(61 days)
Not Found
No
The device description and lack of mentions of AI/ML, image processing, or performance studies related to algorithmic analysis strongly suggest this is a simple illumination device without AI/ML.
No.
The device is used for illumination during surgery, which is a supportive role, not a therapeutic intervention itself. It facilitates the surgery but does not treat the condition.
No
The device is used for illumination during surgery, which is a therapeutic or interventional function, not a diagnostic one. It aids the surgeon in visualizing the area but does not provide information to diagnose a condition.
No
The device description clearly states it is a "Fiber Optic Endoillumination Probe" which is a physical hardware component used for intraocular illumination. It describes the transmission of light through a flexible optical fiber and an illumination probe.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "intraocular illumination in vitreoretinal surgery." This describes a surgical tool used during a procedure to provide light within the eye.
- Device Description: The description confirms it's a probe that transmits light into the eye.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not interact with specimens or provide diagnostic information based on analyzing biological samples.
Therefore, the Fiber Optic Endoillumination Probe is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.
Product codes
FFS
Device Description
The Fiber Optic Endoillumination Probe is provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraocular
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
SEP 1 4 1998
510(k) Summary Fiber Optic Endoillumination Probe (per 21 CFR 807.92)
SUBMITTER NAME AND ADDRESS 1.
MicroVision, Inc. 34 Folly Mill Road, Suite 200 P.O. Box 1651 Seabrook, NH 03874-1651
Leonard Kastrilevich, President Contact Person: Telephone: 603-474-5566 ← -
Date Prepared: July 13, 1998
2. DEVICE NAME
Fiber Probe Trade Name: Fiber Optic Endoillumination Probe Proprietary Name: Light, Surgical, Fiberoptic Classification name:
3. PREDICATE DEVICE
Infinitech, Inc. Fiber Optic Probe (K870942)
4. DEVICE DESCRIPTION
The Fiber Optic Endoillumination Probe is provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.
5. INTENDED USE
The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
Operational and technological characteristics form the basis for the determination of substantial equivalence of the Fiber Optic Endoillumination Probe with legally marketed predicate devices. Information supplied in this premarket notification includes descriptive information about the intended use, operation, and technological characteristics.
1
COMPARISON TABLE
.
| Comparison Criteria | MicroVision, Inc.
Fiber Optic
Endoillumination Probe | Infinitech, Inc.
Fiber Optic
Probe |
|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------|
| Device Type: Fiber Optic
Probe | Yes | Yes |
| Indication: Intraocular
illumination in vitreoretinal
surgery | Yes | Yes |
| Patient Contact Materials:
PMMA and fluoropolymer
fiber and medical grade
Surgical stainless steel | Yes | Yes |
| Sterilitzation Method | Validated ETO | Not Known |
| Packaging | Validated Heat Sealed
Tyvek | Not Known |
- September 19.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1998
Mr. Leonard Kastrilevich President Microvision, Inc. 34 Folly Mill Road, Suite 200 P.O. Box 1651 Seabrook, New Hampshire 03874-1651
Re: K982462
Trade Name: Fiber Optic Endoillumination Probe Regulatory Class: II Product Code: FFS Dated: July 13, 1998 Received: July 15, 1998
Dear Mr. Kastrilevich:
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 legally marketed predicate 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 requirements, 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
3
Page 2 - Mr. Leonard Kastrilevich
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/dsma/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
4
510(k) Number (if known):
Device Name: Fiber Optic Endoillumination Probe
Indication For Use:
ﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
(Per 21 CFR 801.109)
Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number 14982462
Prescription Use X OR
Over-The-Counter Use
OR