(206 days)
No
The description focuses on the physical probes and their function of measuring blood oxygen saturation using light, with no mention of AI or ML algorithms for data processing or interpretation.
No.
This device is described as a probe for measuring blood oxygen saturation, which is a diagnostic function rather than a therapeutic one. It gathers information but does not treat a condition.
No
This device is described as an accessory (SpO2 probe/sensor) used with patient monitoring devices to measure blood oxygen saturation. While it provides a measurement that can be used for diagnosis, the probe itself is a data collection tool, not a diagnostic device that interprets the data to determine a medical condition.
No
The device description explicitly states that the devices are "SpO2 Probes" and "sensors" that measure blood oxygen saturation based on "reflected or scattered light," indicating they are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The TL-101T, TL-120T, and TL-121T SpO2 Probes measure blood oxygen saturation in vivo (within the living body) by using light. They are applied directly to the patient's finger, foot, or other site.
- No mention of samples: The description does not mention the collection or analysis of any biological samples from the patient.
Therefore, since the device operates directly on the patient's body and does not involve the analysis of samples taken from the body, it does not fit the definition of an In Vitro Diagnostic. It is a medical device used for physiological monitoring.
N/A
Intended Use / Indications for Use
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.
Product codes
74 DQA
Device Description
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, multi-site, foot
Indicated Patient Age Range
Adult, infant, neonate
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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.
2
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
3
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_