(221 days)
Not Found
No
The device description and performance studies indicate a chemical indicator that changes color based on physical sterilization parameters, with no mention of AI/ML or related concepts.
No
The device is an integrating integrator that changes color when exposed to specific conditions for steam sterilization. It is used to verify sterilization conditions rather than for treating a medical condition or disease.
No
The device is a chemical indicator used to verify the conditions of steam sterilization, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a polypropylene strip with chemical indicator ink spots, indicating it is a physical, hardware-based device, not software.
Based on the provided information, the Verify Flash Integrator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to indicate whether specific steam sterilization conditions have been met. This is a quality control or process monitoring function, not a diagnostic test performed on a biological sample to diagnose a disease or condition.
- Device Description: The device is a chemical indicator that changes color based on exposure to heat and steam. It does not interact with biological samples.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for the diagnosis, treatment, or prevention of disease
- Measuring analytes in biological specimens
The Verify Flash Integrator is a sterilization process indicator, used to verify that a sterilization cycle has reached the required parameters. This falls under the category of medical device accessories or quality control tools, not IVDs.
N/A
Intended Use / Indications for Use
The Verify Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions:
- 270°F (132°C), 10 min. flash gravity steam sterilization .
- 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization .
Product codes
JOJ
Device Description
The proposed Verify Flash Integrator is a polypropylene strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color. The stated values for the two indicator inks printed on the Verify Flash integrator are provided in Table 1.
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)
Data was provided that demonstrates that the Verify Flash Integrator meets the requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60-1996 "Sterilization of health care products - Chemical indicators - Part 1: General Requirements" for 132°C sterilization cycles. Simulated use testing confirms that the Verify Flash Integrator performed as expected in a 10 min. gravity flash and the 4 min. Express abbreviated prevacuum steam sterilization cycles at 132°C.
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
DEC 6 2005 510(k) Summary for Verify Flash Integrator
1. SPONSOR
Albert Browne Ltd., subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom
| Contact: | Richard Bancroft |
|---|---|
| Telephone: | 0116 276 8636 |
Date Prepared: December 1, 2005
2. DEVICE NAME
| Proprietary Name: | Verify Flash Integrator |
|---|---|
| Common/Usual Name: | Chemical indicator |
| Classification Name: | Physical/chemical sterilization process indicator |
3. PREDICATE DEVICE
- TST Control Integrator for Steam Sterilizers (K002937) .
DEVICE DESCRIPTION 4.
The proposed Verify Flash Integrator is a polypropylene strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color. The stated values for the two indicator inks printed on the Verify Flash integrator are provided in Table 1.
1
| Temp | Exposure Time |
|---|---|
| (°C/°F) | (Min.) |
| 132/270 | 10 |
| 132/270 | 4 |
Table 1. Stated Values for Verify Flash Integrator Inks
ડ. INTENDED USE
The Verify Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions:
- 270°F (132°C), 10 min. flash gravity steam sterilization .
- 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization .
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The proposed Verify Flash Integrator and the predicate TST Control Integrator indicate exposure to critical combination(s) of temperature and exposure time through a visible color change in an indicator ink spot printed on polypropylene. Differences between the proposed and predicate integrators are limited to minor differences in the materials used for construction of the strip and the indicator ink composition.
7. PERFORMANCE TESTING
Data was provided that demonstrates that the Verify Flash Integrator meets the requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSI/AAMI ST60-1996 "Sterilization of health care products - Chemical indicators - Part 1: General Requirements" for 132°C sterilization cycles. Simulated use testing confirms that the Verify Flash Integrator performed as expected in a 10 min. gravity flash and the 4 min. Express abbreviated prevacuum steam sterilization cycles at 132°C.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, curved lines that converge at the bottom, resembling a stylized human form.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 6 2005
Albert Browne Limited C/O Dr. Cynthia J. M. Nolte Senior Staff Consultant Medical Device Consultant, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760-4153
Re: K051101
Trade/Device Name: Verify Flash Integrator Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: November 22, 2005 Received: November 23, 2005
Dear Dr. Nolte:
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 approval applisions 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 (1 wr 1, 1 may 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 Ecderal Register.
3
Page 2 - Mr. Nolte
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be act rised that 12 a determination that your device complies with other requirements moun that + D + + any Federal statutes and regulations administered by other Federal agencies. or the rece of unly 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 and ifing (21 ever forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as bet form 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 premarket notification. - In device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n for accented 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 maj count 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,
Sitta G. Michael MD.
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
4
510(k) Number: K051101
Device Name: Verify Flash Integrator
Indications For Use:
The Verify Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions:
- 270°F (132°C), 10 min. flash gravity steam sterilization .
- 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization .
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule H. Murphy, M.D. 12/6/65
alson General Hus; mtrol, Danusi Devices