(166 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, electrical properties, and biocompatibility of defibrillator electrodes. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated to "treat patients in cardiopulmonary arrest," which involves providing therapy.
No
Explanation: The device is described as "defibrillator electrodes" used to "treat patients in cardiopulmonary arrest," indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it is comprised of physical components (electrodes, packaging, connectors) and describes bench testing related to these physical components and materials.
Based on the provided text, 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 description clearly states the device is used to "treat patients in cardiopulmonary arrest" by delivering "lower-energy therapy." This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Intended Use: The intended use is for treating a medical emergency, not for diagnosing a condition.
- Device Description: The description focuses on the physical characteristics and performance of defibrillator electrodes, which are used externally on the patient's body.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
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. They should only be used by personnel who have been trained in its operation. Used to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55 lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.
Product codes (comma separated list FDA assigned to the subject device)
MKJ
Device Description
These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = Conductive Area: 92 Sq. cm. They are radiotranslucent. They come in two connector styles 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 devices. 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
from 1 year of age to 8 years
Intended User / Care Setting
personnel who have been trained in its operation.
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)
Bench testing summary: Various different lots containing multiple samples each were subjected to the A.AMI tests for DC offset, 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 Hydrogel. The 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 correlation of results.
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
§ 870.5310 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
K120536 ps loPl
510(k) Summarv K12
(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: January 27, 2012
AUG 6 2012
- (2) The name of the device: Pediatric Physio AED Pad; Pediatric Philips AED Pad Common or usual name: Single Use Defibrillator Pad for AED Classification name:/Product Code automated external defibrillators (non-wearable) Code MKJ 21CFR 870.5310
- (3) Predicate devices: K022732 Medtronic/Physio-Control Infant/Child Reduced Energy Electrodes: K003819, Defibrillator Electrodes/Pads PHILIPS - Forerunner 2 Pediatric Defibrillator Pads, K081442 Heart Sync, HEART SYNC PEDIATRIC, MODEL PED-100,
- (4) Description of the device: These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = Conductive Area: 92 Sq. cm. They are radiotranslucent. They come in two connector styles 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 devices. 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. They should only be used by personnel who have been trained in its operation. Used to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55 lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.
- (6) This device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices. 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 submission for a determination of substantial equivalence: Bench testing summary: Various different lots containing multiple samples each were subjected to the A.AMI tests for DC offset, 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 Hydrogel. The 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 correlation of results.
- (8) Conclusion: Based on the results of the nonclinical 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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the left side of the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 6 2012
Heart Sync, Inc. c/o Mr. Daniel Kamm Submission Correspondent 8870 Ravello Ct Naples, FL 34114
Re: K120536
Trade/Device Name: Heart Sync Pediatric AED Pad Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: July 27, 2012 Received: July 31, 2012
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.
2
Page 2 - Mr. Daniel Kamm
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 (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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Bram Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
3
K120536 pg lofl
Indications for Use
510(k) Number(if known): K12
Device Name: Heart Sync Pediatric Physio AED Pad; Heart Sync Pediatric Philips AED Pad
Indications for Use:
Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation. Used to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55 Ibs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 1 of 1
Division Sign-Off) Division of Cardiovascular Devices
510(k) Number