(107 days)
Not Found
No
The device description focuses solely on mechanical components for surgical access and visualization. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
No.
The device is a surgical access system designed to retract tissue and visualize the surgical field, rather than to treat or cure a disease or condition.
No.
The device's intended use is to provide access and visualization of the surgical field, and the device description explicitly states it is "designed for providing diagnostic and surgical access," but its primary function is retraction and providing a working channel during surgery. While visualization can aid diagnosis, the device itself does not perform a diagnostic function (e.g., measuring, analyzing, or interpreting data to determine the presence or nature of a disease).
No
The device description explicitly details physical components such as "retractor devices," "introducer," "port," and "fixation screws," which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To provide for access and allow for visualization of the surgical field during brain and spinal surgery." This describes a surgical tool used during a procedure to facilitate access and visualization, not a device used to perform tests on samples taken from the body outside of the body (in vitro).
- Device Description: The description details a surgical retractor system used to physically spread apart tissue and create a working channel. This is a mechanical surgical instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing diagnostic tests, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
To provide for access and allow for visualization of the surgical field during brain and spinal surgery.
Product codes
GZT
Device Description
The Vycor Medical Surgical Access Systems include a family of retractor devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spinal region.
The variety of devices include:
- Brain Access System including three models of varying shapes and sizes. .
- . TC model (elliptical diameters 2.1cm or 1.7cm, lengths 3,5,7, or 9 cm)
- EC model (3.4 cm diameter, 3,5, 7 cm lengths) .
- . SF model (channel 2.2cm or 2.5cm, length 3,5, or 7 cm)
- . Spinal Access System
- (aperture widths are 2.6 to 5.4 cm, and 3 or 5cm access channel height) .
Each device consists of an introducer and port. The port and introducer are packaged assembled and ready for use. Upon insertion of the device, the introducer is removed and the port is left in place. The introducer has a length greater than the port. The smooth and soft tapered introducer works to spread apart the brain or other portions of delicate tissue. Upon removal of the introducer, the port provides a hollow working channel allowing the surgeon access to the target tissues.
The port is transparent to allow direct visualization of the underlying retracted anatomical structures. The retractors are light weight, non-conductive, and are compatible with Lelya positioning clamps to provide fixation and reduce accidental movement.
The spinal access device can access the spine for surgical procedures. The spinal access device has three components including the introducer, port, and fixation screws. The fixation screws are used to hold the device in place during the surgery. The fixation screws are temporarily screwed into surrounding bone tissue during the surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain and spinal region
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 device complies is composed of materials that either have a long history of usage in the medical community or have passed biocompatibility testing requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043602, K895395, K830332, K896156
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).
0
bo973
510 (k) Summary
Date Prepared [21 CFR 807.92(a)(1)]
Revised July 20, 2006
Submitter's Information [21 CFR 807.92(a)(1)]
This 510(k) is being submitted by Joseph Azary on behalf of Vycor Medical LLC Joseph Azary can be contacted by telephone at (203) 944-9320 or fax at (203) 944-9317. Mailing address; 543 Long Hill Avenue, Shelton, CT 06484.
Vycor Medical LLC is located at 40 Chardonnay Drive, Coram, NY 11727. The establishment registration for Vycor Medical is pending.
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Possible device trade names are:
- . Vycor ViewSite Access System
- � Vycor ViewSite Brain Access System (VBAS)
- Vycor ViewSite Spinal Access System (VSAS) .
Device Common, Usual, or Classification Names
Retractor, Retractor for Neurosurgery, Brain Retractor, Self Retaining Retractor
Classification Panel
Classification of this device would fall under the responsibility of the Division of General, Restorative and Neurological Devices.
Class
Classification: Class 2 Product Code: GZT, 21 CFR 882.4800
Description of the Device [21 CFR 807.92(a)(4)]
The Vycor Medical Surgical Access Systems include a family of retractor devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spinal region.
The variety of devices include:
- Brain Access System including three models of varying shapes and sizes. .
- . TC model (elliptical diameters 2.1cm or 1.7cm, lengths 3,5,7, or 9 cm)
- EC model (3.4 cm diameter, 3,5, 7 cm lengths) .
- . SF model (channel 2.2cm or 2.5cm, length 3,5, or 7 cm)
- . Spinal Access System
- (aperture widths are 2.6 to 5.4 cm, and 3 or 5cm access channel height) .
Each device consists of an introducer and port. The port and introducer are packaged assembled and ready for use. Upon insertion of the device, the introducer is removed and the port is left in place. The introducer has a length greater than the port. The smooth and soft tapered introducer works to spread
JUL 26 2006
1
apart the brain or other portions of delicate tissue. Upon removal of the introducer, the port provides a hollow working channel allowing the surgeon access to the target tissues.
The port is transparent to allow direct visualization of the underlying retracted anatomical structures. The retractors are light weight, non-conductive, and are compatible with Lelya positioning clamps to provide fixation and reduce accidental movement.
The spinal access device can access the spine for surgical procedures. The spinal access device has three components including the introducer, port, and fixation screws. The fixation screws are used to hold the device in place during the surgery. The fixation screws are temporarily screwed into surrounding bone tissue during the surgical procedure.
Packaging
The devices will be packaged in a heat sealed off the shelf low density polyethylene pouch. The types of pouches have been utilized for medical devices for many years and are compatible with gamma radiation sterilization.
The pouches will be placed in different sized labeled boxes depending on the model.
Intended Use [21 CFR 807.92(a)(5)]
To provide for access and allow for visualization of the surgical field during brain and spinal surgery.
Technological Characteristics [21 CFR 807.92(a)(6)]
Vycor Medical LLC believes that the subject device is substantially equivalent to the predicate device.
Performance Data [21 CFR 807.92(b)(1)]
The device complies is composed of materials that either have a long history of usage in the medical community or have passed biocompatibility testing requirements.
Predicate Device [21 CFR 807.92(a)(3)]
The predicate devices are listed as follows:
For Spinal Indications:
-
� Medtronic - Mast Quadrant Retractor System - K043602
For Brain Indications: -
V. Mueller -- Brain Retractor -- K895395 .
-
. Budde Halo Retractor - K830332
-
Compass Stereotactic System -- Retractor K896156 ●
Conclusion [21 CFR 807.92(b)(3)]
We believe the differences between the subject device and predicate device are minor and conclude that the subject devices are as safe and effective as the predicate devices.
2
What about the cohesive gel?
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3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2006
Vycor Medical LLC % TUV Rheinland of North America. Inc. Mr. Tamas Borsai 12 Commerce Road Newton, Connecticut 06470
Re: K060973
Trade/Device Name: Vycor ViewSite Surgical Access System Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining retractor for neurosurgery Regulatory Class: II Product Code: GZT Dated: July 7, 2006 Received: July 11, 2006
Dear Mr. Borsai
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements. including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Tamas Borsai
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hubert Leinweber
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
大060973 510(k) Number (if known):
Vycor ViewSite Surgical Access System Device Name:
Indications For Use:
To provide for access and allow for visualization of the surgical field during brain and spinal surgery.
Prescription Use × (Part 21 CFR 801 Subpart D)
4
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Page 1 of 1
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K060973 |
|---|---|
| --------------- | --------- |