SporView® Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes operating at 121℃ and 132℃ gravity displacement, 132℃ flash gravity displacement and 121°C - 134°C prevacuum cycles.

Device Description

The SPSmedical SporView® biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing Tryptic Soy Broth with Bromnocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SporView® Steam Self-Contained Biological Indicator:

This document describes a 510(k) premarket notification for a Class II medical device, a biological indicator used in sterilization. It focuses on demonstrating substantial equivalence to a predicate device, rather than a novel claim requiring extensive clinical trials or complex AI performance metrics. Therefore, many of the typical acceptance criteria and study details for AI/software devices (like expert adjudication, MRMC studies, or training set details) are not applicable here.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from "label claims and performance characteristics")	Reported Device Performance
Resistance	Met defined criteria for resistance to steam sterilization.	"All test results met the defined acceptance criteria."
Spore Population	Met defined criteria for the number of spores inoculated onto the carrier.	"All test results met the defined acceptance criteria."
Media Recovery in Extended Steam Sterilization Cycles	Met defined criteria for the ability of the media to recover spores after extended exposure.	"All test results met the defined acceptance criteria."
Effects of Holding Time	Met defined criteria for performance after various holding times.	"All test results met the defined acceptance criteria."
Reduced Incubation Period	Met defined criteria for performance within a reduced incubation timeframe.	"All test results met the defined acceptance criteria."
Stability of Color Change	Met defined criteria for the stability and clarity of the pH indicator's color change.	"All test results met the defined acceptance criteria."
Media Evaporation	Met defined criteria for minimal media evaporation.	"All test results met the defined acceptance criteria."
Effects of Carrier and Package Materials	Met defined criteria for the materials not adversely affecting performance.	"All test results met the defined acceptance criteria."
Equivalence to Predicate Device	Intended to monitor steam cycles from 121°C to 134°C, utilize same bacterial strain, same carrier material, virtually same media, similar size/shape, same activation, same incubation temperature.	"Supportive data has demonstrated that the SPSmedical SporView® Steam Self-Contained Biological Indicator is equivalent to the legally marketed predicate device."

Note: The document states that "All test results met the defined acceptance criteria" generally, but does not provide specific numerical values for each criterion. The criteria listed above are inferred from the types of non-clinical testing performed to validate the device's label claims and performance characteristics.

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

The document does not explicitly state the numerical sample size for each specific test (e.g., number of indicators tested for resistance). It mentions "Multiple lots of indicators were tested."

Sample Size: Not explicitly stated as a numerical value, but described as "Multiple lots of indicators."
Data Provenance: The testing was "Non-Clinical Testing" performed by the manufacturer, SPSmedical Supply Corp., in the USA (Rush, NY). The document does not specify if the testing was retrospective or prospective, but given it's for a new product, it would inherently be prospective in nature.

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

Not applicable. This device is a biological indicator; its performance is measured against objective laboratory standards (e.g., spore count, resistance to sterilization, color change) rather than requiring expert interpretation like in image-based diagnostics.

4. Adjudication Method for the Test Set

Not applicable. The performance is determined by objective scientific measurements, not by human adjudication of ambiguous findings.

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

No. This type of study is not relevant for a biological indicator device. It is designed to demonstrate equivalence through non-clinical laboratory testing, not to compare human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, in essence. The documented testing (resistance, spore population, media recovery, etc.) is the standalone performance of the biological indicator itself, as it functions independently within the sterilization process. There is no "human-in-the-loop" component to its primary function or performance assessment.

7. The Type of Ground Truth Used

The ground truth for this device is based on established scientific principles and standards for biological indicators, including:

Microbiological Standards: Known characteristics of Geobacillus stearothermophilus spores (e.g., population, D-value, Z-value).
Sterilization Cycle Parameters: Objective measurements of temperature, pressure, and time in steam sterilization cycles.
Chemical Indicators: The physical and chemical properties of the Tryptic Soy Broth with Bromnocresol Purple pH indicator, which changes color based on microbial growth.
Regulatory Standards: Compliance with relevant FDA regulations (e.g., 21 CFR 880.2800) and consensus standards for biological indicators.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its function is based on biological and chemical reactions, not learned patterns from data.

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

Not applicable, as there is no training set for this type of device.

Summary

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K070595

MAY 2 4 2607

510(k) Summary of Safety and Effectiveness

Submitter:

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 May 24th, 2007 .
Gary J. Socola . Printed name of person submitting for 510(k)

Gary J. Socola

Signature of person submitting for 510(k)

Vice President, Scientific Affairs . Title of person submitting for 510(k)
Device Name and Classification

Trade Name:	SporView® Steam Self-Contained Biological Indicator
Classification Name:	Sterilization Process Biological Indicator
Common Name:	Self-Contained Biological Indicator
Device Classification:	Class II, Regulation Number 880.2800
Product Code:	FRC
Predicate Device:	SGM EZTest® - Steam (K963841)

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Device Description:

Intended Use:

SporView" Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes operating at 121℃ and 132℃ gravity displacement, 132℃ flash gravity displacement and 121°C - 134°C prevacuum cycles.

Statement of Similarity to the Legally Marketed Predicate Device:

Both are intended to monitor steam sterilization cycles from 121°C to134°C. .
. Both utilize the same strain of bacterial spores.
. Both utilize the same carrier material.
. Both use virtually the same media.
. Both are similar in size and shape.
. Both are activated in the same manner.
. Both are incubated at the same temperature

Non-Clinical Testing:

Testing was performed in order to validate the indicators label claims and performance characteristics. Multiple lots of indicators were tested for;

. Resistance
. Spore population
Media recovery in extended steam sterilization cycles .
Effects of holding time
. Reduced incubation period
. Stability of the color change
. Media Evaporation
. Effects of carrier and package materials

All test results met the defined acceptance criteria.

Conclusion:

Supportive data has demonstrated that the SPSmedical SporView® Steam Self-Contained Biological Indicator is equivalent to the legally marketed predicate device and therefore, as safe and effective as the legally marketed device.

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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 consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus.

Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2007

SPSmedical Supply Corporation C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road Twinsburg, Ohio 44087

Re: K070595

Trade/Device Name: SporView® Steam Self Contained BI Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: May 15, 2007 Received: May 16, 2007

Dear Mr. Lehtonen:

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. Lehtonen

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Clues

Chiu Lin, Ph.D. 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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INDICATIONS for USE STATEMENT

Applicant: SPSmedical Supply Corp.

f Chemical Supply Corp.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K070595

SporView® Steam Self Contained BI Device Name:

Indications For Use:

SporView® Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes operating at 121°C and 132°C gravity displacement, 132°C flash gravity displacement and 121°C - 134°C prevacuum cycles.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula H. Murphy MD

ന of Anesthesiology, General Hospital, on Control, Dental Devices

*k) NumberPage 1 of 1 K020595

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).