material) tested after full-cycle exposure. Number not explicitly stated.
Steam Material Compatibility: One 180 mm x 75 mm x 30 mm Instrument Tray, plus tensile bars (fabricated from the same raw materials as mat and holder), processed for "fifty steam cycles."
STERRAD 100 Material Compatibility: APTIMAX Trays and Tensile bars (representative of tray and mat/holder material) processed for "one hundred full cycles."

Data Provenance: The studies were conducted by Advanced Sterilization Products (ASP), a US-based company. The nature of these non-clinical, validation studies indicates they are prospective in the sense that the experiments were specifically designed and executed to test the device performance as part of the 510(k) submission. There is no mention of country of origin of the data beyond the company's location.

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

This information is not applicable to this type of device and study. The "ground truth" here is the biological outcome of sterility (presence or absence of microbial growth) or physical/chemical property changes, which are determined by laboratory testing, not expert consensus.

4. Adjudication Method for the Test Set

This is not applicable to these non-clinical validation studies. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for human interpretation of imaging or other medical data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This submission is for a physical medical device (instrument tray) and its compatibility with sterilization systems, not an AI/ML powered device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This submission is for a physical medical device.

7. The Type of Ground Truth Used

The ground truth used in these validation studies is primarily microbiological and material-science based:

Microbiological Sterility: Absence of microbial growth from biological indicators (B. globigii, B. stearothermophilus endospores) after sterilization cycles. This is an objective laboratory outcome.
Material Compatibility: Physical property measurements (tensile strength, hardness) and visual inspection for surface characteristics after multiple sterilization cycles. This is an objective measurement against defined acceptable limits.
Chemical Residuals: Quantitative analysis of chemical residues (Ethylene Oxide, Ethylene Chlorohydrin, Ethylene Glycol) compared against established safety limits.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI/ML device that requires a training set.

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

This is not applicable. This is a physical medical device, not an AI/ML device that requires a training set.

Summary

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510(k) SUMMARY

K013003

SUBMITTED BY

Kevin Corrigan, R.A.C. Director, Regulatory Affairs Advanced Sterilization Products 33 Technology Drive Irvine, CA 92618

(949) 453-6410

April 15, 2002

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Common/Usual Name: Sterilizable Instrument Tray and Accessories

Product Classification: Class II

Proprietary Name: APTIMAX™ Instrument Tray, Instrument Tray Holder and Instrument Tray Mat

PREDICATE DEVICES

The predicate devices are the APTIMAX™ Instrument Tray for use in the STERRAD® Sterilization System, currently manufactured and distributed by Advanced Sterilization Products, the STERRAD® Instrument Tray which is also currently manufactured and distributed by Advanced Sterilization Products and the Instrument Management System manufactured by Hu-Friedy.

INDICATIONS-FOR-USE

The APTIMAX™M Instrument Trays are designed to encase surgical instruments for sterilization in steam, ethylene oxide and STERRAD Sterilization Systems.

DEVICE DESCRIPTION

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COMPARISON TO THE PREDICATE DEVICE

The APTIMAX™ Instrument Tray and accessories for use in steam and ethylene oxide sterilization are substantially equivalent to the APTIMAX™ Instrument Tray for use in the STERRAD® Sterilization System, the STERRAD® Instrument Tray and the Instrument Management System. All of these devices are intended to encase instruments for sterilization. In addition, all of these devices have a long-standing, basic design concept. Based on the basic design concept, the use of established well known materials, feature comparisons and results of the validation testing. ASP has demonstrated that these devices are substantially equivalent to existing legally marketed devices.

DISCUSSION OF NONCLINICAL STUDIES

Validation Testing

Overkill method was used to demonstrate cvcle lethality.

