(83 days)
Not Found
No
The device description and lack of mentions of AI/ML, image processing, or performance studies related to algorithmic analysis strongly suggest it is a simple light source without AI/ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states "therapeutic applications."
Yes
The 'Intended Use / Indications for Use' explicitly states that the device "Provides light for examination, diagnostic and therapeutic applications".
No
The device description clearly states it is a "light source with one led lamp, electronic iris light intensity control, and connections for a fiber optic light cable," indicating it is a hardware device.
No, 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 during a medical procedure to illuminate the area being examined or treated.
- Device Description: The description details a light source with an LED lamp and connections for a fiber optic cable. This is consistent with a device used for illumination during procedures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not interact with specimens in this way.
The device described is a medical device used for illumination during procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"Provides light for examination, diagnostic and therapeutic applications, particularly in endoscopy"
Product codes (comma separated list FDA assigned to the subject device)
NTN, FCW
Device Description
The SOPRO 281 is a light source with one led lamp, electronic iris light intensity control, and connections for a fiber optic light cable. A switch on the top of the device enables light output and intensity control. A multi-color led indicates device status
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 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
8. Summary of Safety and Effectiveness - "510(k) Summary"
K 103813
A. Submitter Information SOPRO ZAC Athélia Avenue des Genévriers 13705 La Ciotat Cedex FRANCE
Telephone: 33 (0) 442 98 01 01 33 (0) 442 71 76 90 Fax:
Contact Person:
Rick Rosati SOPRO c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: 800 289-6367 Ext. 39 Fax: 856 222-4726 E-mail: rick.rosati@us.acteongroup.com
Date Prepared:
December 27, 2010
B. Device Identification
Led light source Classification Name:
Endoscope and accessories Common/Usual Name:
SOPRO 281 Proprietary Name:
C. Identification of Predicate Device
| Device | Applicant | 510(k) N° | Date cleared |
|---|---|---|---|
| LO-50 LED Light Source | Fiberoptics Technology inc | K102167 | 08/17/2010 |
| LLS-050 | Sunoptic technologie | K093792 | 03/18/2010 |
The SOPRO 281 is substantially equivalent to the predicate devices by the Fiberoptics Technology inc ,LO-50 LED Light Source, or Sunoptic technologie LLS-050 previously cleared by the FDA and currently marketed.
D. Device Description
The SOPRO 281 is a light source with one led lamp, electronic iris light intensity control, and connections for a fiber optic light cable. A switch on the top of the device enables light output and intensity control. A multi-color led indicates device status
1
E. Intended Use
The SOPRO S281 LED light source is intended to be used by qualified physicians in general and plastic surgery to Provides light for examination, diagnostic and therapeutic applications, particularly in endoscopy
F. Substantial Equivalence
The SOPRO 281 LED light source is similar to the LO-50 led light source (K102167) and to LLS-050 (K093792) predicate devices in terms of technical specifications, performances, and intended use. Further the SOPRO 281 has the same properties of safety and effectiveness as the predicates.
The SOPRO 281 , LO-50 LED and LLS-050 Light Source are all LED 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.
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 image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
SOPRO . % Accton. Inc. Mr. Rick Rosati 124 Gaither Drive, Suite 140 Mt. Laurel, New Jersey 08054
NAR 2 2 2011
Re: K103813
Trade/Device Name: SOPRO 281 LED LIGHT SOURCE Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NTN, FCW Dated: December 27, 2010 Received: December 29, 2010
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
3
Page 2 - Mr. Rick Rosati
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the necessoric product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Pant 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1118801.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2175), Previ 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli me (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Aing B. 12. L
fen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
K103813
Device Name:
SOPRO 281 LED 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)
Aling B. Rt. fmn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103813