(41 days)
Not Found
No
The description focuses on standard digital imaging technology and hardware modifications, with no mention of AI or ML algorithms for image analysis or processing beyond basic digital processing.
No.
The "Intended Use" states that the device provides access, illumination, observation, or manipulation of body cavities, hollow organs, and canals. These functions are diagnostic or procedural assistance, not therapeutic in nature. The device description also highlights its image processing capabilities for observation.
No
Explanation: The device is described as a high-resolution digital processing camera system that provides images for observation or manipulation of body cavities, hollow organs, and canals. Its function is to provide visual access and illumination, not to interpret or analyze images to provide a diagnosis.
No
The device description explicitly states it is a "digital processing camera system utilizing a CCD image sensor" and mentions hardware components like a USB2 port, foot control, and electronic board. This indicates it is a hardware device with integrated software, not a software-only medical device.
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 in vivo (within the living body) for visualization and manipulation during surgical or diagnostic procedures.
- Device Description: The description details a digital camera system used for capturing images of the body's internal structures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the living body), such as blood, urine, tissue samples, etc., which is the defining characteristic of an IVD.
Therefore, the SOPRO 162 is a medical device used for internal visualization and manipulation, not an in vitro diagnostic device.
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 162 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 162 is a modification of the SOPRO 61D previously cleared on 510(k) K031593. The modifications are the addition of a USB2 port option, the addition of a foot control that allows for the freezing of an image when using the USB2 port option, and the addition of a stand-by board (electronic board). The SOPRO 162 requires the operator to initially turn on a master switch before turning on the unit with a button on the front panel.
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
qualified physicians in general and plastic surgery
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.
Not Found
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
9. Summary of Safety and Effectiveness - "510(k) Summary"
A. Submitter Information SOPRO ZAC Athélia Avenue des Genévriers 13705 La Ciotat Cedex FRANCE
FEB 2 0 2007
Telephone: 33 (0) 442 98 01 01 Fax: 33 (0) 442 71 76 90
| Contact Person: |
|---|
| ----------------- |
| Steve Salesky
SOPRO
c/o ACTEON, Inc.
124 Gaither Drive, Suite 140
Mt. Laurel, NJ 08054
Tel: 800 289-6367 Ext. 40
Fax: 856 222-4726
| E-mail: steve.salesky@us.acteongroup.com |
|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Date Prepared:
B. Device Identification
Classification Name: Laparoscope, General & Plastic Surgery
January 5, 2007
Common Usual Name: Laparoscope and accessories
Proprietary Name: SOPRO 162 camera
C. Identification of Predicate Device
| Device | Applicant | 510(k) No. | Date Cleared |
|---|---|---|---|
| SOPRO 61D | SOPRO | K031593 | September 16, 2003 |
The SOPRO 162 is substantially equivalent to the predicate device by SOPRO, the SOPRO 61D (K031593) previously cleared by the FDA and currently marketed.
D. Device Description
The SOPRO 162 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 162 is a modification of the SOPRO 61D previously cleared on 510(k) K031593. The modifications are the addition of a USB2 port option, the addition of a foot control that allows for the freezing of an image when using the
1
USB2 port option, and the addition of a stand-by board (electronic board). The SOPRO 162 requires the operator to initially turn on a master switch before turning on the unit with a button on the front panel.
E. Intended Use
The SOPRO 162 camera is intended to be used by qualified physicians in general and plastic surgery to provide access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals.
F. Substantial Equivalence
The SOPRO 162 camera and the predicate device, SOPRO 61D camera (K031593) 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 162.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
DEC 1 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SOPRO % ACETON, Inc. Mr. Steve Salesky Quality Manager 124 Gaither Drive. Suite 140 Mt. Laurel, New Jersey 08054
Re: K070102
Trade/Device Name: SOPRO 162 Camera Regulation Number: 21 CRF 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: January 5, 2007 Received: January 10, 2007
Dear Mr. Salesky:
This letter corrects our substantially equivalent letter of February 20, 2007.
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 (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); good manufacturing practice requirements as set
3
Page 2 - Mr. Steve Salesky
forth in the quality systems (OS) 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 continue 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 vours.
Mark N. Millhusan
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:
Device Name:
SOPRO 162 Digital Endoscopy Camera
Indications for Use:
"Providing access, illumination and allow observation or manipulation of body cavities, hollow organs, and canals."
Prescription Use _ X (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)
Mark A. Milken
mon Sign-Off) non of General, Restorative Lrological Devices