The Getinge Biosign Steam-24 Biological Indicator is a steam sterilization monitor designed specifically for biological testing of 121°C, 134°C gravity and pre-vacuum and flash gravity and prevacuum steam sterilization cycles with results available after 24 hours incubation.

Device Description

The Getinge Biosign Steam-24 Biological Indicator is a self-contained biological indicator designed for biological testing of steam 121°C and 134°C pre-vacuum and gravity and flash steam sterilization cycles. When used to monitor steam cycles, the product is intended to give the user results after 24 hours incubation. The Biosign Steam-24 Biological Indicator contains 10^6 Geobacillus stearothermophilus (nee Bacillus stearothermophilus) spores/carrier. The Biological Indicator is selfcontained with an ampule containing culture medium in the same vial as the spore strip.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the study details:

Acceptance Criteria and Device Performance Study

The Getinge Biosign Steam-24 Biological Indicator is intended to show results after 24 hours of incubation. The primary acceptance criterion for this modified device over its predicate is improved incubation time while maintaining sterilization effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Greater than 97% assurance for 24-hour incubation time (per CDRH Guidelines for incubation time)	"Results provided greater than 97% assurance for 24 hours (incubation time)."
All steam resistance criteria met, including Survival/Kill and D-value for 121°C and 134°C sterilization cycles (per CDRH Guidelines)	"All steam resistance criteria were met including Survival / Kill and D-values... for 121°C and 134°C."
	(Implied: The Biosign Steam-24 Biological Indicator is equivalent to the unmodified Biosign BI for monitoring steam sterilization effectiveness.)

2. Sample Size and Data Provenance

Test Set Sample Size: The document states that "different lots of Biosign Steam-24 were tested." However, no specific number of lots or individual Biological Indicators (BIs) tested is provided.
Data Provenance: The study was likely conducted internally by Getinge USA, Inc. The data is retrospective in the sense that the testing was performed, and the results were then compiled for the 510(k) submission. The country of origin for the data is implicitly the USA, where Getinge USA, Inc. is located.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. This type of device relies on a physicochemical reaction (spore inactivation) for its function, not subjective expert interpretation. The ground truth is intrinsically linked to the biological viability of the Geobacillus stearothermophilus spores and their known resistance to steam sterilization, coupled with objective observation of growth in the culture medium.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The assessment of spore growth/no growth (which determines positive/negative results) is an objective biological outcome based on a color change or turbidity in the culture medium. There is no mention of subjective interpretation or a need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. An MRMC study is not relevant for this type of device. Biological indicators do not involve human readers interpreting complex imaging or data. Their function is to provide a clear, objective biological result (growth or no growth) indicating successful or failed sterilization.

6. Standalone Performance (Algorithm Only) Study

Standalone Study Done: Yes, in effect. The evaluation of the Biosign Steam-24 Biological Indicator's performance (incubation time and steam resistance) is a standalone assessment of the device itself. It operates independently of human interpretation beyond observing the final growth result. There is no "human-in-the-loop" interaction in the function of the BI; it is a direct measurement of sterility conditions.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth is based on biological viability and spore inactivation kinetics. For sterilization, the ground truth is whether the Geobacillus stearothermophilus spores, known to be highly resistant to steam, were successfully killed. This is objectively determined by the absence of growth (no color change/turbidity) in the culture medium after incubation. The D-value (Decimal Reduction Time) also represents a quantitative measure of resistance used to establish ground truth for effectiveness.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. Biological indicators are not machine learning algorithms that require a "training set." Their performance is based on established biological principles and physical testing, not data-driven model training.

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. As there is no training set for a biological indicator in the machine learning sense, there is no ground truth established for a training set. The performance characteristics (spore count, resistance, incubation time) are inherent properties of the biological system and its design, verified through standardized laboratory testing procedures as outlined by the CDRH Guidelines.

Summary

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510(K) SUMMARY

Prepared on July 22, 2003

Submitter: Getinge USA. Inc. 1777 East Henrietta Road Rochester. NY 14623

Karla Byrne, Operations Director Consumable Products Division Contact Person: Telephone: (585) 272-5007 Fax: (585) 272-5271

Self-contained Biological Indicator Common Name: Propietary Name: Biosign Steam-24 Biological Indicator

Classification: Indicator, Biological Sterilization Process - Class II, 80 FRC

Predicate Device: Biosign Biological Indicator (K872867)

Device Description:

The Getinge Biosign Steam-24 Biological Indicator is a self-contained biological indicator designed for biological testing of steam 121°C and 134°C pre-vacuum and gravity and flash steam sterilization cycles. When used to monitor steam cycles, the product is intended to give the user results after 24 hours incubation. The Biosign Steam-24 Biological Indicator contains 10ª Geobacillus stearothermophilus (nee Bacillus stearothermophilus) spores/carrier. The Biological Indicator is selfcontained with an ampule containing culture medium in the same vial as the spore strip.

The shelflife of the new Biosign Steam-24 Biological Indicator is the unmodified Biosign Biological Indicator (18 months).

The Getinge Biosign Steam-24 Biological Indicator is the same size as, utilizes the same materials and manufacturing processes as the Biosign Biological Indicator. The Biosign Steam-24 Biological Indicator does not contain Bacillus atrophaeus (nee B. subtilis var. niger) and therefor is NOT labeled for use in monitoring ethylene oxide sterilization cycles.

There are no technological differences between the Biosign Steam-24 Biological Indicator and the unmodified device. The same steam indicator spores are utilized, the same media ampule is used, the same packaging materials are utilized and the same manufacturing processes have been utilized.

Intended Use:

The Getinge Biosign Steam-24 Biological Indicator is a steam sterilization monitor designed specifically for biological testing of 121°C. 134°C gravity and pre-vacuum and flash steam sterilization cycles with results available after 24 hours incubation.

Comparison to Unmodified Device:

The Getinge Biosign Steam-24 Biological Indicator's manufacturing material, manufacturing methods and storage conditions are the unmodified Biosign Biological Indicator. The new modified design allows for greater than 97% assurance for 24 hour incubation time per CDRH Guidelines. The Biosign Steam-24 design does not include B. atrophaeus spore for monitoring ethylene oxide and therefor is only labeled for monitoring steam cycles.

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ifferent lots of Biosign Steam-24 were tested according to the CDRH ncubation Time. Results provided greater than 97% assurance for 24 ested per CDRH Guidelines.

Biosign Steam-24 were tested according to the unmodified Biosign s. All steam resistance criteria were met including Survival / Kill and D-34°C. The Biosign Steam-24 Biological Indicator is not labeled for use ;ses other than steam.

ıl Indicator is equivalent to the unmodified Biosign BI for monitoring ie improvement of results available after 24 hours incubation.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

OCT - 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karla Byrne Consumable Products Operations Director Getinge USA, Incorporated 1777 East Henrietta Road Rochester, New York 14623-3133

Re: K032723

Trade/Device Name: Biosign Steam-24 Biological Indicator Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: July 23, 2003 Received: September 3, 2003

Dear Ms. Byrne:

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.

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Page 2 -Ms. Byrne

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 (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.

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 (301) 594-4618. 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/dsma/dsmamain.html

Sincerely yours,

Susan Runn

Susan Runner, DDS, MA Interim 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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Getinge USA, Inc. Biosign Steam-24 Biological Indicator

Indications for Use

510(k) Number: _ K032723

Device Name: Biosign Steam-24 Biological Indicator

Indications For Use:

Olu S. Lin

(Division Sign-Off) Division of Anesthesiology, General Hosp Infection Control. Denta

510(k) Number: K032723

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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).