(92 days)
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.
The device is a qualitative, single use, reagent test strip made up of a 0.20 inch square purple reagent pad that has been chemically treated to detect the active ingredient in the Steris 20™ Sterilant® when used in the STERIS SYSTEM 1® Processor™. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip.
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.
The provided text is a 510(k) Premarket Notification for the Serim® Peracetic Acid Chemical Indicator. This document focuses on establishing substantial equivalence to a previously cleared device, not on presenting a standalone study with detailed acceptance criteria and performance data as one would expect for a new, non-equivalent device or an AI/software as a medical device (SaMD).
Therefore, many of the requested points cannot be directly addressed from the provided text because the device, a chemical indicator, is not an AI/Software device, nor is the document an MRMC or standalone study report. It's a regulatory submission for a physical device.
However, I can extract information relevant to the intent of the questions where possible, and clearly state when information is not available due to the nature of the document.
1. Table of Acceptance Criteria and Reported Device Performance
The submission declares substantial equivalence to the STERIS PROCESS™ Chemical Monitoring Strips (K921559). The "acceptance criteria" for this submission appear to be the demonstrated identical nature and functionality to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Detects peracetic acid concentration in the use solution of a STERIS SYSTEM 1® Processor with STERIS 20™ Sterilant. | 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. (Matches) |
| Technological Characteristics: Identical to the STERIS PROCESS™ Chemical Monitoring strip (K921559) in composition and mechanism (dye oxidized/bleached by peracetic acid, color change compared to a chart). | 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 device uses a color change mechanism: dye in a pad is oxidized (bleached) by peracetic acid; user compares reacted indicator to a color chart with "START" and "COMPLETE" color blocks, where "COMPLETE" indicates exposure to ≥ 1500 ppm peracetic acid. (Matches predicate) |
| Performance: Provides an indication of sufficient peracetic acid concentration (at or above 1500 ppm). | Performance: The "COMPLETE" color block of the color chart corresponds to an indicator strip exposed to peracetic acid "at or above a concentration of 1500 ppm." (Implies equivalent performance to predicate) |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) for a physical chemical indicator, not a study involving a test set of data (like medical images or clinical records). The claim is about manufacturing and functional identity to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" as typically understood in a software or AI device study is established for a test set in this 510(k) submission. The performance relies on the chemical reaction and color change.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication in this context.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a chemical indicator, not an AI or software device, and no MRMC study is mentioned or relevant to this type of submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a standalone chemical indicator that produces a visual result. It requires human interpretation to compare the reacted strip to a color chart. There is no "algorithm only" component. The performance discussed is the chemical reaction itself, not a digital algorithm.
7. The type of ground truth used
The "ground truth" for this chemical indicator's functionality is the known chemical concentration of peracetic acid. The device is designed to visually indicate if this concentration is at or above a specific threshold (1500 ppm).
8. The sample size for the training set
Not applicable. This device is a chemical indicator, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is used for this device.
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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 4002Elkhart IN 46514 |
| Phone:Fax: | 574-264-3440574-266-6222 |
| Contact: | Patricia A. RupchockManager 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 issubstantially equivalent to STERIS PROCESS™ ChemicalMonitoring Strips1 (K921559, February 28, 1995) |
| Device Description: | The device is a qualitative, single use, reagent test strip madeup of a 0.20 inch square purple reagent pad that has beenchemically treated to detect the active ingredient in the Steris20™ Sterilant® when used in the STERIS SYSTEM 1®Processor™. The pad is affixed to one end of a 3.25 inch by0.20 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 (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 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:
Page 1 of 1
§ 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).