MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS by RAVEN BIOLOGICAL LABORATORIES, INC.

The Raven Bacterial Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of Chemiclave sterilization cycles at 132°C. A reduced incubation time of 72 hours at 60°C +/- 2°C has been validated for Chemiclave sterilization when the Raven Bacterial Spore Strip (either the single species G. stearothermophilus spore strip or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Raven Bacterial Spore Strips." It does not contain information about the acceptance criteria and study proving a device meets those criteria in the typical format requested for AI/ML device approval.

Instead, this document is a regulatory approval for a sterilization process indicator, which is a biological indicator used to test the efficacy of sterilization cycles. The "acceptance criteria" here refers to the validation of the spore strip's performance in indicating successful sterilization, rather than performance metrics for an AI algorithm.

Therefore, I cannot provide all the requested information for an AI/ML device study. However, I can extract the relevant information from this document regarding the validation of this specific biological indicator:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Intended Use: Test efficacy of Chemiclave sterilization cycles at 132°C.	Validated for Chemiclave sterilization at 132°C.
Microorganisms: Single species G. stearothermophilus ATCC#7953 OR dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372.	The device includes these specified microorganisms.
Reduced Incubation Time: 72 hours at 60°C +/- 2°C.	Validated for a reduced incubation time of 72 hours at 60°C +/- 2°C.
Medium: Used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.	The validation was performed using this specified medium.

Explanation of "Acceptance Criteria" in this Context:

For a biological indicator like the Raven Bacterial Spore Strips, the "acceptance criteria" are not statistical metrics like sensitivity or specificity in an AI model. Instead, they refer to the conditions under which the device is intended and validated to perform effectively, which typically involves demonstrating that the spores on the strip are killed under proper sterilization and survive if sterilization is inadequate within specific parameters (temperature, time, and incubation conditions). The document confirms that the device has been validated to meet these intended uses and conditions.

Regarding the other requested points (2-9), this document does not contain that level of detail as it pertains to AI/ML device studies.

Here's why and what we can infer:

2. Sample size used for the test set and the data provenance: Not applicable in the context of this device. The "test set" would refer to sterilization cycles and spore strips used in rigorous validation studies, but the specific numbers and provenance are not in this FDA letter.
3. Number of experts used to establish the ground truth...: Not applicable. Ground truth for biological indicators is typically established by laboratory standards and established microbiological methods for sterility testing.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI/ML diagnostic device with human readers.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable. This is a physical biological indicator, not an algorithm. Its "performance" is based on the viability of spores after a challenge.
7. The type of ground truth used: For biological indicators, the ground truth is typically the sterility or non-sterility of the challenged item/environment, determined by microbiological culture methods (e.g., absence of growth indicates sterility, presence of growth indicates non-sterility). For the spore strip itself, the ground truth relates to the known resistance of the spores to specific sterilization parameters and their subsequent growth characteristics in a defined medium.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA letter confirms the regulatory clearance of a well-established medical device type (biological indicator) based on its specified intended use and validation using standard microbiological principles, not an AI/ML algorithm requiring the specific study details you've outlined.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) in the United States. The seal features a stylized eagle with three lines forming its body and wings, and two wavy lines representing water beneath it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2005

Ms. Wendy Royalty-Hann Ouality Assurance/Regulatory Affairs Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127

Re: K050591

Trade/Device Name: Raven Bacterial Spore Strips Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: March 7, 2005 Reccived: March 8, 2005

Dear Ms. Royalty-Hann:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{1}------------------------------------------------

Page 2 - Ms. Royalty-Hann

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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 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), please contact the Office of Compliance 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 Division 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,

Syrita Michael Toms

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

{2}------------------------------------------------

Attachment 2

Indications for Use Statement

510(k) Number (if known): Ko 5 ບ 5 ປ 5 ປີ (

Device Name: Raven Bacterial Spore Strips

Indications for Use:

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)

Shula Murphy

on Sim-Off) ി വിവിഹാവിരുന്നു. Ganeral Hospilal Clon Control, Dental Devices

Number: LASO S91

Regulation Number and Section

§ 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).