K Number
K983232
Device Name
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
Manufacturer
Date Cleared
1999-09-15

(366 days)

Product Code
Regulation Number
870.5550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PadTac Pediatric disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency Medical Services for pediatric low-energy defibrillation, cardioversion, pacing and monitoring.
Device Description
PadTac Pediatric Defibrillate/Cardiovert/Pace/Monitoring Electrodes
More Information

Not Found

Not Found

No
The summary describes disposable electrodes and does not mention any AI/ML terms or functionalities.

Yes
The device is used for low-energy defibrillation, cardioversion, and pacing, which are all therapeutic interventions aimed at treating medical conditions.

No
The device description indicates its use for defibrillation, cardioversion, pacing, and monitoring, which are therapeutic and monitoring functions, not primarily diagnostic ones. While monitoring may involve some data collection, the primary stated uses are interventional.

No

The device description explicitly states "PadTac Pediatric Defibrillate/Cardiovert/Pace/Monitoring Electrodes," which are physical electrodes, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the electrodes are used for defibrillation, cardioversion, pacing, and monitoring. These are all procedures performed on the patient's body to treat or assess their physiological state.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.

The PadTac Pediatric disposable electrodes are external devices that interact directly with the patient's skin for therapeutic and monitoring purposes, not for analyzing biological samples.

N/A

Intended Use / Indications for Use

PadTac Pediatric disposable electrodes are used by trained professionals in hospitals, doctors offices and Emergency Medical Services for pediatric low-energy pediatric low-energy Cardioversion and monitoring.

Product codes

DRO

Device Description

PadTac Pediatric Defibrillate/Cardiovert/Pace Fadrac Pedial::trodes from TZ Medical Inc.

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

Pediatric

Intended User / Care Setting

Trained professionals in hospitals, doctors offices and Emergency Medical Services

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)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.5550 External transcutaneous cardiac pacemaker (noninvasive).

(a)
Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.(b)
Classification. Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and
(2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal lines above it, all enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP | 5 1999

Mr. Byron Zahler TZ Medical, Inc. 15858 S.W. Upper Boones Ferry Road Lake Oswego, OR 97035

K983232 Re: PADTAK Pediatric Defib/Cardiovert/Pace/Monitoring Electrodes Requlatory Class: III (three) 74 DRO Product Code: Dated: June 8, 1999 Received: June 11, 1999

Dear Mr. Zahler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

1

Page 2 - Mr. Byron Zahler

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

V

Enclosure

2

¥983232

Device Name:

510(k) Number (if known)__

PadTac Pediatric Defibrillate/Cardiovert/Pace Fadrac Pedial::trodes from TZ Medical Inc.

Indications For Use:

PadTac Pediatric disposable electrodes are used by trained professionals in hospitals,
PadTac Pediatric Madian Madian Camines for nediatric low-energy PadTac Pediathe disposable electrouse are pediatric low-energy
doctors offices and Emergency Medical Services for pediatric low-energy doctors offices and Emergency Modical Cornersion and monitoring.

Please do not WRITE BELOW THIS LINE - CONTINUE on another Page IF NEEDED)

Concurrence Of CDRH, Office OF Device Evaluation (ODE)

M. Ryle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

escription Use
X
(Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

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