(190 days)
No
The description focuses on standard digital imaging technology and hardware modifications, with no mention of AI/ML algorithms or capabilities.
No.
The device's sole stated intended use is for "providing access, illumination and allow observation or manipulation," which are diagnostic and procedural guidance functions, not therapeutic.
No
The device description states its purpose is to "provide access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals," indicating it is a tool for visualization and intervention, not for diagnosing a condition based on observed information.
No
The device description explicitly states it is a "digital processing camera system utilizing a CCD image sensor," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Providing access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals." This describes a device used for direct visualization and intervention within the body, not for examining specimens in vitro (outside the body).
- Device Description: The description details a digital camera system for capturing images of internal body structures. This aligns with an imaging device used in vivo.
- Anatomical Site: The specified anatomical sites are "body cavities, hollow organs, and canals," which are internal to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
This device appears to be an endoscopic or surgical imaging system used for visualization during procedures.
N/A
Intended Use / Indications for Use
"Providing access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals."
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The SOPRO 184 is a high resolution, digital processing camera system utilizing a CCD image sensor. It provides high quality images with excellent resolution and color contrast. Its contour enhancer gives the impression of a 3D image. This makes the camera a multidisciplinary tool.
The SOPRO 184 is a modification of the SOPRO 162 previously cleared on 510(k) K031593. The modifications are the addition of RGBS & USB2 outputs, 2 SD1 outputs as an option and the modification of the head design for the ergonomic.
Mentions image processing
Yes
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
qualified physicians
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K082796 page w of 2
- Summary of Safety and Effectiveness - "510(k) Summary"
A. Submitter Information SOPRO ZAC Athélia Avenue des Genévriers 13705 La Ciotat Cedex FRANCE
APR - 1 2009
Telephone: 33 (0) 442 98 01 01 Fax: 33 (0) 442 71 76 90
Contact Person: Rick Rosati
SOPRO c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: 800 289-6367 Ext. 37 Fax: 856 222-4726 E-mail: rick.rosati@us.acteongroup.com
Date Prepared: September 22, 2008
B. Device Identification
Classification Name: Laparoscope, General & Plastic Surgery
Common Usual Name: Laparoscope and accessories
SOPRO 184 camera Proprietary Name:
C. Identification of Predicate Device
| Device | Applicant | 510(k) No. | Date Cleared |
|---|---|---|---|
| SOPRO 162 | SOPRO | K070102 | February 20, 2007 |
The SOPRO 184 is substantially equivalent to the predicate device by SOPRO, the SOPRO 162 (K070102) previously cleared by the FDA and currently marketed.
1
Page (2) of (2)
D. Device Description
The SOPRO 184 is a high resolution, digital processing camera system utilizing a CCD image sensor. It provides high quality images with excellent resolution and color contrast. Its contour enhancer gives the impression of a 3D image. This makes the camera a multidisciplinary tool.
The SOPRO 184 is a modification of the SOPRO 162 previously cleared on 510(k) K031593. The modifications are the addition of RGBS & USB2 outputs, 2 SD1 outputs as an option and the modification of the head design for the ergonomic.
E. Intended Use
The SOPRO 184 providing access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals.
F. Substantial Equivalence
The SOPRO 184 camera and the predicate device, SOPRO 162 camera (K070102) are both laparoscopes and accessories for use in general and plastic surgery by qualified physicians. Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the SOPRO 184.
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 stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 2009
Sopro % Acteon, Inc. Mr. Rick Rosati 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054
Re: K082796
Trade/Device Name: SOPRO 184 Digital Endoscopy Camera Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 9, 2009 Received: March 11, 2009
Dear Mr. Rosati:
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. Iisting 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
3
Page 2 - Mr. Rick Rosati
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
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:
082796
Device Name:
SOPRO 184 Digital Endoscopy Camera
Indications for Use:
"Providing access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals."
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Knoie for MXM 3/31/09
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062796