(206 days)
The TL-101T, TL-120T and TL-121T SpO2 Probes are intended for use with Nihon Kohlen patient monitoring devices to measure the blood oxygen saturation of a patient based upon the amount of reflected or scattered light.
The TL-101T is a finger probe intended for use on adult patients heavier than 20 kg. The TL-120T is a multi-site probe intended for use on adults and infants heavier than 3 kg. The TL-121T is a foot probe intended for use on infants and neonates lighter than 3 kg.
The TL-101T. TL-120T and TL-121T SpO2 Probes are accessories for use with Nihon Kohden patient monitoring devices and are not individually classified. Common names for the devices include SpO2 probe, SpO2 sensor, pulse oximeter probe, pulse oximeter sensor, probe and sensor.
Nihon Kohden's TL-101T, TL-120T and TL-121T SpO2 Probes are used with Nihon Kohden patient monitoning devices to measure the blood oxygen saturation of a patient based upon the amount of reflected or scattered light.
The provided text describes SpO2 Probes and indicates that safety and performance testing procedures were conducted, which "verified that the device performed within specifications." However, the document does not explicitly define specific acceptance criteria (numerical thresholds for performance metrics) or provide detailed results from a study proving the device meets these criteria. It states that no performance standards or special controls were established at the time.
Therefore, much of the requested information cannot be extracted from the given text.
Here's a breakdown of what can and cannot be provided based on the input:
Acceptance Criteria and Study for Nihon Kohden TL-101T, TL-120T, and TL-121T SpO2 Probes
The provided 510(k) notification summary and FDA letter mention general safety and performance testing but do not detail specific acceptance criteria or the quantitative results of these tests relating to SpO2 measurement accuracy. The document states explicitly: "To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR Part 861."
Therefore, the following table and subsequent sections are largely based on the absence of detailed information in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not explicitly defined in document | Device "performed within specifications" (specific values not provided) |
Note: The document only refers to successful biocompatibility testing with quantitative results for irritation, sensitization, and cytotoxicity, but these are not performance criteria for SpO2 measurement accuracy.
2. Sample Size and Data Provenance for Test Set
- Sample Size for Test Set: Not specified for the SpO2 performance testing.
- Data Provenance: Not specified. The document only mentions "safety and performance testing procedures." It does not indicate if this involved human subjects, animal models, or bench testing, nor does it provide country of origin or whether it was retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Not applicable as the nature of the "performance testing" for SpO2 measurement is not detailed, and no ground truth establishment by experts for such a test is mentioned.
4. Adjudication Method for Test Set
- Not applicable as the nature of the "performance testing" for SpO2 measurement is not detailed, and no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was mentioned or performed. This type of study (comparing human readers with and without AI assistance) is not relevant to a medical device like an SpO2 probe, which provides a direct physiological measurement rather than aiding human interpretation of diagnostic images.
6. Standalone Performance Study
- A standalone performance evaluation was implicitly done in the sense that the "safety and performance testing procedures" would assess the device's function directly. However, the document does not provide the specific metrics or results of this standalone performance. The wording "verified that the device performed within specifications" suggests such a study occurred, but without detailed findings.
7. Type of Ground Truth Used
- The document does not specify the type of ground truth used for the SpO2 performance testing. For SpO2 probes, ground truth is typically established through co-oximetry (blood gas analysis) under controlled desaturation studies. However, this is not detailed in the provided text.
8. Sample Size for Training Set
- Not applicable. SpO2 probes are typically developed through engineering and calibration processes based on physiological models and optical principles, not through machine learning models requiring a "training set" in the conventional sense.
9. How Ground Truth for Training Set Was Established
- Not applicable, as there is no mention of a training set for a machine learning model.
