This instrument has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, document, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen.

Device Description

This subject device "XENF-TP Rhino-Laryngofiberscope" is an endoscope used for treatment and observation within the nasal and nasopharyngeal lumen. This endoscpe can be used with two types of light sources, detachable with an reusable battery powered and light cable source. This device is equipped instrument channel, so this device is suitable for treatment within the nasal and nasopharyngeal lumen using recommended ancillary equipment.

AI/ML Overview

This submission (K013591) for the XENF-TP Rhino-Laryngofiberscope is a 510(k) pre-market notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo clinical study data to prove safety and effectiveness.

Therefore, the document explicitly states: "Reason for not requiring clinical data: Compared to the predicate devices, "XENF-TP Rhino-Laryngofiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Treatment and observation within nasal and nasopharyngeal lumen have been done widely, and established its safety and effectiveness, therefore clinical data is not necessary for its evaluation of safety and efficacy."

Based on this, the requested information regarding acceptance criteria, study details, and data provenance (which would typically be found in a performance study) is not present in this 510(k) summary. The device's "performance" is implicitly deemed equivalent to the predicate devices due to its lack of significant changes.

However, I can provide a table summarizing what would be the implied acceptance criteria based on its design and compliance with standards, and categorize the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from 510(k) Rationale)	Reported Device Performance
Safety & Effectiveness Equivalent to Predicate Devices: - Pentax Naso-Pharyngo-Laryngoscope FNL-15P2/15RP2 (#K921707) - Laparoscope, Hand Instruments (#K950103) - LF-TP/DP (#K981543)	"XENF-TP Rhino-Laryngofiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Treatment and observation within nasal and nasopharyngeal lumen have been done widely, and established its safety and effectiveness.
Intended Use: For endoscopic diagnosis and treatment within the nasal and nasopharyngeal lumen.	Device is designed and purports to be suitable for this intended use.
Design Compliance: Meets recognized safety standards.	Design complies with IEC 60601 -1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-18.
Material Safety: No new patient-contacting materials.	All patient-contacting materials are cleared by previous 510(k) submissions (e.g., LF-TP/DP).
Technological Characteristics: No significant difference from predicate devices.	"This endoscope does not have special technological characteristics compared to the predicate device."

For the remaining points, the information is not available in the provided 510(k) summary because a separate performance study, as would be required for a novel device, was explicitly deemed unnecessary.

Information Not Present (Due to 510(k) Predicate Device Rationale):

2. Sample size used for the test set and the data provenance: Not applicable. No dedicated performance test set was used for this 510(k) submission. The safety and effectiveness are established by substantial equivalence to predicate devices, which are already marketed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth was established for a test set, as no dedicated clinical performance study was conducted.

4. Adjudication method for the test set: Not applicable. No dedicated test set requiring adjudication was used.

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 fiberscope, not an AI-powered diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical instrument, not a standalone algorithm.

7. The type of ground truth used: Not applicable. No new ground truth was established. The basis for safety and effectiveness relies on the widespread and established use of similar devices (predicate devices) for the stated indications.

8. The sample size for the training set: Not applicable. This device is a fiberscope, not an AI model, so there is no "training set."

9. How the ground truth for the training set was established: Not applicable. No training set exists for this device.

Summary

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K013591

510(k) SUMMARY

XENF-TP Rhino-Laryngo fiberscope, its accessories and ancillary equipment

This summary of 510(k) safety and effectiveness information is being submitted in rnis Sammary of U.S. (1) in the requirements of SMDA 1990 and 21 CFR, Section 807.92.

Japan 8010047

Japan

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

1. Manufacturer of the subject device

Name & Address of Manufacturer;

Registration No : Address, Phone and Fax Number of R&D Department Endoscope Division

2 Name of Contact Person Name :

Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL (631)844-5688 FAX (631) 844-5416

Olympus Optical Co, Ltd.

