The SPSmedical SportView® Bacterial Spore Strip is designed to monitor Chemiclave® chemical vapor sterilizers. The combination of SPSmedical's spore strip and SporView Culture Media (Tryptic Soy Broth, Modified with Bromocresol Purple) has been validated at 60 ℃ for a reduced incubation time of 72 hours for the Chemical vapor sterilization process.

Device Description

The SPSmedical SporView® Bacterial Spore Strip is inoculated with either Geobacillus stearothermophilus ATCC# 7953 or Bacillus atrophaeus ATTC# 9372 bacterial spores. A dual species spore strip containing both the Geobacillus stearothermophilus ATCC# 7953 and Bacillus atrophaeus ATTC# 9372 organisms is also manufactured. The strip is packaged in a blue, glassine envelope.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SPSmedical SporView® Bacterial Spore Strip, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Reduced incubation time for Chemiclave® chemical vapor sterilization process when used with SporView® Culture Media.	72 hours (for all tested lots and conditions).

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document states that "three lots of biological indicators" were used. This included a "newly manufactured lot, mid-range expiration lot and a lot nearing its expiration date."
Data Provenance: The study appears to be retrospective and conducted by the manufacturer (SPSmedical). The country of origin is not explicitly stated but implied to be the U.S. as SPSmedical is located in Rush, NY, U.S.A.

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

This information is not provided in the document. The testing was described as "conducted following the FDA guidance for the validation of reduced incubation of biological indicators" and performed by the manufacturer, but there's no mention of external experts establishing ground truth or their qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC study was not done. This device is a biological indicator for sterilization, not an imaging or diagnostic device that would typically involve human readers.

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

Yes, the testing described appears to be a standalone performance evaluation of the biological indicator and its associated culture media. There is no human interpretation component described; the outcome (72-hour reduced incubation resulting in growth/no growth) is inherent to the biological process.

7. The Type of Ground Truth Used

The ground truth is based on the biological response of the Geobacillus stearothermophilus ATCC# 7953 or Bacillus atrophaeus ATTC# 9372 bacterial spores to the Chemiclave® chemical vapor sterilization process and subsequent incubation. The "reduced incubation time of 72 hours" is validated against the expected absence of growth (indicating successful sterilization) within that timeframe. Essentially, the "ground truth" for each test would be whether the spores were killed or not killed by the sterilization process, as determined by their growth or lack thereof after incubation.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This is not a machine learning or AI-based device, so there is no "training set."

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

This information is not applicable. Since there is no training set for an AI/ML algorithm, no ground truth was established for it.

Summary

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MAY - 6 2004

K041099

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 April 2181, 2004 .
Gary J. Socola . Printed name of person submitting for 510(k)
Me Dote ● Signature of befson 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 K023716 K905425

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Device Description:

Intended Use:

The SPSmedical SporView® Bacterial Spore Strip is designed for routine monitoring of Steam, Dry Heat, EO Gas, and Chemiclave® sterilization processes. The indicator should be placed in the most difficult to sterilize location of the Chemiclave® sterilization load. The spore strip is 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 72 hours for the Chemiclave® chemical vapor sterilization process.

Statement of Similarity to the Legally 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 Chemiclave® chemical vapor 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 72 hour reduced incubation time for the chemical vapor 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 72 hour reduced incubation time when used with the SPSmedical SporView® Culture Media in monitoring the Chemiclave® chemical vapor 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing or feather shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 6 2004

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

Re: K041099

Trade/Device Name: SPSmedical SporView® Bacterial Spore Strip Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: April 21, 2004 Received: April 26, 2004

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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

510(k) Number (if known): _ K04) 099

Device Name: SPSmedical SporView® Bacterial Spore Strip

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)

Kei Mulay

(Division Sian-Off Division of Anesthesiology. General Hospital. Infection Control, Dental De

510(k) Number: K 041099

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).