(53 days)
ISE Compensator is for use in the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers.
Not Found
Here's a breakdown of the requested information based on the provided 510(k) summary:
This document is a 510(k) summary for a medical device called "ISE Compensator," a calibrator for Ion Selective Electrodes on Roche/Hitachi analyzers. The summary focuses on demonstrating substantial equivalence to a predicate device, the "ISE Compensation Sera (K870379)." It does not contain the detailed performance study results, acceptance criteria, or ground truth establishment methods typically found in full submissions or clinical study reports.
Therefore, many of your requested points cannot be answered directly from the provided text. I will indicate where the information is "Not Available in Provided Text."
1. Table of Acceptance Criteria and Reported Device Performance
Not Available in Provided Text.
The document states: "The ISE Compensator was evaluated for value assignment and stability. Performance characteristics." However, it does not provide the specific acceptance criteria, the methodology for this evaluation, or the results of the performance characteristics (e.g., value assignment accuracy, stability data). It primarily focuses on comparing the characteristics of the new device to the predicate device to establish substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
Not Available in Provided Text.
The summary mentions "evaluation for value assignment and stability" but does not detail the sample size (e.g., how many batches, how many runs, how many different samples were tested) or the provenance of any testing data. Given the device is a calibrator, "test set" might refer to the number of calibration events or lots tested, but this is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable (for this type of device, as 'ground truth' for human interpretation is not relevant) and Not Available in Provided Text.
For a calibrator, the "ground truth" would typically be derived from highly accurate reference methods or certified reference materials, not expert human interpretation. The document does not describe how the target values for the calibrator (referenced as "Refer to target value sheet of package insert") were established.
4. Adjudication Method for the Test Set
Not Applicable (for this type of device) and Not Available in Provided Text.
Adjudication methods (like 2+1 or 3+1) are used in studies where human readers interpret data, often for diagnostic imaging or pathology. For a calibrator, there is no human interpretation of a "test set" in the sense of a diagnostic decision.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not Applicable.
This device is an in vitro diagnostic calibrator. It does not involve human readers interpreting cases or AI assistance in diagnostic decisions. Therefore, an MRMC comparative effectiveness study is irrelevant for this product.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable.
This device is a calibrator, not an algorithm. The "performance" here relates to its ability to accurately calibrate an analyzer, its stability, and its formulation. There is no "algorithm only" performance to speak of in the context of this device.
7. The Type of Ground Truth Used
Indirectly indicated as "defined concentrations" for components.
The document states, "Human serum matrix preparation with defined Sodium, Potassium and Chloride concentrations." This suggests that the ground truth for these analytes is based on these "defined concentrations," likely established through highly accurate analytical methods or certified reference materials. The "Reactive Components" table also mentions "Refer to target value sheet of package insert," implying that specific, established values serve as the ground truth against which the calibrator's performance is measured.
8. The Sample Size for the Training Set
Not Applicable / Not Available in Provided Text.
Calibrators are not "trained" in the same way machine learning models are. Product development and formulation involve various experiments and optimization, but there isn't a "training set" in the context of AI/ML. If this question refers to the samples used to develop the calibrator's formulation or establish initial values, that information is not provided.
9. How the Ground Truth for the Training Set Was Established
Not Applicable / Not Available in Provided Text.
See answer to point 8.
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510(k) Summary
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence
| Submitter name, address, and contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250317-521-3723 |
|---|---|
| Contact Person: | Corina Harper |
| Date Prepared: | August 9, 2005 |
| Device name | |
|---|---|
| Proprietary name: | ISE Compensator |
| Common name: | Calibrator |
| Classification name: | Calibrator, Multi-Analyte mixture |
| Predicate device | The ISE Compensator is substantially equivalent to the cleared ISE Compensation Sera (K870379). |
|---|---|
| ------------------ | ------------------------------------------------------------------------------------------------- |
| Intended use | ISE Compensator is for use in the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers. |
|---|---|
| -------------- | ------------------------------------------------------------------------------------------------------- |
Continued on next page
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510(k) Summary, Continued
The ISE Compensator is substantially equivalent to other products in Substantial equivalence commercial distribution intended for similar use. We claim equivalency to the currently marketed ISE Compensation Sera (K870379).
The below tables compare ISE Compensator with the predicate device, ISE Substantial equivalence: Compensation Sera (K870379). Similarities
| Characteristic | Predicate DeviceISE CompensationSera (K870379) | ISE Compensator |
|---|---|---|
| Intended Use | For use in thecalibration of Sodium,Potassium, andChloride on theBoehrienger Mannheimdiagnostics/HitachiSystems with IonSelective Electrodes. | For use in thecalibration of IonSelective Electrodes onRoche/Hitachianalyzers. |
| Levels | One | Same |
| Format | Lyophilized | Liquid |
| Handling | Add 5.0 mL distilled ordeionized water. Allowto stand for 30 minutes.Mix carefully, avoidingthe formation of thefoam. | Ready to use. Mix wellprior to use, avoidingthe formation of thefoam. |
| Stability | Unopened:• Store at 2-8 °C untilexpiration dateReconstituted:• 5 days at 2-8 °C• 5 days at -20 °C | Unopened:• SameAfter opening:• 2 weeks at 2-8 °C |
Continued on next page
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510(k) Summary, Continued
| Characteristic | Predicate DeviceISE CompensationSera (K870379) | ISE Compensator |
|---|---|---|
| Matrix | Human serum matrixwith added Sodiumcarbonate, Potassiumchloride,, Sodiumchloride. | Human serum matrixpreparation withdefined Sodium,Potassium and Chlorideconcentrations. |
Substantial equivalence: Similarities (continued)
The table below lists all active ingredients for ISE Compensator. Matrix The active ingredients are spiked into a buffered human serum matrix. composition
- 1
| Components | Concentration | |
|---|---|---|
| Reactive Components | Na+K+Cl- | Refer to target valuesheet of package insert. |
The ISE Compensator was evaluated for value assignment and stability. Performance characteristics
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy base.
Public Health Service
OCT 3 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Corina Harper, RAC Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250-0416
K052193 Re:
Trade/Device Name: ISE Compensator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: September 13, 2005 Received: September 15, 2005
Dear Ms. Harper:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 –
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: ISE Compensator
Indications For Use:
ISE Compensator is for use in the calibration of Ion Selective Electrodes on Roche/Hitachi analyzers.
Prescription Use XXXX (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 In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k
Roche Diagnostics Confidential
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.