For examination, diagnosis, and /or therapy in connection with endoscopic accessories / auxiliary instruments through the working channel of the endoscope. This instruement is used in the medical discipline of ENT (e.g. naso-pharynxngeal cavity - larynx / trachea and bronchial branch by adequately trained and qualified medical personnel.

Device Description

The flexible bronchoscopes and nasopharyngo-laryngoscopes consist of three parts: 1) flexible insertion part with or without a working channel, 2) control part for the deflection of the tip, and 3) an eyepiece for direct view or connection to a video camera.

AI/ML Overview

This device, the Flexible Nasopharyngo-Laryngoscope and Flexible Bronchoscope by Richard Wolf Medical Instruments Corp., is a medical endoscope. The provided 510(k) summary explicitly states that no performance standards are known and no clinical tests were performed. Therefore, the information requested for acceptance criteria and a study proving device performance cannot be fully provided as it pertains to a traditional clinical performance study with acceptance criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards.

Here's a breakdown of the available information:

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

Since no specific acceptance criteria for clinical performance are mentioned, nor is a clinical performance study reported, this table cannot be created in the way typically expected for a clinical study with performance metrics.

Instead, the acceptance criteria here are based on compliance with established safety standards and the inherent "safety and effectiveness" derived from substantial equivalence and design/testing.

Acceptance Criteria (Implied)	Reported Device Performance
- Compliance with IEC601-1 (General medical electrical equipment)	Built according to IEC601-1
- Compliance with IEC601-2-18 (Endoscopic equipment)	Built according to IEC601-2-18
- Compliance with IEC601-2-2 (High frequency surgical equipment)	Built according to IEC601-2-2 (for button electrode component)
- Substantial Equivalence to predicate devices (K980401, K951196/K921707, K811053/K951199)	Declared substantially equivalent in design, materials, and intended use to existing cleared devices. "New technological characteristics have not diminished safety or effectiveness."
- Safety and Effectiveness for expected lifetime	"Designed and tested to guarantee the safety and effectiveness during the expected life time of the device when used according to the instruction manual."

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. The document explicitly states: "No clinical tests performed." The "testing" mentioned refers to design and manufacturing adherence to standards, not clinical data collection.
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. No clinical tests or ground truth establishment by experts for a test set are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical tests requiring adjudication were performed.
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 an endoscope, not an AI-powered diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is not an algorithm, and no standalone performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" for the submission is the adherence to recognized safety standards and the substantial equivalence to predicate devices already cleared by the FDA.
8. The sample size for the training set:

Not applicable. No algorithm or AI model requiring a training set is involved.
9. How the ground truth for the training set was established:

Not applicable. No algorithm or AI model requiring a training set is involved.

Summary of the Study (as presented in the 510(k) submission):

The "study" presented in this 510(k) is a design and manufacturing compliance assessment and a substantial equivalence comparison, rather than a clinical performance study. The core arguments for safety and effectiveness are:

Adherence to Recognized Standards: The devices were built according to IEC601-1 (medical electrical equipment), IEC601-2-18 (endoscopic equipment), and IEC601-2-2 (for the high-frequency surgical component). This implies that the device design and manufacturing process meet established safety requirements.
Substantial Equivalence: The primary method for demonstrating safety and effectiveness is by showing that the new devices are substantially equivalent to previously cleared predicate devices (K980401 from Richard Wolf, and K951196/K921707 and K811053/K951199 from Pentax). The submission explicitly states the new devices use "the same basic design and device material" as K980401 and that "new technological characteristics have not diminished safety or effectiveness."

In conclusion, for this specific 510(k) submission, the "study" proving the device meets acceptance criteria is the documentation of its design and manufacturing practices in accordance with international safety standards and a detailed comparison demonstrating substantial equivalence to already approved devices. Clinical performance data, as typically understood for diagnostic or therapeutic efficacy, was not required or provided.

