TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)

K122214 · Nihon Kohden Corp. · CCK · May 21, 2013 · Anesthesiology

Device Facts

• Record ID: K122214
• Device Name: TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)
• Applicant: Nihon Kohden Corp.
• Product Code: CCK · Anesthesiology
• Decision Date: May 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nihon Kohden TG-970P and is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration. The device is intended for use by qualified medical personnel within a hospital or clinical environment and is available for use on any patient weighing 2kg or more.

Device Story

TG-970P CO2 Sensor Kit measures end-tidal CO2 concentration via infrared absorption. Components include CO2 sensor (photo detector/light emitter), CO2 adapter, and airway adapter. Airway adapter connects between patient airway and respirator; sensor measures CO2 levels during expiration. Data sent to adapter for display on patient monitor. Used in hospitals/clinics by qualified medical personnel. Provides real-time CO2 monitoring to assist clinicians in assessing patient ventilatory status. Benefits include continuous monitoring of respiratory function. New YG-213T airway adapter enables use on patients 2kg or more.

Clinical Evidence

Bench testing only. Verification and validation testing performed to confirm accuracy of CO2 measurement with the new YG-213T airway adapter. Testing verified performance across specified patient weight ranges and confirmed that the reduced dead space (1mL) does not impact measurement accuracy compared to the predicate.

Technological Characteristics

Infrared radiation absorption sensing principle. Components: CO2 sensor (photo detector/light emitter), CO2 adapter, airway adapter. YG-213T airway adapter dead space: 1mL. Transmissivity: >45% at 4.27um. Operating environment: 10-40°C, 30-85% RH. Single patient use. No sterilization. Complies with IEC 60601-1, ISO 10993-1, and ISO 14971.

Indications for Use

Indicated for patients weighing 2kg or more to measure end-tidal CO2 concentration in gas mixtures to aid in determining ventilatory status. Not for patients <2kg or respiration rates >150 bpm.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• TG-970P CO2 Sensor Kit (K083456)

Reference Devices

• YG-211T airway adapter (K083456)
• YG-211TW airway adapter (K083456)

Submission Summary (Full Text)

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## KIZZZIY

Nihon Kohden America, Inc. Revised May 3, 2013

510(k) Notification TG-970P Sensor Kit w/new Airway Adaptor

## 510(k) Summary

# MAY 2 1 2013

| Company Name: | Nihon Kohden Corporation 90 Icon Street Foothill Ranch, CA 92610 | | | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|----------|-----|
| Device Name: | Nihon Kohden TG-970P CO2 Sensor Kit w/new Airway Adaptor | | | |
| 510(k) Sponsor, Contact: | Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610 Steve Geerdes Director Quality Assurance and Regulatory Affairs Phone: [phone] Ext. 3325 Fax: [phone] | | | |
| Summary Date: | Revised 05/03/2013 | | | |
| Common Name: | Carbon Dioxide (CO2) Analyzer | | | |
| Classification Names: | <table><tr><td>Anesthesiology Device</td><td>868.1400</td><td>CCK</td></tr></table> | Anesthesiology Device | 868.1400 | CCK |
| Anesthesiology Device | 868.1400 | CCK | | |
| Predicate Device(s): | | | | |

**Predicate Device(s):**

TG-970P CO2 Sensor Kit

### 1.0 Description of Device

The TG-970P Series CO2 Sensor Kit is comprised of three main components, a CO2 Sensor (photo detector and light emitter) with cable and connector, a CO2 Adapter and an airway adapter. The CO2 Sensor incorporates an infrared light source, of specified wavelength, and an infrared detector. The photo detector and light emitter end of the CO2 sensor is connected to an airway adapter. The airway adapter is connected between the patient airway and the respirator. As the patient completes an expiratory breath the sensor measures the CO2 levels in the expiratory breath and sends that data to the CO2 adapter. The adapter then reads the data and converts the data so it can be displayed on the patient monitor.

K083456

Depending on which airway adapter is used, the TG-970 can be used with patients weighing 2kg or more. The device is not recommended for patients weighing less than 2kg or patients with a respiration rate greater than 150 breaths per minute.

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## Nihon Kohden America, Inc. Revised May 3, 2013

## 510(k) Notification TG-970P Sensor Kit w/new Airway Adaptor

Image /page/1/Figure/2 description: This image shows the parts of a CO2 adapter. The parts include a photo detector and light emitter, a CO2 adapter connector, a JG-970P CO2 adapter, and a TG-221T CO2 sensor. The image also shows an airway adapter, a transparent film, and the connection points to the mask or tracheal tube and to the resuscitation bag or respirator.

#### 2.0 -Intended Use of Device

The Nihon Kohden TG-970P and is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration.

The device is intended for use by qualified medical personnel within a hospital or clinical environment and is available for use on any patient weighing 2kg or more.

