SOPRO 61D

K031593 · Sopro · GCJ · Sep 16, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K031593
• Device Name: SOPRO 61D
• Applicant: Sopro
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Provide access, illumination and allow observation or manipulation of body cavities, hollow organs and canals. The device(s) consist of various rigid or flexible instruments inserted into these spaces and includes an optical system for conveying an image to the users eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the device

Device Story

SOPRO 61D is a high-resolution digital endoscopy camera system; utilizes CCD image sensor for image capture. Device provides illumination and visual feedback of body cavities, hollow organs, and canals. Operated by clinicians in surgical or clinical settings; system conveys images to user's eye via optical interface. Digital processing enhances image quality, resolution, and color contrast. Serves as multidisciplinary tool for general and plastic surgery. Output assists clinicians in real-time observation and manipulation of internal anatomy; facilitates minimally invasive procedures.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to predicate devices.

Technological Characteristics

High-resolution digital processing camera system; utilizes CCD image sensor. Multidisciplinary design for use with rigid or flexible endoscopes. Connectivity via standard endoscopic video output. No specific materials or software algorithm class details provided.

Indications for Use

Indicated for providing access, illumination, and visualization of body cavities, hollow organs, and canals for observation or manipulation during surgical or diagnostic 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

• Smith & Nephew Dyonics cameras (K936071)
• SOPRO 51D camera (K000424)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a black and white graphic with the words "image maker" written in a cursive font. The date "SEP 1 6 2003" is printed in a blocky font to the right of the words. The graphic has a black triangle in the upper left corner with a white circle inside.

# KO31593 pg 1 of 2

## Food and Drug Administration

Center for Devices & Radiological Health Office of device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, MD 20850 Etats Unis

2007820

Re: 510(k) Submission for SOPRO 61D camera VIA UPS EXPRESS

Marseille, May 19, 2003

Dear Document Control Clerk,

This 510(k) summary is being submitted in accordance with the requirements SMDA 1990 and 21 CFR \$807.92.

#### Submitter A.

SOPRO

Place Saint Christophe - Les Accates F-13011 Marseille FRANCE Phone : [phone] Fax : [phone]

#### Company Contact B.

Pierre MONTILLOT C.E.O.

#### C. Device Name

SOPRO 61D Trade Name : Laparoscope and Accessories, General & Plastic Surgery Classification Name

#### Predicate Device D.

The predicate devices for this submission are the existing line of Smith & Nephew Dyonics cameras for which the 510 (k) number K936071 was granted.

#### Description Device and Technological characteristics E.

The SOPRO 61D is a high resolution, digital processing camera system utilizing a CCD image sensor. It provides high quality images with excellent resolution and colour contrast. This makes the camera a multidiciplinary tool.

Image /page/0/Picture/19 description: The image shows the logo for SOPRO ACTEON group. The logo is black and white and features the word "SOPRO" in large, bold letters. Below the word "SOPRO" is the word "ACTEON" in a smaller font, followed by the word "group" in italics. There is a black rectangle above the word "SOPRO" and a graphic to the right of the rectangle.

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### K031593 Py 20f 2

#### Intended Use F.

"Provide access, illumination and allow observation or manipulation of body cavities, hollow organs and canals. The device(s) consist of various rigid or flexible instruments inserted into these spaces and includes an optical system for conveying an image to the users eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the device".

#### Substantial equivalence G.

This product is virtually identical to the SOPRO 51D camera for which a 510(k) Nº K000424 was already granted. It is also virtually identical to many camera systems on the market today with respect to intended use, composition, safety and effectiveness. We cite Dyonics as device of comparison. This one, and other similar devices are virtually identical devices with the same intended uses.

Please examine the Table of Contents for a listing of the necessary components of this 510(k) filing.

We would appreciate your earliest attention to this matter. All required information is contained within, however, should any information not be totally clear or unreadable, please advise us immediatly.

Sincerely,

Pierre MONTILLOT
C.E.O.
SOPRO
Enclosures

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2003

Mr. Pierre MONTILLOT SOPRO Place St. Christophe Les Accates-La Valentine Marseille France F-13011

Re: K031593 Trade/Device Name: SOPRO 61D Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: May 19, 2003 Received: July 14, 2003

Dear: Mr. MoNTILLOT:

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 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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Page 2 - Mr. Pierre MONTILLOT

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

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Page A of A.

| 510(k) Number (if known): | K031593 |
|---------------------------|-------------------------------------|
| Device Name: | SOMRO 617 Digital Endoscopy Camera. |

Indications For Use:Indications I-or Use:

illumination and allow observation hollow cavites manipul andy 200

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use ીનિ (Optional Format 1-2-96) ivision Sign-O.

Division of General, Restorative and Neurological Devices

510(k) Number K031593