(169 days)
The Nihon Kohden TG-980P/TG-980P1 CO2 Sensor Kit 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, ambulatory care, transport, or any other clinical environment.
The TG-980P and TG-980P1, collectively referred to as TG-980P/TG-980P1, are CO2 Sensor Kits used to measure the concentration of carbon dioxide (CO2 or CO2) during patient expiration. The TG-980P/TG-980P1 is intended for use by qualified medical personnel as an aid for determining patient ventilatory status within a hospital, ambulatory care, transport, or any other clinical environment.
The TG-980P/TG-980P1 CO2 Sensor Kit comprises three main components: a CO2 sensor, an interface connector, and a sensor cable. It utilizes the mainstream measurement method to sample gas directly from the patient's airway and non-dispersive infrared (NDIR) absorption technology to measure CO2 concentration during patient expiration. CO2 gas absorbs infrared light at specific wavelengths, and the amount absorbed is directly related to CO2 concentration. The CO2 sensor is equipped with a light source that generates infrared light. The light passes through an attached Nihon Kohden accessory (except the Thermal Airflow Sensor) through which the expired air flows and is converted by photodetectors to voltage, which is used to calculate CO2 concentration. The calculated digital data is then transmitted and displayed on a connected patient monitor or other device.
The TG-980P/TG-980P1 CO2 Sensor Kit can be connected via the interface connector and used with Nihon Kohden devices for which the operator's manual specifies compatibility with the TG-980P/TG-980P1.
This FDA 510(k) clearance letter pertains to a hardware device (CO2 Sensor Kit) and not an AI/ML software. Therefore, many of the requested criteria regarding AI-specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC study) are not applicable.
However, I can extract the relevant acceptance criteria and details of the non-clinical performance studies conducted for the device.
Acceptance Criteria and Device Performance (Non-AI Device)
1. A table of acceptance criteria and the reported device performance
The document provides the performance specifications for the CO2 Sensor Kit, rather than explicit "acceptance criteria" in the typical sense of a target for a specific study. The reported device performance is compared to the predicate device's performance.
| Performance Characteristic | Acceptance/Predicate Specification | Subject Device (TG-980P/TG-980P1) Reported Performance |
|---|---|---|
| Trade/Device Name | Nihon Kohden TG-970P Series CO2 Sensor Kit | Nihon Kohden TG-980P/TG-980P1 CO2 Sensor Kit |
| Regulatory Class | Class II | Class II |
| Product Code | CCK (868.1400) | CCK (868.1400) |
| Intended Use | To be used under the control of a healthcare professional to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status; an indicator of patient carbon dioxide concentration during expiration. | Equivalent, with slightly changed wording but same meaning. |
| Indications for Use | To measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status; an indicator of patient carbon dioxide concentration during expiration. For use by qualified medical personnel within a hospital or clinical environment. | Same as predicate, but with clarification of intended use environments to include "ambulatory care, transport, or any other clinical environment." |
| Type of Use | Prescription Device Only | Prescription Device Only |
| Intended Population | Adult and children patients 7 kg or more (Predicate) / Adults, children, infants and neonates (Reference) | Neonates to adults. All types of genders, races, and languages. (Same as Reference device's broader population) |
| Patient Contact | Intubated (Predicate) / Intubated/Non-intubated (Reference) | Intubated/Non-intubated (Same as Reference device) |
| Configuration | CO2 sensor, Connector, Sensor cable, CO2 adapter | CO2 sensor, Connector, Sensor Cable (CO2 adapter removed) |
| Dimension (CO2 sensor) | 37 x 8.3 x 13.7 mm ±10% | 37 x 8.3 x 13.7 mm ±10% |
| Weight (Sensor part) | 4 g ±1 g | 4 g ±2 g (Weight tolerance adjusted) |
