The "ESDP" instrument set is used for minimally invasive visualization and diagnostic and therapeutic procedures of superficial veins in the lower extremities, e.g. the saphenous vein. The intervention takes place under sterile conditions.

Device Description

The device consists of an operating telescope, endoscopic operating tube, a laser guide, and a hook knife.

AI/ML Overview

The provided text does not contain information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.

The document is a 510(k) summary for a medical device (Instruments for Endoscopic Subfascial Discission of Perforating Veins (ESDP)) and explicitly states:

"Performance Data 5.0 No data generated."
"Clinical Tests 6.0 No clinical tests performed."
"Data Conclusions 7.0 No data available."

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. This device was cleared based on substantial equivalence to predicate devices, not on performance data from a specific study against acceptance criteria.

Summary

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

510(k) Summary of Safety and Effectiveness
K964258 JAN 16 1997
Company / Institution name:RICHARD WOLF MEDICAL INSTRUMENTS CORP.Division name (if applicable):N.A.Street address:353 Corporate Woods ParkwayCity:Vernon HillsState/Province:IllinoisCountry:USAContact name:Mr. Robert L. CasarsaContact title:Quality Assurance Manager		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	Contact name:	Mr. Robert L. Casarsa	Contact title:	Quality Assurance Manager	Date of Preparation:October 21, 1996FDA establishment registration number:14 184 79Phone number (include area code):(847) 913-1113FAX number (include area code):(847) 913-0924ZIP / Postal Code:60061	Date of Preparation:	October 21, 1996	FDA establishment registration number:	14 184 79	Phone number (include area code):	(847) 913-1113	FAX number (include area code):	(847) 913-0924	ZIP / Postal Code:	60061
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
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager
Date of Preparation:	October 21, 1996
FDA establishment registration number:	14 184 79
Phone number (include area code):	(847) 913-1113
FAX number (include area code):	(847) 913-0924
ZIP / Postal Code:	60061
Product Information
Trade name:Instruments for Endoscopic SubfascialDiscision of Perforating Veins (ESDP)Common name:Operating TubesOperating TelescopeLaser GuideKnife		Trade name:	Instruments for Endoscopic SubfascialDiscision of Perforating Veins (ESDP)	Common name:	Operating TubesOperating TelescopeLaser GuideKnife	Model number:8781Classification name:Endoscopic Accessories		Model number:	8781	Classification name:	Endoscopic Accessories
Trade name:	Instruments for Endoscopic SubfascialDiscision of Perforating Veins (ESDP)
Common name:	Operating TubesOperating TelescopeLaser GuideKnife
Model number:	8781
Classification name:	Endoscopic Accessories
Information on devices to which substantial equivalence is claimed:
510(k) Number	Trade or proprietary or model name	Manufacturer
1	1 see Contents of submission	1
2	2	2
3	3	3
4	4	4
5	5	5
6	6	6

1.0 Description

The device consists of an operating telescope, endoscopic operating tube, a laser guide, and a hook knife.

2.0 Intended Use

3.0 Technological Characteristics

There are no significant technological characteristics of the new device compared to the existing device.

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

Substantial Equivalence 4.0

Substantial Equivalence
The ESDP systems substantially equivalent to devices sold or previously sold by Richard Wolf The ESDP systems substantially equivalent to devices sold of provider, on a specifically in the mail.
Medical Instruments. Specifically models 8981.01, 8449.20, 8960.01.02/.0 and 8267.10.

Performance Data 5.0

No data generated.

Clinical Tests 6.0 No clinical tests performed.

Data Conclusions 7.0 No data available.

By: Robert L. Casares

Robert L. Casarsa Quality Assurance Manager

Date: Oct 21, 96

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.