INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM

K081070 · Interlace Medical, Inc. · HIH · Jul 23, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K081070
• Device Name: INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM
• Applicant: Interlace Medical, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jul 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Interlace Medical Operative Hysteroscopy System is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Device Story

System consists of obturator, sheath, and fiber optic hysteroscope; used for visualizing cervical canal and uterine cavity. Obturator facilitates sheath insertion; sheath includes working channel for instrumentation; hysteroscope provides optical visualization and illumination. Used in clinical/OR settings by physicians. Compatible with standard OR camera couplers and external fluid management systems for continuous flow. Enables diagnostic and surgical interventions; benefits patient through minimally invasive uterine access.

Clinical Evidence

Bench testing only; device meets electrical safety standards.

Technological Characteristics

Fiber optic hysteroscope with optical lenses; includes obturator and single-use sheath with working channel. Compatible with standard OR camera couplers. Electrical safety standards met.

Indications for Use

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

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 and Nephew Hysteroscope and Accessories (K013870)

Submission Summary (Full Text)

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K081070

#### Interlace Medical Incorporated Operative Hysteroscopy System

Premarket Notification

## Interlace Medical, Inc. Operative Hysteroscopy System 510K Summary of Safety and Effectiveness April 11, 2008

JUL 23 2008

- 1 . Sponsor Name Interlace Medical Inc. 139 Newbury St Framingham, MA 01701 Telephone: [phone]
- 2. Device Name Proprietary Name: Interlace Medical Operative Hysteroscopy System Common/Usual Name: Hysteroscope and accessories
- 3. Identification of Predicate or Legally Marketed Device The Interlace Medical Operative Hysteroscopy System is substantially equivalent to the Smith and Nephew Hysteroscope and Accessories cleared under K013870

#### 4. Device Description

The Interlace Medical Operative Hysteroscopy System is intended for use in visualizing the uterine cavity and performing operative hysteroscopy procedures. The Operative Hysteroscopy System includes an obturator, a sheath and a hysteroscope. The obturator is used to facilitate introduction of the sheath into the uterine cavity. The single use sheath includes a working channel to permit the introduction of instrumentation. The reusable fiber optic hysteroscope is designed with optical lenses for visualization and optical fibers for illumination. The obturator is inserted into the working channel of the sheath and the hysteroscope is inserted into a designated lumen of the sheath. The Operative Hysteroscopy System can be combined with a hysteroscopic fluid management system (not the subject of this submission) to provide continuous flow hysteroscopy capability. The hysteroscope can be used with standard O.R. camera couplers.

- 5. Intended Use Interlace Medical Operative Hysteroscopy System 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 Technological Characteristics The Interlace Medical Operative Hysteroscopy System is substantially equivalent in design, materials, construction and intended use as that of the predicate. The principal of operation of both devices are exactly the same. Since the Interlace Medical Operative Hysteroscopy System has the same intended use and

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### Interlace Medical Incorporated Operative Hysteroscopy System

technological characteristics as the predicate device, the Interlace Medical Operative Hysteroscopy System does not raise any new safety and efficacy concerns when compared to the similar legally marketed device.

The descriptive characteristics demonstrate that the Interlace Medical Operative Hysteroscopy System are substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.

- 7 Performance Testing The Interlace Medical Operative Hysteroscopy System meets electrical safety standards.
- 8. Statement of Equivalency

The Interlace Medical Operative Hysteroscopy System is substantially equivalent in design, materials, construction and intended use as that of the predicate. The principal of operation of both devices are exactly the same. Since the Interlace Operative Hysteroscopy System has the same in intended use and technological characteristics as the predicate device, the Interlace Operative Hysteroscopy System does not raise any new safety and efficacy concerns when compared to the similar legally marketed device.

The descriptive characteristics demonstrate that the Interlace Operative Hysteroscopy System is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# IJUL 2 3 2008

Mr. Ron Adams Chief Technical Officer Interlace Medical 139 Newbury Street FRAMINGHAM MA 01701

Re: K081070

Trade Name: Interlace Medical Operative Hysteroscopy System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: June 13, 2008 Received: June 17, 2008

Dear Mr. Adams:

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 Fodcral 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 such 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 Actor 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Nancy Brogdon

Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification

# Indications for Use

510(k) Number (if known): TBD KORION

Device Name: Interlace Medical Operative Hysteroscopy System

Indications For Use:

Interlace Medical Operative Hysteroscopy System is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic ond 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)

Huld Semen

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

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