(177 days)
The Verify® Self-Contained Biological Indicator 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
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.
This is a 510(k) summary for a biological indicator and not an AI/ML device per se. Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC study, sample sizes for training/test sets) are not applicable or cannot be extracted from the provided text. The document focuses on performance testing to expand the indications for use of the biological indicator.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Validation of SCBI for use in the Express abbreviated prevacuum steam sterilization cycle. | Performance testing confirmed that the SCBI meets current requirements of FDA guidance and relevant industry standards for monitoring the 270°F (132°C), 4 min. Express abbreviated prevacuum steam sterilization cycle for packaged items. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The document refers to "Performance testing was conducted," implying a controlled study, but details are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/specified. For a biological indicator, the "ground truth" is determined by whether the indicator correctly registers sterilization or growth, which is a direct biological outcome, not an expert interpretation.
- Qualifications: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. The performance of a biological indicator is typically assessed through direct observation of growth or lack thereof in the culture medium, not through expert adjudication in the manner of diagnostic image interpretation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not applicable. This is a biological indicator, not an AI/ML diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: While the "device" (biological indicator) operates independently to indicate sterilization effectiveness, it's not an "algorithm" in the typical sense of AI/ML. Its performance is inherent in its biological response. The study was essentially a standalone performance validation for a specific sterilization cycle.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for a biological indicator's performance is typically established by:
- Microbiological viability: Determining the survival or inactivation of the inoculated Geobacillus stearothermophilus and/or Bacillus atrophaeus spores after exposure to sterilization conditions.
- Sterilization Cycle Parameters: The efficacy of the sterilization cycle itself, under controlled conditions.
The document states, "Performance testing was conducted to validate the SCBI for use in the Express abbreviated prevacuum steam sterilization cycle," implying direct biological/physical validation against established sterilization efficacy.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that undergoes a training phase.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. This is not an AI/ML device that undergoes a training phase.
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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.
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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.
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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.
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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
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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
§ 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).