DIRECTVISION GUIDE SYSTEM

K091600 · Percuvision, LLC · FGC · Aug 25, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K091600
• Device Name: DIRECTVISION GUIDE SYSTEM
• Applicant: Percuvision, LLC
• Product Code: FGC · Gastroenterology, Urology
• Decision Date: Aug 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The DirectVision™ Guide System is indicated for use in the visual examination of the urethra and bladder when placing the PercuCath Urologic Catheter.

Device Story

DirectVision Guide System is a flexible, semirigid microendoscope used for visual examination of the urethra and bladder during PercuCath Urologic Catheter placement. Device consists of a microendoscope, handheld camera, and integral LED illumination. It connects to a separate light source and camera control unit (CCU). The microendoscope is inserted through the catheter, which provides a sheath and an irrigation channel to clear debris from the field of view. Light is transmitted via a fiber optic bundle; images are captured by the camera and displayed on a monitor for the clinician. Used in clinical settings by physicians to guide catheter placement, the system provides real-time visualization to assist in accurate positioning, potentially reducing procedural complications.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics, materials, and design to the predicate device. The device meets recognized consensus standards including ISO 8600-1, IEC 60601-2-18, and ISO 10993-1 for biocompatibility.

Technological Characteristics

Flexible, semirigid microendoscope; materials include biocompatible polyimide and glass. Features objective lens at tip, glass fiber optic bundles for light/image transmission, and camera adapter. Powered by external LED light source and CCU. Multi-use, supplied non-sterile. Complies with ISO 8600, IEC 60601-2-18, and ISO 10993-1 standards.

Indications for Use

Indicated for visual examination of the urethra and bladder during placement of the PercuCath Urologic Catheter in patients requiring such urologic procedures.

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

• Davlite Microendoscope (K020310)

Reference Devices

• Schoelly Imaging Inc. FSC2 light source and CCU (K090601)
• PercuCath Urologic Catheter (K090262)

Submission Summary (Full Text)

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

Ko9/600

## 510k Summary

## Submitted by:

Percuvision LLC 765 North Hamilton Road, Suite 260A Gahanna, Ohio 43230 Telephone: [phone] Facsimile: 614-337-2274 Establishment Registration Number: To be assigned

'AUG 2 5 2009

# Contact

F. David Rothkopf MEDIcept, Inc. 200 Homer Avenue Ashland, MA 01721 Telephone: [phone] Facsimile: [phone]

## Device Name

| Common Name: | Microendoscope Video System |
|-------------------|-----------------------------|
| Proprietary Name: | DirectVisionTM Guide System |

# Classification

| Device: | DirectVision TM Guide System |
|--------------------|------------------------------|
| Medical Specialty: | Urologic |

| Device Class: | 21 CFR 876.1500, Endoscope and Accessories, Class II |
|----------------|------------------------------------------------------|
| Product Codes: | FGC (Endoscope) |

## Predicate Devices

| 510(K): | K020310 |
|---------------|------------------------------------------------------|
| Trade Names: | Davlite Microendoscope |
| Manufacturer: | Davlite Technologies. |
| | 37 Kris Allen Dr |
| | Holden, MA 01520 |
| Device Class: | 21 CFR 876.1500, Endoscope and Accessories, Class II |
| Product Code: | GCJ |
| Regulation #: | 876.1500 |

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

#### General Description

The DirectVision™ Guide System is comprised of two (2) distinct components: a flexible semirigid microendoscope, and a handheld camera with integral LED illumination and camera control unit (CCU). The microendoscope is designed to work with the Schoelly Imaging Inc. FSC2 light source and CCU (K090601). The DirectVision TM Guide System is indicated for use in the endoscopic examination of the urethra and bladder, when placing the PercuCath™ Urologic Catheter (K090262). The catheter provides a sheath around the microendoscope to facilitate its use. The catheter also incorporates a channel to be used for supplying irrigation to the microendoscope tip for clearing away debris from the field of view during use. The microendoscope coupler is connected to the cleared camera and integral light source such that the light source is collinear with the light fiber optic bundle and the camera is collinear with the image fiber optic bundle. The image transmitted through the image fiber optic bundle to the camera is then displayed on a monitor accessory for the clinician to view.

091600

2013

### Intended Use:

The DirectVision™ Guide System is indicated for use in the visual examination of the urethra and bladder when placing the PercuCath Urologic Catheter,

| | | DirectVision™ Guide<br>System | Davlite Microendoscope |
|-----------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | | It is intended to be used<br>in the visual<br>examination of the<br>urethra and bladder<br>when placing the<br>PercuCath™ Urinary<br>Catheter. | This device is to be used<br>by physicians for viewing<br>an interior cavity of the<br>human body through<br>either a natural opening or<br>an incision |
| Design | Stiffness | Flexible | Flexible |
| | Light Carrier | Glass Fiber Optic<br>bundle | Glass Fiber Optic bundle |
| | Image<br>Carrier | Glass Fiber Optic<br>bundle | Glass Fiber Optic bundle |
| | Lens | Objective lens at tip | Objective lens at tip |
| | Camera<br>Adapter | Yes | Yes |
| | Body<br>Contact<br>Material | Biocompatible<br>Polyimide and glass | Biocompatible Polymer<br>and glass |
| | Performance Standard | ISO 8600 | ISO 8600 |
| Biocompatiblity | | Yes | Yes |
| Sterility | | Supplied non sterile | Supplied non sterile |
| Re-Use | | Multi use | Multi use |

#### Comparison to Predicate Device(s):

Percuvision LLC

Proprietary and Confidential

7

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

#### Performance Standards

091600

No applicable mandatory performance standards or special controls exist for this device. Form 3654 may be found in Attachment H

The DirectVision™ Guide System meets the requirements of the following recognized consensus standards, where applicable:

- > ISO 8600-1:2005 Optics and Photonics -- Medical Endoscopes Information to be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices
- > AAMI TIR12: 2004 Designing, Testing, and Labeling Reusable Medical Devices for Preprocessing in Health Care Facilities
- > AAMI / ANSI ST81:2004, Sterilization Of Medical Devices - Information To Be Provided By The Manufacturer For The Processing Of Resterilizable Devices
- > AAMI / ANSI ST35:2003 Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings
- > IEC 60601-2-18 Particular Requirements for the Safety of Endoscopic Equipment
- > ISO10993-1:2003 Biological Evluation of Medical Devices

## Substantial Equivalence

The DirectVision™ Guide System microendoscope is substantially equivalent to the Davlite Microendoscope manufactured by Davlite Technologies in materials, intended use, and basic design concept.

Percuvision LLC

Proprietary and Confidential

DirectVision™ Guide System

8

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

Image /page/3/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes a stylized human figure on the left. To the right of the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a sans-serif font. A horizontal line is placed beneath the text.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Errol O. Singh, M.D. President & CEO Percuvision , LLC 765 North Hamilton Road, Suite 260A GAHANNA OH 43230

AUG 2 6 2009

Re: K091600

Trade/Device Name: DirectVision" Guide System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGC Dated: June 3, 2009 Received: June 3, 2009

Dear Dr. Singh:

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 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); medical device reporting of medical

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

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Landry M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# - Indications for Use Statement - - - - - -

510(k) Number (if known): Ko 9 16 00

Device Name: DirectVision™ Guide System

Indications for Use:

The DirectVision" Guide System is indicated for use in the visual examination of the urethra and bladder when placing the PercuCath Urologic Catheter.

Prescription Use X = =

OR

Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Horace Whang

---

Division Sign-Off

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

Percuvision LLC

Proprietary and Confidential

DirectVision™ Guide System

9