Olympus LF-TP and LF-DP Tracheal Intubation Fiberscope, accessories and ancillary equipment are intended for airway management which includes endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation, and management.

Device Description

The Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes and it's accessories are specifically designed to be used with a Suction Pump and other ancillary equipment for airway management.

AI/ML Overview

This 510(k) summary for the Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes does not contain information on acceptance criteria for device performance, nor does it describe a study demonstrating the device meets such criteria in the way typically seen for AI/ML devices.

Instead, this submission focuses on establishing substantial equivalence to previously marketed predicate devices (Olympus LF-1 Intubation Scope, K850978, and others) by demonstrating similar intended use, method of operation, materials, and design, and compliance with general safety standards.

Therefore, the requested information cannot be fully provided from the given document as it pertains to a different type of device and regulatory submission.

However, based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Not available. The document does not specify performance acceptance criteria, nor does it provide quantitative performance metrics for the Olympus LF-TP and LF-DP fiberscopes. The submission relies on demonstrating substantial equivalence to predicate devices, implying similar performance without explicit numerical targets.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not available. This type of information is relevant for studies evaluating the performance of AI/ML algorithms or human readers. For this device (an endoscope), performance is typically assessed through engineering tests, material compatibility, and functional verification, not through test sets of data in the same way. The document mentions "non-clinical tests" but does not detail their nature or sample sizes.

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/Not available. Ground truth establishment by experts is not a relevant concept for the regulatory submission of an endoscope. Its functionality is assessed through physical and mechanical testing, and its safety through compliance with standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not available. Adjudication methods are used in studies involving human interpretation of data, often in the context of AI evaluation. This is not relevant for the type of device described.

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 device is a medical instrument (fiberscope), not an AI system. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not available. The concept of "ground truth" as used in AI/ML performance evaluation does not apply to this device. For an endoscope, "truth" relates to its physical specifications, image quality, and ability to perform its intended function safely.

8. The sample size for the training set

Not applicable. This device is an endoscope, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this device is not an AI/ML algorithm.

Summary of what is present in the document regarding "studies":

Non-Clinical Tests: The document states that "Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes are designed, manufactured, and tested in compliance with the requirements of the voluntary safety standard, IEC 60601-1."
Conclusion from Non-Clinical Tests: The conclusion is that the new devices do not incorporate any significant changes in intended use, method of operation, material, and design that could affect device safety or effectiveness compared to predicate devices. This implies that the tests performed (likely engineering and safety compliance tests) confirmed that these aspects are equivalent.

In essence, this 510(k) submission is for a conventional medical device (an endoscope) seeking clearance based on substantial equivalence to existing devices and compliance with safety standards, rather than demonstrating performance against specific clinical acceptance criteria via a dedicated human-in-the-loop or standalone AI study.

Summary

{0}------------------------------------------------

K981543

SMDA 510(k) Summary Olympus Tracheal Intubation Fiberscope LF-TP and LF-DP

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.

A. Submitter's Name, Address, Phone and Fax Number:

Olympus Optical Co., Ltd. 22-2 Nishi-Shinjuku Shinjuku-ku, Tokyo 163-8610 Japan

B. Contact Person's Name, Address, Phone and Fax Numbers

Laura Storms-Tyler Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, NY 11747-3157 Telephone: (516) 844-5688 Fax: (516) 844-5416

ﺴﺴ

C. Trade Name, Common Name and Classification Name

Trade Name:	Olympus LF-TP and LF-DP Tracheal IntubationFiberscope, accessories and ancillary equipment
Common Name:	Portable Bronchofiberscope, accessories and ancillary
equipment
Classification:	Bronchoscope and accessories
	Class II, 21 CFR 874.4680

D. Legally Marketed Devices which we Claim Substantial Equivalence

Olympus LF-1 Intubation Scope	K850978
Olympus BF-240 Bronchovideoscope	K963033
Olympus BF-200 Bronchovideoscope	K931154
Olympus BF-P200 Bronchovideoscope	K931154
Olympus Winter & Ibe A5255A Rigid Endoscope	K923982
Olympus A3093 Light Guide Cable, 3.5 mm plug type	K944072

{1}------------------------------------------------

E. Description of the Device

The Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes and it's accessories are specifically designed to be used with a Suction Pump and other ancillary equipment for airway management.

F. Intended Use of the Device

The Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes are specifically designed for airway management which includes endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation, and management.

The difference between the LF-TP and LF-DP fiberscopes are as follows:

Distal end outer diameter
Insertion tube outer diameter
Channel inner diameter
Angulation range

G. Summary of the Technological Characteristics of the Device compared to the Predicate Device(s)

Except for the combined use with the Miniature Light Source and some modifications for the improvement of performance, other characteristics of the Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes are identical to the predicate Olympus LF-1 Intubation Scope.

H. Summary including a Brief Discussion of Non-Clinical Tests and How their Results support Determination of SE

Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes are designed, manufactured, and tested in compliance with the requirements of the voluntary safety standard, IEC 60601-1.

I. Summary including Conclusions drawn from Non-Clinical Tests

When compared to the predicate devices, Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes do not incorporate any significant change in intended use, method of operation, material, and design that could affect device safety or effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 1998

Laura Storms-Taylor Director, Regulatory Affairs Olympus Optical Co., Ltd. 22-2 Nishi-Shinjuku, 1-Chome Shinjuku-ku, Tokyo 163-8610 Japan

Re:

K981543

Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, accessories and ancillary equipment Dated: April 28, 1998 Received: April 30, 1998 Regulatory class: II 21 CFR 874.4680/Procode: 77 EOQ

Dear Ms. Storms-Taylor:

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, Drug, 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 (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 reguirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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) 594-4613. 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 regulation 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/dsmaldsmamain.html".

Sincerely yours,

William Yin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):

Not assigned yet

Device Name:

Olympus LF-TP and LF-DP Tracheal Intubation Fiberscope, accessories and ancillary equipment.

12431543

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21CFR 801.109)

Over-the Counter Use (Optional Format 1-2-96)

Ovid le. Stymm
__
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.