TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS

K132015 · Smith & Nephew, Inc. · HIH · Dec 13, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K132015
• Device Name: TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
• Applicant: Smith & Nephew, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Dec 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TRUCLEAR System and TRUCLEAR Morcellators are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial Polyps Retained products of conception

Device Story

TRUCLEAR Morcellator System uses mechanical resection for hysteroscopic removal of intrauterine tissue. Surgeon operates device to draw targeted tissue into cutting window via suction; inner blade performs mechanical resection. Provides precise control over location and extent of tissue removal. Used in clinical settings by trained gynecologists. Output is physical removal of tissue. Benefits include precise, controlled resection of polyps, myomas, and retained products of conception.

Clinical Evidence

No new clinical trials conducted. Evidence consists of clinical literature supporting the use of the TRUCLEAR Morcellator System for the resection of retained products of conception.

Technological Characteristics

Mechanical resection system. No changes in design or materials from predicate devices. Operates via suction-assisted mechanical cutting. Standalone surgical instrument.

Indications for Use

Indicated for trained gynecologists to hysteroscopically resect and remove intrauterine tissue, including submucous myomas, endometrial polyps, and retained products of conception.

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 Morcellator System (K110038)
• TRUCLEAR Incisor Plus Blade 2.9 (K103389)
• IUR Reciprocating Morcellator (K041774)
• IUR Morcellation System (K031787)

Submission Summary (Full Text)

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## K132015 Page 1 of 2

### 510(k) Summary Smith & Nephew, Inc. TRUCLEAR Morcellator System and TRUCLEAR Morcellators

Smith & Nephew, Inc.

| | 150 Minuteman Road | |
|--------------------------------|------------------------------------------------------|--|
| | Andover, MA 01810 | |
| | | |
| | | |
| Date of Summary: | December 11, 2013 | |
| Contact Person and Address: | Bradley Heil, Regulatory Affairs Specialist | |
| | T [phone]<br>F [phone] | |
| Name of Device(s): | Smith & Nephew, Inc. TRUCLEAR Morcellator System | |
| Common Name: | Hysteroscopes and Accessories | |
| Device Classification Name and | 21 CFR 884.1690 Hysteroscopes and Accessories- Class | |
| Reference: | = | |
| | | |
| Device Class: | Class II | |
| Panel Code: | Obstetrics and Gynecological | |
| Product Code: | HIH | |
| | | |

#### Predicate Devices

Submitted by:

| Manufacturer | Description | Submission Number | Clearance Date |
|----------------------|---------------------------------|-------------------|----------------|
| Smith & Nephew, Inc. | TRUCLEAR Morcellator System | K110038 | 03/30/2011 |
| Smith & Nephew, Inc. | TRUCLEAR Incisor Plus Blade 2.9 | K103389 | 03/25/2011 |
| Smith & Nephew, Inc. | IUR Reciprocating Morcellator | K041774 | 10/07/2004 |
| Smith & Nephew, Inc. | IUR Morcellation System | K031787 | 12/02/2003 |

#### Device Description

Smith & Nephew's TRUCLEAR Morcellator System and TRUCLEAR Morcellators use mechanical resection to remove endometrial polyps and submucous myomas hysteroscopically from the uterus. Mechanical resection allows the surgeon to have precise control of the locations and extent of tissue resected by drawing the targeted tissue into the cutting window under suction while the inner blade cuts the tissue. There have been no major changes in design or materials in the subject TRUCLEAR Morcellator System or its associated morcellators since their market clearance.

Subject of this premarket notification is modifications to the indications for use for the Smith & Nephew, Inc. TRUCLEAR Morcellator System and its associated morcellators.

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#### Intended Use

The TRUCLEAR System and TRUCLEAR Morcellators are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial Polyps Retained products of conception

The predicate devices listed above are intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps. The new proposed indications reword the general indication and specifically list retained products of conception.

#### Technological Characteristics

There have been no major changes in design or materials in the subject TRUCLEAR Morcellator System or its associated morcellators since their market clearance. As such, the technological characteristics of the TRUCLEAR Morcellator System or its associated morcellators have not changed.

#### Performance Data

Clinical literature showcasing the use of the TRUCLEAR Morcellator System and Morcellators support the use of TRUCLEAR for the proposed additional indications.

#### Conclusion

This Traditional 510(k) Premarket Notification is being submitted to modify the indications for use for the Smith & Nephew, Inc. TRUCLEAR Morcellator System and associated morcellators. Based on the similarities to the predicate components and published articles supporting the additional indications, the devices are substantially equivalent to their predicates.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

January 29, 2014

Smith & Nephew, Inc. Bradley Heil Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810

Re: K132015

> Trade/Device Name: TRUCLEAR Morcellator System and TRUECLEAR Morcellators Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated (Date on orig SE ltr): November 15, 2013 Received (Date on orig SE ltr): November 18, 2013

Dear Bradley Heil,

This letter corrects our substantially equivalent letter of December 13, 2013.

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. Iisting 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.

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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 device-related 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert P. Lerner -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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## Premarket Notification Indications for Use Statement

510(k) Number: K132015

Device Name: TRUCLEAR Morcellator System and TRUCLEAR Morcellators

Indications for Use:

The TRUCLEAR System and TRUCLEAR Morcellators are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: Submucous myomas Endometrial Polyps Retained products of conception

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801.109)

AND/OR

Over-the-Counter Use _ (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2014.01.29 15:28:15-05'00'

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