| Sampling method | Mainstream infrared absorption | Mainstream infrared absorption |
| Measurement principle | Single-wave spectroscopic method (Non-dispersive infrared gas analyzing method (NDIR)) | Single-wave spectroscopic method (Non-dispersive infrared gas analyzing method (NDIR)) |
| CO2 measurement method | Quantitative method | Quantitative method |
| Calibration | YES | YES |
| EtCO2 determination | YES | YES |
| No Breath detect limit | CO2 < 5 mmHg for ≥ 20 msec | CO2 < 5 mmHg for ≥ 20 msec |
| Response (EtCO2 Response/Rise time) | 120 msec | 60 msec (Faster response) |
| CO2 partial pressure measuring range | 0 to 20 kPa (0 to 150 mmHg) | 0 to 20 kPa (0 to 150 mmHg) |
| CO2 partial pressure measuring accuracy | ±0.27 kPa (0 ≤ CO2 ≤ 5.33 kPa) (±2 mmHg (0 ≤ CO2 ≤ 40 mmHg )); ±5% of gas level (5.33 < CO2 ≤ 9.33 kPa (40 < CO2 ≤ 70 mmHg)); ±7% of gas level (9.33 < CO2 ≤ 13.3 kPa (70 < CO2 ≤ 100 mmHg)); ±10% of gas level (13.3 < CO2 ≤ 20 kPa (100 < CO2 ≤ 150 mmHg)) (noncondensing) | Same as Predicate Device |
| Respiration Rate* measuring range | 0 to 150 breaths/min | 0 to 150 breaths/min |
| Respiration Rate* measuring accuracy | ±1 breath/min | ±1 breath/min |
| Total system response time | ≤ 0.5 seconds | ≤ 0.5 seconds |
| Data communication interval | 25 msec (40 Hz) (Predicate) | TG-980P: 25 msec (40 Hz), TG-980P1: 16 msec (62.5 Hz) (TG-980P1 is faster) |
| Warm-up time | 10 seconds (Predicate) | TG-980P: About 10 seconds, TG-980P1: About 5 seconds (TG-980P1 is faster) |
| Operation environment | Temperature: 0 to 40°C, Humidity: 30 to 85%RH (non-condensing), Atmosphere pressure: 70 to 106 kPa | Temperature: 0 to 40°C, Humidity: 15 to 95% (non-condensing), Atmosphere pressure: 70 to 106 kPa (Wider humidity range) |
| Storage environment | Temperature: -20 to 65°C, Humidity: 10 to 95%RH (non-condensing), Atmosphere pressure: 70 to 106 kPa | Temperature: -25 to 65°C, Humidity: 10 to 95% (non-condensing), Atmosphere pressure: 70 to 106 kPa (Wider temperature range) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that Nihon Kohden conducted "non-clinical bench testing" as part of design verification and validation. It does not specify a "sample size" in relation to patient data or a test set of clinical cases. The testing appears to be primarily laboratory-based engineering verification and validation, rather than clinical studies with human subjects. Thus, there is no mention of data provenance in terms of country of origin or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is a hardware device primarily undergoing bench testing against engineering specifications and recognized standards, not a diagnostic AI/ML device requiring expert-established ground truth from clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for clinical studies involving multiple human readers interpreting results, especially for AI/ML devices. This device underwent non-clinical bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a hardware CO2 sensor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is fundamentally a standalone hardware device performing a direct physiological measurement. Its performance is evaluated intrinsically through engineering tests and comparison to established standards, rather than as an "algorithm only without human-in-the-loop performance" in the context of AI. The measurements are presented on a host device, but the sensor itself performs the CO2 measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for evaluating this device's performance relies on physical and engineering measurement standards and reference gases. For example, CO2 partial pressure accuracy is measured against known concentrations of CO2 gases under controlled conditions. Similarly, response times, respiration rate accuracy, and environmental tolerances are measured against calibrated physical standards and established test methods outlined in the cited consensus standards (e.g., ISO 80601-2-55).
8. The sample size for the training set
Not applicable. This is a hardware CO2 sensor, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. (See answer to #8).
FDA 510(k) Clearance Letter - TG-980P CO2 Sensor Kit
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 10, 2025
Nihon Kohden Corporation
℅ Charlemagne Chua
Senior Manager, Regulatory Affairs
Nihon Kohden America, LLC
15353 Barranca Parkway
Irvine, California 92618
Re: K243956
Trade/Device Name: TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
Regulation Number: 21 CFR 868.1400
Regulation Name: Carbon Dioxide Gas Analyzer
Regulatory Class: Class II
Product Code: CCK
Dated: May 16, 2025
Received: May 16, 2025
Dear Charlemagne Chua:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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K243956 - Charlemagne Chua Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K243956 - Charlemagne Chua Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K243956
Device Name: TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG--980P1)
Indications for Use (Describe)
The Nihon Kohden TG-980P/TG-980P1 CO2 Sensor Kit 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, ambulatory care, transport, or any other clinical environment.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
TG-980P/TG-980P1 CO2 Sensor Kit 510(K) Summary
16 MAY 2025
Page 1 of 14
510(k) SUMMARY
Administrative Information
Sponsor: Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo, Japan 161-8560
FDA Est. Registration: 9611252
Submitter: Nihon Kohden America, LLC
15353 Barranca Parkway
Irvine, CA 92618
FDA Est. Registration: 2080783
Primary Correspondent: Charlemagne Chua
Senior Manager, Regulatory Affairs
15353 Barranca Parkway
Irvine, CA 92618
Office Phone: (949) 268-0868
Email: charlemgne_chua@nihonkohden.com
U.S. Agent: Charlemagne Chua
Senior Manager, Regulatory Affairs
15353 Barranca Parkway
Irvine, CA
Office Phone: (949) 268-0868
Email: charlemgne_chua@nihonkohden.com
Subject Device Information
Submission Type: Traditional 510(k)
Common Device Name: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation Medical Specialty: Anesthesiology
Classification Panel: Anesthesiology
Product Codes: CCK
Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
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TG-980P/TG-980P1 CO2 Sensor Kit
510(K) Summary
16 MAY 2025
Page 2 of 14
Regulation Number: 868.1400
Classification: Class II
Decision Type: 510(k)
Proprietary Name: TG-980P CO2 Sensor Kit
TG-980P1 CO2 Sensor Kit
Reason for 510(k) Submission: New Device
Previous 510(k) Submissions: None
Predicate Device: Nihon Kohden TG-970P Series CO2 Sensor Kit (K083456)
Submission Date: May 16, 2025
1. PRODUCT DESCRIPTION
The TG-980P and TG-980P1, collectively referred to as TG-980P/TG-980P1, are CO2 Sensor Kits used to measure the concentration of carbon dioxide (CO2 or CO2) during patient expiration. The TG-980P/TG-980P1 is intended for use by qualified medical personnel as an aid for determining patient ventilatory status within a hospital, ambulatory care, transport, or any other clinical environment.
The TG-980P/TG-980P1 CO2 Sensor Kit comprises three main components: a CO2 sensor, an interface connector, and a sensor cable. It utilizes the mainstream measurement method to sample gas directly from the patient's airway and non-dispersive infrared (NDIR) absorption technology to measure CO2 concentration during patient expiration. CO2 gas absorbs infrared light at specific wavelengths, and the amount absorbed is directly related to CO2 concentration. The CO2 sensor is equipped with a light source that generates infrared light. The light passes through an attached Nihon Kohden accessory (except the Thermal Airflow Sensor) through which the expired air flows and is converted by photodetectors to voltage, which is used to calculate CO2 concentration. The calculated digital data is then transmitted and displayed on a connected patient monitor or other device.
The TG-980P/TG-980P1 CO2 Sensor Kit can be connected via the interface connector and used with Nihon Kohden devices for which the operator's manual specifies compatibility with the TG-980P/TG-980P1.
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TG-980P/TG-980P1 CO2 Sensor Kit
510(K) Summary
16 MAY 2025
Page 3 of 14
2. INTENDED USE
The TG-980P/TG-980P1 CO2 Sensor Kit is intended to be used under the control of a healthcare professional 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, the kits are intended as an indicator of patient carbon dioxide concentration during expiration.
3. INDICATIONS FOR USE
The Nihon Kohden TG-980P/TG-980P1 CO2 Sensor Kit 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, ambulatory care, transport, or any other clinical environment.
4. SUBMISSION SCOPE
Nihon Kohden (NK) is requesting market clearance for a new Nihon Kohden device, TG-980P/TG-980P1 CO2 Sensor Kit. The TG-980P/TG-980P1 CO2 Sensor Kit used to measure the concentration of carbon dioxide (CO2 or CO2) during patient expiration. The TG-980P/TG-980P1 is intended for use by qualified medical personnel as an aid for determining patient ventilatory status within a hospital, ambulatory care, transport, or any other clinical environment. Digital data is then transmitted and displayed on a connected patient monitor or other device.