Summary

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

SEP 2 4 1999

<992526

353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: 847.913.1413 Fax: 847.913.1488

RICHARD WOLF

MEDICAL INSTRUMENTS CORPORATION

510(k) Summary of Safety and Effectiveness

Company / Institution name:	Richard Wolf Medical Instruments Corp.	Date of Preparation:	July 26, 1999
Division name (if applicable):	N.A.	FDA establishment regulation number:	14 184 79
Street address:	353 Corporate Woods Parkway	Phone number (include area code):	(847) 913-1113
City:	Vernon Hills	FAX number (include area code):	(847) 913-0924
State/Province:	Illinois
Country:	USA
ZIP/Postal Code:	60061
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager
Product Information:
Trade name:	Flexible nasopharyngo-laryngoscope and Flexible bronchoscope	Model number:	7222, 7223, 7224, 7265, 7325, 7330
Common name:	Naso-pharyngo-laryngo-fiberscope and broncho-fiberscope	Classification Name:	Nasopharyngo-laryngoscope and bronchoscope
Information on devices to which substantial equivalence is claimed:

	510(k) Number	Trade or proprietary or model name	Manufacturer
1	K980401	Flexible fiberscopes and accessories (urology, surgery, and gynecology)	Richard Wolf
2	K951196 /K921707	Naso-pharyngo-laryngo-esophago fiberscopes FNL-7, FNL-10, FNL-13, FNL-15	Pentax
3	K811053 / K951199	Broncho deluxe fiberscoe FB-10, FB18	Pentax

1.0 Description

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

2.0 Intended Use

The flexible nasopharyngo-laryngoscope and the flexible bronchoscope are used to visualize body cavities via natual passages.

The bottom electrode is used for tissue and vessel coagulation by means of high frequency current under endoscopic view.

3.0 Technological Characteristics

They are equivalent to the flexible endoscopes cleared in K980401, Flexible Fiberscopes and Accessories for urology, surgery, and gynecology. The fiberscopes in the submission use the same basic design and device material as submitted in K980401. Some flexible bronchoscopes and nasopharyngo-laryngoscopes have a fixed light cable instead of a removable light cable; some of them have a working channel.

4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety and effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf and Pentax.

5.0 Performance Data

No performance standards are known. The fiberscopes and the button electrode were built according to the specifiecied standards IEC601-1, IEC601-2-18, and IEC601-2-2.

6.0 Clinical Tests

No clinical tests performed.

7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness during the expected life time of the device when used according to the instruction manual.

By: Robert J. Casares

Robert L. Casarsa Quality Assurance Manager

Date: 7/22/99

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1999

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061

Re: K992526

Device: Flexible Nasopharyngo-Larynogoscope and Bronchoscope Dated: July 28, 1999 Received: July 26, 1999 Classification Regulation: 77 EOB, 21 CFR 874.4760 77 EOQ, 21 CFR 874.4680

Regulatory Class: II

Dear Mr. Casarsa:

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 .

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

Page 2 - Mr. Robert L. Casarsa

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

If you desire specific advice for your devices 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 devices, 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 tollfree number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Afvey L. Rosenthal

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

Enclosure

{4}------------------------------------------------

Indie arous i

< 999596 510(k) Number (if known):

Device Name:____ Flexible Nasopharyngo-Laryngoscope and Bronchoscope_

Intended Use:

The flexible nasopharyngo-laryngoscope and the flexible bronchoscope are used to visualize body cavities via natual passages.

The button electrode is used for tissue and vessel coagulation by means of high frequency current under endoscopic view.

Indication and Field of Application:

IMPORTANT! The product dimensions must correspond to the anatomic conditions, i.e., the correct flexible nasopharyngoscope or flexible bronchoscope must be selected for the planned intervention.

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

Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number	K992526

Prescription Use	✓	OR	Over-The Counter
------------------	---------------------------------------------------	----	------------------	--------------------------------------------------

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.