(18 days)
The Sentinel Cholinesterase Liquid assay is used to measure cholinesterase in human specimens. There are two principal type of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is note present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition and disorders. For In Vitro diagnostics use only. CFR 862.3240
Sentinel Cholinesterase Liquid is an in vitro diagnostic assay for the quantitative determination of cholinesterase in serum and plasma.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.
Note: The provided text describes a submission for a chemical assay (Cholinesterase Liquid), not an AI-powered device or an image-based diagnostic. Therefore, many of the requested criteria related to AI, ground truth, expert review, MRMC studies, and training/test sets are not applicable to this type of submission and are not mentioned in the documentation. The description focuses on demonstrating substantial equivalence of a modified in-vitro diagnostic assay to a previously cleared one.
Acceptance Criteria and Device Performance
The acceptance criteria for this device revolve around demonstrating substantial equivalence to a predicate device for its intended use and performance characteristics, specifically after adapting it to new analyzer systems.
Due to the nature of this submission (modification of an IVD assay to run on different analyzers), the acceptance criteria are implicitly met when the comparative performance studies show acceptable correlation.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The modified device must perform for the same intended use as the predicate device. | The modified Sentinel Cholinesterase Liquid assay is used for the quantitative determination of cholinesterase in serum and plasma, which is consistent with the predicate. Measurements obtained are used in the diagnosis and treatment of cholinesterase inhibition and disorders, mirroring the predicate's use. |
| Method Comparison (AEROSET System): Acceptable correlation with the predicate device (Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717). | For the AEROSET System, the modified Sentinel Cholinesterase Liquid assay method comparison "yielded acceptable correlation with the Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717." |
| Method Comparison (ARCHITECT c8000 System): Acceptable correlation with the modified Sentinel Cholinesterase Liquid on the AEROSET system (and by transitive property, to the predicate). | For the ARCHITECT c8000 system, the modified Sentinel Cholinesterase Liquid assay method comparison "yielded acceptable with the modified Sentinel Cholinesterase Liquid on the AEROSET system." This data, along with the AEROSET comparison, demonstrates performance substantially equivalent to the cleared Sentinel Cholinesterase Liquid Model Numbers. |
| Safety and Effectiveness: Modifications must not significantly change the safety and effectiveness of the device. | The modifications (adaptation to Abbott AEROSET and ARCHITECT c8000 Analyzers) "did not significantly change the safety and effectiveness of the device as demonstrated in the Performance Characteristics Summary." |
Study Proving Device Meets Acceptance Criteria:
The study was a comparative performance study aimed at demonstrating the substantial equivalence of the modified Sentinel Cholinesterase Liquid assay when run on the Abbott AEROSET® and ARCHITECT® c8000® Analyzers, compared to the previously cleared Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size used for the comparative performance studies (method comparison studies). It states "comparative performance studies were conducted" but does not detail the number of samples or patients included. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This is not applicable as the device is an in-vitro diagnostic assay for quantitative determination of cholinesterase, not an AI or image-based diagnostic requiring expert interpretation for ground truth. The "ground truth" for method comparison in an IVD context is typically the results obtained from a reference method or a legally marketed predicate device.
4. Adjudication Method:
This is not applicable for the reasons stated above. There is no expert adjudication process described for the performance of a quantitative chemical assay.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No. This is definitively not applicable as this device is a laboratory assay, not an AI or imaging device involving human readers.
6. If a standalone (algorithm only without human-in-the loop performance) was done:
The device itself is standalone in the sense that it is a quantitative assay performed by an analyzer. Its performance is evaluated intrinsically through comparison to a predicate, not in interaction with a human "in the loop" in a diagnostic workflow like an AI algorithm might be. So, yes, the performance assessed is of the assay independent of immediate human interpretative input in a diagnostic decision-making context.
7. The Type of Ground Truth Used:
For the comparative performance studies, the "ground truth" was established by the results obtained from the legally marketed predicate device, Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717, and also by the AEROSET system's results being used as a comparator for the ARCHITECT c8000 system. This is a common approach for demonstrating substantial equivalence of IVD modifications.
8. The Sample Size for the Training Set:
Not applicable. This device is a chemical assay, not a machine learning algorithm that requires a "training set." The development of the assay itself would have involved method optimization and validation, but not in the context of a "training set" for an AI model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
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JUN 2 0 2005
510(k) Summary
Submitter's Name/Address
Contact Person
Sentinel CH. S.r.1. Via Principe Eugenio, 5 20155 Milan Italy
Davide Spada Application Specialist Tel: +39 02 345514.1 Fax: +39 02 345514.64
| Date of Preparation of this Summary: | May 28, 2005 |
|---|---|
| Device Trade or Proprietary Name: | Sentinel Cholinesterase Liquid |
| Device Common/Usual Name orClassification Name: | Cholinesterase |
| Classification Number/Class: | DIH, DLI/Class I |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K051444
Test Description:
Sentinel Cholinesterase Liquid is an in vitro diagnostic assay for the quantitative determination of cholinesterase in serum and plasma.
Substantial Equivalence:
The modified Sentinel Cholinesterase Liquid assay is substantially equivalent to the cleared Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717 (K981800). The modifications consisted of the adaptation of the general purpose Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay to be used on the Abbott AEROSET® and the ARCHITECT® c8000® Analyzers. This (these) modifications did not significantly change the safety and effectiveness of the device as demonstrated in the Performance Characteristics Summary.
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Intended Use:
The modified Sentinel Cholinesterase Liquid assay is used for the quantitative determination of cholinesterase in serum and plasma.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET System and the ARCHITECT® c 8000 System. For the AEROSET System, the modified Sentinel Cholinesterase Liquid assay method comparison yielded acceptable correlation with the Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 assay on Hitachi 717. For the ARCHITECT c8000 system, the modified Sentinel Cholinesterase Liquid assay method comparison yielded acceptable with the modified Sentinel Cholinesterase Liquid on the AEROSET system. These data demonstrate the performance of the modified Sentinel Cholinesterase Liquid assay is substantially equivalent to the performance of the cleared Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606.
Conclusion:
The modified Sentinel Liquid assay is substantially equivalent to the cleared Sentinel Cholinesterase Liquid Model Number 17.019A and 17.606 (K981800) assay as demonstrated by results obtained in the studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
JUN 2 0 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Davide Spada Application Specialist Sentinel CH. S.r.l Via Principe Eugenio, 5 20155 Milan Italy
K051444 Re:
Trade/Device Name: Sentinel Cholinesterase Liquid Regulation Number: 21 CFR 862.3240 Regulation Name: Cholinesterase test system Regulatory Class: Class I Product Code: DIH Dated: May 28, 2005 Received: June 2, 2005
Dear Mr. Spada:
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 for answer of 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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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. Benem
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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510(k) Number (if known): K051444
Sentinel Cholinesterase Liquid Device Name: Device
Indications For Use:
The Sentinel Cholinesterase Liquid assay is used to measure cholinesterase in human specimens. There are two principal type of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is note present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition and disorders. For In Vitro diagnostics use only. CFR 862.3240
Prescription Use V (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
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10/11 051444
§ 862.3240 Cholinesterase test system.
(a)
Identification. A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).(b)
Classification. Class I (general 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.