ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL

K052044 · Acmi Corporation · FGB · Aug 16, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052044
• Device Name: ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
• Applicant: Acmi Corporation
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Aug 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes (MR-6A) are intended for The examination/operation of the urinary tract, and using additional accessories, to the claimmation operation of the exapentic procedures. These devices are marketed as perform various diagnostic and mering, disinfecting and sterilization are included in reusable devices, member for creaming, excition 7.0, "Cleaning, Disinfection, and Sterilization".

Device Story

Semi-rigid ureteroscope; two working channels for flexible accessories (stone baskets, retrievers, forceps, lithotripter probes, laser fibers). Components: metal shaft, eyepiece, optical imaging fibers, light guide connector, distal lens, light carrier fibers. Used by physicians in clinical settings for urinary tract visualization and intervention. Modifications from predicate include MP35N alloy shaft, hermetic sealing via micro-TIG/laser welding, and validated autoclaving sterilization. Device provides direct visualization to assist clinical decision-making during urological procedures; benefits include improved durability and sterilization compatibility.

Clinical Evidence

Bench testing only.

Technological Characteristics

Semi-rigid endoscope; MP35N alloy shaft; micro-TIG and laser welding for hermetic sealing; optical imaging and light carrier fibers; two working channels; autoclavable.

Indications for Use

Indicated for examination and operation of the urinary tract in patients requiring diagnostic or therapeutic procedures via ureteroscope.

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® MR-Series Ureteroscopes (K011849)

Submission Summary (Full Text)

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ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes ACMI Corporation Turnpike Road AUG 1 6 2005 uthborough, MA 01772

Special 510(k) Notification Summary of Safety and July 26, 2005

## 510(k) Summary of Safety and Effectiveness ACMI Corporation ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes

#### General Information

Manufacturer:

K052044
pg 1 of 2

ACMI Corporation 136 Turnpike Rd. Southborough, MA 01772-2104

Establishment Registration Number:

Contact Person:

Director, Regulatory Affairs

Endoscope and accessories

(21 CFR 876.1500), Class II Gastroenterology/Urology Panel

Endoscope and accessories

ACMI® MR-6A/MR-6LA Autoclavable

Terrence E. Sullivan

2020483

July 26, 2005

Date Prepared:

Device Description

Classification Name:

Trade Name:

Generic/Common Name:

#### Predicate Device

ACMI® MR-Series Ureteroscopes

K011849

Ureteroscopes

### Intended Uses

The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes (MR-6A) are intended for The examination/operation of the urinary tract, and using additional accessories, to the claimmation operation of the exapentic procedures. These devices are marketed as perform various diagnostic and mering, disinfecting and sterilization are included in reusable devices, member for creaming, excition 7.0, "Cleaning, Disinfection, and Sterilization".

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Special 510(k) Notification Summary of Safety and Effectiveness July 26, 2005

#### Product Description

K052044
py r of 2

Like the predicate ACMI® MR-Series Ureteroscopes, the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are semi-rigid endoscopes with two working channels. Flexible accessories such as stone baskets, retrievers, forceps, electrohydraulic lithotripter probes and laser fibers may be used through either working channel.

The main component parts of each device include:

- The metal shaft 1.
- 2. Two working channels
- An evepiece 3.
- 4. Optical imaging fibers
- Light guide connector post 5.
- A distal lens 6.
- 7. Light carrier fibers

This Special 510(k) proposes the addition of autoclaving processes as a sterilization method, a change in shaft material from stainless steel to MP35N alloy, as well as a change in the manufacturing process to allow the shaft to be hermetically sealed using a micro-TIG and laser welding process in place of epoxy seals. The indications for use, principles of operation, overall length, working channel length and working channel inner diameters of the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes remain the same or essentially the same as the predicate device.

#### Summary of Safety and Effectiveness

The proposed modifications for the ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes, as described in this submission, are substantially equivalent to the predicate device. The proposed addition of autoclaving as a recommended sterilization process and change in shaft modification in design specifications, performance specifications, and dimensional specifications are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.

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AUG 1 6 2005

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: K052044

> Trade/Device Name: ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: July 26, 2005 Received: July 28, 2005

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 (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.

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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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Device Name: ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes

510(k) Number: K 052044

#### Indications for use:

The ACMI® MR-6A/MR-6LA Autoclavable Ureteroscopes are intended for the examination/operation of the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: __ X ___

OR Over-the-Counter Use: ________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

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Nancy C brogdon
(Division Sign-Off)

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