(186 days)
Not Found
No
The summary describes standard defibrillator and cardiac monitoring functions, including signal processing and transmission, but makes no mention of AI or ML capabilities, training data, or performance metrics typically associated with such technologies.
Yes
Explanation: The device is described as delivering an electrical shock to restore normal heart rhythm or terminate cardiac arrhythmias, which is a therapeutic intervention.
Yes
Explanation: The device serves as a cardiac monitor, measures heart rate, and can sound an alarm indicating abnormal heart rhythms, which are all diagnostic functions. It also conditions and reconditions physiological signals for transmission and reception, further supporting its diagnostic capabilities.
No
The device description explicitly mentions delivering electrical shocks through paddles attached to a main unit, indicating a hardware component 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 taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states the device's function is to deliver electrical shocks to the heart for defibrillation and to act as a cardiac monitor by measuring heart rate and transmitting physiological signals. These are direct interactions with the patient's body and physiological processes, not the analysis of in vitro specimens.
The device is a therapeutic and monitoring device, not a diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
Nihon Kohden's TEC-7511A cardiolife and TEC-7521A cardiolife defibrillators are intended for medical purposes. The devices will deliver an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart mythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The devices deliver the electrical shock through paddles attached to the main unit. These devices will serve 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. The devices will also condition a physicilogical signal to be transmitted via radiofrequency from one location to another, e.g. a central monitoring station, and will recondition a physiological signal to the original format when received from another device, e.g. transmitter.
The TEC-7511A cardiolife and TEC-7521A 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.
Product codes
74 LDD, 74 DRT, 74 DRG
Device Description
Common names for the TEC-7511A cardiolife and the TEC-7521A cardiolife include Low-energy DC-defibrillator, Cardiac Monitor, Radiofrequency Physiological Signal Receiver and Radiofrequency Physiological Signal Transmitter.
Nihon Kohden's TEC-7511A and TEC-7521A cardiolife defibrillators are intended for medical purposes. These devices will deliver an electical shock of a maximum of 360 joules of energy used for defibiliating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arthythmias. The devices deliver the electrical shock through paddles attached to the main unit. The devices will serve as a cardiac monitor, with the ability to measure heart rate and to sound an alam when the heart rate falls outside preset upper and lower limits. The devices will also condition a physiological signal to be transmitted via radiofrequency from one location to another. e.o. a central monitoring station. and will recondition a physiological signal to the original format when received from another device, e.g. 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
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Available for use by 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The TEC-7511A cardiolife and the TEC-7521A cardiolife were 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 devices. The results confirmed that the devices performed within specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K863405, K914971, 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 17, 1997
SECTION 2 - 510(k) SUMMARY K9971436
OCT 2 1 1997
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 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, under 21 CFR Part 870.2300 Cardiac Monitor (including Cardiotachometer and Rate Alam) as per Product Classification Code 74 DRT and under 21 CFR Part 870.2010 Radiofrequency Physiological Signal Transmitter and Receiver as per Product Classification Code 74 DRG.
Common names for the TEC-7511A cardiolife and the TEC-7521A cardiolife include Low-energy DC-defibrillator, Cardiac Monitor, Radiofrequency Physiological Signal Receiver and Radiofrequency Physiological Signal Transmitter.
The predicate devices are the Nihon Kohden TEC-7200A cardiolife Portable Defibrillator per 510(k) #K863405. commercial distribution cated October 31. 1986. the Nihon Kohden TEC-8250A cardiolife Portable Defibrillator per 510(k) #K914971, commercial distribution certification dated December 3, 1991, the Nihon Kohden BSM-8800A Life Scope 14 Bedside Monitor, per 510(k) #K920154, commercial distribution certification dated December 18, 1992 and the Nihon Kohden BSM-2101A Life Scope L Bedside Monitor per 510(k) #K914092, commercial distribution certification dated May 28, 1992.
Nihon Kohden's TEC-7511A and TEC-7521A cardiolife defibrillators are intended for medical purposes. These devices will deliver an electical shock of a maximum of 360 joules of energy used for defibiliating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arthythmias. The devices deliver the electrical shock through paddles attached to the main unit. The devices will serve as a cardiac monitor, with the ability to measure heart rate and to sound an alam when the heart rate falls outside preset upper and lower limits. The devices will also condition a physiological signal to be transmitted via radiofrequency from one location to another. e.o. a central monitoring station. and will recondition a physiological signal to the original format when received from another device, e.g. transmitter. The TEC-7511A and TEC-7521A 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-7511A cardiolife and the TEC-7521A cardiolife were 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 devices. The results confirmed that the devices performed within specifications.
Therefore based on the preceding information, Nihon Kohden believes that the TEC-7511A cardiolife Portable Defibrillator and the TEC-7521A cardiolife Portable Defibrillator are 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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 | 1997
Mr. Gary Reasoner Nihon Kohden America, Inc. 2601 Campus Drive Irvine, California 92715
Re: K971436 Nihon Kohden TEC-7511A and TEC-7521A Cardiolife Defibrillators Regulatory Class: II (two) Product Code: 74 LDD Dated: August 20, 1997 Received: August 21, 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 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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.
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,
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
G. Indications for Use Statement
510(k) Number (if known):
Device Name: TEC-7511A cardiolife Portable Defibrillator TEC-7521A cardiolife Portable Defibrillator
Indications for Use:
Nihon Kohden's TEC-7511A cardiolife and TEC-7521A cardiolife defibrillators are intended for medical purposes. The devices will deliver an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart mythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The devices deliver the electrical shock through paddles attached to the main unit. These devices will serve 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. The devices will also condition a physicilogical signal to be transmitted via radiofrequency from one location to another, e.g. a central monitoring station, and will recondition a physiological signal to the original format when received from another device, e.g. transmitter.
The TEC-7511A cardiolife and TEC-7521A 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.
Mr. Roger
(Division Sign-Off) --Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
/ PRESCRIPTION DEVICE