(28 days)
Use for visualization inside the human body to view surgical procedure(s), by physician.
The Indications for this device use is when medical practitioner needs visualization in order to view surgical procedures, gaining access either through a natural orifice or incision.
The provided text is a 510(k) summary for a "Miniature Endo/Laparoscope" from Solos Endoscopy, Inc. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel safety and effectiveness through extensive clinical studies and acceptance criteria as might be seen for devices requiring Premarket Approval (PMA) or more rigorous 510(k) submissions.
Therefore, the information typically requested in your prompt (e.g., acceptance criteria, samples sizes for test and training sets, expert qualifications, MRMC studies, standalone performance) is not present in this type of submission.
Instead, the document asserts that:
- The device is substantially equivalent to legally marketed predicate devices (K932987, K931065, K926166, and others from various manufacturers).
- Physical characteristics are virtually the same, except for miniaturization.
- Intended use is virtually identical: "visualization of surgical procedures."
- Prior devices were accepted with respect to: performance specifications, composition, technology employed, biocompatibility, manufacturing, QC, physical testing, etc.
- Minor changes (miniaturization) have no impact on safety and/or effectiveness.
This type of 510(k) relies on the premise that if a new device is sufficiently similar to a legally marketed predicate device, it is also safe and effective for its intended use without requiring new, extensive clinical trials to prove performance against specific acceptance criteria.
Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text. The document is a regulatory approval letter and an executive summary of a 510(k) submission, not a study report detailing performance data against specific, quantitative acceptance criteria.
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6 1998 NOV
Exhibit 8 Summarv
Summarv
SOLOS ENDOSCOPY feels the Minature endo/Laparoscope listed in this Special 510(k) is Substantially Equivalent, in terms of physical characteristics, to the legally marketed devices already in commercial distribution. These devices are made or specified by, and Imarketed by Solos Endoscopy. Inc., and no less than 20 other companies with similar devices with very similar characteristics. These devices now under commercial distribution are K932987, K931065 and K926166. Others with very similar characteristics are listed and under commercial distribution by Omega, Candela Laser and other manufacturer's, such as, but not limited to; Fujinon, Olympus, Baxter, Stryker, Linvatec, Karl Storz et al. Each markets similar devices.
The design of SOLOS ENDOSCOPY made/marketed endoscopes K971996, K926166 is virtually the same as soopes approved for intended use for the purpose of visualization of surgical procedures. Each 5100k) intended use is tabulated in this document.
The assessment of this device, from, SOLOS ENDOSCOPY'S point of view is as follows: The physical characteristics, except for miniaturization, are virtually the same as approved devices. The intended use of visualization of surgical procedure is virtually identical and each has been accepted with respect to: performance specifications, composition, technology employed, bio-compatibility, manufacturing, OC, physical testing, etc. These above minor changes have no impact on the safe use and/or effectiveness of the device.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping shapes that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 NOV
Mr. Paul Dias Quality Assurance Manager Solos Endoscopy, Inc. 41 Brooks Drive Braintree, Massachusetts 02184
Re: K983538 Trade Name: Miniature Endo/Laparoscope Regulatory Class: II Product Code: GCJ Dated: October 07, 1998 Received: October 09, 1998
Dear Mr. Dias:
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 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for 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.
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Page 2 - Mr. Paul Dias
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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983538
'Use for visualization inside the human body to view surgical procedure(s), by physician.'
Indications for Use:
The Indications for this device use is when medical practitioner needs visualization in order to view surgical procedures, gaining access either through a natural orifice or incision.
Prescription Use
(Per 21 CFR 801.109)
Acoell
(Division Sign-Off) Division of General Restorative De 510(k) Number .
§ 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.