(28 days)
The Verify® Challenge Packs -Version 2 - are test packs consisting of an emulating indicator surrounded by a steam penetration barrier, intended for use in steam sterilization. The Verify® Challenge Packs indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The challenge pack models and their cycle temperatures, types, and times are:
| MODEL | TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|---|
| Verify® 270F 4 | 270°F (132°C) | Pre-vacuum, Steam Flush Pressure Pulse (SFPP) | 4 minutes |
| Verify® 275F 3 | 275°F (135°C) | Pre-vacuum | 3 minutes |
There is a process indicator outside of the packs which undergoes a visual color change when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).
The proposed Verify® Challenge Packs – Version 2 -consist of an emulating indicator surrounded by a steam penetration barrier. The indicator ink inside the proposed Verify® Challenge Packs changes from yellow to blue/purple color when the steam sterilization cycle is complete:
- The Verify® 270F 4 Challenge Pack -Version 2 can be used to monitor a 4 . minute 270ºF/132ºC Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum steam sterilization cycle.
- The Verify® 275F 3 Challenge Pack -- Version 2 can be used to monitor a 3 . minute 275°F/135°C pre-vacuum steam sterilization cycle.
The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).
This document describes the acceptance criteria and performance of the Verify® Challenge Pack – Version 2. This device is a chemical indicator used to monitor steam sterilization cycles.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on the color change of the indicator within the pack and an external process indicator. The key performance criteria are related to the appropriate color change after exposure to specific sterilization cycles.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Internal Indicator Performance (Emulating Class 6 Indicator) | The indicator sheet within the challenge pack changes color from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle. (Referenced against ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] steam indicators). Specific cycles are: - Verify® 270F 4 Challenge Pack: 4 minute 270ºF/132ºC Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum steam sterilization cycle. - Verify® 275F 3 Challenge Pack: 3 minute 275°F/135°C pre-vacuum steam sterilization cycle. | The performance of the Verify® Challenge Packs -- Version 2 - meets the requirements of ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] steam indicators. "The indicator sheet within the challenge pack changes color from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle." Specific performance for each model: - Verify® 270F 4: Indication of successful monitoring for 4 minute 270°F (132°C) Pre-vacuum, Steam Flush Pressure Pulse (SFPP) cycle. - Verify® 275F 3: Indication of successful monitoring for 3 minute 275°F (135°C) Pre-vacuum cycle. |
| External Process Indicator Performance | The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C). | "The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C)." "Performance testing was conducted to verify that the process indicator on the outside of the challenge packs change color from pink to dark purple when exposed to the following full steam sterilization cycles: - 4 minute 270°F/132°C dynamic air removal steam sterilization cycle. - 3 minute 275°F/135°C dynamic air removal steam sterilization cycle." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Performance testing was conducted," but does not specify the sample size for the test sets (i.e., how many challenge packs were tested for each cycle type). The data provenance is not explicitly stated in terms of country of origin, but it is from STERIS Corporation in Mentor, OH, USA, and the submission is to the FDA. The testing conducted appears to be prospective as it's part of verification and validation activities for a new version of a device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set. For chemical indicators, ground truth is typically based on physical-chemical responses to controlled sterilization parameters rather than expert interpretation of complex images or data. The "ground truth" here is the known successful completion of the sterilization cycle, confirmed by cycle parameters, and the subsequent expected color change of the indicator.
4. Adjudication Method for the Test Set:
Given that the performance is based on an objective color change (yellow to blue/purple, pink to dark purple) in response to a sterilization cycle, an adjudication method in the traditional sense (e.g., 2+1, 3+1) is not applicable or mentioned. The assessment of color change is typically a direct observation against defined color standards or by trained personnel understanding the intended change.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned. This type of study is relevant for diagnostic devices where human interpretation of results is variable and the AI's effect on human performance is being evaluated. For a simple chemical indicator with a clear visual output, such a study would not be appropriate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the performance testing described is essentially a "standalone" assessment of the device. The device itself is a chemical indicator that autonomously changes color based on exposure to sterilization conditions. Its performance is evaluated based on its physical response (color change) to defined sterilization cycles, without human intervention affecting the "reading" of the indicator other than visual confirmation of the color change. There's no "algorithm" in the context of AI; the device's function is purely chemical and physical.
7. The Type of Ground Truth Used:
The ground truth used is based on controlled sterilization cycle parameters and the physical-chemical response of the indicator. Specifically:
* Known exposure to full steam sterilization cycles: 4 minute 270°F/132°C dynamic air removal steam sterilization cycle (SFPP and prevacuum) and 3 minute 275°F/135°C dynamic air removal steam sterilization cycle (prevacuum).
