(188 days)
Not Found
No
The summary describes a passive electrode patch for ECG monitoring and diagnosis. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI/ML. The performance studies focus on electrical characteristics and substantial equivalence to predicate devices, not on diagnostic or analytical capabilities that might be enhanced by AI/ML.
No
The device is an electrocardiograph electrode patch used for ECG monitoring and diagnosis recording; it does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "patient ECG surveillance and ECG diagnosis recording," which directly indicates a diagnostic purpose.
No
The device description explicitly details a physical patch with electrodes and conductive hydrogel, indicating it is a hardware device, not software-only.
Based on the provided information, the Qwiklead™ Electrocardiograph Electrode Patch is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Qwiklead™ Function: The Qwiklead™ Electrocardiograph Electrode Patch is a device that is placed on the patient's skin to acquire electrical signals from the heart for electrocardiographic procedures. It is used on the body, not for testing specimens from the body.
- Intended Use: The intended use clearly states it's for "general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician," including "patient ECG surveillance and ECG diagnosis recording." This involves measuring electrical activity directly from the patient's body.
Therefore, the Qwiklead™ Electrocardiograph Electrode Patch falls under the category of a medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's chest
Indicated Patient Age Range
adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was conducted: AC impedance; DC offset voltage; defibrillation overload recovery; combined offset instability and internal noise; and bias current tolerance. The Qwiklead™ 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. Bench testing demonstrated that the characteristics of the Qwiklead™ Electrocardiograph Electrode Patch are substantially equivalent to those of the predicate devices. Testing was performed according to FDA-recognized standards. Test results support the conclusion 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 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 in adults.
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:
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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.
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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
5
Indications for Use
510(k) Number (if known): K090496
Device Name: Qwiklead™ Electrocardiograph Electrode Patch
Indications For Use:
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.
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
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