(67 days)
VES0281-m is for use as a visual aid for an endoscope when doing diagnostic evaluations or procedures.
The functional package of this unit is as safe as separated components used for general endoscopy. The illuminator for all such systems presents the biggest question mark. This system utilizes a low wattage (28 watt) lamp instead of the usual 150 watt or 300 watt lamp usually used for such applications. This lower wattage provides several safety advantages:
- Longer life (150 hours vs. typically 40 hours).
- Low energy at the light guide end virtually eliminating problems with burning and end tip heating which is common with other systems. (The system has the same hot mirror configuration as other systems.)
- 3400% color temperature.
- Better utilization of the available light because the filament is smaller and capable of being focused to a smaller point on the fiber optic bundle.
The fact that the system is completely pre-wire internally eliminates delays in a procedure because the video equipment was not connected correctly. The use of a single cord minimizes potential problems with tripping over multiple cords.
The fully assembled system meets the current UL544 current leakage requirements.
The effectiveness of this unit is the same as multi-component set ups when used with more conventional 1/2" CCD sensors and 150 watt illuminators which is a common combination especially for office applications, into which this system will be marketed.
The provided text describes a medical device, the AngioLaz VES 0281-m Video Endoscopic System, but it does not contain a detailed study report with specific acceptance criteria, method sections, or outcome measures that would allow for a comprehensive answer to all points of your request.
The document is a safety and effectiveness summary for a 510(k) premarket notification. It primarily focuses on demonstrating substantial equivalence to a predicate device, as required by the FDA for this type of submission.
However, I can extract the information that is present and indicate where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Low wattage (28W) light source | Safety Advantages: Longer lamp life (150 hours vs. typical 40 hours); low energy at light guide end, virtually eliminating problems with burning and end tip heating (common with other systems); same hot mirror configuration as other systems. |
| Safety: Pre-wired internally | Safety Advantages: Eliminates delays in procedures due to incorrect video equipment connection. |
| Safety: Single cord use | Safety Advantages: Minimizes potential problems with tripping over multiple cords. |
| Safety: Current leakage requirements | Meets the current UL544 current leakage requirements. |
| Effectiveness: Image Quality/Performance | "[The effectiveness of this unit is the same as multi-component set ups when used with more conventional 1/2" CCD sensors and 150 watt illuminators which is a common combination especially for office applications, into which this system will be marketed.]" |
| Color Temperature | 3400% color temperature. (Note: The "3400%" appears to be a typo in the original document and likely refers to 3400K or a similar unit for color temperature, not a percentage). |
| Light Utilization | Better utilization of available light because the filament is smaller and capable of being focused to a smaller point on the fiber optic bundle. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document does not describe a formal "test set" in the way a clinical or technical validation study would. It refers to the device's performance based on its design and comparison to existing technology.
- Data Provenance: Not applicable, as detailed test set data is not presented. The statements are general claims about the device's characteristics and equivalence.
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 in the document. The submission is a regulatory filing, not a scientific publication detailing a study with expert ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided in the document. No adjudication method for a test set is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is a video endoscopic system (hardware), not an AI-powered diagnostic tool. The document predates widespread AI in medical devices (1998).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware (a video endoscopic system). It does not involve a standalone algorithm in the sense of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not explicitly stated as a method for establishing the performance claims. The "effectiveness" is stated as being "the same as multi-component set ups when used with more conventional 1/2" CCD sensors and 150 watt illuminators." This suggests a reliance on generally accepted performance standards for video endoscopy systems rather than a specific ground truth derived from expert consensus or pathology data for a new diagnostic claim.
8. The sample size for the training set
- Not applicable. This submission describes a hardware device, not an algorithm that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is a hardware device, not an algorithm requiring a training set.
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P1071
Safety and Effectiveness Summary
The functional package of this unit is as safe as separated components used for general endoscopy. The illuminator for all such systems presents the biggest question mark. This system utilizes a low wattage (28 watt) lamp instead of the usual 150 watt or 300 watt lamp usually used for such applications. This lower wattage provides several safety advantages:
- Longer life (150 hours vs. typically 40 hours). ●
- Low energy at the light guide end virtually eliminating problems with ● burning and end tip heating which is common with other systems. (The system has the same hot mirror configuration as other systems.)
- 3400% color temperature. .
- Better utilization of the available light because the filament is smaller . and capable of being focused to a smaller point on the fiber optic bundle.
The fact that the system is completely pre-wire internally eliminates delays in a procedure because the video equipment was not connected correctly. The use of a single cord minimizes potential problems with tripping over multiple cords.
The fully assembled system meets the current UL544 current leakage requirements.
The effectiveness of this unit is the same as multi-component set ups when used with more conventional 1/2" CCD sensors and 150 watt illuminators which is a common combination especially for office applications, into which this system will be marketed.
{1}------------------------------------------------
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/1/Picture/2 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle, following the circular shape of the logo.
JUL 28 1998
Mr. John D. Plumadore Director of Engineering AngioLaz, Inc. P.O. Box 556 Industrial Park Bellows Falls, VT 05101 Re: K981827 AngioLaz VES 0281-m Video Endoscopic System Dated: May 20, 1998 Received: May 22, 1998 Regulatory Class: II
21 CFR 876.1500/Procode: 78 KOG and 78 GCT
Dear Mr. Plumadore:
We have reviewed your Section 510(k) notification of intent to market the device 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 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 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/cdrb/dsmaldsmam.html".
Sincerely yours
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1_of_l___________________________________________________________________________________________________________________________________________________________________
510(K) Number (if known) Device Name VES0281-m
Indications For Use:
VES0281-m is for use as a visual aid for an endoscope when doing diagnostic evaluations or procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) ============================================================================================================================================================================== - - - - - - - -
Concurrence of CDRH, Office of Device Evaluation (ODE) -
Robert R. Satting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K981827
or
Prescription Use
Over-The-Counter
Ose (Per 21 CFR 801.109) તેર)
(Optional Format 1-2-
§ 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.