#### 3.0 Technical Characteristics

The Nihon Kohden CO2 Sensor Kit, model number TG-970P Series, is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory (end tidal CO2) status. The device measuring technique is through absorption of infrared radiation.

| | Modified Device | Predicate Device | Comments |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | TG-970P with YG-213T<br>airway adapter | TG-970P with YG-211T<br>airway adapter (K#083456) | |
| Intended Use | To measure the | Same | |
| | Modified Device | Predicate Device | Comments |
| Product | TG-970P with YG-213T<br>airway adapter | TG-970P with YG-211T<br>airway adapter (K#083456) | |
| | concentration of carbon<br>dioxide in a gas mixture to<br>aid in determining the<br>patient's ventilatory status | | |
| Use frequency | Single Patient Use | Same | |
| Shelf life | 36 months | Same | |
| Population | YG-213T: For patients 2kg to<br>7kg. | For patients more than<br>approx. 7kg. | Technology & materials<br>are substantially equivalent<br>to the predicate device.<br>Validation/verification<br>testing confirms that the<br>accuracy of the measured<br>gas is substantially<br>equivalent to the predicate<br>device. No new questions<br>of safety or effectiveness<br>were raised |
| Dead space | 1mL | 4mL | The change in dead space<br>is due to smaller airway<br>adapter.<br>Validation/verification<br>testing confirms that the<br>smaller dead space does<br>not affect the accuracy of<br>the measured gas and is<br>substantially equivalent to<br>the predicate device. No<br>new questions of safety or<br>effectiveness were raised |
| Function | Airway adapter with windows<br>which infrared light of the CO2<br>sensor kit can pass through is<br>connected to respiratory<br>circuit. | Same | |
| Specifications | | | |
| Transmissivity | More than approx 45%<br>(at 4.27um±0.02um) | Same | |
| | Modified Device | Predicate Device | Comments |
| Product | TG-970P with YG-213T<br>airway adapter | TG-970P with YG-211T<br>airway adapter (K#083456) | |
| Optical length | 6mm±0.2mm | Same | |
| Ratio of<br>antifogging<br>performance :<br>fog | Ratio of fog: less than 5%(at<br>15°Cto35°C 20% to 80RH 10<br>minutes later) | Same | |
| Ratio of<br>antifogging<br>performance<br>: Wet | Ratio of Wet: less than ±8%<br>(at 15°C to 35°C, 20% to 80RH<br>10 minutes later) | Same | |

## Technical Comparison

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## Nihon Kohden America, Inc. Revised May 3, 2013

# 510(k) Notification

TG-970P Sensor Kit w/new Airway Adaptor

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Nihon Kohden America, Inc. Revised May 3, 2013

510(k) Notification

TG-970P Sensor Kit w/new Airway Adaptor

| <b>Environment</b> | | | |
|-----------------------|---------------------------------------------------|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Facility | Hospitals, Clinics, Physician office | Same | |
| | | Same | |
| | | Same | |
| Operating environment | 10 to 40 degree C<br>30 to 85%RH, non condensing | Same | |
| Storage environment | -20 to 65 degree C<br>10 to 95%RH | Same | |
| Chemical resistance | This product cannot be<br>cleaned or disinfected. | Same | |
| Sterilization | No | No | |
| Continuation use time | 72 hours | 24 hours | Validation/verification testing confirms that the accuracy of the measured gas is not changed with longer continuous use time.<br>No new questions of safety or effectiveness were raised |

### 4.0 Data Summary

·

.

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Testing of the Nihon Kohden TG-970P with new YG-213T Neonatal/Infant Airway Adapter was performed in compliance with Nihon Kohden Corporation design control process. Testing included:

The device is in compliance with the following voluntary industrial standards:

Medical Electrical Equipment

| IEC 60601-1 | Part 1: General requirements for safety 1998-12 |
|--------------------------|------------------------------------------------------------------------------------|
| IEC 60601-1, Amendment 1 | Part 1: General Requirements for safety, Amendment 1 1991-11 |
| IEC 60601-1, Amendment 2 | Part 1: General Requirements for safety, Amendment 2 1995-03 |
| ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, 2003-08 |

Medical Devices - Application of Risk Management to Medical Devices, 2007

#### 5.0 Conclusions

ISO 14971

TG-970P CO2 Sensor Kit was previously cleared in K083456 and the airway adaptor cleared with the TG-970P (YG-211T) is capable of accurately measuring CO2 in the patient's airway during expiration on patients 7kg or larger. A new airway adapter (YG-213T) is being added to the TG-970P. This will allow the TG-970P to accurately measure CO2 in the patient's airway during expiration on patients 2kg or larger.

The technology of the photo detector and light emitter of the TG-970P has not changed. The only change is the new YG-213T airway adapter which has under gone verification and validation testing.

Based on the comparison in the technical comparison chart above and confirmed by verification/validation testing in compliance with the Design Control requirements. The intended use, technology and materials of the YG-213T Airway Adapter was shown to be equivalent in safety and effectiveness to the predicate devices YG-211T and YG-211TW which are accessories of the TG-970P CO2 Sensor Kit K083456 (TG-970P). No new questions of safety or effectiveness are raised.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird, representing the department's mission to protect and promote the health and well-being of Americans.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## May 21, 2013

Mr. Steve Geerdes Director of Regulatory Affairs and Quality Assurance Nihon Kohden Corporation 90 Icon Street FOOTHILL RANCH CA 92610

Re: K122214

Trade/Device Name: Nihon Kohden TG-970P Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: May 8, 2013 Received: May 9, 2013

### Dear Mr. Geerdes:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer -S for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,

Respiratory, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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## Indications for Use Form

510(k) Number (if known): K122214

Nihon Kohden TG-970P Device Name:

Indications for Use:

The Nihon Kohden TG-970P and is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration.

The device is intended for use by qualified medical personnel within a hospital or clinical environment and is available for use on any patient weighing 2kg or more.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off Office of In Device Evaluation 510(k)

Lester W. Schultheis Jr
2013.05.21[13:40:16-04'00']

510(k) Number:

Page 1 of

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices