(82 days)
Not Found
No
The device description and intended use focus on traditional fiber optic technology for visualization. There is no mention of AI, ML, or any advanced image processing beyond basic transmission to an eyepiece or monitor.
No
The device is described as an endoscope for visualization purposes only; it does not perform any therapeutic function.
Yes
Explanation: The device is an endoscope intended for visualization, which is a form of diagnostic imaging used to assess body cavities and organs for medical conditions.
No
The device description clearly states it is a fiber optic endoscope, which is a hardware device. While it can transmit images to a monitor, the core functionality is based on physical components (fiber optics, light source, eyepiece).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "visualization of body cavities, hollow organs, and canals." This is a direct visualization tool used in vivo (within the living body) for diagnostic or procedural purposes.
- Device Description: The description details a fiber optic endoscope that transmits light and images for direct viewing or display on a monitor. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information about a patient's health. This device does not process or analyze biological specimens.
The device is clearly described as an endoscope used for internal examination of the body, which falls under the category of medical devices used for in vivo procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The OmniSonics Endoscopes are fiber optic endoscopes intended for visualization of body cavities, hollow organs, and canals. The OmniSonics Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths of other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The OmniSonics Endoscopes are indicated for the following applications:
- Ureteroscopy Bronshoscopy Thoracoscopy NasopharyngoscopySinuscopy General laparoscopy Urology Gynecological
Product codes
GCJ
Device Description
The OmniSonics Endoscopes are fiber optic designed endoseopes offered in a variety of lengths, diameters and configurations for user convenience. The fiberoptic endoscope functions by light being transmitted from a standard external high intensity light source through illumination fibers to the distal tip of the scope. The image is transmitted via a fiber-imaging bundle to an eyepiece. The image is viewed directly or transmitted through a video camera to a monitor.
The device is provided with a reusable coupler and is also compatible with other standard couplers currently marketed.
Mentions image processing
The image is transmitted via a fiber-imaging bundle to an eyepiece. The image is viewed directly or transmitted through a video camera to a monitor.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, hollow organs, and canals (Ureteroscopy, Bronshoscopy, Thoracoscopy, Nasopharyngoscopy, Sinuscopy, General laparoscopy, Urology, Gynecological)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The OmniSoncis Endoscopes conform to IEC 60601-2-18 All materials used are biocompatable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K962116, K981928, K944079, K943593, K962255
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUL 12 1999
OmniSonics Medical Technologies OmniSonics Fiberoptic Endoscopc and Coupler
04/20/99 Premarket Notification
99/377
OmniSonics Medical Technologies 14 Equestrian Drive No. Reading, MA 01864
510K Summary OmniSonics Medical Technologies Flexible Fiber Optic Endoscope and Coupler
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- Sponsor Name
OmniSonics Medical Technologies 14 Equestrian Drive North Reading, MA 01864
- Sponsor Name
Telephone: (978) 664 8440 Contact Individual: Debbie Iampietro
-
- Device Name
Proprietary Name: OmniSonics Flexible Fiberoptic Endescope and Coupler Common/Usual Name: Endoscope Classification Name: Endoscope and accessories
- Device Name
-
- Identification of Predicate or Legally Marketed Device
The OmniSonics Endoscopes are substantially equivalent to several legally marketed devices including:
- Identification of Predicate or Legally Marketed Device
Galileo Endoscopes K962116 Galileo Disposable Endoscopes K981928 Imagyn Laparascope K944079 Saratoga Medical K943593 Clarus Murphy Scope K962255
1
OmniSonics Medical Technologies 14 Equestrian Drive No. Reading, MA 01864
Device Description 4.
The OmniSonics Endoscopes are fiber optic designed endoseopes offered in a variety of lengths, diameters and configurations for user convenience. The fiberoptic endoscope functions by light being transmitted from a standard external high intensity light source through illumination fibers to the distal tip of the scope. The image is transmitted via a fiber-imaging bundle to an eyepiece. The image is viewed directly or transmitted through a video camera to a monitor.
The device is provided with a reusable coupler and is also compatible with other standard couplers currently marketed.
న్. Intended Use
The OmniSonics Endoscopes are fiber optic endoscopes intended for visualization of body cavities, hollow organs, and canals. The OmniSonics Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths of other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The OmniSonics Endoscopes are indicated for the following applications:
- Ureteroscopy Bronshoscopy Thoracoscopy NasopharyngoscopySinuscopy General laparoscopy Urology Gynecological
Comparison of Technological Characteristics 6.
The intended uses of each of the devces are identical in that they are all fiberoptic endoscopes intended for visualization of body cavities, tissues, organs or canals. The OmniSonics Endoscopes are substantially similar in design, technological characteristics and materials to the above cited predicates. All of the devices on the market offer various configurations, lengths, diameters, use an external light source and are made of either stainless steel or polyamide.
2
000051
OmniSonics Medical Technologies 14 Equestrian Drive No. Reading, MA- 01864
7 Performance Testing The OmniSoncis Endoscopes conform to IEC 60601-2-18 All materials used are biocompatable.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 1999
OmniSonics Medical Technologies c/o Ms. Debbie Iampietro Consultant 7 Tiffany Trail Hopkinton, Massachusetts 01748
Re: K991377
Trade Name: Flexible Fiber Optic Endoscope and Coupler Regulatory Class: II Product Code: GCJ Dated: April 20, 1999 Received: April 21, 1999
Dear Ms. Iampietro:
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.
4
Page 2 - Ms. Debbie Iampietro
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,
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
5
510(k) Number (if known):
Device Name: OmniSoncis Flexible Fiber Optic Endoscope and Coupler
Indications For Use:
The OmniSonics Endoscopes are intended for visualization of body cavities, hollow organs, and canals. The Omail only candoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The OmniSonics Endoscopes are indicated for the following applications:
Ureteroscopy . Bronshoscopy , Thoracoscopy -NasopharyngoscopySinuscopy General laparoscopy Urology . Gynecological -
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.1099
OR
Over-The-Counter Use
Prateep
L991377
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