MYOSURE ROD LENS SCOPE SEALS

K102686 · Interlace Medical, Inc. · HIH · Oct 15, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K102686
• Device Name: MYOSURE ROD LENS SCOPE SEALS
• Applicant: Interlace Medical, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Oct 15, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Intended Use

MyoSure™ Single Use Seals are a component / accessory to the MyoSure™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure™ Rod Lens Hysteroscope and removable outflow channel.

Device Story

MyoSure™ Single Use Seals are silicone accessories for the MyoSure™ Rod Lens Hysteroscope. They function as physical barriers to prevent distension fluid leakage from the proximal ends of the hysteroscope and its removable outflow channel. The seals also provide an insertion pathway for handheld instruments or cautery probes during hysteroscopic procedures. These are single-use, sterile components used in a clinical setting by physicians performing hysteroscopy.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility testing per ISO 10993-1 and performance testing to verify fluid leakage prevention.

Technological Characteristics

Material: white-tinted silicone. Function: proximal seal for hysteroscope working channel and outflow channel. Sterilization: required to be sterile. Connectivity: none. Software: none.

Indications for Use

Indicated for use as a component/accessory to the MyoSure™ Rod Lens Hysteroscope to prevent distension fluid leakage from the proximal ends of the hysteroscope and removable outflow channel.

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

• MyoSure™ Rod Lens Hysteroscope and Accessories (K091465)

Submission Summary (Full Text)

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## Interlace Medical Inc.

K102686
pg. 1 of 2

### 510(k) SUMMARY 5.

- 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: September 14, 2010

#### 2. Device:

Trade Name: MyoSure™ Single Use Seals Common Name: Hysteroscope and accessories Classification Name: Hysteroscope and accessories Class: II

### 3. Predicate Device:

MyoSure™ Rod Lens Hysteroscope and Accessories (K091465)

### 4. Device Description:

The MyoSure™ Rod Lens Hysteroscope incorporates a 3 mm ID working channel and a proximal seal. Additionally, the MyoSure™ Rod Lens Hysteroscope utilizes a removable 3.0 mm OD outflow channel which also 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.

MyoSure™ Rod Lens Scope Seals are comprised of white-tinted silicone.

### 5. Intended Use:

MyoSure™ Single Use Seals are a component / accessory to the MyoSure™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure™ Rod Lens Hysteroscope and removable outflow channel.

OCT 1 5 2010

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### Premarket Notification

K102686
PG: 2 of 2

### Comparison of Characteristics: 6.

The design, principles of operation, primary functional specifications and materials of composition of the modified MyoSure™ Single Use Seals are equivalent to those of the predicate scope seals described in the MyoSure™ Rod Lens Hysteroscope (K091465) submission in that:

- all seals are fabricated from silicone, ●
- all seals are dimensionally identical, .
- all seals are required to be sterile prior to being placed in the . MyoSure™ Rod Lens Hysteroscope and outflow channel,

The modified MyoSure™ Single Use Seals' intended use is identical to that of the predicate scope seals (K091465).

### 7. Performance Testing:

The modified MyoSure™ Single Use Seals meet the biocompatibility requirements .
of ISO 10002, 1 Rialacio d Engle Children of Seat of ISO 10993-1 Biological Evaluation of Medical Devices as well as bench test performance requirements established by Interlace Medical, Inc.

### 8. Conclusion:

Based on the intended use, descriptive information and performance evaluation provided in this submission, the modified MyoSure™ Single Use Seals have been shown to be equivalent in technology, method of operation, functional performance and intended use to the previously referenced predicate seals.

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

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

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Re: K102686

> Trade Name: MyoSURETM Single Use Seals Regulation Number: 21 CFR \$884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: September 14, 2010 Received: September 17, 2010

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. 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 of medical device-related

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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/CDRH/CDRHOffices/ucm115809.htm for 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological 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

OCT 1 5 2010

510(k) Number (if known): KID2696

Device Name: MyoSure™ Single Use Seals

Indications For Use:

MyoSure™ Single Use Seals are a component / accessory to the MyoSURE™ Rod Lens Hysteroscope and are used to prevent distension fluid leakage from the proximal ends of the MyoSure™ Rod Lens Hysteroscope and removable outflow channel.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

510(k) Number .

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)

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| Division of Reproductive, Gastro-Renal, and Urological Devices |

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