(146 days)
No
The device description and performance studies focus on chemical indicators and physical barriers, with no mention of AI or ML.
No.
This device is an indicator used to monitor the effectiveness of a steam sterilization cycle, not to provide therapy or treatment for a medical condition.
No
The device is an emulating indicator (Class 6 chemical indicator) used to monitor the sterilization process, not to diagnose a medical condition in a patient.
No
The device description clearly outlines a physical product consisting of indicator inks on a test sheet surrounded by a steam penetration barrier. It is a hardware-based device used for monitoring sterilization cycles.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor steam sterilization cycles for medical devices. It's a process indicator, not a test performed on a biological sample to diagnose a condition or provide information about a patient's health.
- Device Description: The device consists of indicator inks that change color based on exposure to steam, temperature, and time. This is a physical/chemical reaction, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient
- Analyzing biomarkers or other biological markers
The device falls under the category of sterilization process indicators, which are used to verify that sterilization equipment is functioning correctly.
N/A
Intended Use / Indications for Use
The Verify® 270FP Challenge Pack is a test pack consisting of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier, intended for use in SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization. The Verify® 270FP Challenge Pack indicators change color from yellow to blue/purple when exposed to the following conditions at 270°F (132°C):
- 4 minute indicator SFPP and pre-vacuum steam sterilization for 4 minutes. .
- 10 minute indicator Pre-vacuum steam sterilization for 10 minutes. .
- 20 minute indicator Pre-vacuum steam sterilization for 20 minutes. .
Product codes
JOJ
Device Description
The proposed Verify® 270FP Challenge Pack consists of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier. The indicator inks on the proposed Verify® 270FP Challenge Pack test sheet change from yellow to blue/purple color when exposed to saturated steam at 270°F (132°C) for the following times.
- 4 minute indicator The 4 minute indicator ink on the Verify® 270FP . Challenge Pack can be used to monitor a 4 minute SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization cycle.
- 10 minute indicator The 10 minute indicator ink on the Verify 270FP . Challenge Pack can be used to monitor a 10 minute pre-vacuum steam sterilization cycle.
- 20 minute indicator The 20 minute indicator ink on the Verify® 270FP . Challenge Pack can be used to monitor a 20 minute 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).
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)
Performance testing was conducted to verify that the proposed emulating indicator inks within the test pack meet the requirements for Class 6 indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSI/AAMI/ISO 18472.
Further testing was conducted to demonstrate the efficacy of the barrier material using a 16-towel test pack with biological indicators as a reference. The 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
STERIS®
MAR | Q 2011
510(k) Summary For Verify® 270FP Challenge Pack
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Robert Sullivan Senior Director, Regulatory Affairs
Telephone: (440) 392-7695 Fax No: (440) 357-9198
Submission Date: March 10, 2011
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
1
K103053
p² of 3
1. Device Name
| Indicator Pack Model: | Verify® 270FP Challenge Pack |
|---|---|
| Common Name: | Chemical Indicator |
| Classification Name: | Physical/chemical sterilization process indicator (21 |
| CFR 880.2800 (b), Product Code JOJ). |
Predicate Device 2.
3. Device Description
The proposed Verify® 270FP Challenge Pack consists of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier. The indicator inks on the proposed Verify® 270FP Challenge Pack test sheet change from yellow to blue/purple color when exposed to saturated steam at 270°F (132°C) for the following times.
- 4 minute indicator The 4 minute indicator ink on the Verify® 270FP . Challenge Pack can be used to monitor a 4 minute SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization cycle.
- 10 minute indicator The 10 minute indicator ink on the Verify 270FP . Challenge Pack can be used to monitor a 10 minute pre-vacuum steam sterilization cycle.
- 20 minute indicator The 20 minute indicator ink on the Verify® 270FP . Challenge Pack can be used to monitor a 20 minute 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® 270FP Challenge Pack is a test pack consisting of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier,
2
K103053/S001 STERIS Response to 3/10/11 Request for Clarification Verify 270FP Challenge Pack
intended for use in SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization. The Verify® 270FP Challenge Pack indicators change color from yellow to blue/purple when exposed to the following conditions at 270°F (132°C):
- 4 minute indicator SFPP and pre-vacuum steam sterilization for 4 minutes. .
- 10 minute indicator Pre-vacuum steam sterilization for 10 minutes. .
- 20 minute indicator Pre-vacuum steam sterilization for 20 minutes. .
રાં Description of Safety and Substantial Equivalence
The proposed and predicate devices are all single use indicator test packs for use in steam sterilization cycles. The differences between the proposed Verify® 270FP Challenge Pack and predicate devices are limited to differences in design, materials and parameters of the sterilization cycles these indicator test packs are designed to monitor. These differences do not raise any new issues of safety or efficacy.
Performance Testing 6.
Performance testing was conducted to verify that the proposed emulating indicator inks within the test pack meet the requirements for Class 6 indicators as defined in ANSI/AAMI ISO 11140-1:2005 using a resistometer to ANSI/AAMI/ISO 18472.
Further testing was conducted to demonstrate the efficacy of the barrier material using a 16-towel test pack with biological indicators as a reference. The predicate test packs were included in this testing.
3
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Robert Sullivan Senior Director, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
MAR 1 Q 2011
Re: K103053
Trade/Device Name: Verify® 270FP Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: February 4, 2011 Received: February 7, 2011
Dear Mr. Sullivan;
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class.III (PMA), it may be subject to 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. Sullivan
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vou
Anthony Watson, B.S., M.S., M.B.A. 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):
Device Name:
Verify® 270FP Challenge Pack
Indications For Use:
The Verify® 270FP Challenge Pack is a test pack consisting of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier, intended for use in SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization. The Verify® 270FP Challenge Pack indicators change color from yellow to blue/purple when exposed to the following conditions at 270°F (132°C):
- 4 minute indicator SFPP and pre-vacuum steam sterilization for 4 minutes. .
- 10 minute indicator Pre-vacuum steam sterilization for 10 minutes. .
- 20 minute indicator Pre-vacuum steam sterilization for 20 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)
Page 1 of 1
Eldith S. (Clavis. William
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices,
510(k) Number: K103053