(186 days)
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.
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 provided text describes a 510(k) submission for Nihon Kohden's TEC-7511A and TEC-7521A cardiolife defibrillators, filed in 1997. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria as would be expected for novel AI/software devices today.
Therefore, many of the requested details regarding acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies are not available in this document. The device in question is a physical medical device (defibrillator/monitor) and the testing described is primarily for safety, electromagnetic compatibility, environmental factors, and software validation of its basic operational functions, not for diagnostic performance based on AI.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not specify quantitative acceptance criteria for performance metrics in the way modern AI/software devices do (e.g., accuracy, sensitivity, specificity thresholds). Instead, it states that tests were performed to verify operation and that the devices performed "within specifications." The "performance" here refers to the device's ability to operate as designed (e.g., deliver a shock, monitor heart rate, transmit signals) rather than its diagnostic accuracy.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electromagnetic Compatibility | Verified operation |
| Environmental | Verified operation |
| Safety | Verified operation |
| Performance Testing (e.g., shock delivery, cardiac monitoring, signal transmission) | Verified operation; performed within specifications |
| Software Validation (acquiring, processing, displaying, recording) | Confirmed that devices performed within specifications |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The described tests are likely bench testing and functional verification, not clinical trials with a patient test set in the traditional sense.
- Data Provenance: Not applicable in the context of diagnostic data. The "data" here refers to the operational outcomes of the device during testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for these tests would be the expected functional outcome based on engineering specifications and regulatory standards, not expert consensus on diagnostic images or signals.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is relevant for AI-powered diagnostic tools where human reader performance is compared with and without AI assistance. This device is a defibrillator and monitor, not an AI diagnostic agent.
- Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Standalone Performance Done: The "software validation" section could be considered a form of standalone performance testing for the embedded software. It states that the software functions of acquiring, processing, displaying, and recording were tested and "confirmed that the devices performed within specifications." However, this is not a diagnostic algorithm's standalone performance.
7. Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications, regulatory standards (e.g., for safety, EMC), and functional design requirements. For example, for defibrillation, the ground truth is the device delivering the specified energy; for heart rate monitoring, it's accurately displaying the simulated or actual heart rate.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not employ a machine learning algorithm that requires a training set in the modern sense. The software is likely deterministic and programmed according to established engineering principles.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
{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
§ 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.