(45 days)
Not Found
WEP-4000,ORG-9700/CNS-9700
No
The summary describes a device that transmits physiological data and displays basic parameters. There is no mention of any analytical or interpretive functions that would typically involve AI/ML.
No
The device is intended to transmit physiological data for continuous monitoring, not to treat or alleviate a medical condition.
No
Explanation: The device is intended to transmit physiological data for continuous monitoring, not to diagnose a condition. It transmits data to a separate monitor for display and storage.
No
The device description explicitly mentions hardware components like a "transmitter," "front LCD," and communication via "radiofrequency." It also details hardware-specific functions like changing channels and displaying battery condition. The performance studies section also mentions validation of both software and hardware.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the ZS-940PA series clearly states its purpose is to transmit physiological data directly from a patient (ECG, respiration, SpO2, NIBP, pulse waveform) to a monitor for continuous monitoring. It does not involve the analysis of biological samples.
- The device is used for real-time monitoring of vital signs. This is a typical function of patient monitoring equipment, not IVDs.
The device is a patient monitoring transmitter, not an IVD.
N/A
Intended Use / Indications for Use
The device, ZS-940PA series, is intended to transmit physiological data, such as: electrocardiogram (ECG), respiration, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and pulse waveform from a patient to a Nihon Kohden monitor for continuous monitoring applications. The transmitter can change channels when connected to the QI-910PK channel writer. The front LCD displays SpO2%, NIBP, pulse rate, pulse waveform amplitude, electrode condition mark, battery condition and NIBP measuring mode and interval. The system communicates in the new WMTS band as required by FCC. The monitored physiological parameters communicated via radiofrequency can be displayed, stored and printed at a Nihon Kohden Central monitor, such as WEP-4000 or ORG-9700/CNS-9700.
The device will be available for sale only upon the order of a physician or licensed health care provider and it will be available for use by medical personnel on all patient populations within a medical facility, including ICU, CCU, recovery room and general ward.
Product codes
DRT
Device Description
The device is intended to monitor, display and transfer physiological data. Specifically, the device is intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO22), respiratory rate, and non- invasive blood pressure (NIBP). This device may be used to transmit physiological signals via radio frequency.
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
all patient populations, including neonates. (for all functions except NIBP which is for adults and children)
Intended User / Care Setting
will be available for sale only upon the order of a physician or licensed health care provider and it will be available for use by medical personnel on all patient populations within a medical facility, including ICU, CCU, recovery 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. These tests verified the intended operation of the device. Safety and efficacy was documented through Design validation of the software and hardware of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
510(k) NOTIFICATION ZS-940PA Transmitter
14-3511
FEB - 3 2005
SECTION 2 - 510(K) SUMMARY
Name and Address of Applicant
Phone: (949) 580-1555 Nihon Kohden America, Inc. Dial 9 and then Ext. 4401 Fax: (949) 580-1550 90 Icon St. Attn: Serrah Namini, Foothill Ranch, Ca 92610 Regulatory Affairs Assoc. Dir.
Indications for Use:
The device, ZS-940PA series, is intended to transmit physiological data, such as: electrocardiogram (ECG), respiration, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and pulse waveform from a patient to a Nihon Kohden monitor for continuous monitoring applications. The transmitter can change channels when connected to the QI-910PK channel writer. The front LCD displays SpO2%, NIBP, pulse rate, pulse waveform amplitude, electrode condition mark, battery condition and NIBP measuring mode and interval. The system communicates in the new WMTS band as required by FCC. The monitored physiological parameters communicated via radiofrequency can be displayed, stored and printed at a Nihon Kohden Central monitor, such as WEP-4000 or ORG-9700/CNS-9700.
The device will be available for sale only upon the order of a physician or licensed health care provider and it will be available for use by medical personnel on all patient populations within a medical facility, including ICU, CCU, recovery room and general ward.
