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

Device Description

The IUR Reciprocating Morcellator is a disposable, sterile, reciprocating morcellator used in conjunction with the currently cleared Smith & Nephew IUR Morcellation System (K031787), to remove submucous myomas and endometrial polyps from the uterus. The reciprocating design utilizes both a rotational and reciprocating cutting mechanisms. The predicate design utilizes a rotational cutting mechanism only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Smith & Nephew IUR Reciprocating Morcellator. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or safety through extensive clinical trials as would be required for a novel device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Target)	Reported Device Performance
Safety and Performance	Does not impact safety and performance compared to the predicate device.	"In vitro testing of the IUR Reciprocating Morcellator demonstrates that the addition of new materials and the proposed design modifications does not impact the safety and performance of the proposed device."

Explanation: In the context of a 510(k) submission, the "acceptance criteria" for the new device often revolve around demonstrating that it is as safe and effective as a previously cleared predicate device. For this specific device, the primary acceptance criterion was that its design modifications (reciprocating vs. rotational cutting) and new materials did not negatively impact its safety and performance when compared to the predicate IUR Rotary Morcellator (K031787). The reported device performance, based on in vitro testing, affirmed that this criterion was met.

Study Details

Sample size used for the test set and the data provenance:
- The document mentions "in vitro testing." This suggests that the test set consisted of samples used in a laboratory setting (e.g., excised tissue, phantom materials) rather than human subjects.
- The specific sample size (e.g., number of tissue samples, number of test runs) is not specified in the provided text.
- The data provenance is not explicitly stated beyond being "in vitro testing." There is no mention of country of origin or whether it was retrospective or prospective in a human clinical sense. Being "in vitro" typically implies a controlled laboratory environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide any information regarding experts used to establish ground truth. In vitro testing typically relies on standardized measurements and objective outcomes rather than expert interpretation of results, unless the "safety and performance" criteria involve expert assessment of tissue quality post-morcellation, which is not detailed here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not mention any adjudication method. This is consistent with in vitro testing where objective measurements are usually the primary endpoints, reducing the need for human adjudication of subjective findings.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a surgical instrument (morcellator), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical tool and does not involve algorithms or AI. It inherently requires human-in-the-loop operation. The "standalone" performance here refers to the device's functional characteristics (e.g., cutting ability, structural integrity) as measured in vitro.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For in vitro testing of a mechanical device, the "ground truth" would likely be based on:
  - Objective physical measurements: such as cutting efficiency, tissue fragmentation size, power consumption, blade sharpness retention, or structural integrity under stress.
  - Comparison to predicate device performance: confirming that the new device performs within the same range or better than the predicate's known performance characteristics.
- The text does not specify the exact parameters measured, but it implies that the "safety and performance" were assessed against objective criteria through "in vitro testing."
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of algorithm development. The in vitro testing performed is for validation, not AI training.
How the ground truth for the training set was established:
- Not applicable. As there is no AI or machine learning involved, there is no training set and thus no ground truth to be established for it.

Summary

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K041774
Page 1 of 2

SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

Smith & Nephew IUR Reciprocating Morcellator

Date Prepared: June 30, 2004

A. Submitter's Name:

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

B. Company Contact

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

C. Device Name

Trade Name:	Smith & Nephew IUR Reciprocating Morcellato
Common Name:	Hysteroscopic Morcellator
Classification Name:	Hysteroscopes and Accessories

D. Predicate Devices

The Smith & Nephew Smith & Nephew IUR Reciprocating Morcellator is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution Smith & Nephew IUR Morcellator cleared in K031787.

Description of Device E.

The IUR Reciprocating Morcellator is a disposable, sterile, reciprocating morcellator used in conjunction with the currently cleared Smith & Nephew IUR Morcellation

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K041774
Page 2 of 2

System (K031787), to remove submucous myomas and endometrial polyps from the uterus. The reciprocating design utilizes both a rotational and reciprocating cutting mechanisms. The predicate design utilizes a rotational cutting mechanism only.

F. Intended Use

G. Comparison of Technological Characteristics

Both the proposed IUR Reciprocating Morcellator and the predicate IUR Rotary Morcellator, cleared in K031787, are substantially equivalent in intended use, materials and overall design dimensions. Both devices snap and lock in place into the motor drive unit of the IUR Morcellation control unit, via a latch mechanism on the outer adapter body. Based on these similarities Smith & Nephew believes that the IUR Reciprocating Morcellator is substantially equivalent to the predicate device currently on the market.

H. Summary Performance Data

In vitro testing of the IUR Reciprocating Morcellator demonstrates that the addition of new materials and the proposed design modifications does not impact the safety and performance of the proposed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2004

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

Re: K041774

Trade/Device Name: IUR Reciprocating Morcellator Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: 85 HIH Dated: September 10, 2004 Received: September 13, 2004

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 (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 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) I his letter will and in your is organization of substantial equivalence of your device to a legally premaince notification - 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 rryou debire openite at none of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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: _Smith & Nephew IUR Reciprocating Morcellator ___________________________________________________________________________________________________________________

KOYITY

Indications For Use:

The Smith & Nephew IUR Morcellation System is intended for use in gynecological The Simm & Nephew York Horeenance " "Jocologists to resect and remove endometrial tissue procedures by trained promotions, submucous myomas and endometrial polyps.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


	(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K041774
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Smith
IURith & Nephew, Inc R Reciprocating Morcellator Page 15 of 5

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.