(90 days)
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Not Found
No
The provided text describes a surgical device for ophthalmic procedures and does not mention any AI or ML capabilities, image processing, or data sets related to training or testing algorithms.
Yes
The device is used for surgical procedures to remove substances and treat conditions within the eye, which are therapeutic interventions.
Yes
The document explicitly states "Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis," which indicates the device is used to obtain samples for diagnosis.
No
The 510(k) summary describes a device used in ophthalmic surgical procedures involving the removal of vitreous, lens remnants, and other surgical interventions. These procedures inherently require physical interaction with the eye, which is performed by hardware components (e.g., vitrectomy probes, irrigation/aspiration systems, illumination sources). The summary does not mention any software-only functionality or describe the device as being solely software. The listed intended uses are consistent with a physical surgical device.
Based on the provided information, the Syntec VitMan is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in surgical procedures within the eye (ophthalmic surgery). It is used for removing vitreous, lens remnants, and providing illumination and air pressure during these procedures. While it mentions "Removal of samples of vitreous for diagnostic purposes," the device itself is performing the collection of the sample, not the diagnostic testing of the sample.
- Device Description: Although the description is "Not Found," the intended use strongly indicates a surgical device.
- Anatomical Site: The device is used on the ophthalmic (eye), which is a part of the human body, not a sample taken from the body for testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The Syntec VitMan is a surgical tool used on the body during a procedure.
N/A
Intended Use / Indications for Use
The Syntec VitMan is indicated for use in support of the following ophthalmic surgical procedures: Removal of vitreous in cases of: Vitreous cloudiness Diabetic vitreal hemorrhaging Trauma, including contusions, penetrations, and intraocular foreign bodies; Opacity Inflammation Endophthalmitis Bacterial Fungal Uveitis Removal of lens remnants after cataract surgery; Remove vitreous traction under the retina producing localized or complete retinal detachment; Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis; Treatment of vitreous loss during cataract surgery; Clean vitreous strands from the cataract wound; Perform emulsification of cataractous lens and its removal by aspiration and irrigation; Provide internal illumination for vitreous surgery; Provide air pressure for maintaining intraocular pressure for retinal surgery.
Product codes
86 HQE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem features a staff with a serpent coiled around it, although the design is more abstract and modern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 MAY
Mr. James Easely Director of Engineering Syntec, Inc. 733 Mansion Road Winfield, MO 63389
Re: K980480
Trade Name: Syntec Vitman Vitrectomy System Regulatory Class: II Product Code: 86 HQE Dated: January 30, 1998 Received: February 3, 1998
Dear Easely :
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 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 under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2- Mr. James Easely
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/cdrh/dsmamain.html".
Sincerely yours,
ARalph lorentbal
A. Ralph Rosenthal, M.I Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
The Syntec VitMan is indicated for use in support of the following ophthalmic surgical procedures:
Removal of vitreous in cases of:
Vitreous cloudiness Diabetic vitreal hemorrhaging Trauma, including contusions, penetrations, and intraocular foreign bodies; Opacity Inflammation Endophthalmitis Bacterial Fungal Uveitis
Removal of lens remnants after cataract surgery;
· Remove vitreous traction under the retina producing localized or complete retinal detachment;
Removal of samples of vitreous for diagnostic purposes, i.e. endophthalmitis;
Treatment of vitreous loss during cataract surgery;
Clean vitreous strands from the cataract wound;
Perform emulsification of cataractous lens and its removal by aspiration and irrigation;
Provide internal illumination for vitreous surgery;
Provide air pressure for maintaining intraocular pressure for retinal surgery.
Prescription Use
(Per 21 CFR 801.109)
Massha P. Burke Nicholas
Division Sign-Off) Division of Ophthalmic Devices 510(k) Number.