(95 days)
Not Found
No
The summary describes standard cardiac monitoring, defibrillation, and pacing functions without mentioning any AI/ML capabilities or advanced data analysis beyond basic threshold alarms.
Yes.
The device delivers electrical shocks to restore normal heart rhythm (defibrillation) and provides periodic electrical pulses to pace the heart, which are both therapeutic interventions.
Yes
The device explicitly states it "serves as a cardiac monitor, with the ability to measure heart rate and to sound an alarm when the heart rate falls outside preset upper and lower limits," which are diagnostic functions.
No
The device description explicitly states it delivers electrical shocks through paddles attached to a main unit and supplies electrical pulses through electrodes, indicating it is a hardware device with integrated software.
Based on the provided text, the Nihon Kohden's TEC-7531A cardiolife is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that this device is used for delivering electrical shocks to the heart, pacing the heart through electrodes on the chest surface, and monitoring heart rate. These are all direct interactions with the patient's body, not the analysis of biological samples.
- The functions described are therapeutic and monitoring. Defibrillation and pacing are therapeutic interventions. Cardiac monitoring is a direct physiological measurement. None of these activities involve the in vitro examination of specimens.
Therefore, the TEC-7531A cardiolife is a medical device, but it falls under categories other than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Nihon Kohden's TEC-7531A cardiolife 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. This device will supply a periodic electrical pulse intended to pace the heart when applied to the chest surface through electrodes. This device serves as a cardiac monitor, with the ability to measure heart rate and to sound an alarm when the heart rate falls outside preset upper and lower limits. This device will also condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g. a central monitoring station, and will recondition a physiological signal to its original format when received from another device, e.g. transmitter.
Product codes
74 DRO, 74 LDD, 74 DRT, 74 DRG
Device Description
Common names for the TEC-7531A cardiolife are Low-energy DC-defibrillator, Cardiac Monitor, External Transcutaneous Cardiac Pacemaker, Radiofrequency Physiological Signal Receiver and Radiofrequency Physiological Signal Transmitter.
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, chest surface
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
a physician, or under the supervision of a physician, within a medical facility and in remote environment.
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
The TEC-7531A cardiolife 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 results confirmed that the devices performed within specifications.
Key Metrics
Not Found
Predicate Device(s)
K863405, K913085, K920154, K914092
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
NIHON KOHDEN AMERICA, INC. April 9, 1997
JUL 1 5 1997
510(k) NOTIFICATION TEC-7531A cardiolife
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. Gary Reasoner Director of Product Operations (714) 250-3959 ext. 3387
The TEC-7531A cardiolife is classified as Class III by the Division of Cardiovascular, Respiratory and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR Part 870.5550 External Transcutaneous Cardiac Pacemaker (Non-invasive) as per Product Classification Code 74 DRO. Additional device classification is 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, under 21 CFR Part 870.2300 Monitor, Cardiac Monitor (including Cardiotachometer and Rate Alam) as per Product Classification Code 74 DRT and under 21 CFR Part 870.2910 Radiofrequency Physiological Signal Transmitter and Receiver as per Product Classification Code 74 DRG.
Common names for the TEC-7531A cardiolife are Low-energy DC-defibrillator, Cardiac Monitor, External Transcutaneous Cardiac Pacemaker, Radiofrequency Physiological Signal Receiver and Radiofrequency Physiological Signal Transmitter.
The predicate marketed devices are the Nihon Kohden cardiolife, TEC-7200A Portable Defibrillator per 510(k) #K863405, commercial distribution certification dated October 31, 1986, the Nihon Kohden cardiolife. TEC-8251A Portable Defibrillator per 510(k) #K913085, commercial distribution dated September 25, 1991, the Nihon Kohden Life Scope 14, BSM-8800A Bedside Monitor per 510(k) #K920154, commercial distribution dated December 18, 1992 and the Nihon Kohden Life Scope L, BSM-2101A Bedside Monitor per 510(k) #K914092. commercial distribution dated May 28. 1992.
Nihon Kohden's TEC-7531A cardiolife is intended for medical purposes. The device will deliver an electrical shock of a maximum of 360 ioules of energy used for defibrillating (restoring normal heart mythm) 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. This device will supply a periodic electrical pulse intended to pace the heart when applied to the chest surface through electrodes. This device serves as a cardiac monitor, with the ability to measure heart rate and to sound an alarm when the falls outside preset upper and lower limits. This device will also condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g. a central monitoring station, and will recondition a physiological signal to its original format when received from another device, e.g. transmitter. The TEC-7531A cardiolife will be available for use by a physician, or under the supervision of a physician, within a medical facility and in remote environment.
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-7531A cardiolife 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 results confirmed that the devices performed within specifications.
Therefore based on the preceding information, Nihon Kohden Corporation believes that the TEC-7531A cardiolife Portable Defibrillator is substantially equivalent to the predicate devices: the Nihon Kohden TEC-7200A cardiolife Portable Defibrillator, the Nihon Kohden TEC-8250A cardiolife Portable Defibrillator, the Nihon Kohden BSM-8800A Life Scope 14 Bedside Monitor and the Nihon Kohden BSM-2101A Life Scope L Bedside Monitor.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, with a bird-like shape above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 1997
Mr. Gary Reasoner Nihon Kohden America, Inc. 2601 Campus Drive Irvine, California 92612-1601
Re: K971355 Nihon Kohden TEC-7531A Cardiolife Portable Defibrillator and Accessories Requlatory Class: III (three) Product Code: 74 DRD Dated: April 9, 1997 Received: April 11, 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, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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) 594-4646. 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,
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
Enclosure
3
NIHON KOHDEN AMERICA, INC. April 9, 1997
510(k) NOTIFICATION TEC-7531A cardiolife
G. Indications for Use Statement
K971355 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: TEC-7531A cardiolife Portable Defibrillator
Indications for Use:
Nihon Kohden's TEC-7531A cardiolife 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. This device will supply a periodic electrical pulse intended to pace the heart when applied to the chest surface through electrodes. This device serves as a cardiac monitor, with the ability to measure heart rate and to sound an alarm when the heart rate falls outside preset upper and lower limits. This device will also condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g. a central monitoring station, and will recondition a physiological signal to its original format when received from another device, e.g. transmitter.
The TEC-7531A cardiolife will be available for use by a physician, or under the supervision of a physician, for adult and pediatric patients within a medical facility and in remote environment.
Prescription Device