2951 Ishikawa-cho

TEL 81-426-42-5177 FAX 81-426-46-5613

Shinjuku-ku, Tokyo, 163-0914

Hachioji-shi, Tokyo 192-8507

2-3-1 Shinjuku Monolis Nishi-shinjuku

Address, Phone and Fax :

B. Device Name, Common Name

Device Name :
Common/Usual Name :

accessories and ancillary equipment

XENF-TP Rhino-Laryngofiberscope, its

Fiber Scope for Rhino-Laryng Fiberscope

Classification Name :

21CFR 876.1500 21 CFR 868.5530 21 CFR 874.4760

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C. Predicate Devices:

Model	Device Description &510(k)#/ Date Cleared	Manufacturer
Pentax Naso-Pharyngo-LaryngoscopeFNL-15P2/15RP2	#K92170707/01/1992	Pentax PrecisionInstrument Corp
Laparoscope,Hand Instruments	#K95010303/06/1995	Olympus America,Inc.
LF-TP/DP	#K98154308/06/1998	Olympus Optical Co.,

D. Summary Description of the Device

1. Summary

2. Design

"XENF-TP Rhino-Laryngofiberscope" has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirements of IEC 60601 -1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-18.

3. Materials

There are no new patient-contacting materials. All of patient contact materials are cleared by previous 510(k) submissions such as LF-TP/DP.

E. Intended Use of the device

This instruments has been designed to be used with an Olympus Light Source or an Olympus Miniature Light Source, documentation equipment, display monitor, Endo-Therapy accessories and other ancillary equipment for endoscpic diagnosis and treatment within the nasal and nasopharyngeal lumen. Do not use this instrument for any purpose other than its intended use.

F. Technological Characteristics

This endoscope does not have special technological characteristics compared to the predicate device.

G. Reason for not requiring clinical data

Compared to the predicate devices, "XENF-TP Rhino-Laryngofiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Treatment and observation within nasal and nasopharyngeal lumen have been done widely, and established its safety and effectiveness, therefore clinical data is not necessary for its evaluation of safety and efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "U.S. Department of Health & Human Services - USA" around the perimeter. Inside the circle is an emblem of three stylized lines that resemble an eagle or bird in flight. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 6 2001

Olympus Optical Co., Ltd. c/o Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, NY 11747

Re: K013591

Trade/Device Name: XENF-TP Rhino-Laryngofiberscope, its accessories and ancillary equipment

Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope Regulatory Class: Class II Product Code: EOB Dated: October 29, 2001 Received: October 30, 2001

Dear Ms. Storms-Tyler:

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 (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 Regulation (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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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 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indication for Use Statement

510(k) Number(if known): Not assigned yet. Device Name: XENF-TP Rhino-Larvngofiberscope, its accessories and ancillary equipment.

Indications for Use:

Fiberscope:

Miniature Light Source:

MAJ-524 is a detachable battery powered Miniature Light Source, which has been designed to be used with the XENF-TP.

FB-56D-1

These instruments have been designed to be used with an Olympus endoscope to collect tissue within the nasal and nasopharyngeal lumen.

FG-53SX-1

These instruments has been designed to be used with an Olympus endoscope to retrieve foreign bodies, calculi or resected tissue from the nasal and nasopharyngeal lumen.

BC-201C/ BC-8C/BC-10C

These instruments has been designed to be used with an Olympus endoscope to collect tissue specimens within the nasal and nasopharyngeal lumen.

NM-101C-0427 / NM-201L-0423 / NM-201L-0525

These instruments has been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection within the nasal and nasopharyngeal lumen.

PW-6C-1/MAJ-929

These instruments has been designed to be used with an Olympus endoscope for spraying medications in the nasal and nasopharyngeal lumen.

en. Analyst /qn
Division Sign-Off

(Division Sign-Oll
Division of Ophthalmic Ear,
Nose and Throat Devises
K0135

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

C Prescription Use_

Over-The-Counter Use

(Prescription 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.