The V Quick Patch System is intended to be used as an electrocardiograph electrode and a placement device for the placement of electrocardiograph electrodes.

Device Description

The V Quick Patch™ is a single-use disposable device. It consists of two components. One component is mylar electrode positioning guide. It has pre-cut channels and measurement markings for movement and placement of electrodes. The second component consists of ten post-style Ag/AgCI ECG electrodes six of which are pre-mounted into the channels of the mylar positioning guide. The which are identical to other post-style Ag/AgCI electrodes currently on the market except for a raised mylar disc affixed to the top of the six precordial electrodes which allows the precordial electrodes to remain attached to the positioning guide and to be moved within the channels of the positioning guide for placement on a patient's chest.

AI/ML Overview

The provided text describes the V Quick Patch, an ECG electrode placement device, and a clinical study conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines the acceptance criteria by stating the device was found to be "as safe and as effective" as standard electrodes, and that the produced ECGs were "equivalent." The specific metrics for equivalency are not detailed, but the core criteria appear to be:

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Safety	No skin reaction or loss of skin integrity.
Effectiveness	Produced electrocardiograms (ECGs) equivalent to standard precordial tab-style electrodes.
Placement Time	Reduced placement time and improved accuracy for 12-lead placement compared to manual placement.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: 100 patients.
Data Provenance: Retrospective, as the study was conducted at the University of Cincinnati with patients who "suffered from cardiac or pulmonary disease." This indicates existing medical records were likely utilized or a patient cohort with pre-existing conditions was recruited. The country of origin is implicitly the USA (University of Cincinnati).

3. Number of Experts and Qualifications:

The document does not specify the number of experts used to establish ground truth or their qualifications. It only states that the study "found that the V Quick patch electrodes produced electrocardiograms (ECG's) that were equivalent to ECG's produced by the standard precordial tab-style electrode." This implies expert interpretation, but details are lacking.

4. Adjudication Method:

The document does not specify any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not explicitly mentioned. The study compared the device's ECGs to standard electrodes, but it doesn't describe multiple readers assessing cases to determine an effect size of human improvement with AI assistance. The device itself is a physical placement aid, not an AI for interpretation.

6. Standalone (Algorithm Only) Performance:

This question is not applicable as the V Quick Patch is a physical electrode placement device, not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used:

The ground truth used was expert assessment/comparison of ECGs. The study aimed to show that ECGs produced by the V Quick Patch were "equivalent" to those produced by standard electrodes. This implies that the 'standard' or 'accepted' interpretation of ECGs produced by traditional methods served as the benchmark.

8. Sample Size for the Training Set:

The document does not provide information about a separate training set. The clinical study of 100 patients appears to be the primary evaluation set for demonstrating the device's performance.

9. How Ground Truth for Training Set Was Established:

This question is not applicable as no separate training set is described. If the 100-patient study served as both training and testing (which is unlikely in a rigorous study design but possible for a simple comparison), then the ground truth would have been established as described in point 7.

Summary

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AUG 1 5 2000

VQ CORPORATION

Jennifer Reid Price
President

SECTION 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION FOR THE V QUICK PATCH

Name and address of device manufacturer submitting 510(k) notification: 1.
VQ Corporation 3130 Highland Avenue, Third Floor Cincinnati, OH 45219-2374 Telephone: 513-475-6626 Telecopier: 513-385-4348
Regulatory Correspondent: 2.
Michael A. Price, Vice President, Regulatory Affairs VQ Corporation 3130 Highland Avenue, Third Floor Cincinnati, OH 45219-2374 Telephone: 513-475-6626 Telecopier: 513-385-4348
November 17, 1999 Date summary was prepared: 3.
Name of Device: 4.
- (a) Proprietary Name: V Quick Patch™
- (b) Common, usual name: ECG Electrode
- (c) Classification Name: Electrocardiograph Electrodes
Predicate devices to which VQ is claiming substantial equivalence: 5.
- The device will be marketed as electrocardiograph electrodes with an (i) accessory device for placement of six precordial electrodes for a 12 lead ECG. Under current FDA policy, an accessory device is classified according to the regulatory class of the parent device or the device to which the accessory device will function as an accessory. Accordingly, the V Quick Patch claims substantial equivalence to the parent device, electrocardiograph electrodes for the accessory placement device.
- The V Quick Patch is substantially equivalent to the K-Snap, Silver/Silver (ii) Chloride ECG electrodes of Katecho Inc.; the Fastrace® Tab ECG

Image /page/0/Picture/17 description: The image shows the number "993934" written in black ink. The number is preceded by the letter "K", also written in black ink. A large black shape is partially visible at the bottom left of the image, obscuring the bottom of the letter "K".

