(116 days)
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)
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.
The provided text describes a 510(k) premarket notification for the "T-CardiacSci-AED™ Pads." This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested elements for a study proving device meets acceptance criteria (e.g., sample size for test set, expert ground truth, MRMC study, training set details) are not applicable to this specific submission.
The "acceptance criteria" here relate to engineering and performance standards for defibrillator pads, as well as demonstrating equivalence in design and materials to a legally marketed predicate device.
Here's an analysis based on the provided text, addressing the points where applicable:
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for defibrillator pads, the acceptance criteria are primarily related to meeting established performance standards for such devices and demonstrating material and functional equivalence to a predicate. The "study" proving this is the non-clinical bench testing.
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Compliance with AAMI Standard ANSI/AAMI DF80:2003 | "These pads meet the AAMI Standard ANSI/AAMI DF80:2003" |
| Connectors meet FDA performance standard for touch-proof ECG connectors | "the connectors meet the FDA performance standard for touch proof ECG connectors." "Compliance with the FDA performance standard was verified by inspection of the connectors. (Connectors must be "touch-proof.")" |
| DC offset instability (AAMI tests) | "Various different lots containing multiple samples each were subjected to the AAMI tests for DC offset instability. All units passed these testing routine was applied to a 42 month accelerated age shelf life test. All units passed the tests." |
| AC small signal impedance (AAMI tests) | "Various different lots containing multiple samples each were subjected to the AAMI tests for ... AC small signal impedance. All units passed these testing routine was applied to a 42 month accelerated age shelf life test. All units passed the tests." |
| AC large signal impedance (AAMI tests) | "Various different lots containing multiple samples each were subjected to the AAMI tests for ... AC large signal impedance. All units passed these testing routine was applied to a 42 month accelerated age shelf life test. All units passed the tests." |
| Defibrillator overload (AAMI tests) | "Various different lots containing multiple samples each were subjected to the AAMI tests for ... 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 of patient contact material | "Biocompatibility testing was performed on the patient contact material passed biocompatibility testing." |
| Performance of attenuator system (comparison to predicate) | "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." (Implies demonstration of equivalent or better performance compared to predicate's attenuator system, which would be an implicit acceptance criterion for substantial equivalence). |
| Shelf Life (accelerated aging) | "All units passed these testing routine [AAMI tests] was applied to a 42 month accelerated age shelf life test. All units passed the tests." |
| Identical technological characteristics to predicate | "This device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device." "Furthermore, the materials and construction methods are identical to the predicate." (This is a design characteristic claimed to be met, rather than a quantifiable performance metric). |
Study Details (Bench Testing)
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Sample size used for the test set and the data provenance:
- Sample Size: "Various different lots containing multiple samples each" were subjected to AAMI tests and accelerated shelf-life testing. Specific numbers are not provided in the text.
- Data Provenance: The testing was conducted internally by the manufacturer (Heart Sync, Inc.) or a third-party lab contracted by them. The country of origin for the data is implicitly the USA, as Heart Sync is located in Ann Arbor, MI. The data is prospective in the sense that it was generated specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is Not Applicable (N/A). The "ground truth" for this device is based on objective engineering and material standards (AAMI, FDA performance standards) and direct comparison to a predicate device's characteristics. There's no subjective expert interpretation of, for example, medical images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically used in clinical studies involving subjective assessments (e.g., image interpretation). For bench testing against objective standards, the outcome is pass/fail based on measured parameters.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is a defibrillator pad, not an AI-assisted diagnostic tool. No MRMC study was performed or required. The text explicitly states: "Clinical tests are not required to establish substantial equivalence."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This refers to AI algorithm performance. This device is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for device performance is defined by recognized industry standards (AAMI), regulatory performance standards (FDA for connectors), and direct comparison/equivalence to the established characteristics of the predicate device. For biocompatibility, the ground truth is established by recognized biocompatibility testing protocols (e.g., ISO 10993).
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The sample size for the training set:
- N/A. This concept applies to machine learning models, but this submission is for a physical medical device. There is no "training set" in the AI sense.
-
How the ground truth for the training set was established:
- N/A. As above, there is no training set. The "ground truth" for the device's design and manufacturing processes is established through engineering design specifications, material selections, and manufacturing quality control, all benchmarked against the predicate device and relevant standards.
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(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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§ 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.