5. COMPARISON WITH THE PREDICATE DEVICE
5.1 Subject Device Information
Table 4 provides the regulation and classification for the subject device TG-980P/TG-980P1 CO2 Sensor Kit.
Table 4 Regulatory Information on TG-980P/TG-980P1 CO2 Sensor Kit
| Regulation | Product Code | Device Classification | Classification |
|---|---|---|---|
| §868.1400 | CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class II (performance standards) |
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TG-980P/TG-980P1 CO2 Sensor Kit
510(K) Summary
16 MAY 2025
Page 4 of 14
5.2 Predicate Device Information
Table 5 lists the basic information about the predicate device including 510(k) number, device name, 510(k) holder, and clearance date. Regulatory information used for comparison is provided in Table 6.
Table 5 Predicate Device General Information
| 510(k) Number | Device Name | 510(k) Holder | Clearance Date |
|---|---|---|---|
| K083456 | TG-970P CO2 Sensor Kit | Nihon Kohden Corp. | March 2, 2009 |
Table 6 Predicate Device Regulatory Information
| Regulation | Product Code | Device description | Classification |
|---|---|---|---|
| §868.1400 | CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class II (performance standards) |
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TG-980P/TG-980P1 CO2 Sensor Kit
510(K) Summary
16 MAY 2025
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5.3 Comparison Table
Table 7 Comparison Table of TG-980P/TG-980P1 CO2 Sensor Kit and its Predicate
| Description | Subject Device TG-980P/TG-980P1 | Predicate Device TG-970P (K083456) | Reference Device TG-970P (K161860) | Comments: |
|---|---|---|---|---|
| Trade/Device Name | Nihon Kohden TG-980P/TG-980P1 CO2 Sensor Kit | Nihon Kohden TG-970P Series CO2 Sensor Kit | Nihon Kohden TG-970P Series CO2 Sensor Kit | Different - The model numbers differ for product identification. |
| Regulatory Class | Class II | Class II | Same as Predicate Device | Same |
| Product Code | CCK (868.1400) | CCK (868.1400) | Same as Predicate Device | Same |
| Intended Use | The TG-980 Series CO2 Sensor Kit is intended to be used under the control of a healthcare professional 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, the kits are intended as an indicator of patient carbon dioxide concentration during expiration. | The Nihon Kohden TG-970P Series CO2 Sensor Kit 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. | Same as Predicate Device | Different - Although the wording has changed slightly, the intended use is equivalent in its meaning. |
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TG-980P/TG-980P1 CO2 Sensor Kit
510(K) Summary
16 MAY 2025
Page 6 of 14
| Description | Subject Device TG-980P/TG-980P1 | Predicate Device TG-970P (K083456) | Reference Device TG-970P (K161860) | Comments: |
|---|---|---|---|---|
| Indications for Use | The Nihon Kohden TG-980P/980P1 CO2 Sensor Kit 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, ambulatory care, transport, or any other clinical environment. | The Nihon Kohden TG-970P Series CO2 Sensor Kit 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 Nihon Kohden TG-970P CO2 sensor kit 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. | Different - The intended use environments of TG-980P/TG-980P1 were clarified and the emergency environment, such as ambulatory care or transport, was added. |
| Type of Use | Prescription Device Only | Prescription Device Only | Prescription Device Only | Same |
| Intended Population | Neonates to adults. All types of genders, races, and languages. | Adult and children patients 7 kg or more | Adults, children, infants and neonates | Different from Predicate - Same as Reference device |
