The Qwiklead™ Electrocardiograph Electrode Patch is intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include, in particular, patient ECG surveillance and ECG diagnosis recording. The Qwiklead™ Electrocardiograph Electrode Patch is intended for single-patient/single application use and is intended to be used on intact (uninjured) skin. The Qwiklead™ Electrocardiograph Electrode Patch is to be used on adults.

Device Description

The Qwiklead™ Electrocardiograph Electrode Patch configures pre-positioned ECG electrodes affixed to the underside of a single non-sterile, laminated, flexible patch/pad. The patch is a multi-layer construction containing a first layer surface (made of tricot/polyester fabric, polyethylene foam, or polypropylene substrate) including at least one electrode, a second layer (metallic with Ag/AgCl coating) that contains the electrodes, and a third layer (made of biocompatible conductive hydrogel coupling media). The patch is placed on the patient's chest, and no additional electrodes need be placed on the patient's limbs, as is typical for ECG electrodes.

AI/ML Overview

The provided 510(k) summary for the Qwiklead™ Electrocardiograph Electrode Patch does not describe a study related to acceptance criteria for a device performance, multi-reader multi-case (MRMC) comparative effectiveness, or standalone algorithm performance in the way typically expected for AI-powered diagnostic devices. This submission pertains to an ECG electrode patch, which is a physical medical device, not a software algorithm or AI system.

Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, how ground truth for training was established) are not applicable to this type of device and are not present in the provided documentation.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on bench testing of physical and electrical properties, and biocompatibility.

Here's a breakdown of the information that is available or relevant to this type of device submission based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by recognized standards for ECG electrodes, and the device is reported to meet these.

Acceptance Criteria (Standard)	Device Performance
ANSI/AAMI EC12:2000:
AC impedance	Met specifications
DC offset voltage	Met specifications
Defibrillation overload recovery	Met specifications
Combined offset instability and internal noise	Met specifications
Bias current tolerance	Met specifications
ISO 10993-1 (for skin contact):
Cytotoxicity	Passed
Sensitization	Passed
Primary skin irritation tests	Passed

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

Not applicable in the context of an AI device. For this physical device, "test set" refers to the tested electrode patches. The quantity of patches tested is not specified, but it would have been a sample size sufficient to demonstrate compliance with the standards, likely from a production batch. The provenance of material testing data is generally from the manufacturer's internal testing or a certified lab.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth in this context refers to the defined specifications in the ANSI/AAMI and ISO standards, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

Not applicable. Testing involves quantitative measurements against predefined thresholds in standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is typically for evaluating diagnostic accuracy of interpretations (e.g., by human readers, or humans assisted by AI) on a collection of cases, which is not relevant for an ECG electrode patch itself.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an electrode patch, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation against its acceptance criteria is defined by recognized international standards:

ANSI/AAMI EC12:2000 for electrical performance of disposable ECG electrodes.
ISO 10993-1 for biocompatibility (skin contact).
These standards set the objective, measurable parameters and thresholds that the device must meet.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for an ECG electrode patch as it does not involve machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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K090 496

510(k) Summary 5.

Submitter's Information:

Cardiac Lead Technologies, LLC 5520 Pembroke Rd. Bethesda, MD 20817

Qwiklead™ Electrocardiograph Electrode Patch

Electrocardiographic electrode, 21 C.F.R. § 870.2360

K020003, Telectrode ECG Electrode (Bio Protech Inc.) K073104, Skintact® ECG Electrodes (Leonhard Lang

K040784, PROTAB ECG Tab Electrode (Bio Protech Inc.)

The Qwiklead™ Electrocardiograph Electrode Patch

limbs, as is typical for ECG electrodes.

configures pre-positioned ECG electrodes affixed to the underside of a single non-sterile, laminated, flexible patch/pad. The patch is a multi-layer construction containing a first layer surface (made of tricot/polyester fabric, polyethylene foam, or polypropylene substrate) including at least one electrode, a second layer (metallic with Ag/AgCl coating) that contains the electrodes, and a third layer (made of biocompatible conductive hydrogel coupling media). The patch is placed on the patient's chest, and no additional electrodes need be placed on the patient's

Electrocardiograph (ECG) Electrodes

Electrodes, Electrocardiograph

Class II, Classification Panel 74

SEP -1 2009

Contact Person: Claudia Lewis-Eng Phone: (202) 344-4359 Fax: (202) 344-8300

August 7, 2009

DRX

GmbH)

Date Prepared:

Proprietary Name:

Common Name:

Classification Name:

Regulation:

Regulatory Class:

Product Code:

Predicate Devices:

Description of Device:

CONFIDENTIAL

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Intended Use:

The Qwiklead™ Electrocardiograph Electrode Patch has technological characteristics that are substantially equivalent to those of the predicate devices, as determined by testing. The following testing was conducted: AC impedance; DC offset voltage; defibrillation overload recovery; combined offset instability and internal noise; and bias current tolerance. The Owiklead™ Electrocardiograph Electrode Patch and the predicate devices all meet the specifications as established in ANSI/AAMI EC12:2000.

Biocompatibility testing was performed, and the device passed the required skin sensitivity testing criteria. According to the performance data, the Qwiklead™ Electrocardiograph Electrode Patch met specifications as established in ISO 10993-1 for skin contact. The tests included cytotoxicity, sensitization and primary skin irritation tests. The predicate devices (K020003, K073104, K040784) meet the same ISO 10993 specifications.

Bench testing demonstrated that the characteristics of the Owiklead™ Electrocardiograph Electrode Patch are substantially equivalent to those of the predicate devices.

The labeling of the Owiklead™ Electrocardiograph Electrode Patch is substantially equivalent to that of the predicate devices.

In all material respects, the Qwiklead™ Electrocardiograph Electrode Patch is substantially equivalent to the predicate devices. Testing was performed according to FDArecognized standards. Test results support the conclusion

Basis for Equivalence:

-Performance testing:

Technological Comparison:

-Labeling:

Conclusions from Testing:

CONFIDENTIAL

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that the electrical output is substantially equivalent to the predicate devices, and any differences between the devices do not pose new questions of safety or effectiveness.

September 19.

CONFIDENTIAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is oriented to follow the curve of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cardiac Lead Technologies, Inc. c/o Ms. Claudia Lewis-Eng, Esq. Partner Venable, LLP 575 7th St. NW Washington, DC 20004

SEP - 1 2009

Re: K090496

Trade/Device Name: Owiklead™ Electrocardiograph Electrode Patch Regulatory Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (Two) Product Code: DRX Dated: August 24, 2009 Received: August 25, 2009

Dear Ms. Lewis-Eng:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Claudia Lewis-Eng. Esq.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
W. Wat.

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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Indications for Use

510(k) Number (if known): K090496

Device Name: Qwiklead™ Electrocardiograph Electrode Patch

Indications For Use:

Prescription Use X (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)

W.M.

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number. K090496

Page 1. of 1

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.