(93 days)
Not Found
No
The device description and performance studies focus solely on the physical characteristics, materials, and biocompatibility of standard ECG electrodes, with no mention of data processing, analysis, or algorithmic functions.
No
These electrodes are used for monitoring purposes (resting ECG monitoring), not for treating or preventing a disease or condition. They are diagnostic tools.
Yes
Explanation: The device is used for "resting ECG monitoring," which is a diagnostic procedure for evaluating heart activity.
No
The device description clearly outlines a physical, multi-layer electrode construction with materials like fabric, metallic coating, and hydrogel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "resting ECG monitoring of newborn and premature birth infants." This is a physiological measurement taken directly from the patient's body.
- Device Description: The device is an electrode applied to the surface of the body to pick up electrical signals from the heart.
- Lack of In Vitro Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device does not process or analyze such specimens.
The device is a medical device used for in vivo (within the body) monitoring of a physiological signal.
N/A
Intended Use / Indications for Use
Neonatal ECG Electrodes are intended for use in pediatric or neonatal electrocardiographic procedures where resting ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include, in particular, patient ECG surveillance and ECG diagnosis recording. The Neonatal ECG Electrodes are applied to the surface of the body, single use only, and disposable. Neonatal ECG electrodes should be changed every 24 hours.
These electrodes are to be used in the neonatal or pediatric unit of hospitals for the resting ECG monitoring of newborn and premature birth infants. They are applied to the surface of the body, single use only, and disposable. These electrodes should be changed every 24 hours.
Product codes (comma separated list FDA assigned to the subject device)
DRX, 74 DRX
Device Description
The Neonatal ECG Electrodes are three prewired ECG electrodes supplied on the same release card in a single package. The electrodes are a multi-layer construction containing a first layer surface (made of tricot/polyester fabric, polyethylene foam, or polypropylene substrate), a second layer ( metallic with Ag/AgCl coating ) prewired for connection to patient leadwires, and a third layer (made of biocompatible conductive hydrogel coupling media) The electrodes are placed on the neonate patient's chests.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of the body, patient's chests
Indicated Patient Age Range
pediatric or neonatal, newborn and premature birth infants
Intended User / Care Setting
physician; neonatal or pediatric unit of hospitals
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)
Performance testing: Biocompatibility testing was performed, and the device passed the required skin sensitivity testing criteria. According to the performance data, the Neonatal ECG Electrodes met specifications as established in ANSI/AAMI EC12:2000 (R) 2005 for skin contact. The tests included cytotoxicity, sensitization and primary skin irritation tests. The predicate devices use the same materials and meet the same biocompatibility specifications. Bench testing demonstrated that the characteristics of the Neonatal ECG Electrodes 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 there are no differences in construction and materials between the devices to pose new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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KD912744
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510(k) Summary
.
.
| Submitter's Information: | R&D Medical Products, Inc.
20492 Crescent Bay Drive, Building 106
Lake Forest, CA 92630 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Perrault
Phone: (949) 472-9346 x202
Fax: (949) 472-9347 |
| Date Prepared: | September 3, 2009, revised November 19, 2009 |
| | DEC 10 2009 |
| Proprietary Name: | Neonatal ECG Electrodes |
| Common Name: | Electrocardiograph (ECG) Electrodes |
| Classification Name: | Electrodes, Electrocardiograph |
| Regulation: | Electrocardiographic electrode, 21 C.F.R. § 870.2360 |
| Regulatory Class: | Class II |
| Product Code: | DRX |
| Predicate Devices: | K050443 - Ameritus Accu-Lead of Kentec Medical, Inc.
K011564 - Neolead of Neotech Products, Inc. |
| Description of Device: | The Neonatal ECG Electrodes are three prewired ECG electrodes
supplied on the same release card in a single package. The
electrodes are a multi-layer construction containing a first layer
surface (made of tricot/polyester fabric, polyethylene foam, or
polypropylene substrate), a second layer ( metallic with Ag/AgCl
coating ) prewired for connection to patient leadwires, and a third
layer (made of biocompatible conductive hydrogel coupling media)
The electrodes are placed on the neonate patient's chests. |
| Intended Use: | Neonatal ECG Electrodes are intended for use in pediatric or
neonatal electrocardiographic procedures where resting ECG
monitoring is deemed necessary and is ordered by a physician.
Such procedures include, in particular, patient ECG surveillance
and ECG diagnosis recording. The Neonatal ECG Electrodes are |
1
જેર
applied to the surface of the body, single use only, and disposable. Neonatal ECG electrodes should be changed every 24 hours.
Technological Comparison:
The Neonatal ECG Electrodes have technological characteristics that are substantially equivalent to those of the predicate devices as determined by testing, common materials, and common manufacturer. The following testing was conducted: AC impedance: DC offset voltage: defibrillation overload recovery; combined offset instability and internal noise; and bias current tolerance. The Neonatal ECG Electrodes and the predicate devices all meet the specifications as established in ANSI/AAMI EC12:2000/(R) 2005 and ANSI/AAMI EC53:1995/(R) 2008.
R&D Medical Products, Inc. contract manufactures the predicate Basis for Equivalence: devices and now seeks to make the same product under private label for distribution.
-Performance testing: Biocompatibility testing was performed, and the device passed the required skin sensitivity testing criteria. According to the performance data, the Neonatal ECG Electrodes met specifications as established in ANSI/AAMI EC12:2000 (R) 2005 for skin contact. The tests included cytotoxicity, sensitization and primary skin irritation tests. The predicate devices use the same materials and meet the same biocompatibility specifications.
Bench testing demonstrated that the characteristics of the Neonatal ECG Electrodes are substantially equivalent to those of the predicate devices.
-Labeling:
Conclusions from Testing:
The labeling of the Neonatal ECG Electrodes is substantially equivalent to that of the predicate devices.
In all material respects, the Neonatal ECG Electrodes are substantially equivalent to 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 there are no differences in construction and materials between the devices to pose new questions of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus with three figures representing health, services, and humanity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 1 0 2009
R&D Medical Products, Inc. c/o Mr. James Perrault 20492 Crescent Bay Drive Building 106 Lake Forest, CA 92630
Re: K092744
Trade Name: Neonatal ECG Electrode, M203KEN Regulation Number: 21 CFR § 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: 74 DRX Dated: November 23, 2009 Received: November 24, 2009
Dear Mr. Perrault:
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 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 - Mr. James Perrault
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
W.M.P.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
.
510(k) Number: K092744
Device Name: Neonatal ECG Electrodes
Indications for Use:
These electrodes are to be used in the neonatal or pediatric unit of hospitals for the resting ECG monitoring of newborn and premature birth infants. They are applied to the surface of the body, single use only, and disposable. These electrodes should be changed every 24 hours.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K092744 |
|---|---|
| --------------- | --------- |