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TG-980P/TG-980P1 CO2 Sensor Kit
510(K) Summary
16 MAY 2025
Page 7 of 14
| Description | Subject Device TG-980P/TG-980P1 | Predicate Device TG-970P (K083456) | Reference Device TG-970P (K161860) | Comments: |
|---|---|---|---|---|
| Patient Contact | Intubated/Non-intubated | Intubated | Intubated/Non-intubated | Different from Predicate - Same as Reference device |
| Configuration | CO2 sensor, Connector, Sensor Cable | CO2 sensor, Connector, Sensor cable, CO2 adapter | Same as Predicate Device | Different |
| Dimension | CO2 sensor: 37×8.3×13.7 mm ±10% | CO2 Sensor: 37 x 8.3 x 13.7 mm ±10%, CO2 Adapter: 77.3 x 30 x 15.8 mm ± 10% | Same as Predicate Device | Different - The size of the CO2 sensor of TG-980P/TG-980P1 is equivalent to Predicate. |
| Weight | 65 g±10 g (with cable and connector) (Sensor part: 4 g ±2 g) | 120 g ± 10% (with cable and connector) (Sensor part: 4 g ±1 g) | Same as Predicate Device | Different - Weight is slightly lower for a lightweight product. The weight tolerance of sensor part was adjusted. |
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TG-980P/TG-980P1 CO2 Sensor Kit
510(K) Summary
16 MAY 2025
Page 8 of 14
Principle of operation
| Description | Subject Device TG-980P/TG-980P1 | Predicate Device TG-970P (K083456) | Reference Device TG-970P (K161860) | Comments: |
|---|---|---|---|---|
| Sampling method | Mainstream infrared absorption | Mainstream infrared absorption | Same as Predicate Device | Same |
| Measurement principle | Single-wave spectroscopic method (Non-dispersive infrared gas analyzing method (NDIR)) | Single-wave spectroscopic method (Non-dispersive infrared gas analyzing method (NDIR)) | Same as Predicate Device | Same |
| CO2 measurement method | Quantitative method | Quantitative method | Same as Predicate Device | Same |
| Calibration | YES | YES | Same as Predicate Device | Same |
CO2 Measurement
| Description | Subject Device TG-980P/TG-980P1 | Predicate Device TG-970P (K083456) | Reference Device TG-970P (K161860) | Comments: |
|---|---|---|---|---|
| EtCO2 determination | YES | YES | Same as Predicate Device | Same |
| No Breath detect | YES | YES | Same as Predicate Device | Same |
| No Breath detect limit | CO2 < 5 mmHg for ≥ 20 msec | CO2 < 5 mmHg for ≥ 20 msec | Same as Predicate Device | Same |
| Response (EtCO2 Response/Rise time) | 60 msec | 120 msec | Same as Predicate Device | Different - TG-980P/TG-980P1 response is faster than TG-970P. This function does not affect the monitoring function. |
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TG-980P/TG-980P1 CO2 Sensor Kit
510(K) Summary
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| Description | Subject Device TG-980P/TG-980P1 | Predicate Device TG-970P (K083456) | Reference Device TG-970P (K161860) | Comments: |
|---|---|---|---|---|
| CO2 partial pressure measuring range | 0 to 20 kPa (0 to 150 mmHg) | 0 to 20 kPa (0 to 150 mmHg) | Same as Predicate Device | Same |
| CO2 partial pressure measuring accuracy | ±0.27 kPa (0 ≤ CO2 ≤ 5.33 kPa) (±2 mmHg (0 ≤ CO2 ≤ 40 mmHg )) ±5% of gas level (5.33 < CO2 ≤ 9.33 kPa (40 < CO2 ≤ 70 mmHg)) ±7% of gas level (9.33 < CO2 ≤ 13.3 kPa (70 < CO2 ≤ 100 mmHg)) ±10% of gas level (13.3 < CO2 ≤ 20 kPa (100 < CO2 ≤ 150 mmHg)) (noncondensing) | ±0.27 kPa (0 ≤ CO2 ≤ 5.33 kPa ) (±2 mmHg (0 ≤ CO2 ≤ 40 mmHg )) ±5% of gas level (5.33 < CO2 ≤ 9.33 kPa (40 < CO2 ≤ 70 mmHg)) ±7% of gas level (9.33 < CO2 ≤ 13.3 kPa (70 < CO2 ≤ 100 mmHg)) ±10% of gas level (13.3 < CO2 ≤ 20 kPa (100 < CO2 ≤ 150 mmHg)) (noncondensing) | Same as Predicate Device | Same |