1. Efficacy Testing of the APTIMAX™ Instrument Tray, Mat and Holder in Ethylene Oxide Sterilization Cycles Sub-process cycle exposures were performed on the Instrument Tray, Mat and Holder in order to validate the biological effectiveness of a half-cycle Ethylene Oxide gas exposure using Biological Indicator carriers inoculated with B. globigii endospores (>10°).
  Following half-cycle exposure, all test samples were tested for the presence of surviving microorganisms and were found to be sterile, demonstrating a 6-log spore reduction after half-cycle exposure.

Efficacy Testing of the APTIMAX™ Instrument Tray and Mat in 2) Prevacuum (wrapped) and Flash (unwrapped) Sterilization Cycles

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Efficacy testing in prevacuum and prevacuum flash sterilization cycles was performed using the APTIMAX Tray and Mat. Stainless steel coupons inoculated with B. stearothermophilus endospores (>10°) were placed in the center of stainless steel lumens. The validation was performed at minimum temperature parameters and half cycle exposure with a maximum load.

For 132.2 ℃ pre-vacuum and flash cycles, lethality was achieved with a 1.5 minute half-cycle in lumen configuration (maximum load and test temperature of 131.7 ℃). No growth was observed at half cycle for three consecutive runs for both prevacuum and flash cycles.

3) Efficacy Testing of the APTIMAX™ Instrument Tray Holder in Prevacuum (wrapped) and Flash (unwrapped) Sterilization Cycles

Efficacy testing in prevacuum and prevacuum flash sterilization cycles was performed on the Instrument Tray and Holder. Paper spore strip coupons inoculated with B. stearothermophilus endospores (>10°) were placed between instruments and the contacting surfaces of the holders. The validation was performed at minimum temperature parameters and half cycle exposure with a maximum load.

For 132.2 ℃ pre-vacuum and flash cycles, lethality was achieved with a 1.5 minute half-cycle (test temperature of 131.7 ℃) for both prevacuum and flash cycles. No growth was observed at half cycle for three consecutive runs.

Efficacy Testing of the APTIMAX™ Instrument Tray, Mat and Holder in 4) the STERRAD 100 Sterilization System

Efficacy testing was performed on the APTIMAX Instrument Tray, Mats and Holder in the STERRAD 100 Sterilization System. A stainless steel coupon inoculated with B. stearothermophilus endospores (>10°) was placed in the middle of a 3 mm x 400 mm stainless steel lumens and between an instrument and the contacting surface of the holder, simulating worst case locations for sterilization.

Complete inactivation of challenge biological indicators was achieved for three consecutive runs at half-cycle with minimum injection volume. The results demonstrated a minimum sterility assurance level (SAL) of 10-6.

ર) Efficacy Testing of the APTIMAX™ Instrument Tray, Mat and Holder in the STERRAD 100S Sterilization System

Efficacy testing was performed on the APTIMAX Instrument Tray, Mats and Holder in the STERRAD 100S Sterilization System. A stainless steel coupon inoculated with B. stearothermophilus endospores (>10°) was placed in the middle of a 3 mm x 400 mm stainless steel lumen and between an instrument and the contacting surface of the holder, simulating worst case locations for sterilization.

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Complete inactivation of challenge biological indicators was achieved for three consecutive runs at half-cvcle with minimum injection volume. The results demonstrated a minimum sterility assurance level (SAL) of 10 °.

Efficacy Testing of the APTIMAX™ Instrument Tray, Mat and Holder in 6) the STERRAD 50 Sterilization System

Efficacy testing was performed on the APTIMAX Instrument Tray, Mats and Holder in the STERRAD 50 Sterilization System. A stainless steel coupon inoculated with B. stearothermophilus endospores (>10°) was placed in the middle of a 3 mm x 400 mm stainless steel lumen to simulate a worst case location for sterilization.

A glass substrate spore carrier was inoculated with B. stearothermophilus endospores (>10°). It was placed between an instrument and the contacting surface of the holder, simulating a worst case location for sterilization.

