The TruClear Elite Hysteroscope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

Device Description

TruClear™ Elite Hysteroscopes are reusable instruments for use in visualizing the uterine cavity and performing diagnostic and operative procedures. The TruClear™ Elite Hysteroscopes are stainless steel instruments designed with a rod-lens optical channel for visualization, optical fibers for illumination, and a working channel to permit introduction of instrumentation.

The subject Truclear™ Elite Hysteroscopes Plus (7.25mm) and Mini (6mm) are modifications to the previously cleared Smith & Nephew Operative Hysteroscopes 8.0 (K013870) and 5C (K152143). Both the Truclear™ Elite Plus and Mini Hysteroscopes are rigid hysteroscopes with a slanted distal tip, rod lens optics and disposable proximal fluid seal.

The TruClear™ Elite Hysteroscopes are composed of the working channel insert and the hysteroscope body. The device is designed to be disassembled for access to interior lumens during cleaning and sterilization. Like the predicate devices, the subject devices have an inflow and outflow channel to provide continuous flow during the clinical procedure. The inflow channel passes through the hysteroscope body and provides operative fluid from a fluid management system or pressurized saline bag to distend the uterine cavity. The outflow channel which is contained within the working channel insert, clears the uterine cavity to maintain visualization. The outflow channel also acts as the instrument channel through which the tissue removal device is inserted.

AI/ML Overview

This document describes the TruClear™ Elite Hysteroscopes, a medical device designed for viewing the cervical canal and uterine cavity for diagnostic and operative procedures. It is a reusable instrument with a rod-lens optical channel, optical fibers for illumination, and a working channel.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of AI/ML device submissions. Instead, it demonstrates substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical performance testing.

The document lists various non-clinical bench tests performed to support substantial equivalence. For optical characteristics, some performance metrics are provided in comparison to the predicate devices.

Metric (Acceptance Criteria Implicitly Compared to Predicate)	Predicate K013870 (Smith & Nephew Operative Hysteroscope 8.0)	Predicate K152143 (Smith & Nephew TRUCLEAR Operative Hysteroscope 5C)	TruClear™ Elite Hysteroscope Plus (K180496) (Reported Performance)	TruClear™ Elite Hysteroscope Mini (K180496) (Reported Performance)
Indications for Use Statement	"used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures"	"used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures."	"is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures"	"is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures"
Material of Construction	Stainless Steel, PEEK, Sapphire, Optical Glass	Stainless Steel, PEEK, Sapphire, Optical Glass	Stainless Steel, PEEK, Sapphire, Optical Glass	Stainless Steel, PEEK, Sapphire, Optical Glass
Working Length (mm)	191.5 (scope), 168 (sheath)	219 (scope), 205 (sheath)	201.1	201.1
Outer Diameter (mm)	8.5	5.25	7.25	6
Working Channel Diameter (mm)	D shaped 5.5 by 5.4	D shaped 5.5 by 5.4	4.2	3.1
Distal Tip Shape	Flat	Slanted	Slanted	Slanted
Working Channel Closure	Stopcock	Stopcock	Seal	Seal
Recommended Light Source	Metal Halide and Xenon (≤ 300 W)	Metal Halide and Xenon (≤ 300 W)	Metal Halide and Xenon (≤ 300 W)	Metal Halide and Xenon (≤ 300 W)
Focal Length (mm)	1.3	0.6	1.02	1.02
Working Distance (mm)	30	10	30	30
Field of View (Degrees)	80	85	80	80
Direction of view (Degrees)	0	0	0	0
Optics (Image Transmission System)	Rod lens	Fiber optic (Image bundle)	Rod lens	Rod lens
Ratio of Luminous Energy Transmitted to Energy Delivered	23.5% (12%)	15.6% (12.8%)	23.5%	23.5%
Eyepiece Magnification	21x	37x	19.4x	19.4x
Resolution @ 30 mm Working Distance (lp/mm)	8.5	3	8	8
Distortion	-26% barrel	-23% barrel	-22% barrel	-22% barrel

Note: The "acceptance criteria" here are implicitly that the new devices perform comparably to, or demonstrate equivalent safety and effectiveness as, the predicate devices. The document explicitly states: "The subject and predicate devices have different technological characteristics, including dimensions, device design, and optical characteristics. These differences do not raise different questions of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

The provided document details non-clinical bench testing. It does not mention a "test set" in the context of patient data or clinical imagery. Therefore, information regarding:

Sample size used for a test set (clinical data),
Data provenance (country of origin, retrospective or prospective),

is not applicable to this submission as it focuses on physical device performance and equivalence to a predicate, not AI/ML algorithm evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since this is a submission for a physical medical device (hysteroscope) and not an AI/ML algorithm requiring image interpretation or diagnostic accuracy assessment, there is no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

As there is no mention of a clinical "test set" requiring expert interpretation or ground truth establishment, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this document. This type of study is typically performed to evaluate the impact of AI assistance on human reader performance, which is not relevant for this physical device submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. The device is an optical instrument (hysteroscope) which is used by a human operator for direct visualization. It is not an AI/ML algorithm.

7. The Type of Ground Truth Used

For the non-clinical bench testing, the "ground truth" would be established by engineering standards, physical measurements, and validated testing protocols for device performance characteristics (e.g., resolution measured by optical equipment, flow rates measured by flow meters, material properties, sterility validation). In a regulatory context, the "ground truth" for substantial equivalence is defined by demonstrating that the new device is as safe and effective as the predicate device(s) for its intended use, supported by these engineering and performance tests.

8. The Sample Size for the Training Set

As this is a submission for a physical medical device and not an AI/ML algorithm, there is no concept of a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set mentioned or applicable for this device, the method for establishing its ground truth is not applicable.

