(125 days)
Not Found
No
The description focuses on the physical properties and intended uses of the electrodes for standard cardiac procedures (defibrillation, pacing, monitoring). There is no mention of any computational or analytical functions that would suggest AI/ML is involved.
Yes
The device is used for external pacing, defibrillation, and cardioversion, which are therapeutic interventions to restore or maintain normal heart rhythm.
No
Explanation: The device is described as an electrode for external pacing, defibrillation, cardioversion, and monitoring. While monitoring can involve gathering data, the primary functions—defibrillation, pacing, and cardioversion—are therapeutic interventions. The device provides a conductive interface but does not analyze or interpret medical data for diagnostic purposes.
No
The device description clearly states it is a physical electrode, a hardware component, used for external pacing, defibrillation, and monitoring.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of these electrodes is to be applied directly to the patient's skin for external pacing, defibrillation, and monitoring. They are not used to analyze blood, urine, tissue, or other bodily fluids or substances.
- The device description and intended use clearly describe a device that interacts directly with the patient's body. It provides a conductive interface for electrical signals.
Therefore, this device falls under the category of a medical device that is used externally on the patient, not an IVD.
N/A
Intended Use / Indications for Use
The Heart Sync Pediatric 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 pediatric patients whose weight is less than 25 kg. 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 (comma separated list FDA assigned to the subject device)
LDD
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. 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.
Model differentiation:
| Model | Feature/difference |
|---|---|
| Pediatric PEDIATRIC-100 | Pad Conductive Area 35.3. sq cm. |
| Predicate K020288 | Pad Conductive Area 36.9 sq cm |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
Indicated Patient Age Range
pediatric patients whose weight is less than 25 kg.
Intended User / Care Setting
Hospitals and Paramedic situations
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)
Not Found
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
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
SEP 2 4 2008
EXHIBIT 2
Heart Sync Inc. 5643 Plymouth Rd. Ann Arbor, Mi 48105 Phone: 800-828-4681 Fax: 734-213-5640 Contact: Stephen Shulman, President May 22, 2008 510(k) Summarv
-
- Identification of the Device: Proprietary-Trade Name: "Heart Sync" Pediatric Radiotranslucent Multifunction Electrodes, model # Pediatric-100.
Classification Name: DC-defibrillator Common/Usual Name: Defibrillator Electrode
- Identification of the Device: Proprietary-Trade Name: "Heart Sync" Pediatric Radiotranslucent Multifunction Electrodes, model # Pediatric-100.
-
- Equivalent legally marketed devices: This is identical in function to the Pad Pro K020288.
-
Indications for Use: The Heart Sync Pediatric Radiotranslucent Multifunction Electrodes 3. 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 pediatric patients whose weight is less than 25 kg. 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.
-
- 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. 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.
- Description of the Devices: Features & Benefits:
1
Model differentiation:
| Model | Feature/difference |
|---|---|
| Pediatric PEDIATRIC-100 | Pad Conductive Area 35.3. sq cm. |
| Predicate K020288 | Pad Conductive Area 36.9 sq cm |
5. Safety and Effectiveness, comparison to predicate device:
| Comparison Areas | PadPro K 020288 | "Heart Sync"
Pediatric
PEDIATRIC-100 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Indications for use | For use as disposable electrodes for
Semi-automatic and manual external
defibrillators for monitoring, pacing,
cardioversion, and defibrillation | SAME |
| Where used | Hospitals and Paramedic situations | SAME |
| Basic features | 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-39 (3.3.19)
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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 24 L.
Heart Sync LLC c/o Mr. Stephen Shulman Managing Partner 5643 Plymouth Road Ann Arbor, MI 48105
Rc: K081442
Trade/Device Name: "Heart Sync" Pediatric Radiotranslucent Multifunction Electrodes Regulation Number: 21 CFR 870.5300 Regulation Name: DC-defibrillator (including paddles) Regulatory Class: Class II Product Code: LDD Dated: September 15, 2008 Received: September 16, 2008
Dear Mr. Shulman:
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.
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
3
Page 2 -- Mr. Stephen Shulman
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-3464. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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,
Qamee
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
j) Indications for Use
510(k) Number
Device Name: "Heart Sync" Pediatric Radiotranslucent Multifunction Electrodes
The Heart Sync Pediatric 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 pediatric patients whose weight is less than 25 kg. 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
OR
Over the Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
Qamel
ion Sianision of Cardiovascular Devices
KOS1442 510(k) Number.