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Electrodes marketed by ConMed; and, Q Trace marketed by Graphic Controls.

Statement of the Purpose for which the V Quick Patch Device will be 6. Recommended:

The V Quick Patch is intended to be used as a twelve lead ECG electrode placement device that allows six precordial electrocardiograph electrodes to be placed rapidly on the chest of a human being. The remaining four limb lead placed rapian on the enotivally. This intended use is well understood and does not represent a new or unexpected mode of operation for the users.

7. Device Description:

Safety and Effectiveness of Device: 8.

The positioning guide component of the device is a 5 mil. natural polyester mylar. It is not intended to contact the skin surface because the electrode that it places will be in contact with the skin surface. There may, however, be short term incidental contact from time to time during usage of the device. The electrode component of the device is standard post-style AG/AGCL electrodes with a mylar positioning disc affixed to the top of the six precordial lead electrodes so that they will remain in and move throughout the channel of the positioning guide.

The device underwent clinical testing at the University of Cincinnati. One study involved 100 patients who suffered from cardiac or pulmonary disease. The study found that the V Quick patch was as safe and as effective as the standard precordial tab-style electrodes. Specifically, the study found that the V Quick patch electrodes produced electrocardiograms (ECG's) that were equivalent to ECG's produced by the standard precordial tab-style electrode. The study further found no skin reaction or loss of skin integrity from using the V Quick patch on patients in the study.

3130 Highland Ave. Third Floor Cincinnati, Ohio 45219 - 2374 Ph (513) 475 - 6626 Fax (513) 221 - 1891

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Substantial Equivalence Comparison 9.

General Description: (i)

Current practice is for a health care practitioner to manually place ten Current practice is for a noals the traditional 12 lead ECG electrode Separate Cicolrodoo to oreas a rapid placement of the six precordial recording. The paton alloworeduces placement time and improves electrodes in a fracy. The accuracy and efficacy for 12-lead placement acouraly. The active in comparison to manual electrocardiograms of the in &atudy involving 100 patients with cardiac or placement was evaluation in a stempts trated that use of the V Quick Patch pulhonaly discuse. The otady at notacy as the standard manually and separately placed precordial electrodes.

Substantial Equivalence Comparison Matrix Comparing Primary Features (ii) of Currently Marketed Electrodes to the V Quick Patch™:

Primary Features	Currently Marketed Electrode	V Quick Patch Electrodes
Sensing Element	Ag/AgCl coated plastic sensing element	Same
Conductive Gel that contacts skin	Wet gel or dry adhesive	Wet gel
Adhesive disc that adheres to skinsurface	Compliant polyethylene foam	Compliant polyethylene foam
Adhesive disc size	2.25"	2.0"
Protective Cap (release liner)	Release coated polystyrene film	Release coated polystyrene film
Total Weight (g)	Approx. 1.96 g.	Approx. 4.05 g.
Adhesive on disc	Medical grade acrylic	Medical grade acrylic
Placement of Electrode	Individually place each electrode inposition for lead	Six precordial electrodes areplaced with mylar positioningguides. Four limb lead electrodesplaced manually.

CINTI:493943;1

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, stacked on top of each other. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2000

Michael A. Price Regulatory Affairs, Vice President VQ Corporation 3130 Highland Avenue, Third Floor Cincinnati, OH 45219-2374

K993934 Re: V Quick Patch Regulatory Class: II (two) Product Code: DRX Dated: May 16, 2000 Received: May 17, 2000

Dear Mr. Price:

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 aqainst 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 or

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Page 2 - Michael A. Price

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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- 4648. 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" (21CFR 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mark N Milken

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1_ of 1

510(k) Number (if known): K993934

Device Name: V Quick Patch

Indications For Use:

The V Quick Patch System is intended to be used as an electrocardiograph electrode The V Quick I atch Oystem in intended to a a see.
and a placement device for the placement of electrocardiograph electrodes.

Concurrence of CDRH, Office of Device Evaluation (ODE)

for
Mark n maken
Division of Cardiovascular & Respiratory Devices
510(k) Number K993934

Regulation Number and Section

§ 870.2360 Electrocardiograph electrode.

(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(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 § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.