These instruments have been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes diagnosis, and observation endoscopic treatment. to access airway anatomy, endotracheal/endobronchial intubation and management.

Device Description

The TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 are all-in-one cordless endoscopes with great portability which include light source, video processor, and video monitor functions.

The new endoscopes are basically identical to each predicate device shown in Table 14-1 in intended use, and similar in specifications, performance and materials.

AI/ML Overview

The provided 510(k) summary for the TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 does not contain information about specific acceptance criteria or an associated study that proves the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The document primarily focuses on demonstrating substantial equivalence to predicate devices (Olympus LF-DP Tracheal Intubation Fiberscope, OLYPUS BF TYPE XP160F, and Olympus Bronchoscope BF-XT40) based on intended use, technological characteristics, and safety/effectiveness.

Therefore, most of the requested information cannot be extracted from this summary.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document lists specifications of the subject devices and predicate devices (e.g., Field of View, Depth of Field, Outer Diameter, Angulation, Working Length), but these are technical specifications, not acceptance criteria for a clinical performance study. There are no reported device performance metrics in relation to any acceptance criteria.

2. Sample size used for the test set and the data provenance:

This information is not provided. The document does not describe any test set for a clinical performance study.

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. There is no mention of a test set, experts, or ground truth establishment.

4. Adjudication method for the test set:

This information is not provided.

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:

This information is not provided. The device is an endoscope, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

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

This information is not applicable/not provided. The device is a medical instrument (fibervideoscope), not an algorithm.

7. The type of ground truth used:

This information is not provided. There is no mention of a ground truth in the context of clinical performance testing.

8. The sample size for the training set:

This information is not applicable/not provided. As no AI/algorithm is described, there would be no training set in this context.

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

This information is not applicable/not provided.

Summary of what is available from the document:

The 510(k) summary for the TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 relies on substantial equivalence to predicate devices. The "study" proving the device meets criteria is primarily the comparison of technological characteristics and an assertion that "When compared to the predicate device, the TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This implies that the safety and effectiveness of the subject devices are comparable to those of the legally marketed predicate devices, which were presumably demonstrated as safe and effective through their own regulatory pathways. No new clinical performance data or studies are presented in this 510(k) summary.

Summary

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6082720

510(k) SUMMARY

NOV - 5 2008

TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005

September 8, 2008

1 General Information

트 Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047 북 Official Correspondent: Stacy Abbatiello Kluesner, RAC
Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 Fax: 484-896-7128 Email:stacy.kluesner@olympus.com Establishment Registration No: 2429304
Aizu Olympus Co., Ltd. Manufacturer: 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No: 9610595

Device Identification 2

월

	Device Trade Name:	TRACHEAL INTUBATION FIBERVIDEOSCOPELF-Y0004 and LF-Y0005
	Common Name:	TRACHEAL INTUBATION FIBERVIDEOSCOPE
	Regulation Number:	21 CFR 874.4680
	Regulation Name:	Bronchoscope (flexible or rigid) and accessories
	Regulatory Class:	II
	Classification Panel:	Ear Nose & Throat
	Product Code:	EOQ - Bronchoscope (Flexible Or Rigid)

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3 Predicate Device Information

The following table shows the primary components of the subject devices and the devices to which we claim substantial equivalence (predicate devices).

Table 14-1. Primary Components & Predicate Devices
----------------------------------------------------	--	--	--	--	--	--	--

Subject Devices(Part of this submission)	Predicate Devices	PD's510(k) No.
TRACHEAL INTUBATIONFIBERVIDEOSCOPE LF-Y0004	Olympus LF-DP Tracheal IntubationFiberscope	K981543
TRACHEAL INTUBATIONFIBERVIDEOSCOPE LF-Y0005	EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYPUS BF TYPE XP160FOlympus Bronchoscope BF-XT40	K033225 K023984

Device Description ব

The TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 are all-in-one cordless endoscopes with great portability which include light source, video processor, and video monitor functions.

The new endoscopes are basically identical to each predicate device shown in Table 14-1 in intended use, and similar in specifications, performance and materials.

ട് Indications for Use

б Comparison of Technological Characteristics

The TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 are basically identical to the predicate device in intended use, and similar in specifications except for the all-in-one unit, outer diameter, and optical system. Comparison between the subject and predicate devices is shown in Table 14-2.

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Talions : TRACHEAL MTUBATION FIBERVIDEOSCOPE LE-Y0004 and LF-Y000
Trelicate Devices : TRACHEAL NEWS : Present : Prove and LE-Y000
Predicate Devices : TRACHEAL MTUBERVIOR

Specifications	Subject DeviceLF-Y0004	Subject DeviceLF-Y0005	Predicate DeviceLF-DP	Predicate DeviceBF-XP160F	Predicate DeviceBF-XT40
Field of View	90°	90°	90°	90°	120°
Depth of Field	4-50mm	3-50mm	3-50mm	2-50mm	3-50mm
Direction of View	0° (Forward viewing)	0° (Forward viewing)	0° (Forward viewing)	0° (Forward viewing)	0°(Forward viewing)
Outer Diameterof Distal End	φ3.9mm	φ5.1mm	φ3.1mm	φ2.8mm	φ6.1mm
Outer Diameterof InsertionTube	φ4.1mm	φ5.2mm	φ3.1mm	φ2.8mm	φ6.2mm
AngulationUP/DOWN	UP : 120°DOWN : 120°	UP : 180°DOWN : 130°	UP : 120°DOWN : 120°	UP : 180°DOWN : 130°	UP : 180°DOWN : 130°
Working Length	600mm	600mm	600mm	600mm	550mm
Source ofexaminationlight	These are built-infunctions of theendoscope.	These are built-infunctions of theendoscope.	External Light SourceUnit	External Light SourceUnit	External LightSource Unit
VideoProcessor			External Video SystemCenter Unit (whenconnected via VideoConverter Unit)	External VideoSystem Center Unit	External VideoSystem Center Unit(when connectedvia Video ConverterUnit)
Monitor			External Video MonitorUnit	External Video MonitorUnit	External VideoMonitor Unit

3/4

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7

When compared to the predicate device, the TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004 and LF-Y0005 do not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Medical System Corporation c/o Stacy Abbatiello Kluesner Olympus America, Inc 3500 Corporate Parkway P.O. Box 610 Center Valley, PA 18034

NOV - 5 2008

Re: K082720

Trade/Device Name: Tracheal Intubation Fiberscope LF-Y0004 and LF-Y0005 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: II Product Code: EOQ Dated: September 16, 2008 Received: September 23, 2008

Dear Ms. Kluesner:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Stacy Abbatiello Kluesner

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10(t) marketed predicate device results in a classification for your device and thus, perrorits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Melvina B. Esguerra, M.D.

Malvina B. Eydelman, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: TRACHEAL INTUBATION FIBERVIDEOSCOPE LF-Y0004, LF-Y0005 Indications For Use:

These instruments have been designed to be used with a Suction Pump and EndoTherapy accessories and other ancillary equipment for airway management, which includes endoscopic treatment, diagnosis, and observation to access airway anatomy, endotracheal/endobronchial intubation and management.

Prescription Use (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)

Concur

(Division Sign-Off)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices

510(k) Number K082720

Page 1 of 1

: 032327

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.