Respiration Rate Measurement
| Description | Subject Device TG-980P/TG-980P1 | Predicate Device TG-970P (K083456) | Reference Device TG-970P (K161860) | Comments: |
|---|---|---|---|---|
| Respiration Rate* measuring range | 0 to 150 breaths/min | 0 to 150 breaths/min | 0 to 150 breaths/min | Same - *Value determination from 510(k) Cleared host devices. |
| Respiration Rate* measuring accuracy | ±1 breath/min | ±1 breath/min | ±1 breath/min | Same - *Value determination from 510(k) Cleared host devices. |
Operation/Storage
| Description | Subject Device TG-980P/TG-980P1 | Predicate Device TG-970P (K083456) | Reference Device TG-970P (K161860) | Comments: |
|---|---|---|---|---|
| Power | Auxiliary device attachment provides power | Auxiliary device attachment provides power | Auxiliary device attachment provides power | Same |
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| Description | Subject Device TG-980P/TG-980P1 | Predicate Device TG-970P (K083456) | Reference Device TG-970P (K161860) | Comments: |
|---|---|---|---|---|
| Total system response time | ≤ 0.5 seconds | ≤ 0.5 seconds | Same as Predicate Device | Same |
| Data communication interval (Data sampling rate) | TG-980P: 25 msec (40 Hz), TG-980P1:16 msec (62.5 Hz) | 25 msec (40 Hz) | Same as Predicate Device | Same for TG-980P, Different for TG-980P1 - TG-980P1 communication interval (16 msec) is shorter than the Predicate (25 msec). |
| Warm-up time | TG-980P: About 10 seconds, TG-980P1: About 5 seconds | 10 seconds | Same as Predicate Device | Same for TG-980P, Different for TG-980P1 - TG-980P1 has a shorter Warm-up time but this does not affect the CO2 measurement on a host device. |
| Operation environment | Temperature: 0 to 40°C, Humidity: 15 to 95% (non-condensing), Atmosphere pressure: 70 to 106 kPa | Temperature:0 to 40°C, Humidity: 30 to 85%RH (non-condensing), Atmosphere pressure: 70 to 106 kPa | Same as Predicate Device | Different for humidity - TG-980P/TG-980P1 series has a wider range in upper and lower limits of humidity. operation environment and the equivalency was demonstrated. |
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| Description | Subject Device TG-980P/TG-980P1 | Predicate Device TG-970P (K083456) | Reference Device TG-970P (K161860) | Comments: |
|---|---|---|---|---|
| Storage environment | Temperature: -25 to 65°C, Humidity:10 to 95% (non-condensing), Atmosphere pressure: 70 to 106 kPa | Temperature: -20 to 65°C, Humidity:10 to 95%RH (non-condensing), Atmosphere pressure: 70 to 106 kPa | Same as Predicate Device | Different in temperature - TG-980P/TG-980P1 has a wider range in upper and lower limits of temperature for storage environments. |
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6. PERFORMANCE
6.1 Summary of Non-Clinical Performance Testing
Nihon Kohden conducted non-clinical bench testing for the finished TG-980P/TG-980P1 CO2 Sensor Kit as part of the design verification and validation activities. The TG-980P/TG-980P1 CO2 Sensor Kit was evaluated for reprocessing & shelf-life, biocompatibility, software & firmware, cybersecurity & interoperability, electromagnetic compatibility & electrical, mechanical, wireless & thermal safety, system connection, and usability performance, as well as compatibility with the Nihon Kohden bedside monitors. The same test methods and specifications were used as for the predicate device, establishing equivalency of the TG-980P/TG-980P1 CO2 Sensor Kit to the predicate. These tests were performed according to the international and FDA-recognized consensus standards listed in Table 8.
