NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES

K974292 · Nihon Kohden America, Inc. · DQA · Jun 8, 1998 · Cardiovascular

Device Facts

• Record ID: K974292
• Device Name: NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
• Applicant: Nihon Kohden America, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jun 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

SpO2 probes (TL-101T, TL-120T, TL-121T) function as accessories to Nihon Kohden patient monitors; measure blood oxygen saturation via reflected/scattered light. TL-101T (finger probe) for adults >20 kg; TL-120T (multi-site) for adults/infants >3 kg; TL-121T (foot probe) for infants/neonates <3 kg. Used in clinical settings by healthcare providers; output displayed on compatible Nihon Kohden monitors (AL-800PA, BSM-2101A/2102A, ZB-831PA). Data informs clinical decision-making regarding patient oxygenation status.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993: primary skin irritation (Cumulative Irritation Index 0.00), sensitization (no delayed dermal contact sensitization), and cytotoxicity (no cell lysis/toxicity > USP grade 2). Safety and performance testing verified device operation within specifications.

Technological Characteristics

SpO2 probes utilizing light reflection/scattering principle. Non-sterile. Biocompatibility verified per ISO 10993. Connectivity: compatible with Nihon Kohden patient monitoring modules/transmitters. Form factors: finger probe (TL-101T), multi-site probe (TL-120T), foot probe (TL-121T).

Indications for Use

Indicated for blood oxygen saturation measurement. TL-101T: adults >20 kg. TL-120T: adults and infants >3 kg. TL-121T: infants and neonates <3 kg.

Regulatory Classification

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.

Predicate Devices

• Nihon Kohden TL-101S (K884536)
• Nihon Kohden TL-120S (K884536)
• Nihon Kohden TL-121S (K884536)

Reference Devices

• AL-800PA SpO2 Module (K884536)
• BSM-2101A Patient Monitor (K914092)
• BSM-2102A Patient Monitor (K914092)
• ZB-831PA Telemetry Transmitter (K946175)
• BSM-8800A Bedside Monitor (K920154)

Submission Summary (Full Text)

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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 [phone]

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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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_