K Number

Device Name

TruClear Elite Hysteroscope

Manufacturer

Covidien

Date Cleared

2018-08-29

(184 days)

Product Code

HIH

Regulation Number

884.1690

Intended 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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K013870, K152143

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical and optical hysteroscope with no mention of software, image processing, AI, or ML.

Therapeutic

Yes
The device is used for performing diagnostic and operative procedures within the cervical canal and uterine cavity, which are therapeutic functions.

Diagnostic

No
The device is used for "viewing... for the purpose of performing diagnostic and operative procedures," but it is an instrument for visualization, not a device that itself produces a diagnosis.

SaMD (Software as a Medical Device)

The device description clearly states it is a reusable stainless steel instrument with physical components like rod-lens optics, optical fibers, and a working channel, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Function: The TruClear Elite Hysteroscope is a surgical instrument used to visualize and perform procedures inside the human body (in vivo). It allows a physician to see the cervical canal and uterine cavity directly.
Lack of Specimen Analysis: The description does not mention the device being used to analyze any specimens taken from the patient. Its primary function is visualization and facilitating surgical procedures.

Therefore, based on the provided information, the TruClear Elite Hysteroscope is a surgical endoscope, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

HIH

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cervical canal and uterine cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-clinical bench testing was conducted to support the subject device.

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

Key Metrics

Not Found

Predicate Device(s)

K013870, K152143

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

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

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:

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 &
Nephew
Operative
Hysteroscope
and Accessories
are used to
permit viewing
of the cervical
canal and
uterine cavity for
the purpose of
performing	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	The TruClear™
Elite
Hysteroscope
is used to
permit viewing
of the cervical
canal and
uterine cavity
for the purpose
of performing
diagnostic and	The TruClear™
Elite
Hysteroscope
is used to
permit viewing
of the cervical
canal and
uterine cavity
for the purpose
of performing
diagnostic and
operative
	diagnostic and
surgical
procedures	of performing
diagnostic and
surgical
procedures.	operative
procedures	procedures
Materials of
Construction	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 5.5
by 5.4]	[D shaped 5.5
by 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 Halide
and Xenon	Metal Halide
and Xenon	Metal Halide
and Xenon	Metal Halide
and 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 Transmitted
to 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 Working
Distance (lp/mm)	8.5	3	8	8
Distortion	-26% barrel	-23% barrel	-22% barrel	-22% barrel

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.