(74 days)
No
The device is a chemical indicator that changes color based on exposure to specific sterilization conditions, with no mention of AI or ML in the description or performance studies.
No.
The device is an integrating integrator for monitoring steam sterilization cycles, not a device used to treat or diagnose a medical condition in a patient.
No.
This device is an integrating integrator that changes color to verify sterilization conditions have been met; it is not used to diagnose a patient's medical condition.
No
The device description clearly states it is a physical strip with chemical indicator ink spots, indicating it is a hardware device, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to monitor steam sterilization cycles for medical devices. This is a quality control measure for the sterilization process itself, not a test performed on 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 conditions. It does not 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.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Albert Browne Ltd. Verify Gravity Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions:
- . 270°F (132°C), 3 min. flash gravity steam sterilization
- 270°F (132°C), 10 min. flash gravity steam sterilization .
Product codes
JOJ
Device Description
The proposed Albert Browne, Ltd. Verify Gravity Flash Integrator is a 22 mm x 143 mm strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color. The proposed integrator can be used to monitor 3 min. and 10 min. 132°C gravity flash 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
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)
The performance of both the 3 min. and 10 min. indicator inks used in the proposed Verify Gravity Flash Integrator was evaluated in the 510(k) premarket notifications for the predicate devices (K002937 and K051101). However, the substrates are slightly different for the proposed Verify Gravity Flash Integrator and predicate TST Control Integrator. Therefore, the performance testing for the 3 min. indicator ink was repeated using the Verify Gravity Flash Integrator. Performance testing was conducted to verify that the 3 min. indicator ink printed on the polypropylene substrate meets the requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSVAAMI ST60-1996 "Sterilization of health care products - Chemical indicators - Part 1: General Requirements". Simulated use testing submitted in K060066 confirms that the Verify Gravity Flash Integrator performed as expected 132°C 3 min. gravity in flash steam sterilization cycles.
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
K060066 page 1 of 2
510(k) Summary for Albert Browne Ltd., Verify Gravity Flash Integrator
MAR 2 4 2006
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: March 13, 2006
2. DEVICE NAME
| Proprietary Name: | Albert Browne, Ltd. Verify Gravity Flash Integrator |
|---|---|
| Common/Usual Name: | Chemical indicator |
| Classification Name: | Physical/chemical sterilization process indicator |
3. PREDICATE DEVICE
4. DEVICE DESCRIPTION
The proposed Albert Browne, Ltd. Verify Gravity Flash Integrator is a 22 mm x 143 mm strip with two 12 mm circular chemical indicator ink spots, one located on either side of a reference circle exhibiting the endpoint color. The proposed integrator can be used to monitor 3 min. and 10 min. 132°C gravity flash steam sterilization cycles.
1
K060066 page 2 of 2
5. INTENDED USE
The Albert Browne Ltd. Verify Gravity Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions:
- . 270°F (132°C), 3 min. flash gravity steam sterilization
- 270°F (132°C), 10 min. flash gravity steam sterilization .
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The proposed Albert Browne, I.td. Verify Gravity Flash Integrator (Verify Gravity Flash Integrator) is printed with two chemical indicator inks with stated values of 3 min. and 10 min. at 132°C. The 10 min. integrator ink printed on the proposed Verify Gravity Flash Integrator is identical to the 10 min. ink printed on the predicate Verify Flash Integrator. The 3 min. integrator ink printed on the proposed Verify Gravity Flash Integrator is identical to the indicator ink printed on the predicate TST Control Integrator. The differences between the proposed and predicate devices are limited to minor differences in substrates and configuration that do not raise any new issues of safety and effectiveness.
7. PERFORMANCE TESTING
The performance of both the 3 min. and 10 min. indicator inks used in the proposed Verify Gravity Flash Integrator was evaluated in the 510(k) premarket notifications for the predicate devices (K002937 and K051101). However, the substrates are slightly different for the proposed Verify Gravity Flash Integrator and predicate TST Control Integrator. Therefore, the performance testing for the 3 min. indicator ink was repeated using the Verify Gravity Flash Integrator. Performance testing was conducted to verify that the 3 min. indicator ink printed on the polypropylene substrate meets the requirements for Class 5 integrating indicators as defined in clauses 9.1 and 9.3 of ANSVAAMI ST60-1996 "Sterilization of health care products - Chemical indicators - Part 1: General Requirements". Simulated use testing submitted in K060066 confirms that the Verify Gravity Flash Integrator performed as expected 132°C 3 min. gravity in flash steam sterilization cycles.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of four human profiles facing to the right, with flowing lines representing hair or movement. The profiles are simple and abstract, creating a sense of unity and forward motion.
MAR 2 4 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Albert Browne Limited C/O Dr. Cynthia J. M. Nolte Senior Regulatory Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K060066
Trade/Device Name: Albert Browne Ltd., Verify Gravity Flash Integrator Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: March 13, 2006 Received: March 15, 2006
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 approvisions 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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 writ), it inches an 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.
3
Page 2 -- Dr. Nolte
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 mean that or any Federal statutes and regulations administered by other Federal agencies. or the For of 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 insing (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as lectronic 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 premiumes actived.com - a 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), rryou decire of the Office of Compliance at (240) 276-0120. Also, please note the regulation cntitled, "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 oveans 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,
C. R.
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
4
Indications for Use
510(k) Number: K060066
Device Name: Albert Browne Ltd., Verify Gravity Flash Integrator
Indications for Use:
The Albert Browne Ltd. Verify Gravity Flash Integrator is an integrating integrator that changes color from yellow to blue/purple when exposed to the following conditions:
- 270°F (132°C), 3 min. flash gravity steam sterilization .
- 270°F (132°C), 10 min. flash gravity steam sterilization .
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A. Murphy, MD 3/23/04
General Hospital,
K chloril