(118 days)
No
The summary describes a digital camera system with image processing capabilities but does not mention AI, ML, or any related concepts like deep learning or neural networks.
No
The device provides imaging for observation or manipulation and does not directly treat or mitigate a disease or condition.
No
Explanation: The Intended Use/Indications for Use states that the device is for "observation or manipulation of body cavities, hollow organs and canals," and includes an "optical system for conveying an image to the user's eye." This describes an imaging device used to visualize internal structures for procedures or general examination, but it doesn't explicitly state that it identifies a disease, condition, or provides a diagnosis. While the camera aids in observation, which can contribute to a diagnosis, its primary described function is visualization, not diagnostic detection.
No
The device description explicitly states it is a "digital processing camera system utilizing a CCD image sensor," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for direct observation and manipulation of body cavities, hollow organs, and canals. This is an in vivo application, meaning it's used within a living organism.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The device description and intended use do not involve the analysis of such samples.
- Device Description: The device is a camera system for capturing images within the body. This aligns with an in vivo imaging device, not an IVD.
The information provided clearly indicates the device is used for direct visualization and intervention within the body, which is the domain of in vivo medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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".
Product codes
GCJ
Device Description
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.
Mentions image processing
digital processing camera system
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, hollow organs and canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
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 : 33 (0) 4 91 27 07 27 Fax : 33 (0) 4 91 43 26 75
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.
1
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
2
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.
3
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
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