ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM

K060269 · Acmi Corporation · FBN · Mar 31, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060269
• Device Name: ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM
• Applicant: Acmi Corporation
• Product Code: FBN · Gastroenterology, Urology
• Decision Date: Mar 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System includes the DUR-Digital Invisio™ Flexible Ureteroscope and Choledochoscope and IDC Invisio™ 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. The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Device Story

Flexible endoscope system utilizing distal-tip CMOS sensor technology to capture and transmit images. System comprises endoscope with integrated LED light source, PCB, and electrical cabling connected to a Camera Control Unit (CCU). CCU processes and displays video signals. Operated by physicians in clinical settings for visualization of urinary tract, kidney, and bile ducts. Enables diagnostic and therapeutic interventions via working channel using additional accessories. Benefits include direct visualization for minimally invasive procedures, such as biliary calculi management.

Clinical Evidence

Bench testing only. Performance compared against physical characteristics of DUR®-8E and digital visualization characteristics of Invisio™ ICN. Testing confirmed requirements met and performance comparable to predicates.

Technological Characteristics

Flexible endoscope; distal-tip CMOS sensor; LED light source in handle; PCB-based image processing; CCU-based display. Materials identical to predicate DUR®-8E. Connectivity via electrical cord to CCU. Sterilization method not specified.

Indications for Use

Indicated for examination of urinary tract, interior of kidney (via percutaneous access), and bile ducts. Used for diagnostic and therapeutic procedures in these areas, including management of biliary calculi during cholecystectomy.

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 (K042225)
• ACMI DUR®-8E (K012925 and K023358)

Submission Summary (Full Text)

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ACMI® DUR-Digital Ureteroscope and Choledochoscope System ACMI Corporation 136 Turnpike Road MAR 3 1 2006 Southborough, MA 01772

Traditional 510(k) Notification 510(k) Summary January 30, 2006

# 510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® DUR-Digital Ureteroscope and Choledochoscope S

### General Information

| Manufacturer: | ACMI Corporation<br>136 Turnpike Rd.<br>Southborough, MA 01772-2104 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Terrence E. Sullivan<br>Director, Regulatory Affairs<br>Tel. #: [phone]<br>Fax #: [phone] |
| Date Prepared: | January 30, 2006 |
| Device Description | |
| Classification Name: | Endoscope and accessories<br>(21 CFR 876.1500), Class II<br>Surgical camera and accessories<br>(21 CFR 878.4160), Class I |
| Trade Name: | ACMI® DUR-Digital Ureteroscope and<br>Choledochoscope System (DUR®-D) |
| Generic/Common Name: | Endoscope, Video Camera and accessories |
| Predicate Devices | |
| ACMI® Invisio™ ICN<br>ACMI DUR®-8E | K042225<br>K012925 and K023358 |

#### Intended Uses

The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-1)) System includes the DUR-Digital Invisio™ Flexible Ureteroscope and (which Choledochoscope and IDC Invisio™ Controller) is intended for use to examine bedy 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.

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ACMI® DUR-Digital Ureteroscope and Choledochoscope System ACMI Corporation 136 Turnpike Road Southborough, MA 01772

Traditional 510(k) Notification 510(k) Summary January 30, 2006

K ci.0269 pg 2 of 3

The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

## Product Description

The ACMI® DUR®- Digital Ureteroscope and Choledochoscope (DUR®-D) is a flexible endoscope that incorporates CMOS (complimentary medical oxide semiconductor) 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.

The DUR®-Digital Ureteroscope and Choledochoscope can be introduced either through the urethra into the bladder or through a percutaneous tract into the abdominal cavity or kidney. The DUR®- Digital Ureteroscope and Choledochoscope may also be used to manage biliary calculi in a choledochoscope indication. The DUR®-D System uses a 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.

## Technological Characteristics and Substantial Equivalence

The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System, utilizes features incorporated into the following legally marketed predicate devices:

The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System utilizes the same flexible endoscope technology design as those used in the predicate DUR®-8E device (K012925 and K023358).

The DUR®- Digital Ureteroscope and Choledochoscope is dimensionally similar to the predicate DUR®-8E, having the same working channel diameter and length, and utilizes the same materials in its construction as the predicate DUR®-8E.

The DUR®-Digital Ureteroscope and Choledochoscope incorporates the same basic video imaging technology located in the endoscope as the predicate ACMI® Invisio™ ICN System (K042225).

Like the predicate DUR®-8E, the ACMI® DUR®-Digital Ureteroscope and Choledochoscope (DUR®-D) System is indicated for use in therapeutic and diagnostic procedures in the entire intrarenal collecting system, and may also be used to manage biliary calculi.

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ACMI® DUR-Digital Ureteroscope and Choledochoscope System ACMI Corporation 136 Turnpike Road Southborough, MA 01772

Traditional 510(k) Notification 510(k) Summary January 30, 2006

K060269 Pg 3 of 3

During design verification, the performance of the DUR®-D was compared against the physical performance characteristics of the predicate DUR®-8E and the digital visualization characteristics of the predicate Invisio™ ICN. Testing demonstrated that the performance requirements were met, and that the DUR®-D exhibited comparable performance characteristics to both the predicate DUR®-8E and predicate Invisio™ ICN.

In summary, the ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular logo with a stylized bird in the center. The bird is depicted with three curved lines representing its body and wings. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

MAR 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Terrence E. Sullivan Director, Regulatory Affairs ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772

Re: K060269

Trade/Device Name: ACMI® DUR-Digital Ureteroscope and Choledochoscope System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FBN and FGB Dated: January 30, 2006 Received: February 1, 2006

Dear Mr. Sullivan:

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 (Premarket Approval), 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.

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); 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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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 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" (21 CFR 807.97). 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,

Nancy C. Brogdon

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

Enclosure

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Traditional 510(k) Notification Statement of Intended Use January 30, 2006

Device Name: ACMI® DUR-Digital Ureteroscope and Choledochoscope System

510(k) Number: K

#### Indications for use:

The ACMI® DUR-Digital Ureteroscope and Choledochoscope (DUR®-D) System Flexible Ureteroscope includes the DUR-Digital Invisio™ and (which Choledochoscope and IDC Invisio™ 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.

The DUR®-D System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ____________________________________________________________________________________________________________________________________________________________

OR Over-the-Counter Use:

(Per 21 CFR 801.109)

David A. Lygum

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