(73 days)
Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals.
S - 35 9 Video Imaging
The provided text is a 510(k) summary for the SOPRO S-357 Video Imaging System. This document asserts substantial equivalence to existing devices rather than presenting a performance study with acceptance criteria.
Therefore, the document does not contain information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, or adjudication methods.
Here's an explanation of why the requested information cannot be extracted from the given text:
- Substantial Equivalence (510(k)) vs. Performance Studies: The 510(k) pathway for medical device approval in the US focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, intended use, and performance claims to the predicate. It does not generally require de novo clinical trials or rigorous performance studies with predefined acceptance criteria in the same way a PMA (Pre-Market Approval) or some other regulatory pathways might.
- Content of the 510(k) Summary: The summary states: "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... 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." This clearly indicates a comparative approach based on similarity, not an independent performance study with measurable outcomes.
Thus, I cannot fill in the requested table or answer the questions related to performance studies, ground truth, or expert involvement because the provided text does not contain that information.
The document does provide:
- Device Name: S - 359 Video Imaging (though the summary refers to S-357, and the FDA letter refers to "Video Endoscopic Camera" and uses K972540, implying the S-357/S-359 are closely related or the same product with a minor naming discrepancy in the document).
- Intended Use/Indications For Use: "Assist in the observation and recording of surgical procedures performed in body cavities, hollow organs and canals."
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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.
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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
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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 Devices510(k) Number_1( 9725 Y 0 | ||
| Prescription Use V(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
§ 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.