The ESHV (Endoscopic Subfascial Harvesting of Veins) instrument set is used for minimally invasive preparation and harvesting of the veins for use in cardiac and vascular surgical procedures. The intervention takes place under sterile conditions.

The Veins dissector (stripper) is used for the blunt preparation of tubular structures. specifically for the free-preparation of vessels, e.g. the vein saphena magma.

The ESDP (Endoscopic Subfascial Discision of Perforating Veins) instrument set is used for minimally invasive visualization, diagnostic, and therapeutic procedures of subfascial veins in the lower extremities, e.g. the saphenous vein. The intervention takes place under sterile conditions.

Device Description

The Instruments for endoscopic subfascial Harvesting of Veins (ESHV) and Endoscopic Subfascial Discision of Perforating Beins (ESDP) consists of operating telescopes, endoscopic operating tubes, laser guide, hook knife, various monopolar and bipolar grasping forceps and scissors, and veins dissector (stripper).

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the device:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, there are no specific, quantifiable acceptance criteria or performance metrics reported for the device. The submission explicitly states:

Metric	Acceptance Criteria	Reported Device Performance
Performance Data	Not applicable (no specific criteria defined)	"Performance data not generated."
Clinical Tests	Not applicable (no specific criteria defined)	"No clinical tests performed."

The document concludes with a general statement on design and testing for safety and effectiveness, but this doesn't constitute quantifiable performance data against predefined criteria.

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not applicable. No test set was used for performance evaluation, as "performance data not generated" and "no clinical tests performed."
Data Provenance: Not applicable, as no data was generated or used for performance evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. No ground truth was established as no test set or performance evaluation was conducted.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set 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

MRMC Study: No. The document explicitly states "No clinical tests performed" and "Performance data not generated." This device is from 1998, well before the widespread use and regulatory expectation of AI-assisted device studies.

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

Standalone Performance: No. The document explicitly states "No clinical tests performed" and "Performance data not generated." This device is not an AI algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable. No ground truth was established as no test set or performance evaluation was conducted.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable. This device is not an AI/ML algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided 510(k) summary, there was no study conducted to explicitly prove the device meets pre-defined acceptance criteria through performance data or clinical trials. The submission relies on demonstrating substantial equivalence to existing predicate devices.

The document states:

"Performance data not generated."
"No clinical tests performed."
"These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." (This is a general statement from the manufacturer, not indicative of a specific study proving it.)
"The submitted devices are substantially equivalent to existing pre-enactment and 510(k) devices sold by Richard Wolf and competitors."

The FDA's letter concurs with the substantial equivalence claim, allowing the device to be marketed. This means the device was cleared because it was deemed as safe and effective as a legally marketed predicate device, primarily based on its technological characteristics and intended use, rather than new performance data or clinical studies generated for this specific submission.

Summary

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AUG 27 1998

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Image /page/0/Picture/1 description: The image shows a handwritten number sequence, "16973943". The numbers are written in a dark ink, and the background is white. The numbers are slightly smudged, but they are still legible. There are some other markings on the left side of the image.

RICH ARD INSTRUMENTS CORPORATION

Image /page/0/Picture/3 description: The image shows a black and white square with a stylized symbol inside. The symbol appears to be a combination of lines and shapes, possibly representing a character or logo. The image quality is somewhat degraded, with some pixelation and blurring around the edges of the square and the symbol.

510(k) Summary of Safety and Effectiveness

Submitter:				Date of Preparation:October 10, 1997
Company / Institution name:Richard Wolf Medical Instruments Corp.				FDA establishment regulation 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:	Instruments for Endoscopic Subfascial Harvesting of Veins (ESHV) and Endoscopic Subfascial Discision of Perforating Veins (ESDP)			Model number:8781, 8393, 8394 and others
Common name:Operating Tubes. Operating TelescopeLaser Guide. Knife			Classification Name:Endoscopes and Accessories
Information on devices to which substantial equivalence is claimed:
510(k) Number	Trade or proprietary or model name	Manufacturer
1 K964258	1 Instruments for Endoscopic Subfascial Discision of Perforating Veins "ESDP", Model 8781	1 Richard Wolf
2	2 See section 3, Equivalent Devices	2
3	3	3
4	4	4

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1.0 Description

2.0 Intended Use

The Veins dissector (stripper) is used for the blunt preparation of tubular structures, specifically for the free-preparation of vessels, e.g. the vein saphena magma.

3.0 Technological Characteristics

There are no new technological changes on the submitted devices compared to the existing devices. The EDHV endoscope, tubes, and instruments are longer than the ESDP.

4.0 Substantial Equivalence

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

5.0 Performance Data

Performance data not generated.

6.0 Clinical Tests No clinical tests performed.

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 J. Casassa

Robert L. Casarsa Quality Assurance Manager

Date: Oct 10, 97

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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" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles connected by flowing lines, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1998

Mr. Robert L. Casarsa Manager of Quality Assurance Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, IL 60064

Re : K973943 Instruments for Endoscopic Subfacial Harvesting of Veins and Endoscopic Subfacial Discision of Perforating Veins Regulatory Class: II (two) Product Code: 78 GCJ Dated: June 23, 1998 Received: June 24, 1998

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 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, Druq, 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 Requlations, 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

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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.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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, 2 Misbrandinq by reference to premarket notification² (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K973943 Instruments for Endoscopic Subfascial Harvesting of Veins Device Name: And Endoscopic Subfascial Discision of Perforating Veins

Intended Use:

The Veins dissector (stripper) is used for the blunt preparation of tubular structures. specifically for the free-preparation of vessels, e.g. the vein saphena magma.

Contraindications;

There are no known contraindications directly related to the product. The attending physician must consider the general condition of the patient when determining if the application is appropriate. Refer to the current technical literature for additional instructions.

Combinations:

Auxiliary instruments from 3.5 mm to 5.5 mm diameter are used through the operation channel. Refer to the corresponding auxiliary instruction manuals.

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

Concurrence of CDRH Office of Device Evaluation

Bera R. Kemper a

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K973943

Prescription Use
Per 21 CFR 801.109

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.