Summary

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August 29, 2018

Covidien Heather L. Harvey, MS, RAC Regulatory Affairs Specialist 60 Middletown Ave. North Haven, CT 06473

Re: K180496

Trade/Device Name: TruClear™ Elite Hysteroscopes Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: July 27, 2018 Received: July 30, 2018

Dear Heather L. Harvey:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews -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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Indications for Use

510(k) Number (if known) K180496

Device Name TruClear™ Elite Hysteroscopes

Indications for Use (Describe)

The TruClear Elite Hysteroscope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K180496

Date Prepared:

February 23, 2018

Submitter:

Covidien 60 Middletown Avenue North Haven, CT 06473

Contact:

Harvev L Heather Regulatory Affairs Specialist Telephone: (781) 577-5871 (203) 492-5029 Fax: heather.l.harvey@medtronic.com Email:

Name of Device:

Trade/Proprietary Name:	TruClear™ Elite Hysteroscopes
Common Name:	Hysteroscope
Class:	Class II
Regulation:	21 CFR 884.1690, Hysteroscope and Accessories
Panel Code:	Obstetrics and Gynecology
Product Code:	HIH (Hysteroscope and accessories)

Predicate Device:

Trade/Proprietary Name:	Smith & Nephew TRUCLEAR Operative Hysteroscope 8.0 &
Smith & Nephew TRUCLEAR Operative Hysteroscope 5C
Common Name:	Hysteroscope
Classification Name:	Hysteroscope & Accessories, HIH, 21 CFR 884.1690
510(k) Number:	K013870. K152143
Manufacturer:	Smith & Nephew, 150 Minuteman Drive, Andover, MA

The predicate devices have not been subject to a design related recall.

Device Description:

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Indications for Use:
The TruClear Elite Hysteroscope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures. Predicate Device Comparison:

			K180496	K180496
Device & Predicate Device(s):	K013870	K152143	Truclear Elite	Truclear Elite
			Hysteroscope	Hysteroscope
			Plus	Mini
Indication for Use Statement	The Smith &NephewOperativeHysteroscopeand Accessoriesare used topermit viewingof the cervicalcanal anduterine cavity forthe purpose ofperforming	The Smith &NephewTRUCLEAROperativeHysteroscope5C and Sheath5C are used topermit viewingof the cervicalcanal and theuterine cavityfor the purpose	The TruClear™EliteHysteroscopeis used topermit viewingof the cervicalcanal anduterine cavityfor the purposeof performingdiagnostic and	The TruClear™EliteHysteroscopeis used topermit viewingof the cervicalcanal anduterine cavityfor the purposeof performingdiagnostic andoperative
	diagnostic andsurgicalprocedures	of performingdiagnostic andsurgicalprocedures.	operativeprocedures	procedures
Materials ofConstruction	Stainless Steel,PEEK,	Stainless Steel,PEEK,	Stainless Steel,PEEK,	Stainless Steel,PEEK,
	Sapphire,Optical Glass	Sapphire,Optical Glass	Sapphire,Optical Glass	Sapphire,Optical Glass
Device Components
Dimensions

Working Length (mm)	191.5 (scope)168 (sheath)	219 (scope)205 (sheath)	201.1	201.1
Overall Channel Length (mm)	280	334	Not provided	Not provided
Outer Diameter (mm)	8.5	5.25	7.25	6
Working Channel Diameter (mm)	[D shaped 5.5by 5.4]	[D shaped 5.5by 5.4]	4.2	3.1
Device Design
Distal Tip Shape	Flat	Slanted	Slanted	Slanted
Working Channel Closure	Stopcock	Stopcock	Seal	Seal
Compatible Light Source
Recommended Light source	Metal Halideand Xenon	Metal Halideand Xenon	Metal Halideand Xenon	Metal Halideand Xenon
Power Rating of Light source (watts)	≤ 300 W	≤ 300 W	≤ 300 W	≤ 300 W
Optics
Objective lens
Focal Length (mm)	1.3	0.6	1.02	1.02
Working Distance (mm)	30	10	30	30
Field of View (Degrees)	80	85	80	80
Direction of view (Degrees)	0	0	0	0
Optics	Rod lens	Fiber optic(Image bundle)	Rod lens	Rod lens
Illumination fibers
Ratio of Luminous Energy Transmittedto Energy Delivered	23.5% (12%)	15.6% (12.8%)	23.5%	23.5%
Image Transmission System	Not provided	Not provided	Rod lens	Rod lens
Eyepiece
Eyepiece Magnification	21x	37x	19.4x	19.4x
Image Quality
Resolution @ 30 mm WorkingDistance (lp/mm)	8.5	3	8	8
Distortion	-26% barrel	-23% barrel	-22% barrel	-22% barrel

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The subject and predicate device have the same intended use.

The subject and predicate devices have different technological characteristics, including dimensions, device design, and optical characteristics. These differences do not raise different questions of safety and effectiveness.

Summary of Performance Testing:

To further support a determination of substantial equivalence, non-clinical bench testing was conducted to support the subject device. The specific types of non-clinical testing conducted are listed below.

1. Insertion Force Test
1. Flow Performance Test
Seal Performance Leak Test 3.
1. Image Quality Testing
1. Use Life Testing of Hysteroscopes
Shelf Life of Hysteroscope Seal (Functional Performance and Package Integrity) 6.
1. Biocompatibility
1. Reprocessing Validation of Hysteroscope
1. Sterilization Validation of Hysteroscope Seal
1. Seal Integrity Testing
1. Distribution Testing
1. Electrical Safety Testing per IEC 60601-1:2005
1. EMC Testing per IEC 60601-2-18:2009
1. Usability Testing per IEC 62366-1:2015

Conclusion:

The TruClear™ Elite Hysteroscopes were found to be substantially equivalent to the predicate device.

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.