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JUN - 8 1998
K 974992
NIHON KOHDEN AMERICA, INC. November 13, 1997
510(k) NOTIFICATION TL-101T. TL-1210T and TL-121T SpO2 Probes
SECTION 2 - 510(K) SUMMARY
Name and Address of Applicant Nihon Kohden America, Inc. Attn: Requiatory Affairs 2601 Campus Drive Irvine, California 92612-1601 (714) 250-3959
The TL-101T. TL-120T and TL-121T SpO2 Probes are accessories for use with Nihon Kohden patient monitoring devices and are not individually classified. Common names for the devices include SpO2 probe, SpO2 sensor, pulse oximeter probe, pulse oximeter sensor, probe and sensor.
The TL-101T, TL-120T and TL-121T SpO2 Probes are new optional accessories for use with the following Nihon Kohden devices: AL-800PA SpO2 Module per 510(k) #K884536, dated February 6, 1989; BSM-2101A and BSM-2102A Patent Monitors, per 510(k) #K914092, dated May 28, 1992; and ZB-831PA Telemetry Transmitter, per 510(k) #K946175, dated November 22, 1995
The predicate marketed devices are the Nihon Kohden TL-101S. TL-120S and TL-121S SpO2 Probes. which are accessories for the AL-800PA SpO2 Module, per 510(k) #K884536, dated February 6, 1989, used with the BSM-8800A Bedside Monitor per 510(k) #K920154, dated December 18, 1992.
Nihon Kohden's TL-101T, TL-120T and TL-121T SpO2 Probes are used with Nihon Kohden patient monitoning devices to measure the blood oxygen saturation of a patient based upon the amount of reflected or scattered light.
The TL-101T is a finger probe intended for use on adult patients heavier than 20 kg. The TL-120T is a multi-site probe intended for use on adults and infants heavier than 3 kg. The TL-121T is a foot probe intended for use on infants and neonates lighter than 3 kg.
To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR Part 861.
The TL-101T, TL-120T and TL-121T devices are not intended to be sterile.
Biocompatibility testing was performed in accordance with the guidelines of the International Organization for Standardization Part 10: Tests for Irritation. Primary skin irrilation studies calculated the Cumulative Irritation Index of 0.00.with no irritation observed on the rabbits. Sensitization studies showed no evidence of delayed dermal contact sensitization in the guinea pig. Cytotoxicity studies showed no evidence of causing cell lysis or toxicity greater than a USP grade of 2 (mild reactivity). The test articles passed these ISO studies.
The TL-101T, TL-120T and TL-121T SpO2 Probes were subjected to safety and performance testing procedures. These tests ventied that the device performed within specifications.
Therefore based on the above, Nihon Kohden believes that the TL-101T, TL-120T and TL-121T SpO2 Probes are substantially equivalent to the TL-101S, TL-120S and TL-121S SpO2 Probes.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN -8 199
Mr. Gary Reasoner Nihon Kohden America, Inc. 2601 Campus Drive Irvine, CA 92612
K974292 Re : Nihon Kohden TL-101T, TL-120T and TL-121T SpO2 Probes Requlatory Class: II (two) Product Code: 74 DQA Dated: March 10, 1998 Received: March 12, 1998
Dear Mr. Reasoner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Gary Reasoner
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NIHON KOHDEN AMERICA, INC. November 13, 1997
510(k) NOTIFICATION 510(K) NOTIFICATION
TL-101T, TL-1210T and TL-121T SpO2 Probes
G. Indications for Use Statement
510(k) Number (if known):
K9711292
Device Name: TL-101T, TL-120T and TL-121T SpO2 Probes
Indications for Use:
The TL-101T, TL-120T and TL-121T SpO2 Probes are intended for use with Nihon Kohlen patient The TL-10TT, TL-120T and TE-12TT Open Trobos are intention of a patient based upon the amount of reflected or scattered light.
The TL-101T is a finger probe intended for use on adult patients heavier than 20 kg. The TL-120T is a THE TL-1011 IS a finger probe intended for ase on addits and infants heavier than 3 kg. The TL-121T is a foot probe intended for use on infants and neonates lighter than 3 kg.
- prescription
Lake Mado 6-5-98
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).