Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and sterilization efficacy of instrument trays and accessories, with no mention of AI or ML technologies.

Therapeutic

No.

The device is designed to encase surgical instruments for sterilization, protecting them and maintaining sterility, rather than directly treating or diagnosing a medical condition.

Diagnostic

No

The device is an instrument tray designed to encase surgical instruments for sterilization, not for diagnostic purposes. Its function is to facilitate the sterilization process of other medical instruments.

SaMD (Software as a Medical Device)

No

The device described is a physical instrument tray and accessories made of Liquid Crystal Polymer and silicone, designed to encase surgical instruments for sterilization. It is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as "designed to encase surgical instruments for sterilization". This is a function related to the preparation and handling of surgical tools, not for performing diagnostic tests on biological samples.
Device Description: The description focuses on the physical characteristics of the trays, mats, and holders, their materials, and their compatibility with different sterilization methods. There is no mention of any components or functions related to analyzing biological samples or providing diagnostic information.
Performance Studies: The performance studies described are focused on validating the efficacy of the sterilization process when using the trays and accessories. This involves demonstrating the killing of microorganisms, which is relevant to sterilization, not diagnosis. The key metric is Sterility Assurance Level (SAL), which is a measure of sterilization effectiveness.
Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
- Use in a laboratory setting for diagnostic purposes

The APTIMAX™ Instrument Trays and accessories are devices used in the process of sterilizing surgical instruments, which is a critical step in preventing the spread of infection in a healthcare setting. They are not used to diagnose diseases or conditions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The APTIMAX™M 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.

Product codes (comma separated list FDA assigned to the subject device)

FRG

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.

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)

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
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.

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.

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°.

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.

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 (

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).

Summary

0

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

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.

1

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.

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

2

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.

3

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.

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°.

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.

4

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 (