The Henke Sass Wolf Saphenous Vein Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to the existing line of HSW 5mm Laparoscopes, differing only in working length and angle of view. The materials and basic design are identical. For the purpose of saphenous vein harvesting, a standard 5mm laparoscope is modified to extend the working length to 300mm. The laparoscope in used in conjunction with Ethicon's Endo-Surgery cannula system to provide a complete visualization system. These laparoscopes were designed to be inserted in the Ethicon sheath to help view the surgical area. To facilitate this, the laparoscope working length was modified. These laparoscopes are reusable and employed in conjunction with other cleared devices, to form a complete system.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Henke Sass Wolf Saphenous Vein Laparoscope." It's primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria for an AI-powered device.

Therefore, many of the requested sections about AI-specific criteria, studies, and ground truth are not applicable to this document. I will extract the information that is present concerning safety and effectiveness testing.

Acceptance Criteria and Study for the Henke Sass Wolf Saphenous Vein Laparoscope

This submission is for a conventional medical device, a laparoscope, and not an AI-powered device. As such, the "acceptance criteria" and "device performance" are related to established safety and performance standards for such physical medical instruments, rather than AI model metrics. The study focuses on demonstrating compliance with these standards and substantial equivalence to existing devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test Conducted	Reported Device Performance
Electrical Safety:
EN 60601-1-1	Successfully met requirements
EN 601-2-10	Successfully met requirements
Electromedical System:
EN 60601-1-1	Successfully met requirements
Substantial Equivalence:
Equivalence in Intended Use	Substantially equivalent to Stryker Saphenous Vein Harvest Laparoscope and compatible with Ethicon's Subcu-Retractor. Can also substitute for HSW 5mm Laparoscope (K941967).
Equivalence in Materials	Identical to existing HSW 5mm Laparoscopes.
Equivalence in Modes of Construction	Identical to existing HSW 5mm Laparoscopes.
Equivalence in Optical Performance	Identical to existing HSW 5mm Laparoscopes.
Equivalence in Safety	Identical to existing HSW 5mm Laparoscopes.
Differences (Working Length, Angle of View)	Modified working length to 300mm and angle of view, but materials and basic design are identical to existing HSW 5mm Laparoscopes.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in terms of a "test set" as would be used for AI/software. The testing mentioned (Electrical Safety, Electromedical System) would involve testing of physical device prototypes or production samples. The substantial equivalence argument relies on comparison to known predicate devices already on the market.
Data Provenance: Not applicable in the context of data for an AI model.

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

This information is not applicable as this is a submission for a physical medical device, not an AI or diagnostic application that would require expert-established ground truth on a test set of data.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this type of study is typically done for diagnostic imaging or AI systems where human reader performance is a key metric. This is a surgical instrument.

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

Not applicable, as this is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" here is compliance with established safety standards (EN 60601-1-1, EN 601-2-10) and physical attributes (materials, construction, optical performance, safety) matching a known, legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI or machine learning device.

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

Not applicable.

Summary

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K013611 1/2

SAFETY & EFFECTIVENESS DATA SUMMARY

Submitters Name, Address & Phone Number:	Henke Sass Wolf of AmericaSoroco Industrial Park, Rte. 131529 Ashland Ave.Southbridge, MA 01550
Submission Correspondent:	Lyle Howard Corporation203 Main Street, PMB 166

Laparoscope, General & Plastic Surgery Classification Name: Laparoscope, General & Plastic Surgery Common / Usual Name: Henke Sass Wolf Saphemous Vein Proprietary Name: Laparoscope

Flemington, NJ 08822 Attention: Lynette Howard

1222997 Establishment Registration Number:

Class II, Reg. # 876.1500, 78 GCJ General and Plastic Classification: Surgery Accessories

Performance Standards: No performance standards have been developed for this device.

Substantial Equivalence:

The HSW Saphenous Vein Laparoscope is substantially equivalent to the Stryker Saphenous Vein Harvest Laparoscope intended use and is compatible for use with the Ethicon's Subcu-Retractor for this purpose. The HSW Saphenous Vein Laparoscope can also be used as a substitute for a standard HSW 5mm Laparoscope in similar intended use applications as outlined in Laparoscope 510(k) K941967.

The intended use of the device to which we claim substantial equivalence:

For severe cases of coronary artery disease, in which blood vessel grafts are used to bypass the site of a blocked artery, a procedure known as coronary artery bypass graft surgery (CABG) is performed. To help reduce patient trauma and cost, an endoscopic technique is used in the saphenous vein harvesting procedure. This minimally invasive approach requires only a single 3-4cm incision made medial to the knee.

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Additional Information - Attachment III - January 28, 2002 Revised Page 15

The laparoscope in used in conjunction with Ethicon's Endo-Surgery cannula system to provide a complete visualization system. These laparoscopes were designed to be inserted in the Ethicon sheath to help view the surgical area. To facilitate this, the laparoscope working length was modified. These laparoscopes are reusable and employed in conjunction with other cleared devices, to form a complete system.

Testing conducted to assure safety and effectiveness include but is not limited to:

Electrical Safety:	EN 60601-1-1, EN 601-2-10
Electromedical System:	EN 60601-1-1

Proposed devices have successfully met the requirements of the above.

Description of the new device:

For the purpose of saphenous vein harvesting, a standard 5mm laparoscope is modified to extend the working length to 300mm.

Intended Use:

For use in Endoscopic Saphenous Vein harvesting procedures.

Caution: Federal (USA) law restricts this device to sale, distribution, and use by, or on the order of, a physician.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

Henke Sass Wolf of America, Inc. c/o Ms. Lynette Howard Lyle Howard Corporation 203 Main Street, PMB 166 Flemington, New Jersey 08822

Re: K013611

Trade/Device Name: Henke Sass Wolf Saphenous Vein Laparoscope Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 31, 2001 Received: November 5, 2001

Dear Ms. Howard:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass based in 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, de neces that have been 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set Errt 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.

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Page 2 - Ms. Lynette Howard

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

iriam C. Provost

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

Enclosure

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Additional Information - Attachment III - January 28, 2002 Revised Page 102

Henke Sass Wolf of America

STATEMENT OF INDICATION FOR USE

510(k) Number: K013611

Device Name:

Henke Sass Wolf Saphenous Vein Laparoscope

Indications for Use:

Intended for use in Endoscopic Saphenous Vein harvesting procedures.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K013611

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.