(88 days)
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K/DEN number: Not Found
No
The summary does not mention AI, ML, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML-powered devices.
No.
The 'Intended Use' section describes the device being used for observation, and the 'Device Description' identifies it as a "Video Imaging System." There is no information suggesting it actively treats or modifies a disease or condition. The listed predicate devices are also primarily imaging or surgical visualization systems.
No
The 'Intended Use' section describes the device as being for "observation" and the 'Device Description' identifies it as a "Video Imaging System." There is no mention of analysis, diagnosis, detection, or treatment, which are typical functions of diagnostic devices.
No
The device description "S-57 Video Imaging System" and the input modality "Video Imaging" strongly suggest the device includes hardware components for capturing and processing video, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in "surgical hotow carlies" and "practitioner's hands." This strongly suggests a surgical or procedural application, not a diagnostic test performed on samples outside the body.
- Device Description: "S-57 Video Imaging System" points to a system for capturing visual information, likely during a procedure.
- Input Imaging Modality: "Video Imaging" is consistent with capturing images during a procedure.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's description and intended use do not align with that definition.
N/A
Intended Use / Indications for Use
in the observation secolous Surgical hotow carlies, 2002 dires ir and candy
Product codes
GCJ
Device Description
SOPRO feels the S-57 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-57 is virtually identical to the comparative devices, which are listed and displayed in Exhibit 2 and 3. Since the design is comparable, technology 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
JAN - 2 1998
Exhibit 9.
510(k) Summary
SOPRO feels the S-57 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-57 is virtually identical to the comparative devices, which are listed and displayed in Exhibit 2 and 3. Since the design is comparable, technology 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/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 2 1998
Mr. Pierre Montillot C.E.O. SOPRO Place St. Christophe Les Accates-La Valentine Marseille, FRANCE
K973794 Re: Trade Name: S-57 Video Imaging System Regulatory Class: II Product Code: GCJ Dated: October 2, 1997 Received: October 6, 1997
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 indications for use stated in the enclosure) to 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). 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 (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 requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for
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Page 2 - Mr. Montillot
devices under the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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10(k) Number (if known): Device Name: SSPR Indications For Use: in the observation secolous Surgical hotow carlies, 2002 dires ir and candy
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109)
・・・
CR
Over-The-Counter Use_
(Optional Format 1-2-96)
coell
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K973754