The Mediastinoscope, in connection with various auxiliary instruments, is used for diagnostic and/or surgical interventions in the upper area of the mediastinum.

Mediastinoscopy is carried out

In order to evaluate the operability of patients suffering from bronchial carcinoma which have . already been verified, for treatment planning of other carcinomas in the mediastinal area and for biopsies.
For diagnostic clarification of primary and secondary diseases of the mediastinum, when other . examination methods have been unable to provide the nature, and in particular the histological character of the disturbance.
For the removal of nodes and tumors. .
For the diagnosis and removal of lymphatic nodes.

Various auxiliary instruments are used in mediastinoscopy:

The smoke evacuation tube is used to evacuate smoke during HF or laser applications.
The telescope rinsing tube (optic irriyation tube) is used to keep the distal area of the telescope clear by rinsing with irrigation fluid.
The mediastinal puncture tube is used to puncture lymph nodules and aspirate the content for . cyto/histological purposes.
The tumor grasping forceps are used for grasping and manipulating tissue. .
The micro grasping forceps with HF are used for coagulating small vessels and grasping. .
The HF coagulation suction devices are used for suction and for coagulation while holding tissue 'out of the way' during endoscopic operations of the larynx in connection with CO, lasers or in mediastinoscopy.
The bipolar aspiration tube (bipolar coagulation suction tube) is used for aspiration and for . coagulation of small lesions.

Device Description

The Optical Mediastinoscope is a tubular, conical shaped endoscope with a handle and a build-in telescope with fiber illumination which is bent at a 90° angle. The endoscope tube consists of two spreadable spatulas which allow distention of the operative field, and therefore, optimizes vision. The spatulas may be dismounted for easier cleaning.

For efficiency during diagnostic and therapeutic procedures, a variety of accessory instruments are needed, e.g. biopsy and grasping forceps, puncture, suction and coagulation tubes or telescope rinsing tubes

AI/ML Overview

The provided text describes the 510(k) summary for the "Optical Mediastinoscope and Accessories" (K971166). This document is for a medical device that requires premarket notification but does not describe the use of any AI/ML technologies. Therefore, many of the requested fields related to AI/ML performance and studies are not applicable.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
No permanent deformation under normal use (Optical Mediastinoscope)	Pull tests show no permanent deformation if used normally.
No breakage of jaw or parts under normal use (forceps and stone extractors)	Mechanical load tests show no breakage of the jaw or other parts if used normally.
No influence on functional performance from steam sterilization	Steam sterilization in clinical use and tests performed by Richard Wolf show no influence on functional performance (fractional method).
Safety and effectiveness as per instruction manual	Devices are designed and tested to guarantee safety and effectiveness when used according to the instruction manual.

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

Not applicable. This submission is for a physical medical device (mediastinoscope) and accessories, not an AI/ML algorithm. Performance data described includes mechanical tests and sterilization tests, not a "test set" in the context of an AI/ML model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "ground truth" establishment by experts in the context of an AI/ML model for this device. The performance data relates to physical properties and sterilization effectiveness, assessed through laboratory tests.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the context of an AI/ML model that would require an adjudication method. The performance data is based on physical and sterilization testing.

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 submission is for a physical medical device and does not involve AI/ML or human "readers" or "interpreters" in the context of diagnostic imaging.

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

Not applicable. This submission is for a physical medical device and does not involve an AI/ML algorithm.

7. The type of ground truth used

Not applicable. As this is not an AI/ML device, the concept of "ground truth" in this context is not relevant. The performance data stems from mechanical and sterilization testing to demonstrate the device's physical integrity and functionality.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device and does not involve AI/ML or a "training set."

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

Not applicable. This submission is for a physical medical device and does not involve AI/ML or a "training set" with established ground truth.

Summary

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510(k) Summary of Safety and Effectiveness
Submitter:
Company / Institution name:	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
Division name (if applicable):	N.A.
Street address:	353 Corporate Woods Parkway
City:	Vernon Hills
State/Province:	Illinois
Country:	USA
ZIP / Postal Code:	60061
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager
Date of Preparation:	March 28, 1997
FDA establishment registration number:	14 184 79
Phone number (include area code):	(847) 913-1113
FAX number (include area code):	(847) 913-0924
Product Information:
Trade name:	Optical Mediastinoscope and Accessories
Model number:	8783.401, 8783.411 and accessories(see section 1: Submitted devices)
Common name:	Mediastinoscope
Classification name:	Mediastinoscope and Accessories
Information on devices to which substantial equivalence is claimed:
510(k) Number	Trade or proprietary or model name	Manufacturer
1 pre-enact.	1 Fiber Light Mediastinoscope 8960.01/.03	1 Richard Wolf M.I.C.
2 K 95 49 10	2 Optical Mediastinoscope 10970BV	2 Karl Storz
3	3 Mediastinoscope 'CARLENS' 10970A/B and operating instruments	3 Karl Storz

1.0 Description

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2.0 Intended Use

The Mediastinoscope, in connection with various auxiliary instruments, is used for diagnostic and/or surgical interventions in the upper area of the mediastinum.

