(73 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is very basic ("Video Imaging"). There is no information about image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No
The device is solely for observation and recording of surgical procedures, not for treatment or therapy.
No
The device is described as assisting in the observation and recording of surgical procedures, which are functions related to procedure execution and documentation, not diagnosis. It gathers video for observation and recording but does not analyze or interpret data to determine the nature or cause of a disease or condition.
Unknown
The provided 510(k) summary does not contain enough information to definitively determine if the device is software-only. It describes a video imaging device for surgical procedures but doesn't specify if it includes hardware components or is purely software for processing video from an external source.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals." This describes a device used during a surgical procedure to visualize and document the internal anatomy.
- 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. They are used outside the body (in vitro) to provide information about a patient's health status.
- Device Description: The device is described as "Video Imaging," which aligns with the intended use of visualizing internal structures during surgery.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing performed on samples.
Therefore, this device falls under the category of a surgical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals.
Product codes (comma separated list FDA assigned to the subject device)
78 KOG, GCJ
Device Description
The design of the S-357 is virtually identical to the comparative devices. which are listed and displayed in Exlubil 2 and 3. Since the design is comparable, tcchnology virtually identical, the specifications very similar, and the intended use the sames. SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Video Endoscopic Camera
Anatomical Site
Body cavities, hollow organs and canals
Indicated Patient Age Range
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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): 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.
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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.
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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
Exhibit 9.
SEP 1 8 1997
510(k) Summary
SOPRO feels the S-357 Video Imaging System is substantially equivalent to the many marketed devices already in commercial distribution. The legally marketed devices already In commercial distribution are : Circon/ACMI, Storz, Stryker, Smith & Nephew and Olympus, just to name a few.
The design of the S-357 is virtually identical to the comparative devices. which are listed and displayed in Exlubil 2 and 3. Since the design is comparable, tcchnology virtually identical, the specifications very similar, and the intended use the sames. SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device.
For information purposes and completeness. SOPRO has also incorporated other legally marketed devices in this filling to illustrate the wide general use of similar other devices. This wide use had led us to the safe use of this device in many practitioner's hands.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping lines, resembling a human form or a symbol of interconnectedness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Pierre Montillot C.E.O. SOPRO SA Place Saint Christophe, Les Accates, La Valentine, F-13011 Marseille, FRANCE
Re: K972540 Video Endoscopic Camera Dated: July 1, 1997 Received: July 7, 1997 Regulatory class: II 21 CFR §876.1500/Product codes: 78 KOG and GCJ
Dear Mr. Montillot:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the intentions for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 and additionally 809.10 for in yitr diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
W Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: S - 35 9 Video Imaging
Indications For Use:
Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals.
(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 Reproductive, Abdominal, ENT, | ||
| and Radiological Devices | ||
| 510(k) Number_1( 9725 Y 0 | ||
| Prescription Use V | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) | ||