(159 days)
Not Found
No
The device is a chemical indicator that changes color based on exposure to steam sterilization parameters. There is no mention or indication of AI/ML technology in the description or performance studies.
No.
This device is a chemical indicator test pack used to monitor the effectiveness of steam sterilization cycles, not to provide therapy to a patient.
No
This device is a chemical indicator test pack used to verify the proper function of sterilization equipment, not to diagnose a medical condition in a patient.
No
The device is a chemical indicator test pack, which is a physical product designed to change color based on exposure to steam sterilization conditions. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of a steam sterilization process for medical devices. It's a quality control tool for the sterilization equipment, not a test performed on a biological sample from a patient to diagnose a condition or provide information about a physiological state.
- Mechanism of Action: The device works by a chemical indicator changing color based on exposure to specific time and temperature parameters during a sterilization cycle. This is a chemical reaction, not a biological or immunological test performed on a patient sample.
- Anatomical Site/Patient Information: The device is not applied to or used with a patient. It's used within a sterilization chamber alongside medical devices.
- Lack of Biological Sample Testing: There is no mention of testing blood, urine, tissue, or any other biological sample from a patient.
The device is a sterilization process indicator, specifically a chemical indicator test pack designed to verify that the sterilization cycle has reached the required parameters. This falls under the category of devices used in the processing of medical devices, not in the diagnosis or treatment of patients.
N/A
Intended Use / Indications for Use
The Verify® Challenge Packs 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 meets the requirements of ANSI/AAMI / ISO 11140-1-2005 for emulating [Class 6] steam indicators.
Product codes
JOJ
Device Description
The proposed Verify® Challenge Packs 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® 270°F 4 Challenge Pack can be used to monitor a 4 minute . 270°F/132°C Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum steam sterilization cycle.
- The Verify® 275°F 3 Challenge Pack can be used to monitor a 3 minute ● 275°F/135°C pre-vacuum steam sterilization cycle.
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
health care providers
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)
Performance testing was conducted to verify that the proposed indicators within the challenge packs meet the requirements for emulating [Class 6] indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a prototype resistometer to ANSI/AAMI ISO 18472.
Further testing was conducted to demonstrate the efficacy of the barrier material using an AAMI 16 Towel Pack with biological indicators as references. Predicate test packs were included in this testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the STERIS logo with a wavy line design underneath. The logo is in black and white. Below the logo is the number K070895, which appears to be handwritten.
510(k) Summary For Verify® Steam Indicators
SEP - 5 2007
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 |
Date Prepared: July 23, 2007
STERIS Corporation = 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
1
1. Device Name
| Challenge Packs Models: | Verify® 270°F 4 Challenge Pack
Verify® 275°F 3 Challenge Pack |
|-------------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Chemical Indicator |
| Classification Name: | Physical/chemical sterilization process indicator (21 CFR 880.2800 (b), Product Code JOJ). |
2. Predicate Devices
- STERIS Integrator Challenge Pack (Model LCC003) -K002741 .
Device Description 3.
The proposed Verify® Challenge Packs 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® 270°F 4 Challenge Pack can be used to monitor a 4 minute . 270°F/132°C Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum steam sterilization cycle.
- The Verify® 275°F 3 Challenge Pack can be used to monitor a 3 minute ● 275°F/135°C pre-vacuum steam sterilization cycle.
4. Intended Use
The Verify® Challenge Packs 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 meets the requirements of ANSI/AAMI / ISO 11140-1-2005 for emulating [Class 6] steam indicators.
2
5. Description of Safety and Substantial Equivalence
The proposed and predicate devices are all single use indicator packs for use in steam sterilization cycles. The differences between the proposed bundled Verify® Challenge Packs and predicate device are limited to differences in design, material, and parameters of the sterilization cycles these indicators are designed to monitor. These differences do not raise any new issues of safety and efficacy.
6. Performance Testing
Performance testing was conducted to verify that the proposed indicators within the challenge packs meet the requirements for emulating [Class 6] indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a prototype resistometer to ANSI/AAMI ISO 18472.
Further testing was conducted to demonstrate the efficacy of the barrier material using an AAMI 16 Towel Pack with biological indicators as references. Predicate test packs were included in this testing.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2007
Mr. John Scoville Fellow, Regulatory Affairs Steris, Corporation 5960 Heisley Road Mentor, Ohio 44060-1834
Re: K070895
Trade/Device Name: Verify" Challenge Packs Models Verify 270F 4 and Verify 275F 3 Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: August 23, 2007 Received: August 24, 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.
4
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 (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), 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.
Chiv Lin, Ph.D.
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
5
Indications for Use
K070895 510(k) Number (if known):
Device Name:
Verify® Challenge Packs
Indications For Use:
The Verify® Challenge Packs 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 |
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)
Shule H Murphy MD
Fision Sign-Off) Livision of Anesthesiology, General Hospital, Infection Control, Dental Davices
510(k) Number. N 020
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