(206 days)
INTENDED USE
The Lifestream Cholesterol Monitor is a professional-use, point-of-care in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples, used with the Privalink Software accessory to provide personalized health related information
INDICATIONS FOR USE
Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and with personalized health related information, aid in the management of patients undergoing therapy with lipid lowering drugs.
The measurement range for the Cholestron is 150 - 300 mg/dL.
Prescription Use
Not Found
This document is a 510(k) clearance letter from the FDA for a software accessory to a cholesterol monitor, not a study report or clinical trial. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, and ground truth establishment is not present in the provided text.
However, based on the information that is present, here's what can be inferred or explicitly stated:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance for the Privalink Software Accessory itself. The 510(k) process is primarily about demonstrating substantial equivalence to a predicate device, not necessarily proving new performance against specific criteria.
The only performance-related information mentioned is the measurement range for the Lifestream Cholesterol Monitor: 150 - 300 mg/dL. This is a functional specification of the main device, not the software accessory, and it's presented as an operational range rather than a performance target met through a study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The letter focuses on the regulatory clearance based on substantial equivalence, not on the details of a specific performance study for the software accessory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The Privalink Software Accessory is described as providing "personalized health related information," which suggests it might assist in interpretation, but there's no mention of a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. Given its role as an "accessory" to a cholesterol monitor for personalized health information, it's unlikely to have been evaluated as a standalone diagnostic algorithm in the same way an AI-powered image analysis tool might be.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary based on available information:
The provided document is a regulatory clearance letter, not a detailed study report. It confirms the FDA's finding of "substantial equivalence" for the Privalink Software Accessory to a legally marketed predicate device. This implies that the performance for the purpose of regulatory clearance was demonstrated through comparison to an existing device rather than through a de novo clinical study with specific acceptance criteria and detailed performance metrics as would be expected for a novel diagnostic algorithm.
The only quantitative information related to performance is the measurement range of the Lifestream Cholesterol Monitor from 150 - 300 mg/dL, which is the device the software accessory works with. Details about the software accessory's specific performance (e.g., accuracy of personalized health information, impact on user interpretation) are not included in this letter.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 0 1999
Mr. Jackson B. Connolly Vice President of Product Development Lifestream Technologies, Inc. 510 Clearwater Loop Suite 101 Post Falls, Idaho 83854
Re: K993096
Trade Name: Privalink Software Accessory to the Lifestream Cholesterol Monitor Regulatory Class: I reserved Product Code: CHH Dated: October 6, 1999 Received: October 7, 1999
Dear Mr. Connolly:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrlvdsma/dsmamain.html".
Sincerely yours.
Steven Putman
Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K993096 PRIVALINK SOFTWARE ACCESSORY
INTENDED USE/INDICATIONS FOR USE
INTENDED USE
The Lifestream Cholesterol Monitor is a professional-use, point-of-care in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples, used with the Privalink Software accessory to provide personalized health related information
INDICATIONS FOR USE
Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and with personalized health related information, aid in the management of patients undergoing therapy with lipid lowering drugs.
The measurement range for the Cholestron is 150 - 300 mg/dL.
Prescription Use
Carol Benson for Jean Cooper DVM
(Division Sign-Off)
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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 § 862.9.