SERIM PERACETIC ACID CHEMICAL INDICATOR

K052388 · Serim Research Corp. · JOJ · Dec 1, 2005 · General Hospital

Device Facts

• Record ID: K052388
• Device Name: SERIM PERACETIC ACID CHEMICAL INDICATOR
• Applicant: Serim Research Corp.
• Product Code: JOJ · General Hospital
• Decision Date: Dec 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Serim ® Peracetic Acid Chemical Indicator test strips are designed for use in a STERIS SYSTEM 1® Processor with STERIS 20™ Sterilant to detect peracetic acid concentration in the use solution.

Device Story

Qualitative, single-use reagent test strip; 0.20-inch square purple reagent pad on 3.25-inch white opaque polystyrene strip. Used in STERIS SYSTEM 1® Processor with STERIS 20™ Sterilant. Principle: dye in pad oxidized (bleached) by peracetic acid in use solution. User compares reacted pad to color chart at end of cycle. 'START' block represents unreacted state; 'COMPLETE' block represents concentration ≥1500 ppm. Provides independent monitoring of sterilant concentration to ensure sufficient active agent presence. Benefits patient by verifying sterilization process efficacy.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Qualitative chemical indicator; reagent pad on polystyrene strip. Principle: chemical oxidation (bleaching) of dye by peracetic acid. Single-use. No electronic components, software, or energy source.

Indications for Use

Indicated for use in a STERIS SYSTEM 1® Processor with STERIS 20™ Sterilant to detect peracetic acid concentration in the use solution.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• STERIS PROCESS™ Chemical Monitoring Strips (K921559)

Submission Summary (Full Text)

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K 052388

CONFIDENTIAL

SERIM Research Corporation 510(k) Premarket Notification Serim® Peracetic Acid Chemical Indicator

OEC I 2005

Page 9 of 24

## 510 (K) SUMMARY

| Prepared: | August 29, 2005 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Serim Research Corporation |
| Address | P.O. Box 4002<br>Elkhart IN 46514 |
| Phone:<br>Fax: | 574-264-3440<br>574-266-6222 |
| Contact: | Patricia A. Rupchock<br>Manager of Regulatory Affairs |
| Device Trade Name: | The Serim® Peracetic Acid Chemical Indicator |
| Common or Usual Name: | Chemical Indicator |
| Device Classification Name: | Indicator, Physical/Chemical Sterilization Process |
| Product Code: | JOJ |
| Class: | II |
| Regulation Number: | 880.2800 |
| Substantial Equivalence: | The Serim® Peracetic Acid Chemical Indicator is<br>substantially equivalent to STERIS PROCESS™ Chemical<br>Monitoring Strips1 (K921559, February 28, 1995) |
| Device Description: | The device is a qualitative, single use, reagent test strip made<br>up of a 0.20 inch square purple reagent pad that has been<br>chemically treated to detect the active ingredient in the Steris<br>20™ Sterilant® when used in the STERIS SYSTEM 1®<br>Processor™. The pad is affixed to one end of a 3.25 inch by<br>0.20 inch white opaque polystyrene strip. |

¹ STERIS PROCESS is a trademark of the Steris Corporation

Steris 20 is a trademark of the Steris Corporation

S FERIS SYSTEM 1 is a registered trademark of the Steris Corporation

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## SERIM Research Corporation CONFIDENTIAL 510(k) Premarket Notification Serim® Peracetic Acid Chemical Indicator Page 10 of 24 The Serim ® Peracetic Acid Chemical Indicator test strips are Intended Use: designed for use in a STERIS SYSTEM 1® Processor with STERIS 20" Sterilant to detect peracetic acid concentration in the use solution. Technological Characteristics: The Serim® Peracetic Acid Chemical Indicator is identical to the STERIS PROCESS™Chemical Monitoring strip (manufactured by Serim Research Corp. for Steris Corporation) that has been previously cleared by the FDA (K921559): The STERIS PROCESS™Chemical Monitoring Strip was developed by Serim Research Corporation and has been exclusively manufactured by Serim Research Corporation since the product was introduced. The Serim" Peracetic Acid Chemical Indicator will be used for the independent monitoring of the STERIS SYSTEM 1 employing STERIS 201M Sterilant. The Serim* Peracetic Acid Chemical Indicator is a qualitative, single use, chemical indicator used to detect the active ingredient of the STERIS 20TM Sterilant. The Serim* Peracetic Acid Chemical Indicator is configured as a paper pad on a plastic strip support. A dve in the chemical indicator pad is oxidized (bleached) by the use solution. The extent of bleaching indicates whether a sufficient concentration active agent (peracetic acid) was present. At the end of the processing evele the user compares the reacted indicator to a color chart composed of two color blocks. The "START" color block is similar to the unreacted indicator strip. The =COMPLETE color block is similar to an indicator strip that has been exposed to peracetic acid at or above a concentration of 1500 ppm. Serim Research Corporation hereby certifies that it developed Performance and Conclusion: the product known as the STERIS PROCESS™ Chemical Monitoring strip prior to the FDA 510(k) clearance of this product. Serim Research Corporation also has manufactured this material since the introduction of this product. The role of Serim Research Corporation in the development and manufacture of the product is acknowledged on the bottle

label of the STERIS PROCESS'" Chemical Monttoring Strip

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

DEC I 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia A. Rupchock Manager of Regulatory Affairs Serim Research Corporation 23565 Reedy Drive Elkhart, Indiana 46514

Re: K052388

Trade/Device Name: Serim® Peracetic Acid Chemical Indicator Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: November 14, 2005 Received: November 18, 2005

Dear Ms. Rupchock:

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 approvisions 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 (111), it in 11 ) be all 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 Eederal Register.

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Page 2 - Ms. Rupchock

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 and insuments 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), n you dontact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Snytte H. Michael Oms

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

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## Indications for Use

510(k) Number (if known): K052388

Serim® Peracetic Acid Chemical Indicator Device Name:

## Indications For Use:

The Serim ® Peracetic Acid Chemical Indicator test strips are designed for use in a STERIS SYSTEM 1® Processor with STERIS 20™ Sterilant to detect peracetic acid concentration in the use solution.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shulie K. Murphy, MD 11/30/05

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

t. (%) Number:

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