(64 days)
The flexible laproscope can be used to view complete therapeutic procedures using approved laproscopic instrumentation. The laproscope is used as a viewing device to complete procedures such as Laprosopic Cholecystectomy: Separation of Adhesions: Tubal Pregnancy: Uterine Hypoplasia: Infertilization: Mtritus: Cervical Myoma. Also procedures within the Thoracic Cavity such as the diagnosis and staging of Intrathoracic disease, therapeutic thoracic procedures, wedge resections, tube toracistomy pierodesis, thoracoscopy pleurodesis.
EL2-TF410 Video Laproscope
I am referencing the provided text about the Fujinon EL2-TF410 Video Laproscope for the following response.
Based on the provided document, the device in question is a "Video Laproscope" and the document is a 510(k) clearance letter from the FDA. This type of document declares the device to be "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness.
This document is a marketing clearance letter and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. It primarily focuses on the regulatory determination of substantial equivalence.
Therefore, I cannot provide the specific details requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.
The document states:
- Trade Name: EL2-TF410 Video Laproscope
- Regulatory Class: II
- Product Code: GCJ
- Indications For Use: The flexible laparoscope can be used to view complete therapeutic procedures using approved laparoscopic instrumentation. The laparoscope is used as a viewing device to complete procedures such as Laparoscopic Cholecystectomy: Separation of Adhesions: Tubal Pregnancy: Uterine Hypoplasia: Infertilization: Metritis: Cervical Myoma. Also procedures within the Thoracic Cavity such as the diagnosis and staging of Intrathoracic disease, therapeutic thoracic procedures, wedge resections, tube thoracostomy pleurodesis, thoracoscopy pleurodesis.
To address your specific prompt, if this were a document containing performance study details, here's what would be expected:
- A table of acceptance criteria and the reported device performance: This would typically list quantitative metrics (e.g., resolution, illumination, field of view, color accuracy, distortion) with specific thresholds for acceptance and the actual measured performance of the EL2-TF410.
- Sample size used for the test set and the data provenance: Details on how many trials, images, or observations were used to evaluate the device's performance, and whether the data was collected retrospectively or prospectively, and from what geographical region.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For a device like a laparoscope, this isn't typically applicable in the same way as AI algorithms. Ground truth for a laparoscope is usually based on the physical characteristics of the device and its ability to provide clear visualization, rather than interpreting medical images for diagnosis.
- Adjudication method for the test set: Again, not directly applicable to the physical performance of a laparoscope. This is more relevant for diagnostic AI tools where expert disagreement on ground truth might occur.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: MRMC studies are usually for diagnostic interpretation and comparing human readers with and without AI assistance. This device is a viewing tool, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a medical instrument, not a standalone algorithm.
- The type of ground truth used: For a laparoscope, ground truth would be established through physical measurements and optical testing against industry standards or the performance of the predicate device.
- The sample size for the training set: Not applicable as this is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory clearance for marketing and does not contain the detailed performance study information requested.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
DEC 1 6 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fujinon, Incorporated C/O Mr. Gary A. Adler Bingham Dana Murase 399 Park Avenue New York, New York 10022
K983561 Re:
Trade Name: EL2-TF410 Video Laproscope Regulatory Class: II Product Code: GCJ Dated: November 30, 1998 Received: December 1, 1998
Dear Mr. Adler:
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 (OS) 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.
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Page 2 - Mr. Gary A. Adler
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,
fCelia 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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K983561 510(k) Number (if known):
EL2-TF410 Video Laproscope Device Name:
Indications For Use:
i
Indications for Use:
The flexible laproscope can be used to view complete therapeutic procedures using approved laproscopic instrumentation. The laproscope is used as a viewing device to complete procedures such as Laprosopic Cholecystectomy: Separation of Adhesions: Tubal Pregnancy: Uterine Hypoplasia: Infertilization: Mtritus: Cervical Myoma.
Also procedures within the Thoracic Cavity such as the diagnosis and staging of Intrathoracic disease, therapeutic thoracic procedures, wedge resections, tube toracistomy pierodesis, thoracoscopy pleurodesis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Division of General Restorative Devices | |
| 510(k) Number | K983561 |
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use -----
(Optional Formal 1-2-9G)
§ 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.