Table 8 Applied Standards and Guidance List for the TG-980P/TG-980P1 CO2 Sensor Kit
| No. | Recognized Consensus (Rec) Standard Number | Description |
|---|---|---|
| 1 | 19-49 IEC 60601-1 Edition 3.2 2020-08 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| 2 | 19-46 ANSI AAMI ES60601-1:2005/ (R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/ (R)2012 (Cons. Text) (Incl. AMD2:2021) | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) (Including Amendment 2 (2021)) |
| 3 | 1-140 ISO 80601-2-55 Second edition 2018-02 | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| 4 | 19-36 IEC 60601-1-2 Edition 4.1 2020-09 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. Identical adoption : ANSI AAMI IEC 60601-1-2:2014 (Including AMD 1:2021) |
| 5 | 19-39 IEC 60601-1-12 Edition 1.1 2020-07 | Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment. Identical adoption: ANSI AAMI IEC 60601-1-12:2016 (Including AMD 1:2021) |
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| No. | Recognized Consensus (Rec) Standard Number | Description |
|---|---|---|
| 6 | 2-258 ISO 10993-1 Fifth edition 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Identical adoption: ANSI AAMI ISO 10993-1: 2018 |
| 7 | 5-125 ISO 14971 Third Edition 2019-12 | Medical devices - Application of risk management to medical devices. Identical adoption: ANSI AAMI ISO 14971:2019 |
| 8 | 5-129 IEC 62366-1 Edition 1.1 2020-06 | Medical devices - Part 1: Application of usability engineering to medical devices. Identical adoption: ANSI AAMI IEC 62366-1: 2015 + AMD1: 2020 |
| 9 | 5-132 IEC 60601-1-6 Edition 3.2 2020-07 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| 10 | 13-79 IEC 62304 Edition 1.1 2015-06 | Medical device software - Software life cycle processes. Identical adoption : ANSI AAMI IEC 62304:2006/A1:2016 |
| 11 | 14-579 ISO 17664-2 First edition 2021-02 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices. |
7. SUBSTANTIAL EQUIVALENCE DISCUSSION
The comparison of the TG-980P/TG-980P1 CO2 Sensor Kit to its predicate device (TG-970P CO2 Sensor Kit / K033456) and the discussion of the key aspects are presented in the following sections.
7.1 Discussion for Intended Use
The TG-980P/TG-980P1 CO2 Sensor Kit has the same Intended Use as the predicate device.
7.2 Discussion for Indications for Use
The TG-980P/TG-980P1 CO2 Sensor Kit has the same Indications for Use as the predicate device.
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7.3 Discussion for Technological Characteristics
The TG-980P/TG-980P1 CO2 Sensor has the same Technological Characteristics as the predicate device.
7.4 Discussion for Design Characteristics
The predicate device, reference device and TG-980P/TG-980P1 CO2 Sensor Kit have very similar design characteristics. There were changes to the physical dimensions. The dimensional changes and design changes do not impact the safety and effectiveness of the TG-980P/TG-980P1 CO2 Sensor Kit when compared to the predicate device.
7.4.1
When compared to the predicate and reference devices, the overall size of the TG-980P/TG-980P1 CO2 Sensor Kit is smaller, and the device configuration has changed. This is due to the removal of the CO2 adapter from the subject device.
7.4.2
When compared to the predicate and reference devices, the overall weight of the TG-980P/TG-980P1 CO2 Sensor Kit is lighter. This is a design improvement to make the subject device more lightweight.
7.5 Discussion for Compatible Device
The predicate device, reference device and TG-980P/TG-980P1 CO2 Sensor Kit require the devices to be connected to a Nihon Kohden host device to display the measured data. The differences do not impact the safety and effectiveness of the TG-980P/TG-980P1 CO2 Sensor Kit when compared to the predicate device.
7.6 Discussion for Performance Specifications
The predicate device, reference device and TG-980P/TG-980P1 CO2 Sensor Kit have similar CO2 measurement specifications. The predicate and reference devices have a slower response time when EtCO2 is measured. The difference does not impact the safety and effectiveness of the TG-980P/TG-980P1 CO2 Sensor Kit when compared to the predicate device.
8. CONCLUSION
The results of the substantial equivalence assessment, taken together with non-clinical bench testing, electrical safety and EMC, and electromagnetic compatibility, software verification, and validation demonstrate that the TG-980P/TG-980P1 CO2 Sensor Kit does not raise concerns regarding its safety and effectiveness when compared to its predicate device and operates in accordance with claimed indications for use. Nihon Kohden believes that the TG-980P/TG-980P1 CO2 Sensor Kit is substantially equivalent to the TG-970P predicate and reference devices.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).