← Product Code [DRX](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX) · K050443

# ACCU-LEAD (K050443)

_Kentec Medical, Inc. · DRX · Sep 2, 2005 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K050443

## Device Facts

- **Applicant:** Kentec Medical, Inc.
- **Product Code:** [DRX](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX.md)
- **Decision Date:** Sep 2, 2005
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2360
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Pediatric

## Indications for Use

The NEONATAL PEDIATRIC ECG ELECRODE is intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on the surface of the body,

## Device Story

Accu-Lead Neonatal Pediatric ECG Electrode is a disposable, single-use surface electrode; designed for cardiac monitoring of neonatal and pediatric patients. Device utilizes silver/silver-chloride sensing eyelet, hydrogel, and nonwoven backing; connects via DIN standard socket safety lead wire. Operated by trained medical or emergency personnel in clinical or emergency settings. Device captures electrical cardiac signals from patient skin surface; transmits signals to external monitoring equipment. Healthcare providers use output to assess heart rhythm and cardiac function; facilitates continuous patient monitoring and clinical decision-making.

## Clinical Evidence

Bench testing only. Device performance verified against ANSI/AAMI EC12-1991 and ANSI/AAMI EC53:1995/(R)2001 standards.

## Technological Characteristics

Materials: Silver/silver-chloride sensing eyelet, hydrogel, nonwoven backing. Connectivity: DIN standard socket safety lead wire. Form factor: Disposable surface electrode. Standards: ANSI/AAMI EC12-1991, ANSI/AAMI EC53:1995/(R)2001.

## Regulatory 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

- Neolead ([K011564](/device/K011564.md))

## Submission Summary (Full Text)

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K050443

Page 1 of 1

# 510K SUMMARY

KENTEC MEDICAL, INC. Submitter's Name: SEP 0 2 2005 17871 FITCH, IRVINE, CA 92614, USA Address: 949 863-0810 Telephone No.: DAVID SHERATON Contact Person: APRIL 25, 2005 Date: NEONATAL PEDIATRIC ECG ELECTRODE Common or Usual Name: ELECTRODE, ELECTROCARDIOGRAPH Classification Name: Proprietary Name: Accu-Lead

### INFORMATION ON DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED

| 510(k) Number | Proprietary Name | Manufacturer     |
|---------------|------------------|------------------|
| K011564       | Neolead          | Neotech Products |

#### COMMON TECHNOLOGICAL CHARACTERISTICS

- 1. Silver Silverchloride Sensing Eyelet
- 2. DIN Standard Socket Safety Lead Wire
- 3. Hydrogel
- Nonwoven Backing 4.

#### PERFORMANCE DATA COMPARISON NONCLINICAL TEST

| 510(k) Number | Proprietary Name | Manufacturer     | NON-CLINICAL TEST              |
|---------------|------------------|------------------|--------------------------------|
| K011564       | Neolead          | Neotech Products | ANSI/AAMI EC12-<br>1991        |
| K011564       | Neolead          | Neotech Products | ANSI/AAMI<br>EC53:1995/(R)2001 |

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 2 2005

Kentec Medical, Inc. c/o Mr. David Sheraton Sr. President & CEO R & D Medical, Inc. 20492 Crescent Bay Drive, Building 106 Lake Forest, CA 92630

Re: K050443

Trade Name: Neonatal Pediatric ECG Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: August 9, 2005 Received: August 9, 2005

Dear Mr. Sheraton:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premainted is substantially equivalent (for the indications referenced and nave determined the arrest of creative devices marketed in interstate for use stated in the encrosule) to regally manatiment date of the Medical Device Amendments, or to
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and Cosmetic Act (Act) that do not require approval assesses as provisions of and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the genirements for annual registration, listing of
general controls provisions of the Act include requirements michvending general controls provisions of the Fee Mercials requires against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) mis existing major regulations affecting your device can
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publish further announcements concerning your device in the Federal Register.

{2}------------------------------------------------

Page 2 – Mr. David Sheraton Sr.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advisou has I Dravination that your device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any I vath all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 801), adoming (21 CFR Part 820); and if applicable, the electronic form in the quality by seems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro revice as described in your device as described in your Section 510(k) I mis letter will anon your of substantial equivalence of your device of your device to a legally prematics notification. "The stassification 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), please if you desire specific arrentiance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. IMisoranding of reference on your responsibilities under the Act may be obtained from the Oiner general 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/dsma/dsmamain.html

Sincerely yours,

Bhimmatmar for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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M203/510K/0415A05

### Indications for Use

510(k) Number (if known): K050443

NEONATAL PEDIATRIC ECG ELECTRODE Device Name:

Indications For Use:

## Single Use Only - Disposable

The NEONATAL PEDIATRIC ECG ELECRODE is intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on the surface of the body,

Prescription Use × (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 Device Evaluation (ODE)

Bhumma

intrision Sign-Off) Division of Cardiovascular Devices 510(k) Number_K000443

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