The Raven Bacterial Spore Strip (single species B. stearothermophilus ATCC#7953 or dual species B. stearothermophilus ATCC #7953 and B. subtilis ATCC #9372) is intended for use in testing the efficacy of Steam sterilization cycles at 121°C . A reduced incubation time of 48 hours at 55-60℃ has been validated for Steam sterilization when the Raven Bacterial Spore Strip (either the single species B. 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

Raven Bacterial Spore Strip is a 1.5" x 0.25" Schleicher and Schuell #470 cotton paper filter spore strip inoculated with either single species (B. stearothermophilus ATCC #7953) or dual species (B. stearothermophilus ATCC #7953 and B. subtilis ATCC #19372) bacterial spores. The strip is packaged in a #30 blue glassine peel open pouch.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and details about the study.

Acceptance Criteria and Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
Reduced incubation time for Steam sterilization cycles.	"48 hour reduced incubation period for monitoring Steam Sterilization of Systems Modified Tryptic Soy Broth with Bromocresol Purple." (from conclusion) and "a reduced incubation time for Steam has been validated at 48 hours." (from operational principles).
Efficacy of Steam sterilization cycles at 121°C.	The device is intended for "determining the efficacy of the sterilization process" at 121°C. While the document implies efficacy, it doesn't state a numerical performance metric for this, rather that the reduced incubation time was validated for this purpose. The successful color change or turbidity after 48 hours would indicate a failed sterilization cycle, thereby confirming the indicator's ability to monitor efficacy. No specific numerical success rate for detecting failed cycles is given, but the overall conclusion implies it met the expectations for monitoring efficacy with the reduced incubation time.
Substantial equivalence in composition and function to predicate device.	"The Raven Bacterial Spore Strip is substantially equivalent in composition and function to the Legally Marketed Raven Bacterial Spore Strip, a Pre-amendment device..."
When used with Raven's Modified Tryptic Soy Broth with Bromocresol Purple (MTSB w/ BCP).	The reduced incubation time of 48 hours was validated specifically "when used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple."

Study Information

Sample size used for the test set and the data provenance:
- Test Set Sample Size: "three lots each of newly manufactured spore strips, spore strips nearing expiry, newly manufactured Modified Tryptic Soy Broth with Bromocresol Purple (MTSB w/ BCP) and MTSB w/ BCP nearing expiry."
  - This means 3 lots of new spore strips, 3 lots of expiring spore strips, 3 lots of new media, and 3 lots of expiring media.
  - The exact number of individual spore strips or media vials tested within these lots is not specified.
- Data Provenance: Not explicitly stated, but given the submitter is Raven Biological Laboratories, Inc. in Omaha, NE, and the document is for FDA submission, it's highly probable the testing was conducted in the USA by the manufacturer or a contracted lab. The study is retrospective in the sense that the testing has already been completed to support the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study does not involve human expert interpretation of results, but rather a direct biological outcome (bacterial growth/no growth, indicated by color change/turbidity). The determination of growth is objective.
Adjudication method for the test set: Not applicable. The "ground truth" (presence or absence of bacterial growth) is determined directly by objective observation (color change, turbidity) of incubated media. There's no subjective interpretation requiring adjudication among human readers.
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: Not applicable. This is not a study involving human readers or AI. It's a performance validation of a biological indicator.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a biological indicator, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth is the biological outcome of bacterial growth or inhibition, as evidenced by a color change (purple to yellow) and/or turbidity in the growth media after incubation. This result directly indicates whether sterilization was successful or not.
The sample size for the training set: Not applicable. This is a biological indicator validation, not a machine learning model, so there is no training set in the conventional sense.
How the ground truth for the training set was established: Not applicable, as there is no training set. The "ground truth" for the validation study (test set) was established by observing bacterial growth/no growth.

