MYOSURE ROD LENS HYSTEROSCOPE

K091465 · Interlace Medical, Inc. · HIH · Aug 21, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K091465
• Device Name: MYOSURE ROD LENS HYSTEROSCOPE
• Applicant: Interlace Medical, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Aug 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MyoSURE™ Rod Lens Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Device Story

MyoSURE™ Rod Lens Hysteroscope is a reusable, autoclavable optical instrument for visualizing the cervical canal and uterine cavity. Device consists of a 6.0 mm x 6.4 mm stainless steel tube containing a rod lens optical system, a 3.0 mm working channel, and an inflow channel with stopcock. It utilizes glass fibers for illumination and a 45° prism to direct images to an offset eyepiece. The working channel is compatible with tissue morcellators and allows for the insertion of a removable outflow channel, handheld instruments, or cautery probes. Used by physicians in clinical settings to perform diagnostic and surgical hysteroscopy. The device provides direct visualization, enabling the clinician to navigate the uterine cavity and perform procedures, potentially improving diagnostic accuracy and surgical outcomes.

Clinical Evidence

Bench testing only. The device was evaluated for compliance with IEC 60601-2-18 (electrical safety) and ISO 10993-1 (biocompatibility). Sterilization validation protocols were performed to confirm the device can be adequately sterilized.

Technological Characteristics

Stainless steel construction; rod lens optical system; 0° angle of view; 80° field of view; 6.0 mm x 6.4 mm OD; 3.0 mm working channel; glass fiber illumination; autoclavable; non-sterile, reusable. Complies with IEC 60601-2-18 and ISO 10993-1.

Indications for Use

Indicated for visualization of the cervical canal and uterine cavity to perform diagnostic and surgical procedures in patients requiring hysteroscopic intervention.

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

• Henke Sass Wolf Hysteroscopes, Hysteroscopic Resectoscopes and Accessories (K941541 / K952186 / K991563)
• Smith & Nephew Hysteroscope and Accessories (K013870)
• Stryker Urology and Gynecology Hardware System (K040390)

Reference Devices

• Interlace Medical Hysteroscopic Morcellator (K073690)
• Interlace Medical Hysteroscopy System (K081070)

Submission Summary (Full Text)

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Interlace Medical Inc.

#### న. 510(k) SUMMARY

AUG 21 2009

#### 1. . Submitter:

Interlace Medical Inc. 135 Newbury St Framingham, MA 01701 Telephone: [phone], ext. 112

Contact: John J. Vozella, VP Clinical & Regulatory Affairs Date Prepared: May 8, 2009

#### 2. Device:

Trade Name: MyoSURE™ Rod Lens Hysteroscope and Accessories Common Name: Hysteroscope and accessories Classification Name: Hysteroscope and accessories Class: II

#### 3. Predicate Device:

Henke Sass Wolf Hysteroscopes, Hysteroscopic Resectoscopes and Accessories (K941541 / K952186 / K991563)

Smith & Nephew Hysteroscope and Accessories (K013870)

Stryker Urology and Gynecology Hardware System (K040390)

#### 4. Device Description:

The MyoSURE™ Rod Lens Hysteroscope is comprised of an oval 6.0 mm x 6.4mm OD x 184 mm long stainless steel tube containing a series of rod lenses and a 3.0 mm working channel. At the distal end of the tube, an "objective" lens captures the image of the "object". The series of "rod" lenses relays the image along the length of the tube. The image is directed by a 45° prism to an offset eyepiece that also contains "rod" lenses which relay the image along the length of the eyepiece tube. At the proximal end of the eyepiece, an "ocular" lens forms the image for the human eye and/or camera. The hysteroscope features a 0° angle of view and an 80° field of view.

The MyoSURE™ Rod Lens Hysteroscope also incorporates an inflow channel with stopcock, glass fibers for illumination, a 3 mm working channel and a proximal seal. The 3 mm working channel is dimensionally compatible with the Interlace Medical Hysteroscopic Morcellator (K073690).

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Additionally, the MyoSURE™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD x 283 mm length outflow channel which may be inserted through the hysteroscope's working channel. The outflow channel includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes.

The MyoSURE™ Rod Lens Hysteroscope is autoclavable and will be sold as a non-sterile, reusable device.

#### ડ. Intended Use:

The MyoSURE™ Rod Lens Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

#### 6. Comparison of Characteristics:

The design, principles of operation, primary functional specifications and materials of composition of the MyoSURE™ Rod Lens Hysteroscope are equivalent to those of the predicate Henke Sass Wolf (K941541 / K952186 / K991563), Smith & Nephew (K013870) and Stryker (K040390) hysteroscopes and hysteroscopic resectoscopes in that:

- all devices are fabricated from stainless steel and incorporate a rod lens ● optical system,
- . all hysteroscopes are autoclavable and are provided as non-sterile. reusable devices,
- both the MyoSURE and Smith & Nephew devices employ working � channels that are dimensionally compatible with tissue morcellator devices.

The MyoSURE™ Rod Lens Hysteroscope's intended use is identical to that of both the Interlace Medical Hysteroscopy System (K081070) and the predicate Smith & Nephew Hysteroscope (K013870).

#### 7. Performance Testing:

The MyoSURE™ Rod Lens Hysteroscope complies with applicable portions of IEC 60601-2-18 and meets the biocompatibility requirements of ISO 10993-1 Biological Evaluation of Medical Devices. The ability to adequately sterilize the device is confirmed by validation protocol.

#### 8. Conclusion:

Based on the intended use, descriptive information and performance evaluation provided in this submission, the MyoSURE™ Rod Lens Hysteroscope has been shown to be equivalent in technology, method of operation, functional performance and intended use to the previously referenced predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

# AUG 2 1 2009

Mr. John J. Vozella V.P. Clinical & Regulatory Affairs Interlace Medical, Inc. 135 Newbury Street FRAMINGHAM MA 01701

Re: K091465

Trade/Device Name: Myosure™ Rod Lens Hysteroscope Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: July 24, 2009 Received: July 28, 2009

Dear Mr. Vozella:

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.

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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.html far. the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Interlace Medical Inc.

Premarket Notification

## 4. INDICATIONS FOR USE STATEMENT

K091465 510(k) Number (if known):

Device Name: MyoSURE™ Rod Lens Hysteroscope

Indications For Use:

The MyoSURE™ Rod Lens Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aogn 72272

(Division Sign Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.

CONFIDENTIAL

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