V QUICK PATCH

K993934 · Vq Corp. · DRX · Aug 15, 2000 · Cardiovascular

Device Facts

• Record ID: K993934
• Device Name: V QUICK PATCH
• Applicant: Vq Corp.
• Product Code: DRX · Cardiovascular
• Decision Date: Aug 15, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

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 Story

V Quick Patch is a single-use disposable ECG electrode system; consists of a mylar positioning guide with pre-cut channels and ten post-style Ag/AgCl electrodes. Six precordial electrodes are pre-mounted in the guide; four limb electrodes are placed manually. Used in clinical settings by healthcare practitioners to facilitate rapid, accurate placement of precordial electrodes for 12-lead ECG recording. Device reduces placement time compared to manual individual electrode application. Output is a standard 12-lead ECG signal acquired via the electrodes. Benefits include improved efficiency and accuracy in electrode positioning for diagnostic ECG procedures.

Clinical Evidence

Clinical study conducted at the University of Cincinnati with 100 patients suffering from cardiac or pulmonary disease. Compared V Quick Patch to standard precordial tab-style electrodes. Primary endpoints: ECG signal quality and skin integrity. Results showed V Quick Patch produced ECGs equivalent to standard electrodes; no skin reactions or loss of skin integrity observed.

Technological Characteristics

Single-use disposable device. Sensing element: Ag/AgCl. Adhesive: medical grade acrylic on compliant polyethylene foam. Positioning guide: 5 mil natural polyester mylar. Connectivity: passive electrode interface for standard ECG equipment. Sterilization: not specified.

Indications for Use

Indicated for use as an ECG electrode and placement system for human patients requiring 12-lead ECG monitoring, including those with cardiac or pulmonary disease.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• K-Snap, Silver/Silver Chloride ECG electrodes (Katecho Inc.)
• Fastrace Tab ECG Electrodes (ConMed)
• Q Trace (Graphic Controls)

Submission Summary (Full Text)

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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: [phone] 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: [phone] 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

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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:

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.

#### 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.

2

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 skin<br>surface | 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 in<br>position for lead | Six precordial electrodes are<br>placed with mylar positioning<br>guides. Four limb lead electrodes<br>placed 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 [phone]. 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 [phone] or [phone] 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