MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

K090814 · Gyrus Acmi, Inc. · FAJ · Apr 20, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090814
• Device Name: MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
• Applicant: Gyrus Acmi, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Apr 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Gyrus ACMI® Invisio® ICN Digital Flexible CystoNephroscope System (which includes the ICN scope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.

Device Story

Flexible endoscope system for urological and renal visualization. Input: optical images captured via miniature CMOS sensor at endoscope tip. Processing: CMOS sensor transmits signals through shaft to Camera Control Unit (CCU) containing PCBs and software for image display. Output: real-time video visualization of body cavities. Usage: inserted via urethra or percutaneous tract into kidney/abdominal cavity. Operated by clinicians in clinical settings. Benefits: enables minimally invasive diagnostic and therapeutic procedures in urinary tract and kidney.

Clinical Evidence

No clinical data. Substantial equivalence based on design and performance specification modifications.

Technological Characteristics

Flexible endoscope with miniature CMOS sensor, PCB, and handle-integrated LED light source. Connects to external Camera Control Unit (CCU) via electrical cord. CCU contains power supply, PCBs, and software for image processing. Materials and dimensions unchanged from predicate.

Indications for Use

Indicated for examination of urinary tract body cavities, hollow organs, and canals, and percutaneous examination of the kidney interior. Supports diagnostic and therapeutic procedures when used with accessories. Prescription use only.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• ACMI® Invisio® ICN CystoNephroscope System (K042225)

Submission Summary (Full Text)

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

Special 510(k) Notification Summary of S & E Mar 23, 2009

K090814

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

Gyrus ACMI, Inc.

136 Turnpike Rd.

3003790304

Mar , 2009

Southborough, MA 01772-2104

Senior Regulatory Affairs Specialist

Graham A. L. Baillie, MS

pg 1 of 2

### General Information

APR 2 0 2009

Manufacturer:

Establishment Registration Number:

Contact Person:

Date Prepared:

Device Description

Classification Name:

Endoscope and accessories (21 CFR 876.1500), Class II Gastroenterology & Urology Panel Surgical camera and accessories General & Plastic surgery Panel (21 CFR 878.4160), Class I

Endoscope, Video Camera and accessories

Gyrus ACMI® Invisio® ICN

Trade Name:

Gencric/Common Name:

Predicate Device

ACMI® Invisio® ICN CystoNephroscope System

K042225

#### Intended Uses

The Gyrus ACMI® Invisio® ICN Digital Flexible CystoNephroscope System (which includes the ICN scope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutancously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.

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Special 510(k) Notification Summary of S & E Statement Mar 23, 2009

### Product Description

K1908,14
pg r of r

Like the predicate ACMI® Invisio® ICN CystoNephroscope System, the Gyrus ACMI® Invisio® ICN is a flexible endoscope that incorporates CMOS ACMI® frivision territory is a noxiconi-conductor) sensor technology to generate an (collphillemary motived either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney.

The ICN incorporates the same basic video imaging technology located in the The ICN moorporates and device. There is a miniature CMOS sensor located in the encosope as the proving through the endoscope shaft, a printed circuit board (PCB), a light-cmitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit.

Like the predicate device, the ICN uses the same Camera Control Unit (CCU) that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.

This Special 510(k) proposes video sensor performance modifications to the ACMI® Invisio® ICN. The indications for use, labeling, principles of operation, materials and overall dimensions of the proposed Gyrus ACMI® Invisio® ICN remain the same as in the predicate device.

## Summary of Safety and Effectiveness

The proposed modifications for the Gyrus ACMI® Invisio® ICN, as described in this submission, are substantially equivalent to the predicate device. The proposed modification in design specifications, performance specifications, and software specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

920
Ro

APR 2 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Graham A. L. Baillie, MS Senior Regulatory Affairs Specialist Gyrus ACMI, Inc. 136 Turnpike Road Southborough MA 01772

Re: K090814

Trade/Device Name: Gyrus ACMI® Invisio® ICN Regulation Number: 21 CFR 876.5130 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: March 23, 2009 Received: March 25, 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.

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 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,

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Page 2

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.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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

Special 510(k) Notification Intended Use Statement Mar 23, 2009

# Indications for Use

510(k) Number: K 690814

Device Name: Gyrus ACMI® Invisio® ICN

#### Indications for Use:

The Gyrus ACMI® Invisio® ICN (CystoNephroscope) System (which includes the ICN Endoscope and Controller) is intended for use to examine body cavities, hollow organs and canals in the body, in the urinary tract, and can be used percutaneously to examine the interior of the kidney; and, using additional accessories, can be used to perform various diagnostic and therapeutic procedures.

Prescription Use: X (Per 21 CFR 801:109)

AND/OR

Over-the-Counter Use: (21 CFR 801 Subpart C) ،

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulu Clemen

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