(116 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, electrical properties, and biocompatibility of defibrillator pads, with no mention of AI or ML.
Yes
Explanation: The device is indicated for use to treat patients in cardiopulmonary arrest by delivering defibrillation energy, which is a therapeutic intervention.
Yes
The device, AED pads, is used "to monitor and deliver defibrillation energy to the patient." The monitoring function signifies a diagnostic capability, as it assesses the patient's heart rhythm to determine if defibrillation is needed.
No
The device description clearly states it is a physical product (single use, non-sterile, self-stick defibrillator electrodes) and describes its physical characteristics and materials. It also mentions bench testing related to the physical properties of the electrodes.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: This device, Heart Sync T-Cardiac Science AED pads, is a component used with an Automated External Defibrillator (AED). Its function is to monitor the patient's heart rhythm and deliver electrical energy to the patient's body to treat cardiopulmonary arrest.
- Lack of Specimen Analysis: The description clearly states the pads are used to "monitor and deliver defibrillation energy to the patient." There is no mention of collecting or analyzing any specimens from the patient's body.
The device is a therapeutic device used to deliver electrical therapy directly to the patient's body, not to analyze samples taken from the body.
N/A
Intended Use / Indications for Use
Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. Heart Sync T-Cardiac Science AED pads are single use and intended to be used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The T-Cardiac Science AED pads are used on patients over 8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8 hours).
Product codes
MKJ
Device Description
These are single use. non-sterile, self-stick defibrillator electrodes packaged in pairs. Effective electrode area = 170 Sq. cm. They are Radiotranslucent. They come in an Anderson connector to match the specific defibrillator. The construction and materials employed are similar to the predicates. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate device. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
over 8 years of age or greater than 55 pounds
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
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Summary of Performance Studies
Bench testing summary: Various different lots containing multiple samples each were subjected to the AAMI tests for DC offset instability. AC small signal impedance, AC large signal impedance, defibrillator overload. All units passed these testing routine was applied to a 42 month accelerated age shelf life test. All units passed the tests. Biocompatibility testing was performed on the patient contact material passed biocompatibility testing. Compliance with the FDA performance standard was verified by inspection of the connectors. (Connectors must be "touch-proof."). Performance testing on the attenuator system for both types of pads was performed and testing compared performance directly with the attenuator predicates showing excellent of results.
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
(1) Submitter: Heart Sync, Inc. 5643 Plymouth Road Ann arbor. MI 48105 TEL 800-828-4681 FAX 734-213-5640 Contact: Stephen Shulman, President Date prepared: May 20, 2013
SEP 16 2013
- (2) The name of the device: T-CardiacSci-AED TM Pads Common or usual name: Single Use Sterile Defibrillator Pad Classification name:/Product Code MKJ. Class III
- (3) Predicate devices: 9131 Defibrillation electrode, K082090, Cardiac Science Corporation
- (4) Description of the device: These are single use. non-sterile, self-stick defibrillator electrodes packaged in pairs. Effective electrode area = 170 Sq. cm. They are Radiotranslucent. They come in an Anderson connector to match the specific defibrillator. The construction and materials employed are similar to the predicates. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate device. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.
- (5) Statement of the intended use of the device: Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. Heart Sync T-Cardiac Science AED pads are single use and intended to be used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The T-Cardiac Science AED pads are used on patients over 8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8 hours).
- (6) This device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device. The defibrillator pads meet the AAMI and FDA performance standards for this type of device.
- (7) Discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submitssion for a determination of substantial equivalence: Bench testing summary: Various different lots containing multiple samples each were subjected to the AAMI tests for DC offset instability. AC small signal impedance, AC large signal impedance, defibrillator overload. All units passed these testing routine was applied to a 42 month accelerated age shelf life test. All units passed the tests. Biocompatibility testing was performed on the patient contact material passed biocompatibility testing. Compliance with the FDA performance standard was verified by inspection of the connectors. (Connectors must be "touch-proof."). Performance testing on the attenuator system for both types of pads was performed and testing compared performance directly with the attenuator predicates showing excellent of results.
- (8) Discussion of clinical tests: Clinical tests are not required to establish substantial equivalence.
- (9) Conclusion: Based on the results of the nonciinical tests (that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device) we conclude that these defibrillator pads are as safe and effective as the predicates identified in paragraph (3). Furthermore, the materials and construction methods are identical to the predicate.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002
September 16, 2013
Heart Sync, Inc. c/o Mr. Daniel Kamm, P.E. Kamm & Associates 8870 Ravello Ct. Naples, FL 34114
Re: K131494
Trade/Device Names: Heart Sync T-CardiacSci-AED™ Pads Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: July 29, 2013 Received: August 6, 2013
Dear Mr. Kamm:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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. Daniel Kamm, P.E.
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 (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/CDRH/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
OwenPEaris-S
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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510(k) Number(if known): K131494
Device Name:
Indications for Use:
Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. Heart Sync T-Cardiac Science AED pads are single use and intended to be used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The T-Cardiac Science AED pads are used on patients over 8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8 hours)
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by Owen P. Faris -S ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Date: 2013.09.16 11:21:28-04'00'
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