(35 days)
No
The device description details a traditional light source with mechanical controls and halogen lamps, with no mention of AI/ML or image processing.
No
The intended use states "Provides light for examination, diagnostic and therapeutic applications", but the device description only mentions it as a light source for endoscopy. There is no information or detail about how this device itself provides a therapeutic application. However, the predicate device K010033 'WOLF LP 4251' is identified as a Class II device (Endoscope and Accessories), which are generally diagnostic aids.
Yes
The "Intended Use / Indications for Use" statement explicitly mentions "diagnostic" applications.
No
The device description clearly states it is a light source with physical components like lamps, a mechanical iris, and connections for fiber optic cables, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Provides light for examination, diagnostic and therapeutic applications, particularly in endoscopy." This describes a device used in vivo (within the body) to illuminate internal structures for visualization and procedures.
- Device Description: The description details a light source with lamps and connections for fiber optic cables, consistent with an endoscopic light source.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose conditions. IVDs typically involve reagents, assays, or analysis of biological specimens.
Therefore, the SOPRO 225, as described, functions as a medical device for illumination during procedures, not as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SOPRO 225 Dual halogen light source is intended to be used by qualified physicians in general and plastic surgery to provide light for examination, diagnostic and therapeutic applications, particularly in endoscopy".
Product codes
GCJ
Device Description
The SOPRO 225 is a light source with two 250W Halogen reflector lamps, mechanical iris light intensity control, and connections for fiber optic light cable. A switch on the front panel provides for lamp selection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians / general and plastic surgery, endoscopy
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)
Not Found
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
8. Summary of Safety and Effectiveness - "510(k) Summary"
A. Submitter Information SOPRO ZAC Athélia Avenue des Genévriers 13705 La Ciotat Cedex FRANCE
Telephone: 33 (0) 442 98 01 01 Fax: 33 (0) 442 71 76 90
NOV 1 6 2007
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: October 11, 2007
B. Device Identification
Classification Name: Laparoscope, General & Plastic Surgery
Common Usual Name: Laparoscope and accessories
Proprietary Name: SOPRO 225 Dual halogen light source
C. Identification of Predicate Device
| Device
WOLF LP 4251 | Applicant
Richard Wolf
Medical
Instruments
Corp. | 510(k) No.
K010033 | Date Cleared
January 10, 2002 |
| ------------------------ | -------------------------------------------------------------- | ----------------------- | ---------------------------------- |
|---|
The SOPRO 225 is substantially equivalent to the predicate device by the Richard Wolf Instruments Corporation, the WOLF LP 4251 (K010033) previously cleared by the FDA and currently marketed.
D. Device Description
The SOPRO 225 is a light source with two 250W Halogen reflector lamps, mechanical iris light intensity control, and connections for fiber optic light cable. A switch on the front panel provides for lamp selection.
:
1
E. Intended Use
The SOPRO 225 Dual halogen light source is intended to be used by qualified physicians in general and plastic surgery to provide light for examination, diagnostic and therapeutic applications, particularly in endoscopy".
F. Substantial Equivalence
The SOPRO 225 dual halogen light source and the predicate device WOLF LP 4251 dual halogen light source are both in Class II Endoscope and Accessories intended for use by qualified physicians.
The SOPRO 225 and the predicate are both dual halogen light sources intended to be used by qualified physicians in general and plastic surgery to provide light for examination, diagnostic and therapeutic applications, particularly in endoscopy".
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2007
SOPRO % ACTEON, Inc. Mr. Steve Salesky 124 Gaither Drive, Suite 140 Mt. Laurel, New Jersey 08054
Re: K072912
Trade/Device Name: SOPRO 225 DUAL HALOGEN LIGHT SOURCE Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 11, 2007 Received: October 12, 2007
Dear Mr. Salesky:
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
3
Page 2 - Mr. Steve Salesky
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 Office of Compliance at (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Molkerson
Mark N. Melkerso Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name:
SOPRO 225 DUAL HALOGEN LIGHT SOURCE
Indications for Use:
"Provides light for examination, diagnostic and therapeutic applications, particularly in endoscopy"
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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices 6072912
510(k) Number