(177 days)
No
The document describes a biological indicator for sterilization monitoring, which is a physical device and does not mention any computational or algorithmic components indicative of AI/ML.
No
This device is a biological indicator used to monitor the effectiveness of steam sterilization cycles, not to treat a medical condition or ailment.
No
This device is a biological indicator used to monitor the effectiveness of steam sterilization cycles, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a "Self-Contained Biological Indicator" consisting of a plastic vial, inoculated disc, and culture media, which are physical components, not software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used for "installation testing and routine monitoring of the following steam sterilization cycle". This involves testing the effectiveness of a sterilization process, which is a critical step in ensuring the safety of medical devices and preventing the spread of infections.
- Device Description: The device contains a "disc inoculated with Geobacillus stearothermophilus and/or Bacillus atrophaeus spores and an ampoule of culture media." This is a classic setup for a biological indicator, which works by seeing if the sterilization process successfully kills the spores. The growth of the spores in the culture media indicates a failure in sterilization.
- Mechanism: The device relies on the biological activity of the spores and their growth in culture media to provide a result. This is an in vitro process – it happens outside of the human body, in a laboratory-like setting (the vial).
While the text doesn't explicitly use the term "In Vitro Diagnostic," the function and components of the device clearly align with the definition of an IVD, which are used to examine specimens derived from the human body or to provide information about a physiological state, pathological state, or congenital abnormality. In this case, the device is providing information about the effectiveness of a sterilization process, which directly impacts the safety of medical devices used on or in the human body.
N/A
Intended Use / Indications for Use
The Verify® Self-Contained Biological Indicator described in this 510(k) premarket notification may be used for installation testing and routine monitoring of the following steam sterilization cycle:
- 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle for packaged items
Product codes
FRC
Device Description
The proposed Verify® Self-Contained Biological Indicator (SCBI) is identical in components, design, materials, and manufacturing specifications to the predicate Verify® Self-Contained Biological Indicator (cleared in K855101 as the Assert™ Biological/Chemical Indicator). The SCBI consists of a plastic vial that contains a disc inoculated with Geobacillus stearothermophilus and/or Bacillus atrophaeus spores and an ampoule of culture media.
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 validate the SCBI for use in the Express abbreviated prevacuum steam sterilization cycle. The results support the use of the SCBI for monitoring this cycle and confirms that the SCBI meets the current requirements of FDA guidance and relevant industry standards.
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
OCT 2 0 2005
510(k) Summary
for
Verify® Self-Contained Biological Indicator
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: October 5, 2005
DEVICE NAME 2.
| Proprietary Name: | Verify® Self-Contained Biological Indicator |
|---|---|
| Common/Usual Name: | Biological indicator |
| Classification Name: | Biological sterilization process indicators |
3. PREDICATE DEVICE
- Verify® Self-Contained Biological Indicator (cleared as the Assert™ . Biological/Chemical Indicator, K855101)
DEVICE DESCRIPTION 4.
The proposed Verify® Self-Contained Biological Indicator (SCBI) is identical in components, design, materials, and manufacturing specifications to the predicate Verify® Self-Contained Biological Indicator (cleared in K855101 as the Assert™ Biological/Chemical Indicator). The SCBI consists of a plastic vial that contains a disc inoculated with Geobacillus stearothermophilus and/or Bacillus atrophaeus spores and an ampoule of culture media.
1
The predicate device was cleared for use in 250°F (121°C) gravity steam. 270°F (132°C) gravity flash steam, 270°F (132°C) prevacuum steam, and ethylene oxide sterilization cycles. This 510(k) premarket notification was submitted to expand the indications for use for the biological indicator to include the Express abbreviated prevacuum steam sterilization cycle (see Section 5).
న. INTENDED USE
The Verify® Self-Contained Biological Indicator described in this 510(k) premarket notification may be used for installation testing and routine monitoring of the following steam sterilization cycle:
- 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle . for packaged items
6. PERFORMANCE TESTING
Performance testing was conducted to validate the SCBI for use in the Express abbreviated prevacuum steam sterilization cycle. The results support the use of the SCBI for monitoring this cycle and confirms that the SCBI meets the current requirements of FDA guidance and relevant industry standards.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
OCT 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Albert Brown Limited C/O Cynthia J. M. Nolte, Ph.D., RAC Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K051056
R051050
Trade/Device Name: VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: October 5, 2005 Received: October 6, 2005
Dear Dr. Nolte:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because so 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 interstate comments, or to thay been reclassified in accordance with the provisions of Amendinents, or to de vices that nave oost (Act) that do not require approval of a premarket the rederal I vou, Drag, und Ocentraly, therefore, market the device, subject to the general approval application (1 Mill) - The general controls provisions of the Act include controls provisions of the Fiel. "Inter Jisting 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 II your device is classified (See ass 10) in a controls. Existing major regulations affecting (PMA), it may of subject to such adamar eral Regulations, Title 21, Parts 800 to 898. In your device can be found in the Could of Pecesses on our 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 Incal that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal statute and such and limited to: registration r our must comply with and historial to revelong (21 CFR Part 801); good manufacturing practice alle listing (21 CF reful 077), and ity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality by occase (Sections 531-542 of the Act); applicable, the cloculonie precaswill allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence in 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 regulation (21 CFR Part 801), IT you desire specific ad not to read to your ce 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 may obtain 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,
Sujata Y. Michael D.M.D.
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 (if known): K051056
Device Name: Verify® Self-Contained Biological Indicator
Indications for Use:
The Verify® Self-Contained Biological Indicator may be used for installation testing The ventys och Song of the following steam sterilization cycle:
- 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle • for packaged items
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)
Ruth L. Steel) kowitoy 10/19/05
19:301 Styl-Old
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K051056