CONTINUOUS FLOW HYSTERO-RESECTOSCOPE, KNIFE ELECTRODE, SPIKE ELECTRODE, VAPORISATION ELECTRODE, COAGULATION ELECTRODE, C by HENKE SASS WOLF OF AMERICA, INC.

The Henke Sass Wolf Hysterscopic Resectoscopes and Accessories are intended to enable the viewing and resection/coagulation of soft tissue encountered in but not limited to gynecologic, urologic diagnostic and surgical procedures.

The HENKE SASS WOLF Hysteroscopic Resectoscopes are intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. The HENKE SASS WOLF Resectoscopes and Accessories will include the Sheaths - to establish portals for visualization and surgical access and the electrode devices indicated for resection/coagulation for soft tissue and are intended for the use with the compatible resectoscopes.

The Resectoscopes and Accessories are indicated for use in diagnostic examination and therapeutic surgical procedures of but not limited Urological and Gynecological Fields. The surgical applications to: may include:

Tissue Cutting, removal, and dissection as required or encountered in but not limited to:

Excision of intrauterine myomas
Excision of intrauterine polyps
Lysis of intrauterine adhesions
. Incision of uterine septa

Device Description

The HENKE-SASS, WOLF Hysteroscopic Resectoscopes and Accessories are reusable handheld instruments designed for a means of performing diagnostic and therapeutic procedures. The HENKE-SASS, WOLF Hysteroscopic Resectoscopes and Accessories (available in various lengths and Sizes) have the same operating principals and intended uses as many of the competitive hysteroscopic resectoscopes and accessories already in commercial distribution

AI/ML Overview

This document is a 510(k) summary for a medical device (Hysteroscopic Resectoscope and Accessories), and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics.

Therefore, the information requested for a detailed study demonstrating acceptance criteria is not present in the provided text. The document relies on the "same operating principles and intended uses" and "identical material and design" as already marketed predicate devices to establish safety and efficacy.

Here's a breakdown of why each requested point cannot be answered from the provided text:

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

Not available. The document does not specify quantitative acceptance criteria for device performance (e.g., specific thresholds for cutting efficacy, coagulation efficiency, or instrument durability). It states that the device is "same as the predicate devices" in function and "utilize material and design is identical to the predicate devices."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available. There is no mention of a specific test set, clinical study, or data associated with direct performance evaluation of this new device. The "data" implicitly refers to the long-standing safety record and performance of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not available. No ground truth establishment experts are mentioned because there's no specific test set or clinical data presented for this new device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not available. No test set or adjudication process is mentioned.

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 device is a surgical instrument (Hysteroscopic Resectoscope), not an AI-powered diagnostic or imaging interpretation tool. Therefore, MRMC studies and AI assistance are not relevant to its function.

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

Not applicable. This is a physical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not available for this specific device. The "ground truth" for demonstrating safety and efficacy indirectly relies on the established performance and safety record of the predicate devices in clinical use.

8. The sample size for the training set

Not applicable. This is a physical surgical instrument, not a learning algorithm or AI.

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

Not applicable. See point 8.

Summary of available information regarding safety and effectiveness:

The provided 510(k) summary establishes substantial equivalence based on the following:

Identical Operating Principles and Intended Uses: "The HENKE SASS WOLF Resectoscope and Accessories have the same operating principals and intended uses as many of the competitive resectoscopes and accessories already in commercial distribution."
Identical Material and Design: "The resectoscope and accessories utilize material and design is identical to the predicate devices (Manufactured by HENKE SASS WOLF on an OEM basis)."
Predicate Devices: A list of several predicate hysteroscopic resectoscopes and accessories is provided, implying that the safety and efficacy of the new device are derived from the established safety and efficacy of these legally marketed devices.
Manufacturing Standards: The device is manufactured according to cGMPs, ISO 9001/EN 46001, AAMI/ASTM standards, and EN/IEC 60601 Standards.

In essence, for a Class II device like this undergoing a 510(k) process, the "study that proves the device meets the acceptance criteria" is the demonstration of substantial equivalence to predicate devices, which are already accepted as safe and effective. No new, specific performance study with acceptance criteria is presented in this summary document.

