(112 days)
No
The device is a chemical indicator strip that changes color based on glutaraldehyde concentration, with no mention of AI or ML in the description or performance studies.
No.
The device is an indicator to monitor the concentration of a high-level disinfectant, not for treating any bodily condition or disease.
No
The device monitors the concentration of glutaraldehyde in a disinfectant solution, not a physiological or biological condition of a human or animal. It is used to ensure the efficacy of a disinfectant, not to diagnose a disease or condition.
No
The device description explicitly states it is a "chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals," which is a physical component, not software.
Based on the provided information, the Browne Aldahol Glutaraldehyde Indicator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to monitor the concentration of a high-level disinfectant (glutaraldehyde) in a solution. This is a quality control or process monitoring function, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device is a chemical indicator strip designed to react with glutaraldehyde in a solution. It does not interact with or analyze biological specimens.
- Lack of Biological Sample Interaction: IVD devices are specifically designed to examine specimens derived from the human body (e.g., blood, urine, tissue). This device does not use such specimens.
- Focus on Disinfectant Concentration: The purpose is to ensure the disinfectant solution is at the correct concentration for effective sterilization, not to provide information about a patient's health status.
Therefore, the Browne Aldahol Glutaraldehyde Indicator falls outside the scope of an In Vitro Diagnostic device. It is a chemical indicator used for quality control of a disinfectant solution.
N/A
Intended Use / Indications for Use
The Browne Aldahol Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Aldahol V High-Level Disinfectant. The purpose of the Browne Aldahol Glutaraldehyde Indicator is to monitor glutaraldehyde concentration greater than 1.8%.
Product codes
JOJ
Device Description
The Browne Aldahol Glutaraldehyde Indicator is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals, which is adhesively bonded to one end of a polymer film. The Browne Aldahol Glutaraldehyde Indicator has been developed to monitor the active glutaraldehyde concentration of Aldahol V High-Level Disinfectant (K113015) solution that has an MRC of 1.8% glutaraldehyde.
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
The following table summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the Browne Aldahol Glutaraldehyde Indicator is safe and effective. These studies confirm that the device's performance meets the requirements of its pre-defined acceptance criteria and intended uses.
| Test of 6 Lots | Acceptance Criteria | Study Result | |
|---|---|---|---|
| FAIL @ 1.8% | PASS @ 2.3% | ||
| Performance Testing | 100% | ≥ 80% | Pass |
| Blind Study Testing | 100% | ≥ 80% | Pass |
| Simulated Use (Contaminants) Testing | 100% | ≥ 80% | Pass |
| Test Strip Life Outside the Bottle | 100% | ≥ 80% | Pass |
| Aggressive Chemical Stability Testing | 100% | ≥ 80% | Pass |
| Specificity Testing for glutaraldehyde | 100% | 100% FAIL for Tap Water | Pass |
| Stability Testing in three storage environments | 100% | ≥ 80% | Pass |
| In-Use Stability Testing in three storage environments | 100% | ≥ 80% | Pass |
Key Metrics
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
Image /page/0/Picture/0 description: The image shows the STERIS logo, along with the code K120436. The STERIS logo is a stylized wave pattern. The image also contains the date JUN - 4 2012.
510(k) Summary For Browne Aldahol Glutaraldehyde Indicator
Albert Browne Ltd., a subsidiary of STERIS Corporation Chancery House 190 Waterside Road Hamilton Industrial Park Leicester LES IQZ United Kingdom Phone: +44 116 276 8636 Fax No: +44 116 276 8639
Contact:
Bill Brodbeck Senior Manager Regulatory Affairs Telephone: (440) 392-7690 Fax No: (440) 357-9198
Summary Date:
February 10, 2012
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
.
1
1. Device Name
| Trade Name: | Browne Aldahol Glutaraldehyde Indicator |
|---|---|
| Common/Usual Name: | Browne Aldahol Test Strip |
| Classification Name: | Physical/chemical sterilization process indicator (21 |
| CFR 880.2800 (b), Product Code JOJ). |
2. Predicate Device
- K924681 3M™ ComplyTM Cold Sterilog™ Glutaraldehyde Monitor 3987MM .
3. Description of Device
The Browne Aldahol Glutaraldehyde Indicator is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals, which is adhesively bonded to one end of a polymer film. The Browne Aldahol Glutaraldehyde Indicator has been developed to monitor the active glutaraldehyde concentration of Aldahol V High-Level Disinfectant (K113015) solution that has an MRC of 1.8% glutaraldehyde.
4. Intended Use
The Browne Aldahol Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Aldahol V High-Level Disinfectant solution cleared under K113015. The purpose of the Browne Aldahol Glutaraldehyde Indicator is to determine whether the glutaraldehyde concentration of an Aldahol V High-Level Disinfectant solution is above the minimum recommended concentration, allowing the solution to be re-used for reprocessing temperature-sensitive (and other) instruments if the glutaraldehyde concentration is found to be greater than 1.8%.
5. Description of Safety and Substantial Equivalence
The proposed and predicate devices are all single use indicators used to monitor glutaraldehyde concentration in specific solutions. The differences between the proposed Browne Aldahol Glutaraldehyde Indicator and predicate device are limited to differences in the device design and materials. These differences do not raise any new issues of safety and efficacy.
2
A summary of the technological characteristics of the new device in comparison to those of the predicate device is provided in Section 12 of this premarket notification.
The following table summarizes the verification activities that were performed, with their respective acceptance criteria and results, to demonstrate that the Browne Aldahol Glutaraldehyde Indicator is safe and effective. These studies confirm that .the device's performance meets the requirements of its pre-defined acceptance criteria and intended uses.
| Test of 6 Lots | Acceptance Criteria | | Study
Result |
|-----------------------------------------------------------|---------------------|-------------------------|-----------------|
| | FAIL @ 1.8% | PASS @ 2.3% | |
| Performance Testing | 100% | ≥ 80% | Pass |
| Blind Study Testing | 100% | ≥ 80% | Pass |
| Simulated Use
(Contaminants) Testing | 100% | ≥ 80% | Pass |
| Test Strip Life
Outside the Bottle | 100% | ≥ 80% | Pass |
| Aggressive Chemical
Stability Testing | 100% | ≥ 80% | Pass |
| Specificity Testing
for glutaraldehyde | 100% | 100% FAIL for Tap Water | Pass |
| Stability Testing in three
storage environments | 100% | ≥ 80% | Pass |
| In-Use Stability Testing in
three storage environments | 100% | ≥ 80% | Pass |
The Browne Aldahol Glutaraldehyde Indicator is substantially equivalent to its predicate.
r
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized depiction of a caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with a snake winding around it, and a pair of wings at the top.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Bill Brodbeck Senior Manager, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
JUN - 4 2012
Re: K120435
Trade/Device Name: Browne Aldahol Glutaraldehyde Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: May 10, 2012 Received: May 11, 2012
Dear Dr. Brodbeck:
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 - Dr. Brodbeck
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 yours,
Anthony D. 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): K120435
Device Name:
Browne Aldahol Glutaraldehyde Indicator
Indications for Use:
The Browne Aldahol Glutaraldehyde Indicator is a glutaraldehyde concentration monitor dedicated for use with Aldahol V High-Level Disinfectant. The purpose of the Browne Aldahol Glutaraldehyde Indicator is to monitor glutaraldehyde concentration greater than 1.8%.
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)
Elizabeth F. Clannie-Willin.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K120435 510(k) Number:
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