The TRUCLEAR™ Incisor® Plus Blade 2.9 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. The TRUCLEAR™ Incisor Plus Blade 2.9 is used specifically with the TRUCLEAR Hysteroscopic Morcellator.

The TRUCLEAR Hysteroscopic Morcellator includes:

TRUCLEAR Control Unit .
. TRUCLEAR Footswitch
. TRUCLEAR Handpiece

Device Description

The TRUCLEAR™ Incisor Plus Blade 2.9 consists of an inner and outer stainless steel tube. Both tubes have a molded hub on the proximal end and a cutting window with symmetrical teeth on the distal end. The inner tube fits into the outer tube and is snapped and locked in place into a motor drive unit, which rotates the inner tube of the device. Tissue is simultaneously shaved and suctioned through the cutting window of the disposable blade.

AI/ML Overview

Here's an analysis of the provided text regarding the TRUCLEAR™ Incisor® Plus Blade 2.9, focusing on acceptance criteria and supporting studies:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Material Shed Test: Visual aid ranking scheme met.	Demonstrated that after 6 minutes of continuous use in water, the TRUCLEAR™ Incisor Plus Blade 2.9 met the established criteria of the visual aid ranking scheme.
Cutting Performance Test: No seizing or mechanical failure.	Demonstrated that after running the blade for 15 minutes under simulated use conditions, there was no seizing or mechanical failure of the blade.

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

Sample Size: Not explicitly stated. The tests refer to "6 minutes of continuous use" for the Material Shed Test and "15 minutes under simulated use conditions" for the Cutting Performance Test. These durations likely refer to the operational time for a single blade or a set of blades, but the total number of blades or test repetitions is not specified.
Data Provenance: The study was conducted by Smith & Nephew, Inc., a medical device manufacturer based in Andover, MA, USA. The data would be considered prospective as it involves performance testing newly designed devices. There is no information regarding country of origin of the data beyond the manufacturer's location.

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

This information is not provided. For the Material Shed Test, a "visual aid ranking scheme" was used, implying some form of assessment, but the number or qualifications of individuals involved are not detailed. For the Cutting Performance Test, the criterion is "no seizing or mechanical failure," which is an objective measurement rather than an expert ground truth.

4. Adjudication method for the test set:

This information is not provided. The nature of the tests (material shed, cutting performance) suggests objective measurements and observations rather than a need for complex adjudication methods typical for subjective assessments or image-based diagnostics.

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:

No, an MRMC comparative effectiveness study was not done. This document describes performance testing for a surgical tool (hysteroscope blade), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

Not applicable. This device is a mechanical surgical tool. It does not involve an algorithm or AI.

7. The type of ground truth used:

Material Shed Test: The ground truth was based on an "established criteria of the visual aid ranking scheme." This implies a pre-defined standard for acceptable material shedding, likely involving visual inspection and comparison.
Cutting Performance Test: The ground truth was based on objective mechanical performance: "no seizing or mechanical failure of the blade." This is a physical observation.

8. The sample size for the training set:

Not applicable / Not provided. This device is a mechanical tool. There is no "training set" in the context of machine learning or algorithms. The design and manufacturing processes are refined through engineering principles and iterative testing, not through a data-driven training set.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it. The ground truth for the performance tests (material shed and cutting) are described above.

Summary

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We are smith&nephew

MAR 2 5 2011

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.

TRUCLEAR™ Incisor® Plus Blade 2.9

Date Prepared: November 17, 2010

A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road, Andover, MA 01810

B. Company Contact

Janice Haselton

Sr. Regulatory Affairs Specialist

T 978-749-1494

F 978-749-1443

C. Device Name - - -

Trade Name: TRUCLEAR™ Incisor® Plus Blade 2.9 Common Name: Hysteroscope and Accessories Hysteroscope and Accessories per CFR §884.1690 Classification Name:

D. Predicate Devices

The TRUCLEAR™ Incisor® Plus Blade 2.9 is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution, Hysteroscopic Rotary Morcellator cleared in K031787.

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K103389 page 2 of 3

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Endoscopy

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Description of Device E.

F. Indications for Use

The TRUCLEAR Hysteroscopic Morcellator includes:

TRUCLEAR Control Unit .
. TRUCLEAR Footswitch
. TRUCLEAR Handpiece

G. Comparison of Technological Characteristics

The TRUCLEAR™ Incisor® Plus Blade 2.9 has the same fundamental technological characteristics as the unmodified predicate device and is substantially equivalent in design, materials and intended use as the unmodified predicate device. The proposed TRUCLEAR™ Incisor® Plus Blade 2.9 has the following similarities as the predicate device cleared in K031787:

The same indications for use ●
Utilizes the same operating principle .
Incorporates the same basic mechanical design ●
Manufactured under the same Quality System .

The modifications to the proposed device as compared to the predicate device include:

1. Reducing the overall diameters of the inner and outer blade shafts.
1. Increasing the working length of the blade.
1. Addition of a metal sleeve covering the proximal portion of the outer tube.

The reduction in overall diameters of the blade shafts allows the blade to be used with an appropriate sized hysteroscope in office settings. The increase in the blade working length was necessary in order to be compatible with the TRUCLEAR Operative Hysteroscope.

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The addition of the metal sleeve on the proximal end of the outer tube replicates the same diameter as the predicate 4.0 Rotary blade device.

There are no significant differences between the proposed and predicate devices that raise new questions of safety or efficacy.

H. Summary Performance Data

The TRUCLEAR™ Incisor Plus Blade 2.9 performance testing has demonstrated that the proposed device is substantially equivalent to the predicate device and the proposed modifications to the size and length of the blade does not raise new questions of safety and efficacy. Performance testing consisted of a material shed test and a cutting performance test. The Shed Test demonstrated that after 6 minutes of continuous use in water the TRUCLEAR™ Incisor 9 Plus Blade 2.9 met the established criteria of the visual aid ranking scheme. The Cut Performance Test demonstrated that after running the blade for 15 minutes under simulated use conditions there was no seizing or mechanical failure of the blade.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.

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

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

MAR 2 5 2011

Re: K103389

Trade Name: TRUCLEAR™ Incisor® Plus Blade 2,9 Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: March 1, 2011 Received: March 2, 2011

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. 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.

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 of medical device-related

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Page 2

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office: of Compliance. 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/Resourcesfor You/Industry/default.htm.

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

Sincerely yours,

Herbert Kenion us

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health,

Enclosure

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Indications for Use

K103389 510(k) Number (if known):

Device Name: ' TRUCLEAR™ Incisor® Plus Blade 2.9

Indications For Use:

The TRUCLEAR™ Incisor® Plus Blade 2.9 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. The TRUCLEAR™ Incisor® Plus Blade 2.9 is used specifically with the TRUCLEAR Hysteroscopic Morcellator.

The TRUCLEAR Hysteroscopic Morcellator includes:

TRUCLEAR Control Unit .
TRUCLEAR Footswitch .
TRUCLEAR Handpiece .

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use

(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)

Arace M. Whay

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K103389

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.