Summary

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K 020026

SUMMARY OF RAVEN BACTERIAL SPORE STRIPS

JAN 3 0 2002

Submitter:	Raven Biological Laboratories, Inc.8607 Park DriveOmaha, NE 68127(402) 593-0781(402) 593-0921 Fax
Contact:	Robert DwyerPresident
	Wendy Royalty-HannQuality Assurance/Regulatory Affairs Manager
Prepared on:	January 2, 2002
Device name:	Raven Bacterial Spore Strip
Classification:	Class II medical device, General hospital
Predicate Devices (legally marketed):	Raven Bacterial Spore Strip
Predicate Device 510(k) number:	Pre-amendment device

Description:

Operational Principles:

The bacterial spore strip is exposed in the glassine pouch to a Steam sterilization cycle rice baotenairepens B. stearothermophilus or dual species. The spore strip is intended for (Single Spooler D. Stourother of the sterilization process and should be placed in the use in determining the onealy the load. Upon cycle completion, the spore strip should most unficult to stomics and aseptically transferred into an appropriate growth media. The media should then be incubated at 55-60°C. Media should be monitored daily for growth and results recorded. When used in conjunction with Raven's Modified Tryptic g row aroth with Bromocresol Purple, a reduced incubation time for Steam has been validated at 48 hours. Growth will be indicated by a change in color from purple to/towards yellow and/or by turbidity. Detection of a failed sterilization cycle is facilitated by the use of the Raven Bacterial Spore Strip.

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Statement of Similarity to Legally Marketed Predicate Device

The Raven Bacterial Spore Strip has the following similarities to the legally marketed Pre-amendment Raven Bacterial Spore Strip.

Have the same indicated use
Incorporate the same materials
Have the same shelf life, and
Are packaged using the same materials and processes.

Description of Testing:

Per FDA guidance for validation of reduced incubation of biological indicators, testing Performed for the Steam sterilization process using three lots each of newly was performed for the Gloum Stelliar nearing expiry, newly manufactured Modified manufactured spore strips, opere stipe neal MTSB w/ BCP) and MTSB w/ BCP nearing rryptic Soy Broth with Bromovious i upic (w and media was tested. For all explity. Each Combination of new and noal Siphy sterilization was demonstrated when fols lested, 40 hour reddod in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.

Conclusion

The Raven Bacterial Spore Strip is substantially equivalent in composition and function The Raven Dacterial Opero Only is Suice, Pre-amendment Raven Bacterial Spore Strip, to the Legally Manicitou produced creduced incubation period of 48 hours for montoning Occam Stormization of Systems Modified Tryptic Soy Broth with Bromocresol Purple.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2002

Ms. Wendy Royalty-Hann QA/RA Manager Raven Biological Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127

Re: K020026

Trade/Device Name: Raven Bacterial Spore Strips for Steam Sterilization Regulation Number: 880.2800 Regulation Name: Biological Indicators Regulatory Class: II Product Code: FRC Dated: January 23, 2002 Received: January 4, 2002

Dear Ms. Hann:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nate fortened your and have determined the device is substantially equivalent (for the indications

muleations
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sales in the encreases , 15 the enactment date of the Medical Device Amendments, commerce pror to may as nay lassified in accordance with the provisions of the Federal or to devices and Cosmetic Act (Act) that do not require approval of a premarket approval 1 000, Brug, and Connectore, market the device, subject to the general controls application (1 Mr.) - 1 ou experal controls provisions of the Act include requirements for provisions of ation, 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 (1 will), it indy of budget of Federal Regulations, Title 21, Parts 800 to 898. In your device anay publish further announcements concerning your device in the Federal Register.

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

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Page 2 - Ms. Hann

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I edelar statues and registereds, including, but not limited to: registration 1 ou must comply with and Hovering (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 807), laceling (21 CFR Pat 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 This icity will and w you to began interest of substantial equivalence of your device to 310(K) premarket notification. I rice 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 If you desire specific at not 2017 your in vitro diagnostic devices), please contact the allo auditionally 21 OF N 2 at 1 and 1 and 1 and tionally, for questions on the promotion and Office of Comphance at (e please contact the Office of Compliance at (301) 594-4639. ad veraling or your working entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nother in the relation of Small Manufacturers, International and the Act may be obtained from the enumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Timothy A. Ulatowski

A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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Attachment 2

Indications for Use Statement

510(k) Number K020026

Number

Device Name Raven Bacterial Spore Strips

The Raven Bacterial Spore Strip (single species B. Indications for stearothermophilus ATCC#7953 or dual species B. Use stearothermophilus ATCC #7953 and B. subtilis ATCC #9372) is intended for use in testing the efficacy of Steam sterilization cycles at 121°C . A reduced incubation time of 48 hours at 55-60℃ has been validated for Steam sterilization when the Raven Bacterial Spore Strip (either the single species B. stearothermophilus spore strip or the dual species spore strip) is used in conjunction with Raven's Modified Tryptic Soy Broth with Bromocresol Purple.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Olin S. Lahn

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K020026

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).