The Steri-Pak LF Bowie Dick Test Pack manufactured by SteriTec Products Mfg. Co., Inc. is designed to detect the presence of residual air in prevacuum steam sterilizers operating at 132 °C. It is designed to be used for daily Bowie Dick testing of hospital sterilizers as described in AAMI/ANSI ST46 section 7.7. It contains no Lead.

Device Description

The Steri-Pak LF Bowie-Dick Test Pack is designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air. The test pack is approximately 3%" x 5/4" x2/" in size consisting of a stack of 25 layers of porous blotter paper with a plastic laminated layer at the bottom. Embedded within the pack is an indicator sheet with steam sensitive ink printed on it. The indicator sheet changes to black during a typical Bowie-Dick test and will have a lighter, blue color in the center if a significant amount of air is present during the test.

AI/ML Overview

The provided text describes a 510(k) submission for the Steri-Pak LF Bowie-Dick Test Pack. While it mentions "laboratory tests" for comparison to a predicate device, it does not explicitly detail acceptance criteria or a specific study that proves the device meets those criteria in a format that would allow for a direct fill-in of all your requested fields. The provided document is a summary for regulatory approval, not a detailed scientific study report.

However, I can extract the information that is present and indicate where information is not provided based on your specific questions:

Acceptance Criteria and Study Details for the Steri-Pak LF Bowie-Dick Test Pack

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Bowie-Dick Test Functionality: Detect the presence of residual air in prevacuum steam sterilizers operating at 132°C.	The indicator sheet changes to black during a typical Bowie-Dick test and will have a lighter, blue color in the center if a significant amount of air is present during the test. Performance is stated to be "substantially equivalent" to predicate device (SteriTec Steri-Pak Bowie Dick Test Pack 510(k) 982188).
Intended Use: Daily monitoring of pre-vacuum steam sterilizers to detect residual air.	"Laboratory tests show the Steri-Pak LF Bowie-Dick Test Pack and the above named predicate device have the same intended use."
Material Composition: Contains no Lead.	Stated in the device description and indications for use.
Physical Dimensions: Approximately 3¾" x 5¾" x 2" in size.	Stated in the device description.
Comparison to Predicate Device: Substantial equivalence to SteriTec Steri-Pak Bowie Dick Test Pack (K982188).	"Based on the results of laboratory tests, the Steri-Pak LF Bowie-Dick Test Pack is substantially equivalent to the SteriTec Steri-Pak Bowie Dick Test Pack 510(k) 982188."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document only mentions "laboratory tests."
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It is implied to be internal testing by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not provided. Bowie-Dick tests are physical/chemical indicators; their performance is assessed by color change under specific conditions, not typically by expert human interpretation in the same way an AI algorithm for medical imaging would be. The "ground truth" for a Bowie-Dick test is the successful removal of air in a sterilizer (resulting in a uniform color change) or the presence of residual air (resulting in an incomplete color change).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. This is a physical/chemical indicator, not a diagnostic device requiring human interpretation and adjudication for "ground truth."

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

Not applicable. This device is a standalone chemical indicator, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, effectively. The device itself is the standalone "algorithm" (or chemical reaction) that produces a result (color change pattern) without human intervention in its function. The "performance" mentioned in the summary is the performance of this standalone indicator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for a Bowie-Dick test is the physical conditions within the sterilizer, specifically the presence or absence of residual air. This is established by observing whether the indicator achieves a uniform color change (absence of air) or an incomplete color change (presence of air). This would be validated against calibrated sterilization equipment and known air leaks.

8. The sample size for the training set

Not applicable/Not provided. This is a physical/chemical indicator, not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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JUN 10 1999

510(k) SUMMARY 990246

SUBMITTER:

STERITEC PRODUCTS MFG. CO., INC. 680 Atchison Way - Suite 600 Castle Rock, CO. 80104 (303) 660-4201 (303) 660-4213 Fax

Establishment Registration Number:

2028456

Date Summary was Prepared:

January 20, 1999

TOM ROLL Printed name of person required to submit 510(k)

Tom Roll

Signature of person required to submit 510(k)

PRESIDENT Title of person submitting 510(k)

Proprietary Name:	Steri-Pak LF Bowie-Dick Test Pack
Common/ Usual Name:	Disposable Bowie-Dick Test Pack
Classification Name:	Physical/Chemical Sterilization Indicator
Classification:	The Steri-Pak LF Bowie-Dick Test Pack for use in prevacuum steam sterilizers is a disposable "Physical/Chemical sterilization indicators" test pack for the daily monitoring of prevacuum steam sterilizers to detect air leaks, inadequate steam penetration, and vacuum pump failures. It contains no Lead. It falls under the FDA classification of Indicator, Physical/Chemical Sterilization Process in Class II under Regulation Number 880.2800.
Predicate Device:	SteriTec Steri-Pak Bowie Dick Test Pack 510(k) 982188

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510(k) Summary - continued

Description of 510(k) Submission Device:

Intended use/Device Description:

Comparison to Predicate Device:

Laboratory tests show the Steri-Pak LF Bowie-Dick Test Pack and the above named predicate device have the same intended use in that they are disposable chemical indicator test packs designed specifically for daily monitoring of pre-vacuum steam sterilizers to detect the presence of residual air.

Summary of Performance Testing:

Based on the results of laboratory tests, the Steri-Pak LF Bowie-Dick Test Pack is substantially equivalent to the SteriTec Steri-Pak Bowie Dick Test Pack 510(k) 982188.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 1999

Mr. Lon Bruso Vice President SteriTec Products Manufacturing Company, Incorporated 680 Atchison Way - Suite 600 Castle Rock, Colorado 80104

Re : K990246 Trade Name: Steri-Pak LF Bowie-Dick Test Pack Requlatory Class: II Product Code: JOJ Dated: March 29, 1999 Received: March 30, 1999

Dear Mr. Bruso:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895, ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Bruso

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-20,41 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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Page _ 1______________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ___________________

Device Name:__Steri-Pak LF Bowie Dick Test Pack

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		OR	Over-The-Counter Use	√
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

	K990246
	(Division Sign-Off)
	Division of Dental, Infection Control,
	and General Hospital Devices
510(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).