Summary

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OCT 1 3 1999

K991563

510(k) Summary / Statement
Submitters Name:	HENKE- SASS, WOLF of America, Inc.Soroco Industrial Part, Rte. 131529 Ashland AvenueSouthbridge, MA 01550Ph: 508-764-3200 Fax: 508-764-8242
Contact Name:	Ellen Henke, Official Correspondent for SubmissionWayne Knupp, Jr., Director Sales & Marketing-HENKE SASS WOLF
Name of Device:	Hysteroscopic Resectoscope and Accessories
	SAFETY & EFFECTIVENESS DATA SUMMARY
Classification Name:	Hysteroscopic Resectoscope and Accessories
Common/Usual Name:	Resectoscope and Accessories
Proprietary Name:	N/A

Classification: Class II
Hysteroscopic Resectoscope	Reg. # 884.1690	Code # 85 HIH
Endoscopic Electrosurgical Instruments and Accessories	Reg. # 878.4400	Code # 79 JOS

Performance Standards: Devices are manufactured according to cGMP's, Applicable Harmonized Standards ISO 9001/EN 46001, applicable AAMI/ASTM standards, EN/IEC 60601 Standards.

Material Composition: Surgical grade Stainless Steel (300 Series), Commercially pure titanium , Anodized Aluminum Type 6061, DELRIN or P.E.E.K. Glass (Type BK-7) or Optical Grade Pure Sapphire, Type Z , and PTFE. There are no significant differences to the materials, design or other noted features.

Intended Use: The Henke Sass Wolf Hysterscopic Resectoscopes and Accessories are intended to enable the viewing and resection/coagulation of soft tissue encountered in but not limited to gynecologic, urologic diagnostic and surgical procedures.

Device Description: The HENKE-SASS, WOLF Hysteroscopic Resectoscopes and Accessories are reusable handheld instruments designed for a means of performing diagnostic and therapeutic procedures. The HENKE-SASS, WOLF Hysteroscopic Resectoscopes and Accessories (available in various lengths and Sizes) have the same operating principals and intended uses as many of the competitive hysteroscopic resectoscopes and accessories already in commercial distribution

Predicate Devices: Henke Sass Wolf GmbH Hysterscopes and Accessories; Smith& Nephew Dyonics Hysterscopes and Accessories, Cooper Surgical RG-27 Series Resectoscope and Accessories , Cooper Surgical HT4 Series Hysterscopes and Accessories, Karl Storz Endoscopic Hysterscopes and K954050, Richard Wolf GmbH Hysterscopes and Accessories, Gyrus Axipoler™, Omnitech Systems Inc. Resectoscope Electrodes.

Comparison of Technological Characteristics: The resectoscope and accessories utilize material and design is identical to the predicate devices (Manufactured by HENKE SASS WOLF on an OEM basis). In function, the resectoscope and accessories are the same as the predicate devices.

Safety and Efficacy Information: The HENKE SASS WOLF Resectoscope and Accessories have the same operating principals and intended uses as many of the competitive resectoscopes and accessories already in commercial distribution.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 1999

Henke Sass Wolf of America, Inc. c/o Ellen J. Henke European Surgical, Inc. 73 Eagles Nest Road Duxbury, Massachusetts 02332

Re: K991563 Hysteroscopic Resectoscopes and Accessories

Dated: September 2, 1999 Received: September 7, 1999 Regulatory Class: II 21 CFR §884.1690/Procode: 85 HIH

Dear Ms. Henke:

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, Drug, 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 III (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 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 device in the Federal Register. Please note: this 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) 594-4613. 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"(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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Hysteroscopic Resectoscopes and Accessories: Device Name:

K991563

Indications For Use:

::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Tissue Cutting, removal, and dissection as required or encountered in but not limited to:

- Excision of intrauterine myomas
મ Excision of intrauterine polyps
- Lysis of intrauterine adhesions
- . Incision of uterine septa

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David L. Skaggs

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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 § 884.9.