* Adherence to recognized standards: The internal indicator's performance is stated to meet the requirements of ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] steam indicators, which sets industry standards for chemical indicator performance.
8. The Sample Size for the Training Set:
This information is not provided in the document. As this device is a physical chemical indicator, there isn't a "training set" in the context of machine learning. The term "training set" is generally used for AI/ML algorithms where data is used to teach a model. For a chemical indicator, the development process involves chemical formulation and design testing, rather than data-driven training.
9. How the Ground Truth for the Training Set Was Established:
Since there is no "training set" in the AI/ML sense, this question is not applicable. The underlying chemical properties and reactions for the indicator's color change are established through chemical research and development, and then validated through performance testing as described above.
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Image /page/0/Picture/0 description: The image shows the word "STERIS" in all capital letters with the registered trademark symbol. Below the word is a symbol that looks like a series of stacked, wavy lines. Underneath the symbol is the number "K073683" written in a handwritten style.
510(k) Summary For Verify® Challenge Packs – Version 2 -
JAN 25 Cars
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Richard Bancroft Development and Technical Service Director
Telephone: 011 44 116 2747337 Fax No: 011 44 116 2768639
Submission Date: December 26, 2007
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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Device Name 1.
| Indicator Pack Models: | Verify® 270F 4 Challenge PackVerify® 275F 3 Challenge Pack |
|---|---|
| Common Name: | Chemical Indicator |
| Classification Name: | Physical/chemical sterilization process indicator (21CFR 880.2800 (b), Product Code JOJ). |
2. Predicate Devices
- . Verify® Challenge Packs - K070895.
- Modified Browne Packaging and Label Steam Process Indicator K032801. .
3. Device Description
The proposed Verify® Challenge Packs – Version 2 -consist of an emulating indicator surrounded by a steam penetration barrier. The indicator ink inside the proposed Verify® Challenge Packs changes from yellow to blue/purple color when the steam sterilization cycle is complete:
- The Verify® 270F 4 Challenge Pack -Version 2 can be used to monitor a 4 . minute 270ºF/132ºC Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum steam sterilization cycle.
- The Verify® 275F 3 Challenge Pack -- Version 2 can be used to monitor a 3 . minute 275°F/135°C pre-vacuum steam sterilization cycle.
The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).
4. Intended Use
The Verify® Challenge Packs -- Version 2- are chemical indicator test packs intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The indicator sheet within the challenge pack changes color from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle. The performance of the Verify Challenge Packs -- Version 2 - meets the requirements of ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] steam indicators.
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The process indicator printed outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).
Description of Safety and Substantial Equivalence 5.
The proposed and predicate devices are all single use indicator test packs for use in steam sterilization cycles. The differences between the proposed Verify® Challenge Packs – Version 2 - and the predicate device Verify® Challenge Packs described in K070895 are limited to the presence of an outside pack process indicator identical to the predicate device described in K032801. There are no differences in design, materials, and parameters of the sterilization cycles these indicator test packs are designed to monitor. The addition of the process indicator to the outside of the challenge packs does not raise any new issues of safety and efficacy.
6. Verification and Validation Activities
A risk analysis and the necessary verification and validation activities were performed to demonstrate that the design outputs of the modified device meet the design input requirements.
Performance testing was conducted to verify that the process indicator on the outside of the challenge packs change color from pink to dark purple when exposed to the following full steam sterilization cycles.
- 4 minute 270°F/132°C dynamic air removal steam sterilization cycle. .
- 3 minute 275°F/135°C dynamic air removal steam sterilization cycle. .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
JAN 25 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Scoville Fellow, Regulatory Affairs Sterilization Technology STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060-1834
Re: K073683
Trade/Device Name: Verify® Challenge Packs - Versions 2 -Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: December 26, 2007 Received: December 28, 2007
Dear Mr. Scoville:
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.
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Page 2 - Mr. Scoville
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. 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), please contact the Office of Compliance 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 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/industry/support/index.html.
Sincerely yours.
Clars
Chiu Lin, Ph.D. 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
510(k) Number (if known):
Device Name:
Verify® Challenge Packs - Version 2 -
Indications For Use:
The Verify® Challenge Packs -Version 2 - are test packs consisting of an emulating indicator surrounded by a steam penetration barrier, intended for use in steam sterilization. The Verify® Challenge Packs indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The challenge pack models and their cycle temperatures, types, and times are:
| MODEL | TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|---|
| Verify® 270F 4 | 270°F (132°C) | Pre-vacuum, Steam FlushPressure Pulse (SFPP) | 4 minutes |
| Verify® 275F 3 | 275°F (135°C) | Pre-vacuum | 3 minutes |
There is a process indicator outside of the packs which undergoes a visual color change when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula H. Murphy, RO
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of 1
December 26, 2007
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).