The SPSmedical SporView® Bacterial Spore Strip is designed for routine monitoring of Steam, Dry Heat, EO Gas, and Chemiclave® sterilization processes. For steam sterilizers operating at 121℃ and at 132℃ a 24 hour incubation time has been validated. The indicator should be placed in the most difficult to sterilize location of the sterilization load. After cycle completion, the spore strip is removed from the load and aseptically transferred into SPSmedical's SporView® Culture Media (Tryptic Soy Broth with Bromocresol Purple) and incubated at 60°C. The combination of SPSmedical's spore strip and media has been validated for a reduced incubation time of 24 hours for steam processes. For Dry Heat, EO Gas, or Chemiclave® sterilization processes, the incubation period is seven (7) days.

The SPSmedical SporView® Bacterial Spore Strip is designed to monitor steam sterilizer cycles at 121°C and 132°C. The combination of SPSmedical's spore strip and Sportiew® Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple) has Oper notice of 60°C for a reduced incubation time of 24 hours for steam sterilization processes.

Device Description

The SPSmedical SporView® Bacterial Spore Strip is a .250" x 1 1/2" Whatman 3MM chromatography filter paper inoculated with either a single species (Geobacillus stearothermophilus ATCC# 7953) or a dual species (Geobacillus stearothermophilus ATCC# 7953 and Bacillus atrophaeus ATTC# 9372) bacterial spores. The strip is packaged in a blue glassine envelope.

AI/ML Overview

This looks like a 510(k) premarket notification for a biological indicator for sterilization processes, not a medical device in the typical sense that would have "acceptance criteria" and "device performance" in terms of diagnostic accuracy or clinical outcomes.

The document describes the SPSmedical SporView® Bacterial Spore Strip as a device used to monitor the effectiveness of sterilization processes (Steam, Dry Heat, EO Gas, Chemiclave®). The primary "performance" being evaluated is its ability to provide a reduced incubation time for detecting sterilization failures, specifically 24 hours for steam sterilization when used with SPSmedical's SporView® Culture Media.

Therefore, the requested information categories need to be reframed to fit the nature of this particular device and its submission. Many of the requested categories (like number of experts, adjudication methods, MRMC studies, standalone performance with humans-in-the-loop, training set details) are not applicable to the biological indicator's validation.

Here's an interpretation of the requested information based on the provided text, adapting the categories to fit the context of biological indicator validation:

Description of Acceptance Criteria and Enabling Study for SPSmedical SporView® Bacterial Spore Strip

The acceptance criteria for the SPSmedical SporView® Bacterial Spore Strip's 24-hour reduced incubation time for steam sterilization are based on its ability to accurately indicate the success or failure of a sterilization cycle within that timeframe. The study demonstrates the equivalence to a predicate device and validates the reduced incubation time.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for 24-hour reduced incubation of steam sterilization)	Reported Device Performance
Equivalence to Predicate Device: The device must demonstrate similar performance characteristics and indicated use as the predicate device (SPSmedical SporView® Bacterial Spore Strip, K905425).	The device was found to be "substantially equivalent" to the predicate device, having the same indicated use, materials, shelf life, and packaging.
Validation of 24-hour Reduced Incubation Time for Steam: When used with SPSmedical's SporView® Culture Media, the strip must reliably indicate sterilization failure (or success) within 24 hours for steam processes at 121°C and 132°C.	"All lots tested resulted in a 24 hour reduced incubation time for the steam sterilization process when using the combination of the SPSmedical SporView® Bacterial Spore Strip and the SPSmedical's SporView® Culture Media."
Consistency Across Device Lots: The reduced incubation time performance must be consistent across different manufacturing lots, including newly manufactured, mid-range expiration, and near-expiration lots.	Testing was performed using three lots (newly manufactured, mid-range expiration, and nearing expiration), and "All lots tested resulted in a 24 hour reduced incubation time."
Incubation Conditions: The 24-hour reduced incubation time is specifically validated at 60°C.	The validation explicitly states incubation at 60°C for 24 hours for steam sterilization.

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

Sample Size: "three lots of biological indicators; this included a newly manufactured lot, mid-range expiration lot and a lot nearing its expiration date." The exact number of individual strips per lot tested is not specified in the document.
Data Provenance: The study was conducted internally by SPSmedical Supply Corp. ("Testing was performed... using three lots of biological indicators; this included a newly manufactured lot, mid-range expiration lot and a lot nearing its expiration date. All lots were tested using SPSmedical's SporView® Culture Media"). The country of origin is implicitly the USA, where SPSmedical is located. The study is prospective as it involves controlled testing of the manufactured product.

