(49 days)
The PRONEO Neonatal ECG Electrodes are designed for use whenever cardiac monitoring for neonatal or pediatric patients is deemed or desirable by trained medical or emergency This electrode is for use on neonatal and pediatric patients. The PRONEO Neonatal ECG Electrodes are non-sterile and are to be used on intact (uninjured) skin.
The PRONEO Neonatal ECG Electrodes (and also to be sold under various private label trade names; i.e. Multiple Labels) are 22mm in square and consist of a conductive adhesive hydrogel, a Ag/AgCl plated sensor element a non-woven substrate and vinyl label, and a 100cm flexible tinned copper or carbon lead wire terminating in a 1.5mm, 2.0mm standard DIN connector. Electrodes are packaged in pouches of 3, 100 pouches per carton and are supplied non-strerile.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for PRO-NEO NEONATAL ECG ELECTRODE (K053011)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reference Standard | Device Performance | Predicate Device Performance |
|---|---|---|---|
| Electrical Performance | ANSI/AAMI EC12:2000 Disposable ECG Electrodes | Met specifications | Met specifications |
| Biocompatibility (Non-irritating, Non-cytotoxic, Non-sensitizing) | ISO 10993 (FDA Memorandum) | Non-irritating, Non-cytotoxic, Non-sensitizing | Not explicitly stated, but implied to meet standards as the predicate was approved |
| Shelf Life | N/A (Accelerated aging testing) | 24 months | Not explicitly stated |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not explicitly stated for electrical performance tests. For biocompatibility and shelf life, the sample sizes are not detailed in the provided summary.
- Data Provenance: The device was manufactured in the Republic of Korea. The testing was conducted by Bio Protech Inc.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The performance testing for this device (ECG electrodes) involved objective, standardized electrical and biological tests, not human interpretation or expert-established ground truth in the way it would for an AI-powered diagnostic device.
4. Adjudication Method
Not applicable, for the same reasons as #3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a medical accessory (ECG electrode) and does not involve AI or human interpretation in its primary function. Therefore, a comparative effectiveness study involving human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is an electrode, not an algorithm or AI system.
7. Type of Ground Truth Used
- Electrical Performance: Standardized measurements against the specifications outlined in ANSI/AAMI EC12:2000. These are objective engineering and electrical performance metrics.
- Biocompatibility: Results of laboratory tests (e.g., irritation, cytotoxicity, sensitization tests) against established biological evaluation criteria from ISO 10993.
- Shelf Life: Results from accelerated aging studies extrapolated to real-time shelf life.
8. Sample Size for Training Set
Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning model, this question is not relevant.
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K053011
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Image /page/0/Picture/2 description: The image shows a logo with the letters "BV" in a stylized, handwritten font. To the right of the letters, the word "Protech" is written in a bold, sans-serif font. The logo appears to be for a company or organization named "BV Protech."
DEC 1 4 2005
BIO PROTECH INC.
Bio Sensors & Bio Products
510(k) Summary
Data : June 30, 2005
Manufacturing Facility : BIO PROTECH, INC. 1720-26, Taejang 2-Dong, Wonju Medical Instrument Ind. Park Wonju-Si, Gangwon-Do, REPUBLIC OF KOREA Tel: 82-33-735-7720 Fax: 82-33-735-7736
Contract Person : Eunseo Heo Researcher of Regulatory Affairs Tel: 82-33-735-7720 Fax: 82-33-735-7736
Device Trade Name : PRO-NEO NEONATAL ECG ELECTRODE
Device Common Name : Neonatal ECG Monitoring Electrode
Classification Name : Electrocardiograph Electrode
Regulatory Reference : 74 DRX
Predicate Device :
K000206, PALS NEONATAL PEDIATRIC ECG ELECTRODE, AXELGAARD MFG, CO., LTD.
Description:
The PRONEO Neonatal ECG Electrodes (and also to be sold under various private label trade names; i.e. Multiple Labels) are 22mm in square and consist of a conductive adhesive hydrogel, a Ag/AgCl plated sensor element a non-woven substrate and vinyl label, and a 100cm flexible tinned copper or carbon lead wire terminating in a 1.5mm, 2.0mm standard DIN connector. Electrodes are packaged in pouches of 3, 100 pouches per carton and are supplied non-strerile.
Intended Use:
The PRONEO Neonatal ECG Electrodes are designed for use whenever cardiac monitoring for neonatal or pediatric patients is deemed or desirable by trained medical or emergency This electrode is for use on neonatal and pediatric patients. personnel.
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Image /page/1/Picture/2 description: The image shows a logo with the text "BV Protech". The "BV" is written in a stylized, cursive font, with the letters connected. There is a circular design element above the "V". The word "Protech" is written in a simpler, sans-serif font to the right of "BV".
BIO PROTECH INC.
Bio Sensors & Bio Products
Performance Summary:
The device and the predicate were subjected to AAMI electrical tests as described in ANSI/AAMI voluntary standard, EC12:2000, Disposable ECG Electrodes. Test results for both the device and the predicate met the specifications as established in ANSI/AAMI EC12:2000.
Biocompatibility Testing:
The device was subjected to biocompatibility testing as recommended FDA memorandum entitled Use of International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The device was found to be non-irritating, non-cytotoxic and non-sensitizing.
Shelf Life:
Accelerated aging testing was performed to substantiate an expiration of 24 months.
Conclusion:
This device is substantially equivalent to the devices approved as K000206
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines forming the body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2005
Bio Protech, Inc. c/o Mr. E. J. Smith Smith Associates 1676 Village Green Suite A Crofton, MD 21114
Re: K053011
Trade Name: Neonatal Electrocardiograph (ECG) Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: June 29, 2005 Received: October 26, 2005
Dear Mr. Smith:
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 - Mr. E. J. Smith
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blymmmer 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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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: NEONATAL ELECTROCARDIOGRAPH (ECG) ELECTRODE
Indications for Use:
The PRONEO Neonatal ECG Electrodes are designed for use whenever cardiac monitoring for neonatal or pediatric patients is deemed or desirable by trained medical or monitoring for noonata. This electrode is for use on neonatal and pediatric patients. The PRONEO Neonatal ECG Electrodes are non-sterile and are to be used on intact (uninjured) skin.
Caution: Federal law restricts this device to sale by or on the order of physician.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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lvision Sign-Off; vision of Cardiovascular Devices -10(k) Number K0530/ | -------------------------------------------------------------------------------------------------------------------------------------------------------
§ 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.