(192 days)
Not Found
No
The 510(k) summary describes a passive electrode for ECG monitoring and does not mention any AI/ML components or functionalities.
No.
The device is an ECG electrode, used for monitoring cardiac activity, not for treating a condition.
Yes
Explanation: The device is an ECG electrode, used for cardiac monitoring, which is a diagnostic procedure.
No
The device description explicitly states "NEONATAL PEDIATRIC ECG ELECTRODE," indicating a physical electrode, which is a hardware component.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cardiac monitoring of neonatal or pediatric patients" by being placed "on the surface of the body." This describes a device used for in vivo monitoring (on a living patient), not in vitro testing (testing samples outside the body).
- Device Description: It's an "ECG ELECTRODE," which is a component used to pick up electrical signals from the heart on the body's surface.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
Therefore, the NEONATAL PEDIATRIC ECG ELECTRODE is a medical device used for physiological monitoring on the body, not an in vitro diagnostic device.
N/A
Intended Use / 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,
Product codes
DRX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of the body
Indicated Patient Age Range
neonatal or pediatric patients
Intended User / Care Setting
trained medical or emergency personnel
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)
NONCLINICAL TEST: ANSI/AAMI EC12-1991, ANSI/AAMI EC53:1995/(R)2001
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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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
-
- Silver Silverchloride Sensing Eyelet
-
- DIN Standard Socket Safety Lead Wire
-
- 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- |
| 1991 | |||
| K011564 | Neolead | Neotech Products | ANSI/AAMI |
| EC53:1995/(R)2001 |
1
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
commerce prior to May 28, 1976, the enactment date of the Federal Food Tru commerce prof to May 20, 1970, the chaemience with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance who are archarted approval application (PMA).
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
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional Controlist Extronic - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - be found in the Code of Peachar Reg...
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
3
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