(14 days)
Not Found
No
The device description and intended use focus solely on the physical properties and function of the electrodes for electrical signal transmission. There is no mention of any computational analysis, algorithms, or learning capabilities.
Yes
The device is used for external pacing, defibrillation, and cardioversion, which are therapeutic interventions to treat cardiac issues.
No
The device is described as an electrode for external pacing, defibrillation, and monitoring applications, which are therapeutic and measurement functions, not diagnostic.
No
The device description clearly states it is a physical electrode, a hardware component, used for defibrillation, pacing, cardioversion, and monitoring. It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Heart Sync electrodes are used externally on the patient's skin for electrical interventions (pacing, defibrillation, monitoring). They provide a conductive interface for delivering electrical current to the body.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is to facilitate the delivery of electrical energy to the patient's body.
Therefore, the intended use and function of this device clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Heart Sync Adult Radio Transparent Multi Function Electrodes and Heart Sync Adult Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers.
Product codes
MLN
Device Description
The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. Heart Sync electrodes can be used on Physio Control, Zoll, Hewlett-Packard, Philips and Welch-Allyn makes and models of monophasic and bi-phasic defibrillator. Radiotransparent and or Radiotranslucent "One Pad System" enables the pads to stay with the patient as they move through departments. Heart Sync has an electrode for any clinical need or patient situation. Heart Sync can provide onsite conversion of current cables to accept the Heart Sync electrodes. The polymer adhesive gel provides contact for uniform current distribution and more effective defibrillation and pacing. All Heart Sync products are Latex free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Kosoyzl
EXHIBIT 2
Heart Sync
FEB 2 9 2008
LLC. 5643 Plymouth Rd. Ann Arbor, Mi 48105 Phone: 800-828-4681 Fax: 734-213-5640 Contact: Stephen Shulman, Managing Partner January 16, 2008 510(k) Summary of Safety and Effectiveness
-
Identification of the Device: 1. Proprietary-Trade Name: "Heart Sync" C-100 Adult Radiotransparent, Multifunction Electrodes and "Heart Sync" T-100 Adult Radiotranslucent Multifunction Electrodes
Classification Name: Electrode, Electrocardiograph, Multi-Function; MLN Common/Usual Name: Defibrillator Electrode -
- Indications for Use: The Heart Sync Adult Radio Transparent and/or Translucent Multi Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
-
- Description of the Devices: Features & Benefits:
The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. Heart Sync electrodes can be used on Physio Control, Zoll, Hewlett-Packard, Philips and Welch-Allyn makes and models of monophasic and bi-phasic defibrillator. Radiotransparent and or Radiotranslucent "One Pad System" enables the pads to stay with the patient as they move through departments. Heart Sync has an electrode for any clinical need or patient situation. Heart Sync can provide onsite conversion of current cables to accept the Heart Sync electrodes. The polymer adhesive gel provides contact for uniform current distribution and more effective defibrillation and pacing. All Heart Sync products are Latex free.
1
Model differentiation:
| vioder | But the designed and the contraction of the contribution of the contribution of the comments of the contribution of the contribution of the contribution of the contribution o
. Feature/difference | |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| ( | ransparent to x-ray | |
| | ranslucent to x-ray
Status Canadian Career Station Company of Children Company of | |
| COLOR OF ANY | .
Non-Amore, Andrew | |
-
- Safety and Effectiveness, comparison to predicate device:
| Comparison Areas | PadPro (K020203), and Katecho
(K981737) | "Heart Sync" C-100
and T-100 Electrodes |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Indications for use | For use as disposable electrodes for
automatic and manual external
defibrillators for monitoring, pacing,
cardioversion, and defibrillation | SAME |
| Where used | Hospitals and Paramedic situations | SAME |
| Basic features | Radiotransparent and or
Radiotranslucent, non sterile, latex
free, single patient use, self
adhesive, in sealed foil pouch. | SAME |
| Standard met | 21CFR 898.12 Performance
standard; ANSI/AAMI DF-80 2003
standard, self adhesive electrodes for
monitoring and defibrillation | SAME |
-
- Conclusion In all respects, the Heart Sync System Defibrillator Electrodes are substantially equivalent to other electrodes that are legally marketed for this purpose. The device meets the standards referenced above.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black and white, and the text is in a simple sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 9 2008
Heart Sync LLC Mr. Mark Job c/o Regulatory Technology Services 1394 25th Street, NW Buffalo, MN 55313
Re: K080421
Trade/Device Name: Heart Sync C-100 and Heart Sync T-100 Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: Class II (two) Product Code: MLN Dated: February 14, 2008 Received: February 15, 2008
Dear Mr. Job:
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.
3
Page 2 - Mr. Mark Job
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Bfhimmer for
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 (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: "Heart Sync" C-100 Adult Radiotransparent Multifunction Electrodes and "Heart Sync" T-100 Adult Radiotranslucent Multifunction Electrodes
Indications for Use:
The Heart Sync Adult Radio Transparent Multi Function Electrodes and Heart Sync Adult Radiotranslucent Multifunction Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum).
Compatible with Medtronic Physio Control, Zoll, Hewlett-Packard, Philips Medical, and Welch-Allyn models of monophasic and bi-phasic defibrillators, external pacemakers.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bhumumo
(Division Sign Off)
(Division Sign-Off) Division of Cardiovascular Deyices 510(k) Number
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