TruClear Elite Hysteroscope

K180496 · Covidien · HIH · Aug 29, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K180496
• Device Name: TruClear Elite Hysteroscope
• Applicant: Covidien
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Aug 29, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

TruClear Elite Hysteroscopes are reusable, rigid stainless steel instruments for uterine cavity visualization and operative procedures. Devices feature rod-lens optics for visualization, optical fibers for illumination, and a working channel for instrument introduction. Inflow/outflow channels maintain uterine distension and visualization via fluid management systems or pressurized saline. Used in clinical settings by physicians; device is disassembled for cleaning and sterilization. Output is direct visualization of the uterine cavity, enabling diagnostic assessment and surgical intervention. Benefits include improved visualization and access for operative procedures.

Clinical Evidence

Bench testing only. Performance testing included insertion force, flow performance, seal leak testing, image quality, use-life testing, shelf-life, biocompatibility, reprocessing validation, sterilization validation, electrical safety (IEC 60601-1), EMC (IEC 60601-2-18), and usability (IEC 62366-1).

Technological Characteristics

Rigid hysteroscope; stainless steel, PEEK, sapphire, and optical glass construction. Rod-lens optical system; fiber optic illumination. Dimensions: 7.25mm (Plus) and 6mm (Mini) outer diameters. Inflow/outflow channels for continuous fluid flow. Compatible with ≤300W metal halide/xenon light sources. Electrical safety per IEC 60601-1; EMC per IEC 60601-2-18. Reusable design; disassembled for reprocessing.

Indications for Use

Indicated for visualization of the cervical canal and uterine cavity to perform diagnostic and operative procedures in patients requiring hysteroscopy.

Regulatory Classification

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.

Predicate Devices

• Smith & Nephew TRUCLEAR Operative Hysteroscope 8.0 (K013870)
• Smith & Nephew TRUCLEAR Operative Hysteroscope 5C (K152143)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] [phone] Fax: [e-mail] 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:

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.

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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 &<br>Nephew<br>Operative<br>Hysteroscope<br>and Accessories<br>are used to<br>permit viewing<br>of the cervical<br>canal and<br>uterine cavity for<br>the purpose of<br>performing | The Smith &<br>Nephew<br>TRUCLEAR<br>Operative<br>Hysteroscope<br>5C and Sheath<br>5C are used to<br>permit viewing<br>of the cervical<br>canal and the<br>uterine cavity<br>for the purpose | The TruClear™<br>Elite<br>Hysteroscope<br>is used to<br>permit viewing<br>of the cervical<br>canal and<br>uterine cavity<br>for the purpose<br>of performing<br>diagnostic and | The TruClear™<br>Elite<br>Hysteroscope<br>is used to<br>permit viewing<br>of the cervical<br>canal and<br>uterine cavity<br>for the purpose<br>of performing<br>diagnostic and<br>operative |
| | diagnostic and<br>surgical<br>procedures | of performing<br>diagnostic and<br>surgical<br>procedures. | operative<br>procedures | procedures |
| Materials of<br>Construction | Stainless Steel,<br>PEEK, | Stainless Steel,<br>PEEK, | Stainless Steel,<br>PEEK, | Stainless Steel,<br>PEEK, |
| | Sapphire,<br>Optical Glass | Sapphire,<br>Optical Glass | Sapphire,<br>Optical Glass | Sapphire,<br>Optical Glass |
| Device Components | | | | |
| Dimensions | | | | |
| | | | | |
| Working Length (mm) | 191.5 (scope)<br>168 (sheath) | 219 (scope)<br>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<br>by 5.4] | [D shaped 5.5<br>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<br>and Xenon | Metal Halide<br>and Xenon | Metal Halide<br>and Xenon | Metal Halide<br>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<br>(Image bundle) | Rod lens | Rod lens |
| Illumination fibers | | | | |
| Ratio of Luminous Energy Transmitted<br>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<br>Distance (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
- 2. Flow Performance Test
- Seal Performance Leak Test 3.
- 4. Image Quality Testing
- 5. Use Life Testing of Hysteroscopes
- Shelf Life of Hysteroscope Seal (Functional Performance and Package Integrity) 6.
- 7. Biocompatibility
- 8. Reprocessing Validation of Hysteroscope
- 9. Sterilization Validation of Hysteroscope Seal
- 10. Seal Integrity Testing
- 11. Distribution Testing
- 12. Electrical Safety Testing per IEC 60601-1:2005
- 13. EMC Testing per IEC 60601-2-18:2009
- 14. Usability Testing per IEC 62366-1:2015

#### Conclusion:

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