(146 days)
No
The device is a chemical indicator that changes color based on temperature and steam exposure, with no mention of AI or ML in its description or performance studies.
No
The device is a chemical indicator used to confirm exposure to steam in a sterilizer, not for treating a disease or condition in a patient.
No
Explanation: This device is a chemical process indicator used to verify exposure to steam sterilization conditions, not to diagnose a disease or condition in a patient.
No
The device is a chemical indicator consisting of ink applied to a substrate, which undergoes a physical color change. This is a hardware-based device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to indicate exposure to steam sterilization conditions (temperature and time) in an autoclave. This is a process control for sterilization, not a diagnostic test performed on biological samples.
- Device Description: The device is a chemical indicator that changes color based on exposure to steam. It does not interact with or analyze biological specimens.
- Performance Studies: The performance studies focus on the indicator's ability to meet standards for process indicators for steam sterilization (ANSI/AAMI ST60). There are no studies related to diagnosing or monitoring a medical condition.
- Lack of IVD Characteristics: The text lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnosing, monitoring, or predicting a disease or condition
- Providing information about a patient's health status
This device is clearly intended as a sterilization process indicator, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Browne Packaging and Label Steam Process Indicator (Packaging and Label Steam Indicator) is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 134°C (250°F to 273°F).
Product codes
JOJ
Device Description
The Packaging and Label Steam Indicator is a chemical indicator consisting of indicator ink applied to a suitable substrate. The indicator ink changes color from pink to purple in a steam autoclave in a temperature range of 121°C to 134°C (250°F to 273°F).
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
Albert Browne Ltd. has performed testing which demonstrates that the Browne Packaging and Label Steam Indicator conform to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization. Additional testing showed that the indicator changed color after approximately 2.5 minutes exposure to a 132°C autoclave processing cycle. Data was provided to support a two-year shelf life.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
ABBREVIATED 510(K) SUMMARY ALBERT BROWNE LTD. BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
-
- Albert Browne Ltd. SUBMITTED BY: Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom
- CONTACT PERSON: Alan Charlton Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LE5 1QZ United Kingdom
November 8, 1999 Date Prepared:
-
- Browne Packaging and Label Steam Process Indicator DEVICE NAME: Physical/chemical sterilization process indicator Classification Name: Classification Status: Physical/chemical process indicators are classified as
- Class II under Sterilization process indicator in 21 CFR 880.2800 by the General Hospital and Personal Use Devices Panel.
3. PREDICATE DEVICE
3M Autoclave Tape, 3M Health Care (K932129)
1
INTENDED USE 4.
The Browne Packaging and Label Steam Process Indicator (Packaging and Label Steam Indicator) is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 134°C (250°F to 273°F).
5. DEVICE DESCRIPTION
The Packaging and Label Steam Indicator is a chemical indicator consisting of indicator ink applied to a suitable substrate. The indicator ink changes color from pink to purple in a steam autoclave in a temperature range of 121°C to 134°C (250°F to 273°F).
The purpose of this submission is to:
- . Replace the process indicator on the outer wrapper of the Browne TST Single Use Bowie Dick Type Test Pack (Browne Bowie Dick Test Pack, K971971) with the Packaging and Label Steam Indicator;
- Market the Packaging and Label Steam Indicator, consisting of indicator ink . printed onto clay-coated label stock with permanent or peelable adhesive and a siliconized backing.
6. TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the Packaging and Label Steam Indicator and the 3M Autoclave Tape are similar. The proposed and predicate devices consist of indicator ink applied to a substrate. The indicator ink changes color to confirm exposure to steam. The proposed device changes color from pink to purple and the predicate device changes color from off white to brown.
The predicate device is composed of indicator ink applied to a paper substrate. The Packaging and Label Steam Indicator consists of indicator ink applied using a printing method to steam sterilizable paper or clay-coated label stock.
Browne Packaging and Label Steam Process Indicator 11/8/99 Additional Information - K992767
2
7. PERFORMANCE TESTING
Albert Browne Ltd. has performed testing which demonstrates that the Browne Packaging and Label Steam Indicator conform to the applicable requirements of ANSI/AAMI ST60 for Class I process indicators for steam sterilization. Additional testing showed that the indicator changed color after approximately 2.5 minutes exposure to a 132°C autoclave processing cycle. Data was provided to support a two-year shelf life.
Browne Packaging and Label Steam Process Indicator 11/8/99 い Additional Information - K992767
3
Image /page/3/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized lines that resemble a person or a bird.
JAN 1 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cynthia J.M. Nolte, Ph.D., RAC Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, MA 02760
K992767 Re : Browne Packaging and Label Steam Process Trade Name: Indicator Class: II Product Code: JOJ Dated: November 8, 1999 Received: November 9, 1999
Dear Dr. Nolte:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in
4
Page 2 & Dr. Nolte
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of obligation you might have the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaf.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K992767
Device Name: Browne Packaging and Label Steam Process Indicator
Indications for Use:
The Browne Packaging and Label Steam Process Indicator is a process indicator which undergoes a visual color change when exposed to steam in a temperature range of 121°C to 134°C (250°F to 273°F).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olin S. Lakin
(Division Sign Off)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Albert Browne Ltd. 8/16/99 Packaging and Label Steam Indicator 510(k)
CONFIDENTIAL Page vii