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.

Spor View self-contained biological indicators are also appropriate for use in monitoring the efficacy of saturated steam prevacuum sterilization processes operating at 135°C for 3 minutes exposure time.

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 Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the SPSmedical SporView® Steam Self-Contained Biological Indicator. It describes the device, its intended use, and the non-clinical testing performed to demonstrate its equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance values in a quantitative manner. Instead, it states that "All test results met the defined acceptance criteria."

However, we can infer the types of criteria based on the tests conducted:

Acceptance Criteria Category (Inferred)	Reported Device Performance
Resistance	Met acceptance criteria
Spore population	Met acceptance criteria
Media recovery in extended steam sterilization cycles	Met acceptance criteria
Effects of holding time	Met acceptance criteria
Reduced incubation period	Met acceptance criteria
Stability of the color change	Met acceptance criteria
Media Evaporation	Met acceptance criteria
Survival Response Time	Met acceptance criteria
Effects of carrier and package materials	Met acceptance criteria

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

The document states "Multiple lots of indicators were tested for" the various performance characteristics. However, it does not specify the exact sample size for the test set or the number of indicators from each lot.

The data provenance is retrospective in the sense that the testing was performed before the 510(k) submission. The country of origin of the data is not explicitly stated, but given the submitter is "SPSmedical Supply Corp." with an address in Rush, NY, U.S.A., it is highly probable the testing was conducted within the United States.

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

This type of device (biological indicator for sterilization processes) does not typically involve human experts establishing "ground truth" in the way, for example, a diagnostic image analysis AI would. The "ground truth" in this context is based on established microbiological and sterilization testing standards and protocols. Therefore, the concept of and number of "experts" and their qualifications for establishing ground truth is not applicable in the same way as it would be for a medical AI device. The ground truth is determined by the results of the microbiological assays and physical integrity tests themselves, evaluated against pre-defined scientific criteria.

4. Adjudication Method for the Test Set

As the "ground truth" is established through scientific testing and adherence to predefined protocols rather than expert consensus, an adjudication method is not applicable in the traditional sense for this type of device. The results are objectively measured and compared against established scientific and regulatory standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs Without AI Assistance

A Multi Reader Multi Case (MRMC) comparative effectiveness study is not applicable to this device. This is a biological indicator, not an AI-powered diagnostic tool that assists human readers.

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

This is not applicable. The device is a physical biological indicator, not a software algorithm. Its performance is inherent to its physical and biological properties.

7. The Type of Ground Truth Used

The ground truth used for this device is based on microbiological and physical testing standards and protocols. Specifically:

Viable spore count (for spore population).
Sterility or growth of the inoculated organism after exposure to specific sterilization conditions and subsequent incubation (for resistance, media recovery, survival response time).
Visual observation of color change for pH indicator and physical integrity (for stability of color change, media evaporation, effects of carrier/package materials, effects of holding time).

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI/ML algorithm that requires a training set. The "training" in the context of biological indicators refers to the development and refinement of the manufacturing process and formulation, not data-driven model training.

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

This is not applicable for the same reason as point 8.

Summary

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K111515

510(k) Summary of Safety and Effectiveness

FEB - 1 2012

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 January 27th, 2012 ●
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:	SPSmedical SporView® Steam Self Contained BI (K070595)

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Device Description:

SPSmedical Supply Corp. is using its SporView® Self Contained Steam BI (K070595) to show equivalence to the proposed SporView® self contained steam Bl. Both devices are essentially the same device however; the proposed device was tested at 135°C, where as the device cleared under K070595 was tested at 121°C, 132°C and 134°C.

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°C and 132°C gravity displacement, 132°C flash gravity displacement and 121°C - 134°C prevacuum cycles.

Statement of Similarity to the Legally Marketed Predicate Device:

Both devices are essentially the same device tested at different sterilization temperatures. �
Both are intended to monitor steam sterilization cycles. .
Both utilize the same strain of bacterial spores. ●
. Both utilize the same carrier material.
. Both use Tryptic Soy Broth as media.
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 ●
Survival Response Time .
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 is the same device tested at a different sterilization temperature. Therefore, the proposed device is as safe and effective as the legally marketed device.

P. 20f 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top half of the circle. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or other national bird, with its wings outstretched.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SPSMedical Supply Corporation C/O Mr. Gary J. Socola Vice President, Scientific Affairs 6789 West Henrietta Road Rush, New York 14543

REB - 1 2012

Re: K111515

Trade/Device Name: SporView® Steam Self Contained BI Regulation Number: 21 CFR 880.2800 Regulation Name: Biological Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: January 27, 2012 Received: January 31, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

fer Anthras. Duktsm

Anthony D. Watson, B.S., M.S., M.B.A. 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.

510(k) Number (if known): K11515

SporView® Steam Self Contained BI Device Name:

Indications For Use:

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)

Elizabeth F. Clausing-Wille

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

Page 1 of 1

510(k) Number: KIIL515

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).