(74 days)
Not Found
No
The document mentions an "algorithm to detect cardiac arrhythmias" but does not provide any details suggesting it uses AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a monitoring system that receives and transmits physiological data and generates alarms, but it does not provide any therapy or treatment.
Yes
The device detects patient vital sign alarm conditions and includes an algorithm to detect cardiac arrhythmias, which are aspects of diagnosing a medical condition.
No
The device description explicitly states it is a "Multiple Patient Receiver" and a "component of a central monitor network," implying it is a physical hardware device that receives and transmits data. The performance studies also mention electromagnetic, environmental, and safety testing, which are typically associated with hardware devices.
Based on the provided information, the ORG-9700A Multiple Patient Receiver is not an IVD (In Vitro Diagnostic) device.
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 about a person's health. This testing is performed outside the body (in vitro).
- ORG-9700A Function: The ORG-9700A receives and transmits physiological data (ECG, respiration, SpO2, NIBP) directly from telemetry transmitters connected to the patient. It monitors vital signs and detects arrhythmias based on this real-time physiological data.
- No Specimen Testing: The device does not involve the collection or analysis of any biological specimens from the patient. It is a monitoring system that processes signals received from sensors attached to the patient's body.
Therefore, the ORG-9700A falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ORG-9700A Multiple Patient Receiver is intended for use by medical professionals with Nihon Kohden telemetry transmitters and central stations to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The device detects patient vital sign alarm conditions and includes an algorithm to detect cardiac arrhythmias. The intended use of the modified device has not changed as a result of the modifications. The device is available for use on all patient populations.
Product codes (comma separated list FDA assigned to the subject device)
DRG
Device Description
New ORG-9700A has the same intended use as the previously marketed telemetry system, which is for use by medical professionals with Nihon Kohden telemetry transmitters and central stations to provide cardiac and vital signs monitoring for multiple patients. The device can receive the patient's ECG, respiration, SpO2, and non-invasive blood pressure data (NIBP value is only displayed on the central monitor) from a transmitter and send it to Nihon Kohden Central monitor within the medical facility. The device is designed as a component of a central monitor network to be used in the ICU, CCU, HCU, recovery room, operating room and general ward. The device will receive and transmit physiological data from telemetry transmitters/receivers and generate an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected.
The device is not sterile. The device is not directly connected to patients. It is used as a central monitoring system for obtaining a series of patient vital information.
The device was subject to electromagnetic, environmental, safety and performance testing procedures. Software validation was satisfactory completed as part of product's design validation. The results confirmed that the device performed within specifications.
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
The device is available for use on all patient populations.
Intended User / Care Setting
medical professionals / ICU, CCU, HCU, recovery room, operating room and general ward
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 device was subject to electromagnetic, environmental, safety and performance testing procedures. Software validation was satisfactory completed as part of product's design validation. The results confirmed that the device performed within specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ORG-9700 and ORG-9200A Multiple Patient Receiver per 510(k) #K002068
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
K07/058
NIHON KOHDEN AMERICA, INC.
510(k) NOTIFICATION ORG-9700A Multiple Patient Receiver
SECTION 2 - 510(K) SUMMARY
JUN 2 9 2007
Name and Address of Applicant
Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610
Date: April 13, 2007
Contact: Serrah Namini, Regulatory Affairs Assoc. Director (949) 580-1555 Ext. 4401 Fax: (949) 580-1550
- Device Name: Telemetry receiver .
- Trade or proprietary name: ORG-9700A �
- . The common or usual name: Signal Exchanger and Telemetry Receiver
- The classification: Class II Special control; Detector and Alarm, Arrhythmia under 21 ● CFR Part 870.1025; Transmitter and Receiver Physiological Signal, Radio frequency under 21 CFR 870.2910
- Legally Marketed Predicate: ORG-9700 and ORG-9200A Multiple Patient Receiver per ● 510(k) #K002068, commercial distribution certification dated February 8, 2001
Description and Intended Use:
New ORG-9700A has the same intended use as the previously marketed telemetry system, which is for use by medical professionals with Nihon Kohden telemetry transmitters and central stations to provide cardiac and vital signs monitoring for multiple patients. The device can receive the patient's ECG, respiration, SpO2, and non-invasive blood pressure data (NIBP value is only displayed on the central monitor) from a transmitter and send it to Nihon Kohden Central monitor within the medical facility. The device is designed as a component of a central monitor network to be used in the ICU, CCU, HCU, recovery room, operating room and general ward. The device will receive and transmit physiological data from telemetry transmitters/receivers and generate an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected.
The device is not sterile. The device is not directly connected to patients. It is used as a central monitoring system for obtaining a series of patient vital information.
The device was subject to electromagnetic, environmental, safety and performance testing procedures. Software validation was satisfactory completed as part of product's design validation. The results confirmed that the device performed within specifications.
Therefore based on the above, Nihon Kohden believes that the ORG-9700A Multiple Patient Receiver is substantially equivalent to the Nihon Kohden predicate Multiple Patient Receivers.
Page 6 of 21 page 1 of 1
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2007
Nihon Kohden America, Inc. c/o Serrah Namini Regulatory Affairs, Associate Director 90 Icon St. Foothill Ranch, CA 92610
Re: K071058
Trade/Device Name: ORG-9700A Multiple Patient Receiver and accessories Regulation Number: 21 CFR 870. 2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: May 29, 2007 Received: June 7, 2007
Dear Ms. Namini:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Serrah Namini
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. hochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
NIHON KOHDEN AMERICA, INC.
510(k) NOTIFICATION ORG-9700A Multiple Patient Receiver
G. Indications for Use Statement
| 510(k) Number (if known): | K071058 |
|---|---|
| --------------------------- | --------- |
Device Name: ORG-9700A Multiple Patient Receiver
Indications for Use:
The ORG-9700A Multiple Patient Receiver is intended for use by medical professionals with Nihon Kohden telemetry transmitters and central stations to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The device detects patient vital sign alarm conditions and includes an algorithm to detect cardiac arrhythmias. The intended use of the modified device has not changed as a result of the modifications. The device is available for use on all patient populations.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ound n Sign-Off
n of Cardiovascular Devices
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