Various auxiliary instruments are used in mediastinoscopy:

The smoke evacuation tube is used to evacuate smoke during HF or laser applications. .
The telescope rinsing tube (optic irrigation tube) is used to keep the distal part of the telescope . clear by rinsing with irrigation fluid.
The mediastinal puncture tube is used to puncture lymph nodules and aspirate the content for . cyto/hystological purposes.
The tumor grasping forceps are used for grasping and manipulating tissue. .
The micro graspiny forceps with HF are used for coagulating small vessels and grasping.
The HF coagulation suction devices are used for suction and for coagulation while holding . tissue `out of the way' during endoscopic operations of the larynx in connection with CO2 lasers or in mediastinoscopy.
The bipolar coagulation suction tube (bipolar aspiration tube) is used for aspiration and for . coagulation of small lesions.

Technological Characteristics 3.0

· 90° bent telescope, diameter of lens 2.78 mm
direction of view 35°, angle of view 98° .
spreadable spatula, consisting of two half pieces, wall thickness 1 mm .
spatula diameter: distal ca. 17 mm, proximal 28 x 18.5 mm .
· working length 160 mm

4.0 Substantial Equivalence

The submitted devices are substantially equivalent to existing pre-enactment devices sold by Richard Wolf and 510(k) devices sold by Storz.

5.0 Performance Data

· Pull tests of the optical mediastinoscope show that there is no permanent deformation if used normally
· Mechanical load tests of the forceps and stone extractors show that there is no breakage of the jaw or other parts if used normally.
Steam sterilization in clinical use and tests performed by Richard Wolf show that the steam . sterilization has no influence on the functional performance of the submitted devices when using the fractional method.

Clinical Tests 6.0

No clinical tests performed.

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Conclusions Drawn 7.0

Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the Instruction manual

By: Robert L. Pearson

Robert L. Casarsa
Quality Assurance Manager

Date: July 14, 1992

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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG 27 1997

Re: K971166 Trade Name: Optical Mediastinoscope and Accessories Regulatory Class: II Product Code: EWY Dated: June 14, 1997 Received: July 16, 1997

Dear Mr. Casarsa:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices in the Federal Register. Please note: this response to your premarket notification submissions 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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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 a legally marketed predicate device 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) 594-4595. 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): __ K 97 1166 _______________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Mediastifascope, in connection with various auxiliary instruments, is used for diagnostic and/or surgical interventions in the upper area of the mediastinum

Mediastinoscopy is carried out

In order to evaluate the operability of patients suffering from bronchial carcinoma which have . already been verified, for treatment planning of other carcinomas in the mediastinal area and for biopsies.
For diagnostic clarification of primary and secondary diseases of the mediastinum, when other . examination methods have been unable to provide the nature, and in particular the histological character of the disturbance.
For the removal of nodes and tumors. .
For the diagnosis and removal of lymphatic nodes.

Revised 2/14/97 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

scolley

General Restorative Davio

Prescription Use
Per 21 CFR 801.109

Over-The Counter_

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

Indications Continued:

Various auxiliary instruments are used in mediastinoscopy:

The smoke evacuation tube is used to evacuate smoke during HF or laser applications.
The telescope rinsing tube (optic irriyation tube) is used to keep the distal area of the telescope clear by rinsing with irrigation fluid.
The mediastinal puncture tube is used to puncture lymph nodules and aspirate the content for . cyto/histological purposes.
The tumor grasping forceps are used for grasping and manipulating tissue. .
The micro grasping forceps with HF are used for coagulating small vessels and grasping. .
The HF coagulation suction devices are used for suction and for coagulation while holding tissue 'out of the way' during endoscopic operations of the larynx in connection with CO, lasers or in mediastinoscopy.
The bipolar aspiration tube (bipolar coagulation suction tube) is used for aspiration and for . coagulation of small lesions.

Contraindications:

Contraindications for the patient which result findings are described in the relevant literature and must be observed.

Revised 7/14/97

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

Concurrence of CDRH Office of Device Evaluation (OHE)

picolep

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971166

Prescription Use
Per 21 CFR 801.109

Over-The Counter______________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 874.4720 Mediastinoscope and accessories.

(a)
Identification. A mediastinoscope and accessories is a tubular tapered electrical endoscopic device with any of a group of accessory devices which attach to the mediastinoscope and is intended to examine or treat tissue in the area separating the lungs. The device is inserted transthoracicly and is used in diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.