Raven ProChem Indicator Tape is a process chemical indicator tape intended to seal packs and provide visual evidence that packs have been exposed when subjected to steam sterilization (121°C gravity cycles and 121°C – 134°C pre-vacuum cycles) processes as well as Harvey Chemiclave® chemical vapor sterilization process.

Device Description

ProChem Indicator Tape is a saturated crepe paper printed with white indicator lines that turn to dark brown/black upon exposure to saturated steam or Chemiclave® chemical vapor sterilization. It is coated on the back with a dry natural rubber based adhesive for adherence to packs/packages.

AI/ML Overview

The provided document describes the ProChem Indicator Tape, a process chemical indicator designed to distinguish processed packages from unprocessed ones after exposure to steam or chemical vapor sterilization. The performance testing section mentions adherence to specific standards but lacks the detailed breakdown requested for a complete acceptance criteria and study report.

Here's an attempt to extract and synthesize the information based on the provided text, while also noting what is missing:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from ANSI/AAMI/ISO 11140-1:2005 for Class 1 Indicators)	Reported Device Performance (ProChem Indicator Tape)
Indicator Color Change	Clear and distinct color change to indicate exposure to sterilization conditions.	White indicator lines turn to dark brown/black upon exposure to saturated steam or Chemiclave® chemical vapor sterilization.
Class 1 Indicator Requirements	Meets all requirements for Class 1 indicators as defined in ANSI/AAMI/ISO 11140-1:2005. (Specifics not detailed in the provided text).	Performance was equivalent to the predicate device and meets the requirements of Class 1 indicators as defined in ANSI/AAMI/ISO 11140-1:2005.
Functionality (Tape)	Adheres to packs/packages.	Coated on the back with a dry natural rubber based adhesive for adherence to packs/packages.

Missing Information: The specific quantitative acceptance criteria for Class 1 indicators within ANSI/AAMI/ISO 11140-1:2005 are not detailed in the provided text. For example, parameters like minimum exposure conditions for color change, color change uniformity, stability, and absence of color change under non-sterilizing conditions are typically part of such standards. The document only states that the device "meets the requirements."

2. Sample Size and Data Provenance

Sample Size for Test Set: 3 separate production lots of chemical indicator tapes.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the testing was conducted "in an AAMI compliant steam resistometer," suggesting laboratory-controlled prospective testing.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. The ground truth for chemical indicators is typically established by comparing the indicator's performance against defined physical and chemical sterilization parameters, not through expert human interpretation.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The assessment of chemical indicators is based on a direct physical or chemical reaction (color change) against a known standard. It does not involve human adjudication in the typical sense for medical imaging or diagnostics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This type of study is not relevant for the evaluation of a chemical process indicator. MRMC studies are typically used to assess diagnostic accuracy or the impact of AI on human reader performance for tasks involving interpretation (e.g., radiology).

6. Standalone (Algorithm Only) Performance Study

Standalone Performance: Yes, in essence. The "Performance testing was conducted... in an AAMI compliant steam resistometer." This implies the device's performance (color change) was evaluated on its own against the defined sterilization parameters without human-in-the-loop assistance for the core function of indicating sterilization. The "algorithm" here is the chemical reaction itself.

7. Type of Ground Truth Used

Type of Ground Truth: Physical and chemical parameters of sterilization processes, specifically "saturated steam or Chemiclave® chemical vapor sterilization," in accordance with "ANSI/AAMI/ISO 11140-1:2005." The color change is correlated directly with these physical parameters meeting the standard's criteria for sterilization.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The ProChem Indicator Tape is a chemical indicator, not an AI/ML algorithm that requires a training set. Its performance relies on inherent chemical properties and manufacturing consistency.

9. How Ground Truth for Training Set was Established

How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

Summary

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K 080307

510(k) Summary of Safety and Effectiveness

MAY - 1 2008

510(k) Notification ProChem Indicator Tape - Process Indicator

Submitted by:

Contact:

Raven Biological Laboratories 8607 Park Drive Omaha, NE 68127

Wendy Royalty-Hann Quality Assurance/Regulatory Affairs Manager

Robert V. Dwyer, Jr. President

Phone: (402) 593-0781 Fax: (402) 593-0921

Prepared on:

Device:

Trade name: ProChem Indicator Tape, Models CI-STP, CI-STP-EA, CI-STP 12, CI-STP-12EA, CI-STP-24, CI-STP-24EA Common name: Physical/chemical sterilization process indicator

Classification:

Class II

Predicate Device:

Steritec Sterilization Process Indicator Tapes Models Cl 122 and Cl 123, 510(k) #K003002

DEVICE DESCRIPTION

INTENDED USE

ProChem Indicator Tape is process chemical indicator tape designed to hold packages together and distinguish processed packages/trays from unprocessed packages/trays.

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TECHNOLOGICAL CHARACTERISTICS

The ProChem Indicator Tape consists of a saturated crepe paper printed with white indicator lines that turn to dark brown/black once an autoclave process or Chemiclave® chemical vapor process is completed. The tape is coated on the back with a dry natural rubber based adhesive.

PERFORMANCE TESTING AND SUBSTANTIAL EQUIVALENCE

Performance testing was conducted in accordance with ANSI/AAMI/ISO 11140-1:2005 in an AAMI compliant steam resistometer using 3 separate production lots of chemical indicator tapes. The performance of the ProChem Indicator Tape was equivalent to that of the predicate device and meets the requirements of Class 1 indicators as defined in ANSI/AAMI/ISO 11140-1:2005.

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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 graphic element resembling a bird or abstract human form, positioned to the right. To the left of the graphic is text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2008

Ms. Wendy Royalty-Hann Quality Assurance/ Regulatory Affairs Manager Raven Laboratories, Incorporated 8607 Park Drive Omaha, Nebraska 68127

Re: K080307

Trade/Device Name: ProChem Indicator Tape Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: April 9, 2008 Received: April 10, 2008

Dear Ms. Royalty-Hann:

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 – Ms. Royalty-Hann

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

Sincerely yours.

Syrtie Y. Michie Omd.

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

Device Name

ProChem Indicator Tape

Indications for

Raven ProChem Indicator Tape is a process chemical indicator tape intended to seal packs and provide visual evidence that packs have been exposed when subjected to steam sterilization (121°C gravity cycles and 121°C – 134°C pre-vacuum cycles) processes as
well as Harvey Chemiclave® chemical vapor sterilization process.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of GDRH, Office of Device Evaluation (ODE)

Shela A. Murphy, MS
(Division Sign-Off)

AND/OR

Division of Anesthesiology. General Hospital Infection Control, Dental Devices

K 080307 510(k) Number:

Page 4

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).