(57 days)
The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in Cidex® OPA Solution, is above or below the minimum effective concentration (MEC) established for Cidex OPA Solution.
The device is a qualitative, single use, reagent test strip made up of a 0.40 inch square test pad that has been chemically treated to detect OPA in Cidex OPA Solution. The pad is affixed to one end of a 3.25 inch by 0.40 inch white opaque polystyrene strip.
The provided text describes the Serim DISINTEK OPA Test Strips and the study conducted to demonstrate its substantial equivalence to a predicate device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are implicitly defined by the performance of the predicate device, the Cidex OPA Solution Test Strip, and the ability to accurately indicate the OPA concentration above or below the Minimum Effective Concentration (MEC). The device's performance is reported in comparison to this predicate.
Acceptance Criteria & Reported Device Performance for Serim DISINTEK OPA Test Strips
| Acceptance Criteria (Implied) | Reported Device Performance and Comparison |
|---|---|
| Accuracy: Reliably indicate if OPA concentration is above or below the MEC of 0.3%. | The device "will reliably indicate if the OPA concentration is above or below the MEC level of 0.3% OPA." |
| Comparison to Predicate: Performance should be substantially equivalent to Cidex® OPA Solution Test Strip. | Performance was "evaluated in split samples blind studies and compared to test results obtained with Cidex OPA Solution Test Strips." |
| "The performance of the Serim DISINTEK OPA Test Strips is substantially equivalent to the predicate device, Cidex OPA Solution Test Strips." | |
| Intended Use Equivalence: Have the same intended use as the predicate device (measuring OPA potency in Cidex OPA Solution, above/below 0.3% MEC). | "The Serim DISINTEK OPA Test Strips have the same intended use as the predicate device." |
| Safety and Effectiveness: Not raise any new safety or effectiveness issues compared to the predicate. | "The Serim DISINTEK OPA Test Strips do not raise any new safety or effectiveness issues." |
| Mechanism of Action: React with OPA to show color change based on concentration relative to MEC. | The device contains chemicals that react with OPA; a "first step involves a reaction in which a chemical at a concentration equivalent to 0.3% OPA (MEC) reacts with the OPA to form a colorless product. A second reaction then occurs in which OPA at levels above 0.3% reacts with a second chemical to form a colored compound, resulting in green color." |
| Physical Characteristics: Test pad size allows for easy interpretation of color change. | "The test pad size of 0.4" x 0.4" allows for easy interpretation of the change in color." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "split samples blind studies" were used, but it does not specify the exact sample size used for the test set.
- Data Provenance: Not explicitly stated, but typical for device submissions in the US, the studies would likely be conducted in the country of origin of the submitter (Serim Research Corporation, Elkhart IN, USA). The study is described as performance evaluation, implying it was prospective in nature, as new data was generated using the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of "experts" in establishing ground truth in the context of human readers or medical professionals for this type of chemical indicator. The ground truth for chemical concentration is typically established by analytical chemistry methods rather than expert consensus on visual interpretation.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For a chemical indicator, "adjudication" in the sense of reconciling differing expert opinions would not typically apply. The "ground truth" for OPA concentration would be determined by quantitative chemical analysis.
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
No, an MRMC comparative effectiveness study was not done. This device is a chemical indicator, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with or without AI assistance does not apply.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The device itself is a passive chemical indicator. Its performance is inherent to its chemical reaction properties. While human interpretation of the color change is necessary, the "test strip" itself acts as a "standalone" indicator in the sense that its chemical reaction and color formation occur independently of human judgment. The study evaluated the device's performance directly by comparing its indications to those of the predicate device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this chemical indicator would be the actual chemical concentration of ortho-phthalaldehyde (OPA) in the Cidex OPA Solution, determined by a validated analytical method (e.g., spectrophotometry, titration, or other quantitative chemical analysis). The device's color change is then compared against this known OPA concentration to determine its accuracy in indicating above or below the MEC of 0.3%.
8. The Sample Size for the Training Set
The document does not mention a "training set" as this device is a chemical indicator and not a machine learning or AI model. The concept of training data does not apply here.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this chemical indicator, this question is not applicable.
