USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8

K023358 · Acmi Corporation · FGB · Jan 3, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K023358
• Device Name: USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
• Applicant: Acmi Corporation
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Jan 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ACMI USA Series™ DUR™-8 and DUR™-8 Elite (DUR™-8E) Flexible Ureteropyeloscope and Choledochoscope are indicated for therapeutic and diagnostic procedures in the entire intrarenal collecting system and are also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Device Story

Non-sterile, reusable flexible fiberoptic endoscopes; used for intrarenal and bile duct procedures. Features include lubricious polyurethane outer covering, cable compensation system, torque-stabilization shaft, dual light transmission, rotating light post, and luer lock irrigation/biopsy ports. DUR-8 features passive deflection; DUR-8 Elite adds secondary active deflection control lever for enhanced distal tip maneuverability. Operated by clinicians in clinical settings. Provides visualization of internal anatomy to guide diagnostic and therapeutic interventions. Benefits include improved access and control during urological and biliary procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison.

Technological Characteristics

Reusable flexible fiberoptic endoscope; polyurethane outer covering; cable compensation and torque-stabilization shaft construction; dual light transmission; luer lock irrigation/biopsy ports; detachable light guide. Mechanical deflection system.

Indications for Use

Indicated for therapeutic and diagnostic procedures in the intrarenal collecting system and examination of bile ducts, including diagnostic and therapeutic procedures during cholecystectomy, in patients requiring endoscopic intervention.

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 APN™-2 (K012951)
• Karl Storz MVM 7.5 Fr. Flexible Choledochoscope (K972926)
• Karl Storz 15.5 Fr. Flexible Choledocho-Fiberscope (K971977)
• ACMI DURTM-8 (K012925)

Submission Summary (Full Text)

{0}------------------------------------------------

-K023358

# 510(k) Summary for the ACMI USA Series™ DUR™-8 and DUR™-8 Elite Flexible Ureteropyeloscope and Choledochoscope

#### 1. Sponsor

ACMI Corporation 136 Turnpike Road Southborough, MA 01771-2104

Contact Person: Terrence E. Sullivan Telephone: [phone] Date Prepared: October 4, 2002

#### 2. Device Name

| Proprietary Name: | ACMI Corporation USA Series™ DUR™-8 and<br>DUR™-8 Elite Flexible Ureteropyeloscope and<br>Choledochoscope |
|----------------------|-----------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Flexible endoscope |
| Classification Name: | Endoscope and accessories |

#### Predicate Devices 3.

- ACMI APN™-2 (K012951)
- Karl Storz MVM 7.5 Fr. Flexible Choledochoscope (K972926)
- Karl Storz 15.5 Fr. Flexible Choledocho-Fiberscope (K971977) ●
- ACMI DURTM-8 (K012925)

#### 4. Device Description

Both the DUR™-8 and DUR™-8E are non-sterile, reusable flexible fiberoptic endoscopes. They feature a lubricious polyurethane outer covering, a patented cable compensation system, a patented torque-stabilization shaft construction, duel light transmission, a rotating light post, luer lock irrigation and biopsy ports, and a detachable light guide. The optics, illumination carriers, working channel, manufacturing methods and specifications of both devices are identical.

The DUR™-8E is a modification of the DUR™-8 designed to provide the clinician with greater control over the distal tip of the endoscope. The DUR™-8 has a passive deflection section, while the DURTM-8 Elite has an actively controllable

{1}------------------------------------------------

Ka23358

section proximal to the primary active deflection section. A secondary deflection control lever has been added to the head of the DURTM-8 Elite.

#### ട. Intended Use

The ACMI USA Series™ DUR™-8 and DUR™-8 Elite (DUR™-8E) Flexible Ureteropyeloscope and Choledochoscope are indicated for therapeutic and diagnostic procedures in the entire intrarenal collecting system and are also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

#### 6. Technological Characteristics and Substantial Equivalence

ACMI Corporation bases the claim of equivalence on similarities in indications for use, design, materials, technological characteristics, and operational characteristics.

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized heads.

### Public Health Service

JAN 0 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Terrence Sullivan Corporate Quality Systems Manager ACMI Corporation 136 Turnpike Road SOUTHBOROUGH MA 01772

Re: K023358

Trade/Device Name: USA Series™ DUR-8™ Elite and USA Series DUR™-8 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FGB and FBN Dated: October 4, 2002 Received: October 7, 2002

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. Iisting 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); 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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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

Page 2

{4}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known):

ACMI USA Series™ DUR™-8 and DUR™-8 Elite (DUR™-8E) Flexible Device Name: Ureteropyeloscope and Choledochoscope

Indications For Use:

The ACMI USA Series™ DUR™-8 and DUR™-8 Elite (DUR™-8E) Flexible Ureteropyeloscope and Choledochoscope are indicated for therapeutic and diagnostic procedures in the entire intrarenal collecting system. The DUR™-8 and DUR™-8E are 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 NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancye Brogdon
```
(Division Sign-Off)
Division of Reproductive, **Abdominal**,
and Radiological Devices
510(k) Number K022358

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________