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

Device Description

Smith & Nephew's TRUCLEAR Operative Hyteroscope is a rigid hysteroscope 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 inflow-channel.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew TRUCLEAR Operative Hysteroscope:

This document is a 510(k) Summary of Safety and Effectiveness for a medical device seeking substantial equivalence to a predicate device, not a report on a clinical study for a novel AI or diagnostic device. Therefore, many of the requested fields (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone algorithm performance) are not applicable as the submission focuses on engineering and performance testing to demonstrate equivalence, rather than a clinical efficacy study with human interpretation of data.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests/Criteria	Reported Device Performance
Optical Performance	Brightness	Demonstrated substantial equivalence to predicate device.
	Vignetting	Demonstrated substantial equivalence to predicate device.
	Resolution	Demonstrated substantial equivalence to predicate device.
	Near and Far Focus	Demonstrated substantial equivalence to predicate device.
	Image Run Out	Demonstrated substantial equivalence to predicate device.
	Depth of Field	Demonstrated substantial equivalence to predicate device.
	Image Distortion	Demonstrated substantial equivalence to predicate device.
Mechanical/Physical	Sheath Force Testing	Performed comparably to predicate device under similar conditions.
	Working Channel Instrument Compatibility Testing	Performed comparably to predicate device under similar conditions.
Electrical Safety	Compliance with IEC 60601-2-18 and IEC 60601 standards	Complies with applicable portions of these standards.
Cleaning & Sterilization	Cleaning and Sterilization Validations	Successfully passed validations per AAMI TIR 30 and AAMI TIR 12.
Biocompatibility	Biocompatibility Requirements	All materials demonstrated to meet biocompatibility requirements according to FDA General Program Memorandum #G95-1, Use of International Standards ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".
Overall Conclusion	Safety and Effectiveness	Optical and performance testing demonstrates that the proposed device is as safe, effective and performs as well as or better than the predicate.

The "study" that proves the device meets the acceptance criteria is the sum of these various performance, optical, electrical, and materials testing. The objective was to demonstrate substantial equivalence to the predicate device (Smith & Nephew Operative Hysteroscope cleared in K013870) based on these technical characteristics.

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

Sample Size: Not applicable in the context of a 510(k) for a physical medical device. The "test set" would refer to the specific physical units of the TRUCLEAR Operative Hysteroscope that underwent the various performance, optical, mechanical, and safety tests. The document does not specify the number of units tested. This kind of submission typically involves engineering and bench testing rather than patient data.
Data Provenance: Not applicable in the context of patient data. The testing was likely conducted in laboratories or facilities belonging to Smith & Nephew or a contracted testing organization, presumably in the USA given the company address. This is engineering/bench data, not clinical data from patients.

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)

Not applicable. Establishing ground truth by experts is relevant for diagnostic devices that process clinical data (e.g., images, signals) and require human interpretation as a gold standard. For this physical hysteroscope, the "ground truth" for its performance is determined by objective measurements against established engineering, optical, and safety standards and comparison to the predicate device's known performance.

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

Not applicable. Adjudication methods are typically used in clinical studies where human readers or interpreters might disagree on an outcome. This document describes engineering and performance testing.

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 is not mentioned and is not relevant for a 510(k) submission of a physical hysteroscope which is not an AI diagnostic device.

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

No. This is not an algorithm or AI device. It is a physical instrument.

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

The "ground truth" used for this submission is based on engineering specifications, recognized national and international standards (e.g., IEC 60601, ISO 10993, AAMI TIR), and the established performance characteristics of the predicate device. The objective was to show that the new device met these objective criteria and performed comparably to the legally marketed predicate.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary

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K112134

We are smith&nephew

Endoscopy Smith & Nenhew Inc 150 Minuteman Road Andover, MA 01810 USA

T 978 749 1000 F 978 740 1500 www.smith-nephew.com

NOV 2 2 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. Smith & Nephew TRUCLEAR Operative Hysteroscope Date Prepared: July 15, 2011

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:	Smith & Nephew TRUCLEAR Operative Hysteroscope
Common Name:	Hysteroscope
Classification Name:	Hysteroscope and Accessories per CFR §884.1690

D. Predicate Device

The predicate device is the Smith & Nephew Operative Hysteroscope cleared in K013870.

E. Description of Device

F. Intended Use

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

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>< We are smith&nephew

Comparison of Technological Characteristics ে

The Smith & Nephew TRUCLEAR Operative Hysteroscope 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 Smith & Nephew TRUCLEAR Operative Hysteroscope has the following similarities as the predicate device cleared in K013870:

the same indications for use .
utilizes the same operating principle .
. incorporates the same basic mechanical design.
. manufactured under the same Quality System.

The Smith & Nephew TRUCLEAR Operative Hysteroscope differs from the predicate Smith & Nephew Operative Hysteroscope cleared in K013870 in that:

. The overall diameter of the operative hysteroscope with sheath has been reduced from 9 mm to a minimum of 5.5 mm.
The rod/lens design has been replaced by an imaging bundle. The imaging bundle . transmit the image similar to the rod/lens design as both designs relay an image through a fiber bundle or rod/lenses from the objective lens to the eyepiece.
. The working length of the operative hysteroscope and sheath has been increased.

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

H. Summary Performance Data

The Smith & Nephew TRUCLEAR Operative Hysteroscope optical performance testing has demonstrated that the operative hysteroscope is substantially equivalent to the predicate Smith & Nephew Operative Hysteroscope (K013870). Optical performance tests included brightness, vignetting, resolution, near and far focus, image run out, depth of field and image distortion testing.

Performance tests included sheath force testing and working channel instrument compatibility testing.

Optical and performance testing demonstrated that the Smith & Nephew TRUCLEAR Operative performed comparably under similar conditions.

Additionally, the Smith & Nephew TRUCLEAR Operative Hysteroscope complies with applicable portions of IEC 60601-2-18 and IEC 60601 electrical standards and has successfully passed cleaning and sterilization validations per AAMI TIR 30 and AAMI TIR 12.

All materials have been demonstrated to meet biocompatibility requirements according to FDA General Program Memorandum #G95-1, Use of International Standards ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".

In conclusion, the optical and performance testing demonstrates that the proposed device is as safe, effective and performs as well as or better than the predicate.

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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 consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the top half of the circle.

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

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

NOV 2 2 2011

Re: K112134

Trade/Device Name: Smith & Nephew TRUCLEAR Operative Hysteroscope Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: October 25, 2011 Received: October 26, 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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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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Hubert Lewin, MD

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

510(k) Number (if known):

Smith & Nephew TRUCLEAR Operative Hysteroscope Device Name:

Indications For Use:

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

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hebert Kern

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K112134

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.