PREVU POINT OF CARE SKIN STEROL TEST

K062092 · Premd, Inc. · LBS · Sep 15, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062092
• Device Name: PREVU POINT OF CARE SKIN STEROL TEST
• Applicant: Premd, Inc.
• Product Code: LBS · Clinical Chemistry
• Decision Date: Sep 15, 2006
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

The safety and effectiveness of this device for use in screening the general population for coronary artery disease or for use as a substitute for blood cholesterol tests or a substitute for other risk factors identified for coronary artery disease have not been established.

Device Story

PREVU POC Skin Sterol Test measures skin cholesterol levels to assist in coronary heart disease risk assessment. Device used in clinical settings by healthcare professionals. Input: skin sterol measurement. Output: quantitative or qualitative skin cholesterol result. Physician integrates result with clinical evaluation, blood cholesterol tests, and other risk factors to focus diagnostic and patient management options. Benefits: provides additional data point for patients with history of myocardial infarction or suspected multi-vessel coronary artery disease to guide further diagnostic evaluation.

Clinical Evidence

No clinical data provided; substantial equivalence established via design control activities, risk analysis, and verification/validation testing of device modifications.

Technological Characteristics

Lipoprotein test system; point-of-care diagnostic device. Class I, 21 CFR 862.1475, Product Code LBS.

Indications for Use

Indicated for use as a cholesterol monitoring device; not for general population screening for coronary artery disease; not a substitute for blood cholesterol tests or other coronary artery disease risk factor assessments.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k062092

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. Cholesterol 1,2,3 k014018
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for a) from a corded to a cordless device b) software and user interface changes (instructions on the display designed to guide the user in the operation of the device).

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, user interface, and software.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

Comments: The k014018 device was found to be substantial equivalent to the predicate device with the following limitations:

The safety and effectiveness of this device for use in screening the general population for coronary artery disease or for use as a substitute for blood cholesterol tests or a substitute for other risk factors identified for coronary artery disease have not been established.