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

This question is not applicable in the context of validating a biological indicator. Ground truth for a biological indicator's performance is typically established by physical/chemical sterilization parameters and microbiological growth/no-growth, not by expert interpretation of images or clinical data. The outcome (growth/no growth) is an objective measure.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication typically refers to resolving disagreements among human readers or experts. The assessment of growth/no-growth for a biological indicator is an objective, deterministic outcome.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices interpreted by human readers, often with or without AI assistance. This document describes the validation of a biological indicator, which does not involve human interpretation in the same manner.

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

This question is largely not applicable in the AI/algorithm sense. The device itself (the spore strip and culture media) acts in a "standalone" manner to indicate sterilization effectiveness through a biochemical reaction (spore growth). There is no "algorithm" in the computational sense, nor is there a "human-in-the-loop" for interpreting the primary outcome (color change indicating growth/no growth). The performance described is the inherent performance of the biological indicator system.

7. The Type of Ground Truth Used

The ground truth used is microbiological growth/no-growth as evaluated in a controlled laboratory setting against known sterilization parameters. The strips are inoculated with specific bacterial spores (Geobacillus stearothermophilus ATCC# 7953 and/or Bacillus atrophaeus ATTC# 9372). Successful sterilization means no spore growth; failed sterilization means spore growth. This is the direct biological outcome of the sterilization process the indicator is designed to monitor.

8. Sample Size for the Training Set

This question is not applicable. This device is not an AI/machine learning model that requires a "training set." The validation process involves testing the physical product itself.

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

This question is not applicable as there is no "training set" for this type of device.

Summary

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Ko23716

510(k) Summary of Safety and Effectiveness

Submitter:

DEC 0 5 2002

SPSmedical Supply Corp. . 6789 West Henrietta Road Rush, NY 14543 U.S.A. Phone: (585)-359-0130 Fax: (585)-359-0167
Establishment FDA Registration No.: 1319130 .
Date Summary was Prepared November 1st, 2002 ●
Gary J. Socola ● Printed name of person sybmitting for 510(k)
are . Signature of person submitting for 510(k)
Director of Quality Assurance . Title of person submitting for 510(k)

Device Name and Classification

Trade Name:	SPSmedical SporView® Bacterial Spore Strip
Classification Name:	Sterilization Process Biological Indicator
Common Name:	Spore Strip Biological Indicator
Device Classification:	Class II, Regulation Number 880.2800
Product Code:	FRC
Predicate Device:	SPSmedical SporView® Bacterial Spore Strip (K905425)

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Device Description:

Intended Use:

Statement of Similarity to the Leqally Marketed Predicate Device:

Have the same indicated use .
Incorporate the same materials .
Have the same shelf life .
Packaged using the same materials and processes .

Non-Clinical Testing:

Testing was conducted following the FDA guidance for the validation of reduced incubation of biological indicators. Testing was performed for the steam sterilization process using three lots of biological indicators; this included a newly manufactured lot, mid-range expiration lot and a lot nearing its expiration date. All lots were tested using SPSmedical's SporView® Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple). All lots tested resulted in a 24 hour reduced incubation time for the steam sterilization process when using the combination of the SPSmedical SporView® Bacterial Spore Strip and the SPSmedical's SporView® Culture Media.

Conclusion:

Supportive data has demonstrated that the SPSmedical SporView® Bacterial Spore Strip is equivalent to the legally marketed predicate device. Results of performance testing validate that the SPSmedical SporView® Bacterial Spore Strip provides a 24 hour reduced incubation time when used with the SPSmedical SporView® Culture Media in monitoring the steam sterilization process.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Mr. Gary J. Socola Director, Quality Assurance SPSmedical Supply Corporation 6789 West Henrietta Road Rush, New York 14543

Re: K023716

Trade/Device Name: SPSmedical SporView® Bacterial Strip Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: November 1, 2002 Received: November 5, 2002

Dear Mr. Socola:

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 -- Mr. Socola

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 . 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.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

f. Akilestolansen for;

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

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INDICATIONS for USE STATEM

SPSmedical Supply Corp. Applicant:

510(k) Number (if known): _

Device Name: SPSmedical SporView® Bacterial Spore Strip

Indications For Use:

The SPSmedical SporView® Bacterial Spore Strip is designed to monitor steam sterilizer The combination of SPSmedical's spore strip and cycles at 121°C and 132°C. Sportiew® Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple) has Oper notice of 60°C for a reduced incubation time of 24 hours for steam sterilization processes.

Quy Lim

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

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).