(90 days)
to allow surgeons to view the interior cavities of the human body under direct vision through the scope for the purpose of performing surgery by general surgeons and thoracic surgeons.
Solos 10mm Operating Laparoscope
According to the provided documents, this is a 510(k) clearance letter for the "Solos 10mm Operating Laparoscope" (K970917) from the FDA dated June 10, 1997. This document grants market clearance based on a finding of substantial equivalence to a legally marketed predicate device.
Key takeaway: A 510(k) clearance is based on substantial equivalence to a predicate device, not on acceptance criteria validated by new studies for the device itself.
Therefore, most of the requested information regarding acceptance criteria and performance studies for this specific device (Solos 10mm Operating Laparoscope) is not available in this document. The FDA letter states: "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."
This means that Woodbine Optical Corporation demonstrated that their device performs as safely and effectively as a previously cleared device, rather than providing new clinical study data with acceptance criteria for the Solos 10mm Operating Laparoscope itself.
Therefore, I cannot provide you with a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details on ground truth for this device based on the provided text.
However, I can still elaborate on the limitations of this document regarding your request:
- A table of acceptance criteria and the reported device performance: Not provided. The performance is assumed to be equivalent to the predicate device.
- Sample sized used for the test set and the data provenance: Not provided. No new test set data is discussed in this letter for the Solos device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No new ground truth establishment is discussed for the Solos device.
- Adjudication method for the test set: Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laparoscope, not an AI-assisted diagnostic tool for "human readers."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a manual operating laparoscope, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided for the Solos device. The substantial equivalence is likely based on the predicate device's established performance and the Solos's design, materials, and intended use being comparable.
- The sample size for the training set: Not provided. No training set is mentioned as this is not an AI/ML device.
- How the ground truth for the training set was established: Not provided.
The crucial information here is that the FDA's decision is based on substantial equivalence to a predicate device, not on independent, new studies demonstrating specific acceptance criteria for the Solos 10mm Operating Laparoscope.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 10 1997
Mr. John M. Ahern CEO Woodbine Optical Corporation 41 Brooks Drive Braintree, Massachusetts 02184
:4 K970917 Re : Solos 10mm Operating Laparoscope Requlatory Class: II Product Code: GCJ Dated: December 12, 1996 Received: March 12, 1997
Dear Mr. Ahern:
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will
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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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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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Ref: K# 970917 Solos Operating Laparoscope
Indications for use: to allow surgeons to view the interior cavities of * the human body under direct vision through the scope for the purpose of performing surgery by general surgeons and thoracic surgeons.
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Peatlefo
Prescription Use
(Per 21 CFR 801.109)
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.