(188 days)
This question cannot be answered from the given input. The field "Predicate Device(s)" is marked as "Not Found".
Not Found
No
The 510(k) summary describes multi-function electrodes for use with existing defibrillators and pacemakers. There is no mention of AI, ML, or any computational processing beyond the basic function of the electrodes.
Yes
The device is used for applications like defibrillation, cardioversion, and noninvasive pacing, which are therapeutic interventions.
No
The device is described as multi-function electrodes used for therapeutic applications like defibrillation, cardioversion, and pacing, as well as monitoring (electrocardiograph). While ECG monitoring is diagnostic, the primary described uses involve intervention rather than solely diagnosis. It's an accessory to devices that perform both diagnostic monitoring and therapeutic actions.
No
The device is described as "Adult Multi-Function Electrodes," which are hardware components used for defibrillation, cardioversion, pacing, and monitoring. The description explicitly lists compatible hardware devices (defibrillators and pacemakers) with which these electrodes are used. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (Defibrillation, Cardioversion, Noninvasive Pacing, Electrocardiograph Monitoring) are all direct medical interventions or monitoring of physiological signals on the patient. IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health.
- Device Description: While the description is "Not Found," the intended uses clearly point to a device that interacts directly with the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the Modified star padz Adult Multi-Function Electrodes are a medical device used for therapeutic and monitoring purposes directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Modified star padz Adult Multi-Function Electrodes will be used for the following clinical applications:
- Defibrillation .
- Cardioversion .
- Noninvasive Pacing .
- Electrocardingraph Monitoring ●
In conjuction with these devices:
- ZOLL PDTM 1200 Pacemaker/Defibrillator
- ZOLL PDTM 1400 Pacemaker/Defibrillator .
- ZOLL PDTM 2000 Pacemaker/Defibrillator
- ZOLL D 900 Defibrillator ●
- ZOLL D 1400 Defibrillator ●
- ZOLL D 2000 Defibrillator ●
- ZOLL 1600 Pacemaker/Defibrillator
- ZOLL 1700 Pacemaker/Defibrillator .
- ZOLL NTP 1000 Noninvasive Temporary Pacemaker .
- ZOLL M Series .
Product codes
74 MKJ
Device Description
Modified stat padz Adult Multi-Function Electrodes
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
Adult
Intended User / Care Setting
By trained medical personnel, including:
- Physicians .
- Nurses ●
- Paramedics .
- Emergency Medical Technicians (EMT) ●
- Cardiovascular Laboratory Technicians
In typical settings.
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
§ 870.5310 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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a row. Above the profiles are three diagonal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
NOV 2.5 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael R. Dupelle Bio-Detek Incorporated 525 Narragensett Park Drive Fawtucket, RI 02861-4323
Re: K981802 Modified stat•padz Adult Multi-Function Electrodes Regulatory Class: III (three) Product Code: 74 MKJ Dated: May 15, 1998 Received: May 21, 1998
Dear Mr. Dupelle:
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, Drug, 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlatory 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. Michael R. Dupelle
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 regulation (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. Callahon
Thomas J. 9 allahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATION FOR USE
Page 1 of 2
510(k) Number (if known): __ K981802
Device Name: Modified stat padz Adult Multi-Function Electrodes
Indications For Use:
Modified star padz Adult Multi-Function Electrodes will be used for the following clinical applications:
- Defibrillation .
- Cardioversion .
- Noninvasive Pacing .
- Electrocardingraph Monitoring ●
In conjuction with these devices:
- ZOLL PD™ 1200 Pacemaker/Defibrillator �
- ZOLL PD™ 1400 Pacemaker/Defibrillator .
- ZOLL PD™ 2000 Pacemaker/Defibrillator ◆
- ZOLL D 900 Defibrillator ●
- ZOLL D 1400 Defibrillator ●
- ZOLL D 2000 Defibrillator ●
- ZOLL 1600 Pacemaker/Defibrillator �
- ZOLL 1700 Pacemaker/Defibrillator .
- ZOLL NTP 1000 Noninvasive Temporary Pacemaker .
- ZOLL M Series .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
miliame
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number |
| Perscription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |
ر
3
Page 2 of 2
By trained medical personnel, including:
- Physicians .
- Nurses ●
- Paramedics .
- Emergency Medical Technicians (EMT) ●
- Cardiovascular Laboratory Technicians �
In typical settings.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE) James 'ign-Off) Divisia: Cardiovascular, Respiratory, Division and Need ogical Devices 510(k) Monber _ OR Over-The-Counter Use Perscription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)