MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL

K122563 · Hologic, Inc. · HIH · Sep 19, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K122563
• Device Name: MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
• Applicant: Hologic, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Sep 19, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Myosure XL 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 XL Rod Lens Hysteroscope is a rigid endoscope for visualization of the cervical canal and uterine cavity. Device consists of a stainless steel tube containing a series of rod lenses, an objective lens, a 45° prism, and an ocular lens. Features include a 0° angle of view, 80° field of view, inflow channel with stopcock, glass fibers for illumination, and a 4 mm working channel. A removable 4.0 mm OD outflow channel can be inserted through the working channel to manage distension fluid and provide a pathway for handheld instruments or cautery probes. Used by physicians in clinical settings to perform diagnostic and surgical hysteroscopic procedures. Output is a direct optical image viewed by the clinician through the eyepiece or via an attached camera. Benefits include enhanced visualization of the uterine environment to facilitate surgical intervention.

Clinical Evidence

Bench testing only. Performance evaluation included flow rate testing and seal effectiveness testing to ensure the device meets functional requirements comparable to the predicate.

Technological Characteristics

Rigid rod lens hysteroscope; stainless steel construction; 0° angle of view; 80° field of view; 4.0 mm working channel; glass fiber illumination; removable outflow channel with seal. Sterilizable. No software or electronic components.

Indications for Use

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

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 (K091465)

Submission Summary (Full Text)

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## HOLOGIC, Inc.

Premarket Notification

K122563

## DATE: September 13, 2012

#### ડી 510(k) SUMMARY

l. Submitter:

> Hologic, Inc. 250 Campus Dr. Marlborough, MA 01752 Telephone: [phone]

Contact: Sarah Fairfield, Sr. Regulatory Affairs Specialist

- 2. Device:
Trade Name: MyoSure XL Rod Lens Hysteroscope Common Name: Hysteroscope and accessories Classification Name: Hysteroscope and accessories Class: II Regulation number: 884.1690 Product code: HIH

#### Predicate Device: 3.

MyoSure Rod Lens Hysteroscope (K091465)

#### 4. Device Description:

The Myosure XL 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 4.0 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 evepiece 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 XL Rod Lens Hysteroscope also incorporates an inflow channel with stopcock, glass fibers for illumination, a 4 mm working channel and a proximal seal.

Additionally, the Myosure XL Rod Lens Hysteroscope utilizes a removable 4.0 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 XL Rod Lens Hysteroscope is intended to be sterilized prior to use.

SEP 19 2012

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#### Intended Use: 5.

The Myosure XL 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 Technological Characteristics:

The design, principles of operation, primary functional specifications and materials of composition of the Myosure XL Rod Lens Hysteroscope are equivalent to those of the predicate Myosure Rod Lens Hysteroscope with the exception:

- the outer diameter of the working channel has been increased to ● 4.0mm
- the outer diameter of the hysteroscope has been increased to 6.49 x 7.64 mm (oval).

The Myosure XL Rod Lens Hysteroscope's intended use is identical to that of the predicate Myosure Rod Lens Hysteroscope (K091465).

#### 7. Performance Testing:

The Myosure XL Rod Lens Hysteroscope complies with the functional and performance characteristics of the predicate device including flow rate testing, and seal effectiveness associated with the use of the device.

#### 8. Conclusion:

Based on the intended use, descriptive information and performance evaluation provided in this submission, the Myosure XL 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

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

Ms. Sarah Fairfield Senior Regulatory Affairs Specialist. Hologic, Inc. 250 Campus Drive MARLBOROUGH MA 01752

SEP 1 9 2012

Re: K122563

Trade/Device Name: Myosure XL Rod Lens Hysteroscope Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: August 22, 2012 Received: August 22, 2012

Dear Ms. Fairfield:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your occuon >10(x) premaired is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure for segary manated provide Medical Device Ameralments, or to commerce prior to May 20, 1970, the chaoinent and the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presisions of the Act. and Cosment Act (Act) that do not require apple for the general controls provisions of the Act. The Y ou may, therefore, market the device, bactor is annual registration, listing of
general controls provisions of the Act include requirements for annual registration, listing general controls provisions of the fiel her her her hibitions against miss and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note: CDAT does not of article labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into cation major regulations affecting your device can be
it may be subject to additional controls. Existing major regulation affic if may be subject to additional controls. DATS in and 100 to 808. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to Sederal Register found in the Code of I edelui Rogatations, concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a varies with other requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA nas made a decemmanon and 70 an every by other Federal agencies. You must in or any Federal statutes and regulations administed to: registration and listing and listing of media comply with all the Act STEquilients, metading, occirculars and one of the ording of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-related daverse overse (2) CFR Part 820); and if applicable, the electronic form in the quant) Byteriors (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 II you desire specific advice for your do receive offices/CDRHOffices/ucm115809.html for go to mus.na.gov/rtbout Britised Brill St (CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance (21 GEFF the Concertification entitled, "Misbranding by reference to premarket notification" (21CFR Parti 100€ the regulations 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 I ou may obtain 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,

Benjamin R. Fisher

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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HOLOGIC, Inc.

Premarket Notification

# 4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Myosure XL Rod Lens Hysteroscope

Indications For Use:

The Myosure XL Rod Lens Hysteroscope is used to provide viewing of the cervical canal and The Myosure XL Rod Lens Trysteroseope is assure provins and surgical procedures.
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)

Hulut Leun

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K122563