(99 days)
Not Found
No
The summary describes a standard defibrillator and cardiac monitor with no mention of AI or ML capabilities. The performance studies focus on basic device functionality and software validation, not AI/ML model performance.
Yes
The device is described as a defibrillator, which restores normal heart rhythm, indicating its therapeutic purpose.
Yes
The device explicitly states it "serves as a cardiac monitor, with the ability to measure heart rate," which indicates a diagnostic function.
No
The device description explicitly states it is a "DC-Defibrillator, Low-energy (including paddles)" and that "The electrical shock is delivered through paddles attached to the main unit." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device's function is to deliver electrical shocks to the heart for defibrillation and to monitor heart rate. These are direct interventions and measurements on the patient's body, not analyses of specimens taken from the body.
- Classification: The device is classified as a DC-Defibrillator and Cardiac Monitor, which are categories for devices that interact directly with the patient.
Therefore, the Nihon Kohden cardiolife, model number TEC-6100A, is a therapeutic and monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Nihon Kohden's cardiolife, model number TEC-6100A, is intended for medical purposes. The device will deliver an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device also serves as a cardiac monitor, with the ability to measure heart rate.
Product codes
74 LDD, 74 DRT
Device Description
The TEC-6100A cardiolife device is classified as Class II by the Division of Cardiovascular, Respiratory and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR, Part 870.5300 DC-Defibrillator, Low-energy (including paddles) as per Product Classification Code 74 LDD and under 21 CFR Part 870.2300 Monitor. Cardiac (including Cardiotachometer) as per Product Classification Code 74 DRT. Common names for the TEC-6100A cardiolife device include Low-energy DC-defibrillator and Cardiac Monitor. The device will deliver an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The electrical shock is delivered through paddles attached to the main unit. The device also serves as a cardiac monitor, with the ability to measure heart rate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atria or ventricles of the heart
Indicated Patient Age Range
The device is intended for use with adult and pediatric patients.
Intended User / Care Setting
The TEC-6100A cardiolife will be available for use by a physician or under the supervision of a physician, within a medical facility and in a remote anying mant. The TEC-6100A will be available for use by a physician or under the supervision of a physician, within a medical facility and in a move envice envice is not intended for use in ambulances.
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)
The TEC-6100A cardiolife device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of acquiring, processing, displaying and recording of the device. The results confirmed that the device performed within specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
510(k) NOTIFICATION TEC-6100A cardiolife
JUL - 9 1997
NIHON KOHDEN AMERICA, INC. March 31, 1997
SECTION 2 - 510(k) SUMMARY
Name and Address of Applicant Nihon Kohden America, Inc. 2601 Campus Drive Irvine, California 92612-1601
Contact Person and Telephone Mr. Garv Reasoner Director of Product Operations (714) 250-3959 ext. 3387
The TEC-6100A cardiolife device is classified as Class II by the Division of Cardiovascular. Respiratory and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR, Part 870.5300 DC-Defibrillator, Low-energy (including paddles) as per Product Classification Code 74 LDD and under 21 CFR Part 870.2300 Monitor. Cardiac (including Cardiotachometer) as per Product Classification Code 74 DRT.
Common names for the TEC-6100A cardiolife device include Low-energy DC-defibrillator and Cardiac Monitor.
The predicate marketed devices are the Nihon Kohden cardiolife, TEC-7100A Portable Defibrillator per 510(k) #K863404, commercial distribution certification dated October 31, 1986 and the Nihon Kohden cardiolife, TEC-8250A Portable Defibrillator per 510(k) #K914971, commercial distribution dated December 3, 1991.
Nihon Kohden's cardiolife, model number TEC-6100A, is intended for medical purposes. The device will deliver an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The electrical shock is delivered through paddles attached to the main unit. The device also serves as a cardiac monitor, with the ability to measure heart rate. The TEC-6100A cardiolife will be available for use by a physician or under the supervision of a physician, within a medical facility and in a remote anying mant.
To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR Part 861.
The TEC-6100A cardiolife device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of acquiring, processing, displaying and recording of the device. The results confirmed that the device performed within specifications.
Therefore based on the preceding information, Nihon Kohden believes that the TEC-6100A cardiolife is substantially equivalent to the predicate devices: the Nihon Kohden TEC-7100A cardiolife and the Nihon Kohden TEC-8250A cardiolife.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gary Reasoner JUL - 9 1997 Nihon Kohden America, Inc. 2601 Campus Drive Irvine, California 92715
Re: K971194 Nihon Kohden TEC-6100A Cardiolife Mini Defibrillator Requlatory Class: II (two) Product Code: 74 LDD Dated: March 31, 1997 Received: April 1, 1997
Dear Mr. Reasoner:
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 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 registration, listing of devices, qood 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.
2
Page 2 - Mr. Gary Reasoner
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/dsmamain.html".
Sincerely yours,
E. Parker J. Allelton
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): K971194
Device Name: TEC-6100A cardiolife Mini Defibrillator *************************************************************************************************************************
Indications for Use:
Nihon Kohden's cardiolife, model number TEC-6100A, is intended for medical purposes. The device will deliver an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device also serves as a cardiac monitor, with the ability to measure heart rate.
The TEC-6100A will be available for use by a physician or under the supervision of a physician, within a medical facility and in a move envice envice is not intended for use in ambulances. The device is intended for use with adult and pediatric patients.
Richard N. Phillips
(Division Sign-Off) (Division Sign-Olt)
Division of Cardiovascular, Respiratory, Division of Neurological Devices 510(k) Number
Prescription Use $\checkmark$