(128 days)
Not Found
No
The device is a chemical indicator that changes color based on exposure to specific sterilization parameters. There is no mention of AI or ML in the description, intended use, or performance studies.
No.
The device is a chemical indicator used to monitor the effectiveness of a sterilization procedure, not to directly treat a medical condition or disease.
No
Explanation: This device is a chemical indicator used to monitor the completion of sterilization cycles by changing color, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a physical polypropylene strip with a chemical indicator ink spot, which is a hardware component.
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 a sterilization process for medical devices used by healthcare providers. It's a process indicator, not a diagnostic tool used to test a biological sample from a patient to diagnose a condition or provide information about their health.
- Device Description: The device is a chemical indicator that changes color based on exposure to specific sterilization parameters (temperature and time). It doesn't interact with biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing diseases, or providing information about a patient's health status.
- Performance Studies: The performance studies focus on verifying the indicator's ability to meet standards for emulating sterilization indicators, not on diagnostic accuracy metrics like sensitivity, specificity, etc.
This device falls under the category of a sterilization process indicator, which is a type of medical device used to monitor the effectiveness of sterilization cycles.
N/A
Intended Use / Indications for Use
The Verify® 275F 3 Indicator is a chemical indicator intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The Verify® 275F 3 Indicator is an emulating indicator intended for use in steam sterilization. The indicator changes color from yellow to blue/purple when exposed to 275°F (135°C) pre-vacuum sterilization cycles for 3 minutes as indicated in the following table:
| MODEL | TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|---|
| Verify 275F 3 | 275°F (135°C) | Pre-vacuum steam | 3 minutes |
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The proposed Verify® 275F 3 Indicator consist of:
- A 22 mm x 143 mm polypropylene strip with one 12 mm chemical indicator . ink spot.
The indicator ink spot is located on one end of the strip, adjacent to a reference block exhibiting the endpoint color. The indicator ink on the proposed Verify" 275F 3 Indicator changes from yellow to blue/purple color when the steam sterilization cvclc is complete.
The Verify® 275F 3 Indicator can be used to monitor 3 minute 275°F (135°C) prevacuum steam sterilization cycles.
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 Verify® 275F 3 Indicator mect the requirements for emulating [Class 6] indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSI/AAMI ST44.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K894399, K012195, K960441, K902958, K002937, K963841
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KO71895
STERIS®
NOV 1 4 2007
510(k) Summary For Verify® 275F 3 Indicator
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (216) 354-2600 Fax No: (216) 639-4459
Contact:
Jack Scoville Fellow, Regulatory Affairs
Telephone: 440 392 7330 Fax No: 440 397 9198
Submission Date:
July 06, 2007
STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600
1
1. Device Name
| Indicator: | Verify® 275F 3 Indicator. |
|---|---|
| Common Name: | Chemical Indicator. |
| Classification Name: | Physical/chemical sterilization process indicator (21 |
| CFR 880.2800 (b), Product Code JOJ). |
2. Predicate Devices
- 3M SteriGage Chemical Indicators (K894399) .
- DANA SteriScan Indicators (K012195) .
- SteriTec Integraph (Cardinal Steam Integrators' ) (K960441) .
- STERIS Verify Integrators (K902958, K002937) .
- EZ Test Steam Biological Indicator (K963841) .
3. Device Description
The proposed Verify® 275F 3 Indicator consist of:
- A 22 mm x 143 mm polypropylene strip with one 12 mm chemical indicator . ink spot.
The indicator ink spot is located on one end of the strip, adjacent to a reference block exhibiting the endpoint color. The indicator ink on the proposed Verify" 275F 3 Indicator changes from yellow to blue/purple color when the steam sterilization cvclc is complete.
The Verify® 275F 3 Indicator can be used to monitor 3 minute 275°F (135°C) prevacuum steam sterilization cycles.
4. Intended Use
The Verify® 275F 3 Indicator is a chemical indicator intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The Verify® 275F 3 Indicator is an emulating indicator intended for use in steam sterilization. The indicator changes color from yellow to blue/purple when exposed to 275°F (135°C) pre-vacuum sterilization cycles for 3 minutes. The performance of
Cardinal is a private label brand produced by Steritec under K960441.
2
STERIS ABBREVIATED 510(k) PREMARKET NOTIFICATION VERIFY® 275F 3 INDICATOR
the Verify® 275F 3 Indicator meets the requirements of ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] steam indicators.
5. Description of Safety and Substantial Equivalence
The proposed and predicate devices are all single use indicators for use in steam sterilization cycles. The differences between the proposed Verify" 275F 3 Indicator and the predicate device are limited to differences in design, matcrial, 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 Verify® 275F 3 Indicator mect the requirements for emulating [Class 6] indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSI/AAMI ST44.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a row. The profiles are simple and abstract, with flowing lines suggesting hair or movement. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2007
Mr. John Scoville Fellow, Regulatory Affairs Sterilization Technology STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
Re: K071895
Trade/Device Name: Verify® 275F 3 Indicator Regulation Number: 880.2800 Regulation Name: Sterilization process Indicator Regulatory Class: II Product Code: JOJ Dated: October 25, 2007 Received: October 26, 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 (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,
Chiu 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
510(k) Number (if known): K071895
Verify® 275F 3 Indicator Device Name:
Indications for Use:
The Verify® 275F 3 Indicator is a chemical indicator intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The Verify® 275F 3 Indicator is an emulating indicator intended for use in steam sterilization. The indicator changes color from yellow to blue/purple when exposed to 275°F (135°C) pre-vacuum sterilization cycles for 3 minutes as indicated in the following table:
| MODEL | TEMPERATURE | STERILIZATION TYPE | TIME |
|---|---|---|---|
| Verify 275F 3 | 275°F (135°C) | Pre-vacuum steam | 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)
Sheila A. Murphy, MD
logy Center
Neal Davis
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