The Smith & Nephew IUR Morcellation System is intended for use in gynecological procedures by trained professional gynocologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.

Device Description

The Smith & Nephew IUR Morcellation System is used to perform hysteroscopic surgery for the removal of Submucous myomas and endemontar peopator, a motor drive unit, and a motor drive control unit. Smith & Nephew's IUR Morcellation System uses mechanical resection to remove endometrial polyps and submucous myomas. The Smith & Nephew IUR Morcellation control unit meets UL 2601-1 and IEC 60601-1, electrical safety standards for BF type equipment.

AI/ML Overview

The provided document is a 510(k) summary for the Smith & Nephew IUR Morcellation System. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a detailed study proving performance is not available in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not provided in the document. The 510(k) summary focuses on substantial equivalence to predicate devices, not on proving performance against specific quantitative metrics or acceptance criteria through a clinical or performance study.

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

This information is not provided in the document. No specific test set, patient data, or study details are discussed.

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)

This information is not provided in the document. No discussion on ground truth establishment or expert involvement in a test set is present.

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

This information is not provided in the document. No adjudication method is mentioned as there is no test set or performance evaluation described.

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

This information is not provided in the document. The device described is a mechanical tissue resection system, not an AI-assisted diagnostic tool, so an MRMC study or AI-related considerations are not applicable and not mentioned.

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

This information is not provided in the document. As this is a mechanical device, the concept of "standalone algorithm performance" is not applicable.

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

This information is not provided in the document. No ground truth is discussed as there is no performance study.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" as this is not an AI/ML device.

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

This information is not provided in the document. As there is no training set, this question is not applicable.

Summary of what the document DOES provide, relevant to its purpose:

The document serves as a 510(k) summary, which aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than a performance study against specific acceptance criteria.

Predicate Devices: The Smith & Nephew IUR Morcellation System is deemed substantially equivalent in intended use and fundamental technological characteristics to:
- FemRx™ Focused Monopolar (FMP) 9002 Star System, K964441
- Smith & Nephew Dyonics Disposable Arthroscopic Blades, K953695
- Smith & Nephew Dyonics Power Control Unit, K954989
Intended Use: The device is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for submucous myomas and endometrial polyps.
Technological Characteristics Comparison: The system is stated to be substantially equivalent in design, materials of construction, function, and/or intended use to the predicate devices. It also mentions meeting electrical safety standards (UL 2601-1 and IEC 60601-1 for BF type equipment).

Conclusion:

The provided document is a regulatory submission for premarket clearance based on substantial equivalence, not a detailed study outlining acceptance criteria and device performance metrics. Therefore, most of the questions related to clinical study design, sample sizes, ground truth establishment, and performance outcomes cannot be answered from this text.

Summary

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DEC = 2 2003

Ko3/787

Endoscopy Division

Smith & Nephew, Inc. 150 Minuteman Road, Andover, MA 01810-1031 U.S.A. Telephone: 978-749-1000 Fax: 978-749-1599

Smith+Nephew

510(k) Summary Smith & Nephew IUR Morcellation System Date Prepared: June 9, 2003

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.

Submitter's Name A.

Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover, MA 01810

Company Contact B.

Janice Haselton Regulatory Affairs Specialist II Phone: (978) 749-1494 (978) 749-1443 Fax:

Device Name j

Trade Name:	Smith & Nephew IUR Morcellation System
Common Name:	Mechanical Tissue Resection System
Classification Name:	Hysteroscopes and Accessories

Predicate Devices D.

The Smith & Nephew IUR Morcellation System is substantially equivalent in intended use and fundamental The Smith & Nephon TOTC Horomanen of Junarketed device in commercial distribution. FemRx™ Focused Scientific to the Star System, K964441. The materials of construction and design are similar to the Monopolal (1 MI) K953695 and Smith & Nephew Dyonics Power Control Unit, K954989

Description of Device E.

The Smith & Nephew IUR Morcellation System is used to perform hysteroscopic surgery for the removal of I he smilli & Nephow LDI Horocalists of a ... This system incorporates the use of an operative channel Submucous myomas and endemontar peopator, a motor drive unit, and a motor drive control unit. Smith &

Smith+Nephew IUR Morcellation System Page 22 of 211

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Nephew's IUR Morcellation System uses mechanical resection to remove endometrial polyps and submucous myomas. The Smith & Nephew IUR Morcellation control unit meets UL 2601-1 and IEC 60601-1, electrical safety standards for BF type equipment.

D. Intended Use

Comparison of Technological Characteristics E.

The Smith & Nephew IUR Morcellation System is substantially equivalent in design, materials of construction, function and/or intended use to the following devices cleared for commercial distribution: FemRx™ Focused Monopolar (FMP) 9002 Star System, K964441 Smith & Nephew Dyonics Disposable Arthroscopic Blades, K953695 Smith & Nephew Dyonics Power Control Unit, K954989

Jann Haselton

Janice Haselton Regulatory Affairs Specialist II

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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 features a stylized eagle with three stripes extending from its back, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 2003

Ms. Janice Haselton Regulatory Affairs Specialist Endoscopy Smith & Nephew, Inc. 150 Minuteman Road ANDOVER MA 01810

Re: K031787

Trade/Device Name: The Smith & Nephew IUR Morcellation System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: 85 HIH Dated: September 24, 2003 Received: September 25, 2003

Dear Ms. Haselton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not 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 forth 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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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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) you may obtain. 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,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ The Smith & Nephew IUR Morcellation System

Indications For Use:

The Smith & Nephew IUR Morcellation System is intended for use in gynecological procedures I he Ghian & Replies - Norocologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR	Over-The-Counter Use ______

Prescription Use
OR
Over-The-Cou
(Per 21 CFR 801.109)

(Division Sign-Off)

Division Sign-Off) ivision of Reproductive, Abdominal,

510(k) Number

Smith+Nephew Simalineersellation System Page 25 of 211

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.