The Castle ® SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated.

Castle SPOR-TEST PA Biological Indicators are qualified using Castle Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the Castle SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.

Device Description

The Castle® SPOR-TEST PA Biological Indicator Kit is exclusively intended to monitor the Steris® System 1 peracetic acid sterilization process, with Steris 20 sterilant. The product contains chromatography paper strips that are inoculated with Bacillus stearothermophilus (or G. stearothermophilus) spores at a nominal population of 105 per strip. Sterile tubes of Castle Culture Media (modified soybean casein broth) and a transfer clip are included. The materials of construction are equivalent to the Unispore® product. The product is intended to be used in an identical manner as the Steris® Process Biological Indicator Kit.

AI/ML Overview

The provided document is a 510(k) summary for the Castle® SPOR-TEST PA Biological Indicator Kit. This type of document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device. As such, it does not contain details of a clinical study with human subjects, test sets, training sets, or expert evaluations in the typical sense of AI/ML device studies.

Instead, the "study" described herein refers to the performance testing of the biological indicator in a laboratory setting to demonstrate its efficacy in monitoring a sterilization process compared to a predicate device.

Here's the information extracted and interpreted based on the context of a biological indicator's regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for biological indicators are usually defined in terms of their D-value (decimal reduction time) and population count. However, this submission focuses on specific "survival" and "kill" times under defined conditions.

Acceptance Criteria (Intended Use Statement)	Reported Device Performance (Implied by equivalence to predicate)
When tested at 1,000 ppm peracetic acid, 50°C, the Castle SPOR-TEST PA Biological Indicator will survive at 41 seconds.	The device is substantially equivalent to the predicate (Steris® Process Biological Indicator Kit), which implies it meets this survival time under the specified conditions.
When tested at 1,000 ppm peracetic acid, 50°C, the Castle SPOR-TEST PA Biological Indicator will be killed at 6 minutes.	The device is substantially equivalent to the predicate, implying it meets this kill time under the specified conditions.
Exclusively intended to monitor the Steris System 1 liquid chemical sterilization system, with Steris 20 sterilant.	Matches the intended use of the predicate device.
Uses Bacillus stearothermophilus (or G. stearothermophilus) spores at a nominal population of 10^5 per strip.	Matches the predicate device's spore type and population.
Recovered in tubes of sterile growth medium that uses phenol red as a color change indicator (open-loop biological indicator).	Matches the predicate device's recovery and indicator method.
Qualified using Castle Culture Media.	Explicitly stated for the device.
May only monitor sterilization efficacy on exterior surfaces to loads processed in the Steris® peracetic acid process.	Matches the predicate device's monitoring capability.
Material of construction equivalent to Unispore® product.	Stated as equivalent.
Intended to be used in an identical manner as the Steris® Process Biological Indicator Kit.	Stated as identical use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of individual biological indicators tested. For this type of device, testing would involve multiple runs under controlled conditions to ensure consistency and reliability. The submission focuses on the performance parameters (survival/kill times) rather than a statistical sample size in the clinical trial sense.
Data Provenance: The testing would have been conducted in a laboratory environment by Getinge/Castle Inc. to demonstrate the device's performance characteristics. This is a prospective test for the device's performance against established criteria, not a retrospective analysis of patient data. There is no mention of country of origin for test data, but it would typically be from the manufacturer's R&D facilities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable in the context of this device. Biological indicator testing involves laboratory measurements and observation of microbial growth (or lack thereof), not expert interpretation of images or clinical data. The "ground truth" is established by the clear presence or absence of spore viability after exposure to the sterilant under controlled conditions.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" are relevant for subjective interpretations (e.g., radiology reads). For a biological indicator, the result is objective: either the spores grow (failure to sterilize) or they do not (successful sterilization).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is for evaluating human performance, often with and without AI assistance, in interpreting medical information. Biological indicators are objective tests, not subject to human interpretation in the same way.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in spirit. The performance described is inherently "standalone" for the biological indicator. It functions mechanically and biologically without human "in-the-loop" interpretation beyond observing the color change in the culture medium. There is no algorithm, but the device's performance parameters (survival and kill times) are tested directly and objectively.

7. The Type of Ground Truth Used

Microbial Viability/Inviability: The ground truth is the confirmed presence or absence of viable Bacillus stearothermophilus spores after exposure to the sterilant under specified conditions, as indicated by growth in the culture media (color change).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product whose performance is inherent to its design and manufacturing.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is involved for this type of device.

Summary

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K020205

510(k) Summary Statement

Date Prepared:	June 12, 2002
Submitter's Name/Address:	Getinge/Castle Inc.1777 East Henrietta RoadRochester, NY 14623
Contact Person:	Karla Byrne, Operations Director, Consumable Products Dept.Telephone: (585) 272- 5007
Trade Name:	Castle® SPOR-TEST PA Biological Indicator Kit (K020205)
Classification:	Sterilization Process Indicator - 21 CFR 880.2800 (a)Class II
Predicate Devices:	Steris® Process Biological Indicator Kit (K960570)MDT Unispore® and Spor-Test Biological Indicator (K960777)

Device Description:

Intended Use:

The Castle® SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated. Castle SPOR-TEST PA Biological Indicators are qualified using Castle Culture Media. When tested at 1,000 ppm peracetic acid. 50°C, the Castle SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.

Comparison to the Predicate Device: Steris® Process Biological Indicator Kit

Both devices are exclusively used to monitor the Steris® peracetic acid process. ●
Both devices are assessed in process conditions of 1000 parts per million peracetic acid at 50°C. ●
Both devices use a chromatography paper carrier inoculated with 10° B. stearothermophilus ● spores.
Both devices are processed in the Sterilizer when held by a tension clamp. .
Both devices are open-loop biological indicators that are recovered in tubes of sterile growth ● medium that uses phenol red as a color change indicator.
. Both devices may only monitor sterilization efficacy on exterior surfaces to loads processed in the Steris® peracetic acid process.

Conclusion:

The Castle® SPOR-TEST PA Biological Indicator Kit is substantially equivalent the Steris® Process Biological Indicator Kit for monitoring the Steris ® System 1 peracetic acid process.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2002

Mr. Mark N. Smith Director, Corporate QA/RA Getinge/Castle. Incorporated 1777 East Henrietta Road Rochester, New York 14623-3133

Re: K020205

Trade/Device Name: Castle ® SPOR-TEST PA Biological Indicator Kit Regulation Number: 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: II Product Code: FRC Dated: April 8, 2002 Received: April 10, 2002

Dear Mr. Smith:

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.

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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

Enclosure

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INDICATIONS FOR USE STATEMENT

06/17/02 Date:

K020205 510(k) Number:

Castle® SPOR-TEST PA Biological Indicator Kit Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
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Over-The-Counter Use
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(Division Sign-Off)

Division of Dental, Infection Control,

and General Hospital Devices

K020205510(k) Number ---------

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).