The Smith & Nephew TRUCLEAR Operative Hysteroscope 5C and Sheath 5C are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Device Description

The subject TRUCLEAR Operative Hysteroscope 5C and TRUCLEAR Sheath 5C are modifications to the TRUCLEAR Operative Hysteroscope 5.0 and TRUCLEAR Sheath 5.6 previously cleared in K112134. The TRUCLEAR Operative Hysteroscope 5C is a rigid hysteroscope with a slanted distal tip that is intended for use in office based, hospital and ambulatory surgical centers. The operative hysteroscope incorporates an optical fiber bundle design in order to reduce the overall diameter of the needle portion of the hysteroscope and still provide adequate space in the working channel for instrumentation. The Smith & Nephew TRUCLEAR Operative Hysteroscope internal design consists of a "D" shaped working channel into the needle portion of the hysteroscope. The working channel also acts as an inflowchannel.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the TRUCLEAR Operative Hysteroscope 5C and Sheath 5C. This type of submission does not typically include an acceptance criteria table or a detailed study proving the device meets specific performance metrics in the way a clinical trial for a new drug or novel AI algorithm would. Instead, it focuses on demonstrating "substantial equivalence" to a legally marketed predicate device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, AI-related studies) are not applicable to this type of regulatory submission for this particular device.

Here's an analysis based on the provided text, addressing the applicable points:

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

This document does not provide a formal table of acceptance criteria with specific numerical thresholds for performance. The "acceptance criteria" are implied by the demonstration of "substantial equivalence" to the predicate device and success in the non-clinical bench testing. The reported "performance" is qualitative, showing that the device meets drawing dimensions, achieves clear vision within a certain time, and has reduced insertion force.

Acceptance Criteria (Implied)	Reported Device Performance
Meet drawing dimensions for physical specifications.	All devices met drawing dimensions.
Allow for assembly of scopes with sheaths.	All scopes could be assembled with all sheaths.
Achieve clear vision during flow and visualization testing within an acceptable timeframe.	Average time to attain clear vision was 14.2 seconds.
Exhibit comparable or improved insertion force compared to predicate device.	Showed an average 29% reduction in insertion force compared to the predicate devices.
Maintain integrity and functionality after packaging/shipping.	Product will not be damaged during shipping and will function properly post-shipping.
Function similarly to predicate devices regarding intended use and indications for use.	Substantially equivalent to predicate devices regarding intended use, indications for use, and performance characteristics.

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

Test Set Sample Size: The document does not specify the exact sample size for the individual non-clinical tests (e.g., how many hysteroscopes and sheaths were tested for dimensional inspection, flow and visualization, or insertion force). It refers to "all devices" in some instances but doesn't provide a number.
Data Provenance: The testing was "non-clinical bench testing," meaning it was conducted in a lab setting, not on human subjects. The country of origin of the data is not specified, but the applicant (Smith & Nephew, Inc.) is based in Andover, MA, USA, and the submission is to the US FDA, so it's likely conducted or overseen in the USA. The data is prospective for the purpose of this submission (i.e., new testing was performed for this modified device).

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

Not applicable. This is a bench study on a physical medical device, not an AI algorithm requiring expert consensus for ground truth on clinical images or data. The "ground truth" for these tests comes from objective measurements against engineering specifications and comparisons to the predicate device.

4. Adjudication method for the test set

Not applicable. There was no expert adjudication needed for these non-clinical bench tests. The tests involve objective measurements and observations.

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 submission is for a physical medical device (hysteroscope and sheath), not an AI-powered diagnostic tool. MRMC studies are typically relevant for evaluating the impact of AI algorithms on human reader performance.

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

Not applicable. This is for a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was based on:

Engineering specifications and drawing dimensions (for dimensional inspection).
Objective measurements (e.g., time to clear vision, insertion force measurements).
Comparison to the performance of the legally marketed predicate device (for substantial equivalence).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this physical medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

September 2, 2015

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

Re: K152143

Trade/Device Name: TRUCLEAR Operative Hysteroscope 5C and Sheath 5C. Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: July 31, 2015 Received: August 3, 2015

Dear Bradley Heil,

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152143

Device Name

TRUCLEAR Operative Hysteroscope 5C and Sheath 5C

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The text "We are" is in gray, while "smith&nephew" is in orange, matching the color of the flower symbol.

Submitted by:	Smith & Nephew, Inc.150 Minuteman RdAndover, MA 01810
Date of Summary:	September 1, 2015
Contact Person and Address:	Bradley HeilRegulatory Affairs ManagerT 901-399-6339F 901-566-7831
Name of Device:	TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
Common Name:	Hysteroscope and Accessories
Device Classification Name andReference:	Class II21 CFR 884.1690 Hysteroscope and Accessories
Panel Code:	Obstetrics and Gynecological
Product Code:	HIH

Table 1: Substantially Equivalent Predicates to the TRUCLEAR Operative Hysteroscop
5C & Sheath 5C

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew, Inc.	TRUCLEAR OperativeHysteroscope 5.0 and Sheath5.6	K112134	11-22-2011

Device Description

{4}------------------------------------------------

Intended Use

Technological Characteristics

Device comparisons described in this premarket notification, including the proposed changes of a slanted distal tip, a change in outer diameter, and the movement of the outflow holes, demonstrate that the proposed hysteroscope and sheath are substantially equivalent to the legally marketed predicate devices (listed above in Table 1) with regard to intended use, indications for use, and performance characteristics.

Summary of Pre-Clinical Testing

To further support a determination of substantial equivalence, non-clinical bench testing was conducted to support the proposed hysteroscope and sheath. Test results demonstrated that the proposed devices are substantially equivalent to the previously cleared predicate devices listed above. The specific types of non-clinical testing conducted are listed below.

. Dimensional Inspection testing was conducted to show that all devices met drawing dimensions and that all scopes could be assembled with all sheaths.
Flow and Visualization testing was also performed on the proposed devices. All devices showed an average time to attain clear vision was 14.2 seconds.
Insertion Force testing of the proposed devices showed an average 29% reduction in ● insertion force compared to the predicate devices.
Packaging/Ship Testing with visual inspection and functional testing showed that . product will not be damaged during shipping and will function properly post-shipping

Conclusion

As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for TRUCLEAR Operative Hysteroscope 5C and Sheath 5C. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the predicate operative hysteroscope/sheath listed above in Table 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.