(196 days)
The Nihon Kohden TG-920P 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 (end tidal CO>) status. As interpreted by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration.
The TG-920P 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 (end tidal CO>) status. The device measuring technique is through absorption of infrared radiation. The mouth/nose piece airway adapter, is a Single-Patient-Use and hence, disposable. The device is intended as an indicator of patient carbon dioxide concentration during expiration, for non-intubated patients.
The provided text does not contain detailed information about specific acceptance criteria and the study that proves the device meets them for the TG-920P CO2 Sensor Kit. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.
However, based on the text, I can extract and infer some general information related to device performance and testing:
1. A table of acceptance criteria and the reported device performance:
The document states: "The device performance and specifications are consistent with all requirements for this device type." However, it does not provide a table of precise acceptance criteria (e.g., accuracy, precision ranges) or specific numerical performance results. It only broadly states compliance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in detail, but expected to be in line with gas analyzer performance characteristics) | "The device performance and specifications are consistent with all requirements for this device type." |
| Electromagnetic compatibility | Device was subject to electromagnetic testing. |
| Environmental stability | Device was subject to environmental testing. |
| Safety | Device was subject to safety testing. |
| Performance | Device was subject to performance testing. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document only mentions "performance testing procedures" without detailing the number of cases or samples.
- Data provenance: Not specified. It's unclear if testing involved human subjects, simulated data, or a combination, nor is the country of origin mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The document does not describe the establishment of a "ground truth" using experts for the performance testing.
4. Adjudication method for the test set:
Not specified. No details are provided regarding any adjudication methods used for performance 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:
- MRMC study: Not applicable and not mentioned. This device is a CO2 sensor kit, not an AI-powered diagnostic imaging tool that would typically involve human "readers" or AI assistance in interpretation.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone performance: The entire device, as a sensor, operates in a "standalone" fashion in terms of its measurement function. Its stated intended use is "to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory (end tidal CO2) status." The performance testing mentioned would implicitly be evaluating this standalone measurement capability. However, the document doesn't explicitly frame it as an "algorithm only" study in the context of AI.
7. The type of ground truth used:
The type of ground truth for the "performance testing" is not explicitly stated. For a CO2 sensor, the ground truth would typically be established by a highly accurate reference method or calibrated gas mixtures. The document only mentions "performance testing procedures."
8. The sample size for the training set:
- Training set: Not applicable and not mentioned. This device is a sensor, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established:
- Ground truth for training set: Not applicable, as there is no training set for this type of device.
In summary:
The provided 510(k) summary is focused on demonstrating substantial equivalence, meaning it relies on the predicate device's established safety and effectiveness. It confirms that the new device underwent standard safety and performance testing for its type, but it does not provide the detailed scientific study results, specific acceptance criteria values, or methodologies typical of AI/software device submissions.
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SECTION 2 - 510(K) SUMMARY
OCT 1-5 2004
Name and Address of Applicant: Nihon Kohden America, Inc. 90 Icon St. Foothill Ranch, California 92610 Attn: Regulatory Affairs, Ms. Serrah Namini
Name and address of Manufacturer: Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-ku, Tokyo, 161-8560 Japan
The TG-920P CO2 Sensor Kit is classified as Class II by the Division of Anesthesiology Devices and the Anesthesiology Device Classification Panel under 21 CFR Part 868.1400 "Analyzer, Gas, Carbon dioxide, Gaseous-phase" as per part 73 CCK.
Common names for the TG-920P CO2 Sensor Kit include CO2 Analyzer and CO2 Indicator.
The predicate marketed device is the Nihon Kohden TG-901T CO2 Sensor Kit as per 510(k): K990063, commercial distribution certification dated June 1999.
The Nihon Kohden CO2 Sensor Kit, model number TG-920P, 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 CO>) status. The device measuring technique is through absorption of infrared radiation. The mouth/nose piece airway adapter, is a Single-Patient-Use and hence, disposable.
The device is intended as an indicator of patient carbon dioxide concentration during expiration, for non-intubated patients. This device is intended for use with patients of ages three (3) years and older. This device is not recommended for patients with low tidal volume such as patients younger than three (3) years of age or weighing less than 22 pounds or patients with a respiration rate greater than or equal to 150 breaths per minute.
The device performance and specifications are consistent with all requirements for this device type. To date, no performance standards or special controls are known or established for this type of device. The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the safety and efficacy of the device under intended operation for this device. The device is not sterile.
Therefore, based on the above, Nihon Kohden believes that the TG-920P CO2 Sensor Kit is substantially equivalent to Nihon Kohden's TG-901T CO2 Sensor Kit.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the logo. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 15 2004
Ms. Serrah Namini Regulatory Affairs, Associate Director Nihon Kohden America, Incorporated 90 Icon Street Foothill Ranch, California 92610
Re: K040875
Trade/Device Name: TG-920P CO2 Sensor Kit Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: October 7, 2004 Received: October 8, 2004
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.
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Page 2 - Ms. Namini
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DT of issuaires on that your device complies with other requirements Incall that I DA mas made a aversand regulations administered by other Federal agencies. of the Act of any I oderal baters and surface and such and limited to: registration 1 ou must comply with an are habeling (21 CFR Part 801); good manufacturing practice allu listing (21 er revers) (QS) regulation (QS) regulation (21 CFR Part 820); and if requirements as sections are quality ajon 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) I mis letter will and in J o The FDA finding of substantial equivalence of your device to a premarket notification - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you desire specific a a Compliance at (240) 276-0115. 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 Inter Small Manufacturers, International and Consumer 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,
Susan Runner
for Shirin Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NIHON KOHDEN
Indications for Use Statement G.____________________________________________________________________________________________________________________________________________________________________________
040895 510(k) Number (if known):
Device Name: TG-920P CO2 Sensor Kit
Indications for Use:
The Nihon Kohden TG-920P CO2 Sensor Kit, is intended for medical purposes to measure the The Ninon Xondon 1 0 720 in a gas mixture to aid in determining the patient's ventilatory concentiation of earbon dromation in a gia ted by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration.
Prescription Use X (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)
Ques Sefiver
(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental De 510(k) Number:
§ 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).