The TRUCLEAR System and TRUCLEAR Morcellators are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial Polyps Retained products of conception

Device Description

Smith & Nephew's TRUCLEAR Morcellator System and TRUCLEAR Morcellators use mechanical resection to remove endometrial polyps and submucous myomas hysteroscopically from the uterus. Mechanical resection allows the surgeon to have precise control of the locations and extent of tissue resected by drawing the targeted tissue into the cutting window under suction while the inner blade cuts the tissue. There have been no major changes in design or materials in the subject TRUCLEAR Morcellator System or its associated morcellators since their market clearance.

Subject of this premarket notification is modifications to the indications for use for the Smith & Nephew, Inc. TRUCLEAR Morcellator System and its associated morcellators.

AI/ML Overview

The provided text is a 510(k) summary for the Smith & Nephew TRUCLEAR Morcellator System and TRUCLEAR Morcellators. This submission aims to modify the indications for use of an already cleared device, primarily by adding "Retained products of conception" to the list of tissues that can be resected.

The document does not describe a study that establishes acceptance criteria and then proves the device meets those criteria in the way typically expected for a novel diagnostic or AI-powered device. Instead, it is a notification for a modification to the intended use of an existing, already cleared medical device that operates via mechanical resection.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set size, etc.) are not applicable to this type of submission and are not present in the provided text.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document is a 510(k) for a change in intended use for an already cleared mechanical device, not a performance study comparing the device against specific metrics. The "performance data" mentioned refers to clinical literature supporting the additional indications, not direct device performance against pre-defined acceptance criteria.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This is not a study assessing diagnostic performance or AI algorithm accuracy. The submission relies on "Clinical literature showcasing the use of the TRUCLEAR Morcellator System and Morcellators" to support the expanded indications. There is no mention of a specific test set, its size, or data provenance for algorithmic validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. No specific test set with expert-established ground truth is described.

4. Adjudication method for the test set

Not applicable/Not provided.

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/Not provided. This device is a mechanical morcellator, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

Not applicable/Not provided. This is a mechanical device.

7. The type of ground truth used

Not applicable/Not provided. For a mechanical device, performance is typically confirmed through engineering testing (e.g., tissue resection speed, morcellation efficiency, safety features like sharps exposure control), biocompatibility, and sterilization validation, not against a "ground truth" in the diagnostic sense. The clinical literature cited likely presents observational data or comparative studies of clinical outcomes for the procedure itself, not "ground truth" for an algorithm.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI device.

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

Not applicable/Not provided.

Summary of the document's approach:

The core of this 510(k) submission (K132015) is that Smith & Nephew is seeking to expand the "Indications for Use" for their already cleared TRUCLEAR Morcellator System and TRUCLEAR Morcellators.

Predicate Devices: The submission identifies several previously cleared Smith & Nephew TRUCLEAR Morcellator Systems and blades (K110038, K103389, K041774, K031787) as predicates.
Device Description and Technological Characteristics: The key point is explicitly stated: "There have been no major changes in design or materials in the subject TRUCLEAR Morcellator System or its associated morcellators since their market clearance." This means the device itself, its mechanism of action (mechanical resection), and its safety profile are considered unchanged from the previously cleared versions.
Proposed New Indications: The new proposed indications include "Retained products of conception" alongside the previously cleared "Submucous myomas" and "Endometrial Polyps."
Performance Data (Justification for new indications): Rather than presenting new device performance data from a specific study against acceptance criteria, the submission states: "Clinical literature showcasing the use of the TRUCLEAR Morcellator System and Morcellators support the use of TRUCLEAR for the proposed additional indications." This implies that existing published studies demonstrate the clinical utility and safety of using this type of device for resecting retained products of conception.
Conclusion: The FDA grants clearance based on the determination that the device is "substantially equivalent" to its predicates, given that there are no major design changes and that the expanded indications are supported by existing clinical literature.

In essence, for this specific 510(k), the acceptance criteria for the modification are that (a) there are no significant changes to the device itself that would raise new questions of safety or efficacy, and (b) sufficient clinical evidence (from literature) exists to support the expanded use without introducing new risks or questions about effectiveness. The "study" proving this is the body of existing clinical literature, rather than a de novo performance study.

Summary

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K132015 Page 1 of 2

510(k) Summary Smith & Nephew, Inc. TRUCLEAR Morcellator System and TRUCLEAR Morcellators

Smith & Nephew, Inc.

	150 Minuteman Road
	Andover, MA 01810


Date of Summary:	December 11, 2013
Contact Person and Address:	Bradley Heil, Regulatory Affairs Specialist
	T (901) 399-6339F (901) 566-7831
Name of Device(s):	Smith & Nephew, Inc. TRUCLEAR Morcellator System
Common Name:	Hysteroscopes and Accessories
Device Classification Name and	21 CFR 884.1690 Hysteroscopes and Accessories- Class
Reference:	=

Device Class:	Class II
Panel Code:	Obstetrics and Gynecological
Product Code:	HIH

Predicate Devices

Submitted by:

Manufacturer	Description	Submission Number	Clearance Date
Smith & Nephew, Inc.	TRUCLEAR Morcellator System	K110038	03/30/2011
Smith & Nephew, Inc.	TRUCLEAR Incisor Plus Blade 2.9	K103389	03/25/2011
Smith & Nephew, Inc.	IUR Reciprocating Morcellator	K041774	10/07/2004
Smith & Nephew, Inc.	IUR Morcellation System	K031787	12/02/2003

Device Description

Subject of this premarket notification is modifications to the indications for use for the Smith & Nephew, Inc. TRUCLEAR Morcellator System and its associated morcellators.

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Intended Use

The predicate devices listed above are 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. The new proposed indications reword the general indication and specifically list retained products of conception.

Technological Characteristics

There have been no major changes in design or materials in the subject TRUCLEAR Morcellator System or its associated morcellators since their market clearance. As such, the technological characteristics of the TRUCLEAR Morcellator System or its associated morcellators have not changed.

Performance Data

Clinical literature showcasing the use of the TRUCLEAR Morcellator System and Morcellators support the use of TRUCLEAR for the proposed additional indications.

Conclusion

This Traditional 510(k) Premarket Notification is being submitted to modify the indications for use for the Smith & Nephew, Inc. TRUCLEAR Morcellator System and associated morcellators. Based on the similarities to the predicate components and published articles supporting the additional indications, the devices are substantially equivalent to their predicates.

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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 consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 29, 2014

Smith & Nephew, Inc. Bradley Heil Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810

Re: K132015

Trade/Device Name: TRUCLEAR Morcellator System and TRUECLEAR Morcellators Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated (Date on orig SE ltr): November 15, 2013 Received (Date on orig SE ltr): November 18, 2013

Dear Bradley Heil,

This letter corrects our substantially equivalent letter of December 13, 2013.

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications for Use Statement

510(k) Number: K132015

Device Name: TRUCLEAR Morcellator System and TRUCLEAR Morcellators

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801.109)

AND/OR

Over-the-Counter Use _ (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2014.01.29 15:28:15-05'00'

Page 1 of 1

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.