GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4

K092278 · Gyrus Acmi, Inc. · HIH · Sep 29, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K092278
• Device Name: GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
• Applicant: Gyrus Acmi, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Sep 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gyrus ACMI Invisio Digital Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. The Gyrus ACMI Invisio Digital Hysteroscope System includes the Invisio Digital Hysteroscope and IDC Invision™ Controller. The IDC Controller is intended to be used to process the video signal from the Invisio Digital Hysteroscope and ensure brightness, image clarity and color.

Device Story

Semi-rigid (rigi-flex) hysteroscope system for visualization of cervical canal and uterine cavity. Input: optical images captured by distal-tip CMOS sensor. Processing: IDC-1500 Controller processes video signals (brightness, clarity, color) via internal PCBs and software. Output: displayed video feed for clinician. Used in clinical settings by physicians for diagnostic and operative procedures (biopsy, polypectomy, myomectomy, adhesiolysis, septal transection). Benefits: provides direct visualization to facilitate minimally invasive intrauterine surgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing comparisons to predicate devices.

Technological Characteristics

Semi-rigid hysteroscope with distal CMOS sensor, LED light source in handle, and bifurcated fiber optic illumination. Connects to IDC-1500 Controller via electrical cord. Features articulating distal section with deflection pulleys/wires. Patient-contacting materials consistent with predicate DUR-D. Software-driven image processing.

Indications for Use

Indicated for diagnostic and operative hysteroscopy in patients requiring visualization of the cervical canal and uterine cavity. Diagnostic indications: abnormal uterine bleeding, infertility, pregnancy wastage, abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain. Operative indications: directed biopsy, removal of fibroids and polyps, and transection of intrauterine adhesions or septa.

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

• ACMI DUR®-Digital Ureteroscope & Choledochoscope (K060269)
• Gyrus ACMI IPN-2505 Percutaneous Nephroscope (K072594)
• Karl Storz MVM 7.5French Flexible Hysteroscope (K990411)
• Olympus Visera HFY-V Hysterovideoscope (K022445)

Submission Summary (Full Text)

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K092278

Gyrus ACMI® Invisio® Digital Hysteroscope System Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

#### Traditional 510(k) Notification Summary of S & E July 24, 2009

# 510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI® Invisio® Digital Hysteroscope System

General Information

Manufacturer:

136 Turnpike Rd. Southborough, MA 01772-2104

Establishment Registration Number:

Contact Person:

3003790304

July 24, 2009

Gyrus ACMI Inc.

Graham A. L. Baillie, MS Sr Regulatory Affairs Specialist Tel. # [phone] Fax # [phone]

Date Prepared:

Trade Name:

Device Description Classification Name:

Hysteroscope and accessories (21CFR 886.1690). Class II Surgical camera and accessories, (21 CFR 878.4160), Class I

Gyrus ACMI Invisio Digital Hysteroscope System

Endoscope, Video Camera and accessories Hysteroscope and accessories

## Predicate Devices

Generic/Common Name:

K060269 ACMI DUR®-Digital Ureteroscope & Choledochoscope, (DUR-D) Gyrus ACMI IPN-2505 Percutaneous Nephroscope K072594 K990411 Karl Storz MVM 7.5French Flexible Hysteroscope K022445 Olympus Visera HFY-V Hysterovideoscope

# Intended Use

The Gyrus ACMI Invisio Digital Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

The Gyrus ACMI Invisio Digital Hysteroscope System includes the Invisio Digital Hysteroscope and IDC Invision™ Controller. The IDC Controller is intended to be used to process the video signal from the Invisio Digital Hysteroscope and ensure brightness, image clarity and color.

