(86 days)
Precision Optics Corporation's ENT Endoscopes - Sinuscopes are indicated for use to mination and visualization of these regions.
ENT Endoscope - Sinuscope
This 510(k) summary does not contain the detailed information necessary to complete all parts of the requested table and study description. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) summary does not outline specific performance criteria or report results from a study designed to meet them. It primarily states that the device is substantially equivalent to predicate devices because its basic features, design, and primary functions are the same, and any minor differences raise no new issues of safety and effectiveness.
2. Sample size used for the test set and the data provenance
This information is not provided. As no specific performance study is detailed, there's no mention of a test set or its sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. There is no mention of an expert panel or ground truth establishment for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. No adjudication method is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided. The device is an ENT Endoscope (Sinuscope), which is a hardware device for direct visualization, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not provided. As an endoscope, there is no "algorithm only" performance separate from human-in-the-loop use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. There is no mention of a ground truth being established for any performance evaluation in this 510(k) summary.
8. The sample size for the training set
This information is not applicable/not provided. As this is a hardware device (endoscope), there wouldn't typically be a "training set" in the context of machine learning or algorithms. The manufacturing and design process relies on established engineering principles and materials science.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as point 8.
Summary of the Study (as described in the 510(k) statement):
The "study" or justification for clearance in this 510(k) document is a substantial equivalence comparison to predicate devices, not a performance study with specific acceptance criteria.
- Rationale for Substantial Equivalence: Precision Optics Corporation's ENT Endoscope - Sinuscope is considered substantially equivalent to previously cleared endoscopes (Laparoscope and Arthroscope by Precision Optics Corporation) because:
- Basic features, design, and primary functions are the same.
- Any minor differences in design and dimensions (e.g., tube diameter and insertion length) are not deemed to raise new issues of safety and effectiveness.
- External materials, construction, and fundamental operational principles are identical to the cleared predicate devices (K914084 and K945684), with only variations in physical dimensions.
This type of submission relies on the established safety and effectiveness of the predicate devices. The "proof" is the detailed comparison of design, materials, and intended use to those already cleared devices, demonstrating that the new device does not introduce new risks or questions of effectiveness.
{0}------------------------------------------------
Section 7
2 2 1998 510(k) SUMMARY
SUBMITTERS INFORMATION
Name and Address
Precision Optics Corporation 22 E. Broadway Gardner, MA 01440 Telephone 978.630.1800
Contact Person James A. Reilly, Quality Assurance Manager
Date of Summary 26 June 1998
DEVICE NAME
Proprietary Name: Common Name: Classification Name: ENT Endoscope - Sinuscope Sinuscope Sinuscope
PREDICATE DEVICE IDENTIFICATION
Predicate devices referenced include Precision Optics Corporation's endoscopes (Laparoscope and Arthroscope).
SUBSTANTIAL EQUIVALENCE
Precision Optics Corporation's ENT Endoscope is substantially equivalent to cited predicate Endoscope devices since the basic features, design, and primary functions are the same. Any minor differences in design and dimensions between the Precision Optics Corporation's ENT Endoscope - Sinuscope and the predicate devices raise no new issues of safety and effectiveness as these differences have no effect on the safety, performance and function of the ENT Endoscopes.
This device will be identical with respect to external materials, construction, and fundamental operational principles to Precision Optics Corporation's current line of cleared Laparoscopes (K914084) and Arthroscopes (K945684) except for variations of tube diameter and insertion length.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the words "Public Health Service" in a simple, sans-serif font. The text is black and appears to be printed on a white background. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 1998
James A. Reilly Manager, Quality Assurance Precision Optics Corporation 22 East Broadway Gardner, MA 01240
Re:
K983123 POC ENT Endoscope - Sinuscope Dated: June 30, 1998 Received: July 1, 1998 Regulatory class: II 21 CFR 874.4760/Procode: 77 EOB
Dear Mr. Reilly:
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 (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 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.
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) 594-4613. 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/cdch/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
STATEMENT OF INDICATIONS FOR USE
Intended Use:
Precision Optics Corporation's ENT Endoscopes - Sinuscopes are indicated for use to Precision Optics Corporation 3 22 x 22.3 x 22.3 x 25.5 x 12.0 x 11.0 mination and visualization of these regions.
Vinit C. Sejpm
(Division Sign-Off)
(Division of Reproductive, Abdominal, ENT,
and Radiological Devices Provision of Reproductive, and Radiological Devices 510(k) Number . 4983123
Prescription Use
(Per 21 CFR 801.109)
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.