Flexible Fiberscope: For examination, diagnosis, and/or therapy in connection with Flexible Fiberscope. Tor exammation, chughts used through the working channel of the instrument for use in lumbar spine applications.

Flexible Biopsy Forcep: Used to obtain small biopsies from tissue

Electrodes: Used for unipolar coagulation.

Flexible fiberscopes are used for examination, diagnosis, and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in lumbar spine applications.

Device Description

The flexible endoscope consists of an eyepiece, with a focusing ring for direct view or connection to a video camera, a lever to control the flexible tip of the scope, and the flexible insertion portion.

The tip of the sheath has an active deflection up to 360°, depending on the fiberscope. The deflecting position can be locked with a brake on some fiberscopes. The image is transmitted via objective, fiber bundle and eyepiece for direct view or connection to a video camera. The total number of pixels and the fibers per mm² are increased to get an image with higher resolution. Biopsy material can be taken by the wide working channel, which is simultaneously used for irrigation. Auxiliarv instruments such as forceps are inserted via a proximal mounted insertion cock with supply and discharge.

AI/ML Overview

The provided text is a 510(k) summary for the Richard Wolf Medical Instruments Corporation's Flexible Fiberscopes and Accessories. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria in the manner of a clinical trial or performance study comparing a new device against a defined standard.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for demonstrating device performance against specific metrics is not available in the provided document. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use compared to predicate devices.

However, I can extract information related to the device and its claimed equivalence:

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

This information is not provided in the document. The filing is a 510(k) premarket notification claiming substantial equivalence, not a report on meeting specific performance acceptance criteria from a pre-defined study.

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

This information is not provided. No specific test set or data provenance is mentioned as this is a premarket notification based on substantial equivalence to existing devices.

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. Ground truth establishment, in the context of performance testing with a test set, is not described.

4. Adjudication method for the test set:

This information is not provided. An adjudication method for a test set is not 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:

This information is not applicable and not provided. The device is a "Flexible Fiberscope and Accessories," which are physical medical instruments, not an AI-based system. Therefore, MRMC studies with AI assistance are irrelevant to this filing.

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

This information is not applicable and not provided. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used:

This information is not provided. Ground truth, in the context of performance testing, is not described.

8. The sample size for the training set:

This information is not provided. A training set, in the context of algorithm development, is not applicable to this physical medical device.

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

This information is not provided. Ground truth establishment for a training set is not applicable.

Information that is available from the document related to the device and its claims:

Device Name: Flexible Fiberscopes and Accessories
Intended Use: For examination, diagnosis, and/or therapy in connection with flexible fiberscope. Accessories and auxiliary instruments used through the working channel of the instrument for use in lumbar spine applications. Flexible Biopsy Forcep: Used to obtain small biopsies from tissue. Electrodes: Used for unipolar coagulation.
Field of Application: Spine, urology, surgery, gynecology, and ENT, by adequately trained and qualified medical personnel.
Technological Characteristics (claimed relevance for equivalence):
- Tip of the sheath has active deflection up to 360°, depending on the fiberscope (some can be locked).
- Image transmitted via objective, fiber bundle, and eyepiece for direct view or connection to a video camera.
- Increased total number of pixels and fibers per mm² for higher resolution image.
- Wide working channel for biopsy material and irrigation.
- Auxiliary instruments (e.g., forceps) inserted via a proximal mounted insertion cock with supply and discharge.
Substantial Equivalence Claim: The submitted devices are claimed to be substantially equivalent to existing pre-enactment and 510(k) devices sold by Richard Wolf in the urology branch, and to devices sold by Clarus and Sofamor Danek.
Predicate Devices (for claiming substantial equivalence):
1. K962172 - Flexible Mini-Fiberscopes (Richard Wolf)
2. LASE Flexible Endoscope (Clarus)
3. K971455 - SITEprobe diagnostic spinal endoscope (Clarus)
4. K946087 - The Inclusive ™ Endoscope System (Sofamor Danek)
Performance Data & Clinical Tests:
- No known FDA performance standard exists.
- Clinical tests were not performed.
Conclusions Drawn (by applicant): Devices are designed and tested to assure safety and effectiveness when used according to instructions manual.

In summary, the provided document is a regulatory filing for market clearance based on substantial equivalence, and therefore does not contain the detailed performance study information requested.

Summary

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

Image /page/0/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

MEMORANDUM

Food and Drug Administration Office of Device Evaluation 10903 New Hampshire Avenue Silver Spring, MD 20904

Premarket Notification [510(k)] Review Corrected Substantial Equivalence Letters - New Product Codes

K990397

Date: 1/30/2014 To: The Record From: Tuan Nguyen, Biomedical Engineer Office: ODE Division: DRGUD Branch: ULDB

510(k) Holder: K990397

Flexible Fiberscopes and Accessories Device Name:

Kellie Straughn (Clerk Typist), DRGUD

Previous Product Code: HRX, KOG

New Product Code: HRX

The product code KOG Endoscope and/or accessories under the requlation 876.1500 Endoscope and accessories has been used extensively to include a large variety of medical devices associated with endoscopes. Subsequent to the generation of KOG additional product codes have been generated that group similar devices into more specific groups. It was decided that the product code KOG would be no longer used and that all endoscopes and/or accessories would use the more specific product codes.