Material Compatibility Studies

Residual Testing of the APTIMAX™ Instrument Tray, Mat and Holder 1) Following Ethylene Oxide Sterilization Following full-cycle exposure, tensile bars (representative of tray and matholder material) were tested for Ethylene Oxide, Ethylene Chlorohydrin and Ethylene Glycol residuals. Residual results were far below limits proposed in the Federal Register of June 23, 1978.
1. Material Compatibility of the APTIMAX™ Instrument Tray, Mat and Holder with Steam Sterilization Processing

This study was designed to simulate the possible material degradation in hospital processing conditions for steam sterilization of trays and accessories over multiple cycles. The 180 mm x 75 mm x 30 mm Instrument Tray was chosen as the sample for this study because it has the smallest physical size as well as the thinnest wall thickness, therefore, it represents the worst case scenario for chemical stress cracking. Tensile bars (fabricated from the same raw materials used for the mat and holder) were used in order to test for tensile strength, indicating bulk phase material degradation. The mats and holders are included in this study so the effect of steam sterilization on design configuration could be evaluated.

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The cycle chosen was a gravity-displacement sterilization cycle set at a temperature of 270°F with an exposure time of 15 minutes. This cycle condition was chosen to represent the high temperature range cvcle of the longest duration time within the cycle.

The trays are loaded with approximately .25 lb. of weight to simulate the heaviest loading of microsurgical instruments.

After processing all of the samples in fifty steam cycles, no change in surface characteristics was observed. The physical properties, represented by tensile strength, had changes within the acceptable limit.

It is therefore concluded that the APTIMAX™ Instrument Tray, Mat and Holder are compatible with steam sterilization processes.

Material Compatibility of the APTIMAX™ Instrument Tray, Mat and 3) Holder in the STERRAD 100 Sterilization System

The purpose of this study was to simulate possible material degradation of the APTIMAX Trays, Mats and Holders over multiple cycles of STERRAD Sterilization processing. The STERRAD 100 cycle was chosen to represent a typical cycle of all STERRAD Systems. It was chosen due to the fact that materials processed by the STERRAD 50 and the STERRAD 100S generally have less hydrogen peroxide residual than the materials processed in the STERRAD 100. Therefore, the compatibility of most materials processed in the STERRAD 50 and STERRAD 100S are expected to be equal to or better than the STERRAD 100.

After processing the APTIMAX Trays and Tensile bars (representative of tray and mat/holder material) in one hundred full cycles, no change in surface characteristics was observed. The physical properties, as represented by tensile strength had changes within the acceptable limit (<10%) for the trays. All but one of the tensile bars were within acceptable limits. The one that was over the acceptable limit was an one-hundred cycle sample. The tensile bar was tested for hardness change and the results indicated that the change was not significant.

CONCLUSION

Results of validation testing demonstrate that the APTIMAX™ Instrument Tray, Mat and Holder are compatible for use in steam and ethylene oxide sterilization cycles.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a symbol of three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2002

Ms. Natalie Bennington Senior Regulatory Affairs Specialist Advanced Sterilization Products 33 Technology Drive Irvine, California 92618

Re: K013003

Trade/Device Name: APTIMAX™ Instrument Tray and Accessories Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: July 2, 2002 Received: July 3, 2002

Dear Ms. Bennington:

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 vour 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 - Ms. Bennington

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 (OS) 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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ADVANCED STERILIZATION PRODUC a younsonal Johnon compa REGULATORY AFFAIRS DEPARTMENT

510(k) Number (K013003):

APTIMAX™ Instrument Tray and Accessories Device Name:

Indications-For-Use:

Prescription Use (PER 21 CFR 801.109)

The APTIMAX™ Instrument Trays and accessories are designed to encase surgical instruments for sterilization.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Qlin S. Lim

Division Sinn-Division of Anesthesiology, General Hospital Infection Control. Dental Devices

510(k) Number: K013003

Over-The-Counter Use

(Optional Format 1-2-96)

DIVISION OF ETHICON, INC. . . 33 TECHNOLOCY DRIVE . IRVINE, CA 92618 . (949) 581-5799 . FAX (949) 789-3900

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).