# Diagnostic Hysteroscopy:

- Abnormal uterine bleeding o
- Infertility & pregnancy wastage o

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Gyrus ACMI® Invisio® Digital Hysteroscope Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

Traditional 510(k) Notification Truthfuiness Statement July 24, 2009

- Evaluation of abnormal hysterosalpingogram �
- Intrauterine foreign body o
- Amenorrhea �
- Pelvic pain �

## Operative Hysteroscopy:

- Directed biopsy a
- Removal of fibroids and polyps �
- Transection of intrauterine adhesions .
- Transection intrauterine septa �

## Product Description

The Gyrus ACMI® Invisio® Digital Hysteroscope System is comprised of the Invisio Digital Hysteroscope and Invisio Digital Controller (IDC-1500). The Gyrus ACMI Invisio Digital Hysteroscope is a semi-rigid (rigi-flex) hysteroscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit (CCU).. The Invisio Digital Hysteroscope connects to a CCU, (the Invisio Digital Controller (IDC-1500)), that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.

# Technological Characteristics and Substantial Equivalence

The Gyrus ACMI® Invisio® Digital Hysteroscope System, utilizes features included in the predicate Gyrus ACMI Invisio Digital, IPN-2505 Percutaneous Nephroscope K072594, and the ACMI DUR®-Digital Ureteroscope & Choledochoscope, DUR®-D K060269. The proposed device incorporates the same CMOS video imaging technology located in the endoscope as the aforementioned Invisio predicates. The subject Invisio Digital Hysteroscope System utilizes the same model Invisio Controller loaded with the same Invisio digital software. The internal shaft construction and flexible/articulating distal section contains similarly designed defection pulleys/wires, and electrical wiring as the predicate Invisio DUR®-D. The subject and two aforementioned Invisio predicates also incorporate similarly designed bifurcated fiber optic illumination bundles that carry/transmit light from the same design LEDs, located in the handles of each device, through the shaft to the distal tip. The subject hysteroscope and predicate DUR®-D also share the same patient contacting materials used in the distal tip, working channel and deflection cover.

Like other predicate hysteroscopes: the Karl Storz MVM 7.5 Fr Flexible Hysteroscope (K99041 1); and the Olympus Visera HFY-V Hysterovideoscope (K022445); the proposed hysteroscope has similar shaft diameter and working length and is intended for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

In summary, the Gyrus ACMI® Invisio® Digital Hysteroscope System is substantially equivalent to the four predicate devices and presents no new questions of safety or efficacy.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SEP 2 9 2009

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

Graham A. L. Baillie, MS Sr. Regulatory Affairs Specialist Gyrus ACMI, Inc. 136 Turnpike Road SOUTHBOROUGH MA 01772-2104

Re: K092278

Trade/Device Name: Invisio Digital Hysteroscope System Regulation Number: 21 CFR 8884,1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: July 24, 2009 Received: July 28, 2009

Dear Mr. Baillie:

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 (OS) 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,

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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Gyrus ACMI® Invisio® Digital Hysteroscope System Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

Traditional 510(k) Notification Intended Use Statement July 24, 2009

# Indications for Use

K092278 510(k) Number: Device Name: Invisio Digital Hysteroscope System

# Indications for Use

The Gyrus ACMI Invisio Digital Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

The Gyrus ACMI Invisio Digital Hysteroscope System includes the Invisio Digital Hysteroscope and IDC InvisionM Controller. The IDC Controller is intended to be used to process the video signal from the Invisio Digital Hysteroscope and ensure brightness, image clarity and color.

## Diagnostic Hysteroscopy:

- 0 Abnormal uterine bleeding
- Infertility & pregnancy wastage .
- Evaluation of abnormal hysterosalpingogram �
- Intrauterine foreign body 0
- � Amenorrhea
- � Pelvic pain

ð

Operative Hysteroscopy:

- � Directed biopsy
- Removal of fibroids and polyps ね
- Transection of intrauterine adhesions 0
- Transection intrauterine septa

Prescription Use: *X*

Over-the-Counter Use :________________________________________________________________________________________________________________________________________________________

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(Per 21 CFR 801.109)

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OR

Concurrence of CDRH, Office of Device Evaluation (ODE),

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