The device complies with IEC 60601-1 sub-clause 56.3(c) implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables. The device is also in compliance with applicable sections of IEC standard as listed in this application.
Sterilization is not required for the device.
The device does not directly contact patients; It is place in a pocket of a non-latex blood pressure cuff on a patient's arm. Accessories that contact patients, such as SpO2 probes, are the same accessories as used with other legally marketed products or are comprised of the same component materials as the accessories of predicate devices. Therefore, good laboratory practice studies required per 21 CFR Part 58 are not applicable for this submission.
The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the intended operation of the device. Safety and efficacy was documented through Design validation of the software and hardware of the device.
Therefore, Nihon Kohden believes that the device is substantially equivalent to the Nihon Kohden predicate devices.
1
K043517
p2/2
SECTION 3 - PROPOSED LABELING
A. Intended Use
The device is intended to monitor, display and transfer physiological data. Specifically, the device is intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO22), respiratory rate, and non- invasive blood pressure (NIBP). This device may be used to transmit physiological signals via radio frequency. The device will be available for use by medical personnel on all patient populations within a medical facility.
Device/Package Labels B.
The proposed product labels for the device are located in Attachment # A .
C. Proposed Packaging
Packaging drawings/ specifications for the device is depicted in Attachment # A.
D. Instructions for Use
The proposed instructions for use is provided with each packaged device and is presented in Attachment # H, Operator's Manual .
Advertisement/Promotional Literature E.
To date, no advertisement or promotional literature has been created for the distribution in the United States.
F. Contraindications, Precautions & Warnings
Warnings and Cautions listed in the Operator's Manual are depicted in Attachment # B.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 3 2005
Nihon Kohden America, Inc. c/o Ms. Serrah Namini RA Associate Director 90 Icon St. Foothill Ranch, CA 92610
Re: K043517
Trade Name: ZS-940PA Transmitter Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: DRT Dated: December 16, 2004 Received: December 20, 2004
Dear Ms. Namini:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section >10(x) premainter as abstantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to tegary manated president Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 26, 1976, the enaordance with the provisions of the Federal Food, Drug.
In a lead have been reclassified in accordance with the provisions of the United devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act . Je and Costheric Ac. (Act) that do not require approvince subject to the general controls provisions of the Act. The You may, merefore, mance the do rece, solo, e requirements for annual registration, listing of the general controls provisions of the flor 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
may be subject to such additional controls. Existing major may be subject to such additional bonatorior Linkstong Collections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pouch oncerning your device in the Federal Register.
3
Page 2 - Ms. Serrah Namini
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualled of a succession with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regalations and adding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, more and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 807), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declons our device as described in your Section 510(k) This letter will anow you to ogin manseans your and equivalence of your device to a legally premarket notheation: "The PDF mining of easification 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 If you desire specific acvice for your as (240) 276-0120 Also, please note the regulation entitled, Comact the Office of Compularse an (21CFR Part 807.97). You may obtain Misbranding by reference to premantonitiiiiiiiis under the Act from the Division of Small other general information on your responses Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
B. Zimmer for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NIHON KOHDEN AMERICA, INC.
510(k) NOTIFICATION ZS-940PA Transmitter
G. Indications for Use Statement
K043517 510(k) Number (if known): __
Device Name: ZS-940PA Series
Indications for Use:
The device is intended to transmit physiological data, such as: electrocardiogram (ECG), respiration, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), and pulse waveform from a patient to a Nihon Kohden monitor for continuous monitoring. The transmitter can change channels when connected to the QI-910PK channel writer. The front LCD displays SpO2%, NIBP, pulse rate, pulse waveform amplitude, electrode condition mark, battery condition and NIBP measuring mode and interval. The system communicates in the new WMTS band as required by FCC. The device will be available for use within a medical facility, including ICU, CCU, recovery room and general ward by medical personnel on adults and children for NIBP and all other functions for all patient populations, including neonates.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
K043517 B/Ammer
i Cardiovascular Devices 510(k) Number
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