VIADUCT MINISCOPE AND ACCESSORIES

K040949 · Acueity, Inc. · GCT · May 7, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040949
• Device Name: VIADUCT MINISCOPE AND ACCESSORIES
• Applicant: Acueity, Inc.
• Product Code: GCT · Gastroenterology, Urology
• Decision Date: May 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Acueity ViaDuct Miniscope and Accessories are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision. The accessory device is capable of grasping soft tissue for biopsy. The instruments are to be used for diagnostic purposes only and are not intended for therapeutic use.

Device Story

Semi-rigid fiberscope with irrigating outer sheath/introducer; includes inner grasping sheath/tube for soft tissue biopsy. Used by physicians in clinical settings to access finite spaces for visualization and diagnostic sampling. Device provides visual access to internal cavities; grasping mechanism allows tissue retrieval. Output is direct visualization for physician assessment; aids in diagnostic decision-making. Benefits patient through minimally invasive diagnostic access to soft tissue sites.

Clinical Evidence

No clinical data. Substantial equivalence based on design, intended use, and performance testing.

Technological Characteristics

Semi-rigid fiberscope; irrigating outer sheath/introducer; inner grasping sheath/tube for biopsy. Mechanical operation. No electronic or software components described.

Indications for Use

Indicated for physicians to view interior human body cavities via natural openings or incisions and to grasp soft tissue for diagnostic biopsy. Not for therapeutic use.

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

• Miniaturized Biopsy Scope (K011189)
• ViaDuct Microendoscope and Accessories (K983527)

Submission Summary (Full Text)

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

# MAY - 7 2004 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

- A. Name, Address, Phone and Fax number of the Applicant
Acueity, Inc. 100 Hamilton Avenue, Suite 140 Palo Alto, CA 94301

Telephone: [phone] [phone] Fax:

# B. Contact Person

Nancy Lincé Regulatory Affairs Consultant

Telephone: [phone]

- ். Date Prepared
March 2, 2004

## D. Device Name

Trade Name: ViaDuct Miniscope and Accessories Classification Name: Endoscope and Accessories and Bioosv Instruments and Non-electric biopsy forceps

## Device Description ட்ட

Like the predicate devices, the Acueity ViaDuct Miniscope and Accessories consist of a semi-rigid fiberscope with an irrigating outer sheath or introducer capable of passing a biopsy needle to a soft tissue site for view or, to view and assess/biopsy soft tissue. The Acueity ViaDuct Miniscope and Accessories is also designed with an inner grasping sheath or tube that can be placed within the outer introducer, which together act as forceps capable of grasping soft tissue for biopsy. The combination of these devices allows access to very finite spaces.

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

#### F. Intended Use

The Acueity ViaDuct Miniscope and Accessories are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision. - The accessory device is capable of grasping soft tissue for biopsy. The instruments are to be used for diagnostic purposes only and are not intended for therapeutic use.

#### G. Substantial Equivalence

The Acueity ViaDuct Miniscope and Accessories is substantially equivalent to the Acueity (formerly DOFI Communications, Inc.) Miniaturized Biopsy Scope and the Acueity ViaDuct Microendoscope and Accessories, cleared by the FDA under K011189 and K983527, respectively. The design of the ViaDuct Miniscope and Accessories is similar to the predicate device insofar as intended use, principles or operation, anatomical site for viewing and sampling, safety characteristics and physical characteristics.

#### Device Testing Results and Conclusion H.

All necessary testing was or will be performed on the ViaDuct Miniscope and Accessories to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare and medicine. The caduceus consists of a staff with two snakes coiled around it, topped with a pair of wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2004

Acueity, Inc. c/o Mr. J.A. van Vugt KEMA Quality B.V. P.O. Box 5185 6802 Ed Arnhem Arnhem. Netherlands

Re: K040949

Trade/Device Name: ViaDuct™ Miniscope and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCT Dated: April 27, 2004 Received: April 28, 2004

Dear Mr. van Vugt:

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 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 complics 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}------------------------------------------------

Page 2 - Mr. J.A. van Vugt

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known):

Device Name: ViaDuct™ Miniscope and Accessories

Indications For Use:

The Acueity ViaDuct Miniscope and Accessories are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision. The accessory device is capable of grasping soft tissue for biopsy. The instruments are to be used for diagnostic or graspilly son thisue not intended for therapeutic use.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

**510(k) Number** K040949

Page 1 of 1