Ms Cheryl Mackey (Program Analyst, DRUGD) identified the past 510(k)s that included the product code KOG, and Ms Christine Lee (Assistant Director Program Operations, DRGUD) assigned the new procode(s). Correction letters will be generated by Kellie Straughn (Clerk Typist) to update these devices using the new product codes.

Tuan Nguyen -A 2014.01.30 09:42:53 -05'00'

Tuan Nguyen, Biomedical Engineer, ULDB

1/30/2014 Date

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

Page 3 -

	Digital Signature Concurrence Table
Reviewer Sign-Off	Christine Lee
Branch Chief Sign-Off	Glenn Bell
Division Sign-Off	Benjamin R. Fisher -S

Template Name: Corrected Substantially Equivalent Letter: Classified and Not Classified; v2013-04-02

------------- REMOVE BELOW WHEN USING TEMPLATE --------------

Template History:

Date of Update	By	Description of Update
7/27/09	Brandi Stuart	Added Updates to Boiler Table
8/7/09	Brandi Stuart	Updated HFZ Table
9/25/12	Edwena Jones	Added digital signature format
12/12/2012	Margaret McCabeJanicki	One digit was missing from 4-digit ZIP code extension in letterhead ("002" should read"0002"). Revised to fix this.
04/02/2013	Sara Aguel	Clarified letter instructions; added OIR option in signature block. Added option for IVDlabeling regulation. Edited sentence that starts "If you desire specific advice for yourdevice on our labeling regulation (21 CFR Part 801)..." Replaced broken Compliancelink with general link to DSMICA. Added sentence that starts "Please note: CDRH doesnot evaluate information related to contract liability warranties..." to be consistent withlanguage in K1(A) SE letter. Added instructions to "Re: [510(k) NUMBER]" section tobe consistent with language in KI(A) SE letter.
4/12/2013	Margaret McCabeJanicki	Fixed typos in paragraph 1, final sentence: "We remind you; however, that...misleading"- replaced the incorrect semicolon with a comma and added a period at the end of thesentence.

cc: DCC – sign-off & original ODE/DRGUD/ULDB – (GBB)
Final: KAS:kas

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JUL 2 7 2015

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

Re: K990397 Trade/Device Name: Flexible Fiberscopes and Accessories Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated (Date on orig SE ltr): August 11, 1999 Received (Date on orig SE ltr): August 12, 1999

Dear Mr. Casarsa,

This letter corrects our substantially equivalent letter of October 25, 1999.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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

Page 2 -

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known):	K990397
---------------------------	---------

Flexible Fiberscopes and Accessories Device Name:__________________________________________________________________________________________________________________________________________________________________

Intended Use:

Flexible Biopsy Forcep: Used to obtain small biopsies from tissue

Electrodes: Used for unipolar coagulation.

Field of Application:

The instruments are designed to be used by adequately trained and qualified medical personnel . in the fields of spine, urology, surgery, gynecology, and ENT.

IMPORTANT! The product dimensions must correspond with the anatomic proportions, i.e., the correct flexible fiberscope must be selected for the medical procedure.

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

scally

General Restorative Devic

Prescription Use
Per 21 CFR 801.109

Over-The Counter_

{5}------------------------------------------------

OCT 2 5 1999

353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: 847.913.1113 Fax: 847.943.1488

RICHARD WOL

MEDICAL INSTRUMENTS CORPORATIO

510(k) Summary of Safety and Effectiveness

K990397

Date of Preparation:	February 5, 1999
Company / Institution name:	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
FDA establishment registration number:	14 184 79
Division name (if applicable):	N.A.
Phone number (include area code):	(847) 913-1113
Street address:	353 Corporate Woods Parkway
FAX number (include area code):	(847) 913-0924
City:	Vernon Hills
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 fiberscopes and accessories
Model number:	7265.001, 7305.xxx, 7321.xxx, 7325.xxx, 7330.xxx
Common name:	Flexible fiberscopes
Classification name:	Flexible endoscopes

Information on devices to which substantial equivalence is claimed:

	510(k) Number	Trade or proprietary or model name	Manufacturer
1	K962172	Flexible Mini-Fiberscopes	Richard Wolf
2		LASE Flexible Endoscope	Clarus
3	K971455	SITEprobe diagnostic spinal endoscope	Clarus
4	K946087	The Inclusive TM Endoscope System	Sofamor Danek

1.0 Description

2.0 Intended Use

: 2

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows a black square with a white symbol inside. The symbol appears to be a stylized or abstract representation of a dog or wolf-like creature. The symbol is simple and geometric, with sharp lines and angles.

3.0 Technological Characteristics

There are no significant technological changes or characteristics to the new devices compared to the existing devices.

4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing pre-enactment and 510(k) devices sold by Richard Wolf in the urology branch. In addition, the submitted devices are substantially equivalent to devices sold by Clarus, and Sofamor Danek.

5.0 Performance Data

No known FDA performance standard exists.

6.0 Clinical Tests

Clinical tests performed were not performed.

7.0 Conclusions Drawn

These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual.

By: Robert L. Casassa

Robert L. Casarsa Quality Assurance Manager

Date: Feb 5, 99

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.