TRUCLEAR Operative Hysteroscope 5C and Sheath 5C

K152143 · Smith & Nephew, Inc. · HIH · Sep 2, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K152143
• Device Name: TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
• Applicant: Smith & Nephew, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Sep 2, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

The TRUCLEAR Operative Hysteroscope 5C and Sheath 5C are rigid hysteroscopes used for visualizing the cervical canal and uterine cavity. The device features a slanted distal tip, a modified outer diameter, and relocated outflow holes compared to the predicate. It incorporates an optical fiber bundle design to minimize the needle diameter while maintaining a 'D'-shaped working channel that doubles as an inflow channel for instrumentation. Used in office-based settings, hospitals, and ambulatory surgical centers by physicians, the device allows for diagnostic and surgical interventions. The healthcare provider views the uterine cavity through the hysteroscope to guide surgical procedures, potentially improving patient outcomes by facilitating minimally invasive access to the uterine environment.

Clinical Evidence

Bench testing only. Testing included dimensional inspection, flow and visualization (average time to clear vision 14.2 seconds), insertion force (29% reduction compared to predicate), and packaging/shipping validation.

Technological Characteristics

Rigid hysteroscope with slanted distal tip. Features optical fiber bundle design and 'D'-shaped working/inflow channel. Dimensions modified from predicate. No energy source or software components described.

Indications for Use

Indicated for patients requiring diagnostic or surgical procedures of the cervical canal and uterine cavity.

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

• TRUCLEAR Operative Hysteroscope 5.0 and Sheath 5.6 (K112134)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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 [e-mail]

"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.<br>150 Minuteman Rd<br>Andover, MA 01810 |
|----------------------------------------------|--------------------------------------------------------------------------------|
| Date of Summary: | September 1, 2015 |
| Contact Person and Address: | Bradley Heil<br>Regulatory Affairs Manager<br>T 901-399-6339<br>F 901-566-7831 |
| Name of Device: | TRUCLEAR Operative Hysteroscope 5C and Sheath 5C |
| Common Name: | Hysteroscope and Accessories |
| Device Classification Name and<br>Reference: | Class II<br>21 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 | Submission<br>Number | Clearance Date |
|----------------------|----------------------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | TRUCLEAR Operative<br>Hysteroscope 5.0 and Sheath<br>5.6 | K112134 | 11-22-2011 |

### 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.

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

### Intended Use

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.

# 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.