{0}------------------------------------------------
:
:
Ko81370
510 (K) SUMMARY
| Prepared: | May 9, 2008 | JUL 11 2008 |
|---|---|---|
| Submitter: | Serim Research Corporation | |
| Address | P.O. Box 4002Elkhart IN 46514 | |
| Phone: | 574-264-3440 | |
| Fax: | 574-266-6222 | |
| Contact: | Patricia A. RupchockDirector of Regulatory Affairs | |
| Device Trade Name: | Serim ® DISINTEK ™ OPA Test Strips | |
| Common or Usual Name: | Indicator for ortho-phthalaldehyde (OPA) high leveldisinfectant | |
| Device Classification Name: | Chemical Indicators for Liquid Chemical Germicide. (b)Class II (Physical/Chemical Sterilization ProcessIndicator). | |
| Product Code: | JOJ | |
| Class: | II | |
| Regulation Number: | 21CFR 880.2800 | |
| Substantial Equivalence: | The Serim DISINTEK OPA Test Strip is substantiallyequivalent to Cidex ® OPA Solution Test Strip; K991709. | |
| Device Description: | The device is a qualitative, single use, reagent test stripmade up of a 0.40 inch square test pad that has beenchemically treated to detect OPA in Cidex OPA Solution.The pad is affixed to one end of a 3.25 inch by 0.40 inchwhite opaque polystyrene strip. | |
| Intended Use: | The Serim ® DISINTEK ™ OPA Test Strip is a chemicalindicator for use in determining whether the concentrationof ortho-phthalaldehyde, the active ingredient in Cidex ®OPA Solution, is above or below the minimum effectiveconcentration (MEC) established for Cidex OPA Solution. |
.
:
:
{1}------------------------------------------------
SERIM Research Corporation 510(k) Premarket Notification Serim® DISINTEK™ OPA Test Strip
Technological Characteristics: The Serim DISINTEK OPA Test Strips contains two reacting chemicals, a stabilizer, and other non-reacting ingredients. The reaction process involved with the test strip is based on a two step reaction. The first step involves a reaction in which a chemical at a concentration equivalent to 0.3% OPA (MEC) reacts with the OPA to form a colorless product. A second reaction then occurs in which OPA at levels above 0.3% reacts with a second chemical to form a colored compound, resulting in green color. The test pad size of 0.4" x 0.4" allows for easy interpretation of the change in color. The device will reliably indicate if the OPA concentration is above or below the MEC level of 0.3% OPA.
- The performance of the Serim DISINTEK OPA Test Strips Performance: was evaluated in split samples blind studies and compared to test results obtained with Cidex OPA Solution Test Strips. The performance of the Serim DISINTEK OPA Test Strips is substantially equivalent to the predicate device, Cidex OPA Solution Test Strips.
- Conclusion: The Serim DISINTEK OPA Test Strips have the same intended use as the predicate device. Both test strips measure the potency of OPA in Cidex OPA Solution, above or below the Minimum Effective Concentration of 0.3%. The Serim DISINTEK OPA Test Strips do not raise any new safety or effectiveness issues.
{2}------------------------------------------------
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three wing-like shapes.
Public Health Service
JUL 11 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Rupchock Director of Regulatory Affairs Serim Research Corporation 3506 Reedy Street Elkhart, Indiana 46561
Re: K081370
Trade/Device Name: Serim® DISINTEKTM OPA Test Strips Regulation Number: 21 CFR 880.2800 Regulation Name: Indicator, Physical/Chemical Sterilization Process Regulatory Class: Class II Product Code: JOJ Dated: May 9, 2008 Received: May 15, 2008
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 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.
{3}------------------------------------------------
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 requirements as set forth in the quality systems (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-{See Below For Phone Numbers]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clare
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
{4}------------------------------------------------
INDICATIONS FOR USE
K 08/020 510(k) Number (if known):
Serim® DISINTEK™ OPA Test Strips Device Name:
Indications For Use: The Serim® DISINTEK™ OPA Test Strip is a chemical indicator for use in determining whether the concentration of orthophthalaldehyde, the active ingredient in Cidex® OPA Solution, is above or below the minimum effective concentration (MEC) established for Cidex OPA 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)
Shula H Murphy, R
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 081372
§ 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).