(37 days)
Not Found
Not Found
No
The device description is purely material and dimensional, and there is no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a cover for vessels following surgery and does not appear to treat, mitigate, or prevent a disease or condition, which are characteristics of a therapeutic device.
No
Explanation: The device is indicated as a cover for vessels following anterior vertebral surgery and is described as a flexible sheet of material. Its function is to cover, not to diagnose conditions or diseases.
No
The device description clearly states it is a flexible sheet of material, indicating a physical hardware component, not software.
Based on the provided information, the SpineMedica Paradis Vaso Shield™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a cover for vessels following anterior vertebral surgery." This describes a device used in vivo (within the body) during a surgical procedure to protect anatomical structures.
- Device Description: The description details a physical sheet of material used as a barrier or cover.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, calibrators, controls, or instruments used to perform tests on these specimens.
Therefore, the SpineMedica Paradis Vaso Shield™ is a surgical device intended for direct use within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SpineMedica Paradís Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.
Product codes
OMR
Device Description
The SpineMedica Paradis Vaso Shield™ is a flexible sheet of 30 Wt.1% polyvinyl alcohol (PVA) material with dimensions of 60 ±6 mm X 100 ±10 mm and a thickness of 1.0 ±0.2 mm. The corners of the sheet are rounded. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated in saline solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels following anterior vertebral surgery
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
Testing performed indicates the SpineMedica Paradis Vaso Shield™ is substantially equivalent to predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).
0
093551
DEC 2 4 2009
510(k) Summary
| Contact: | Sally Thorsen |
|---|---|
| SpineMedica, LLC | |
| 811 Livingston Court, Suite B | |
| Marietta GA 30067 | |
| (678) 384-6727 | |
| Fax 678-384-6741 | |
| sthorsen@spinemedica.com | |
| Device Trade Name: | Paradís Vaso Shield™ |
| Manufacturer: | SpineMedica, LLC |
| 811 Livingstone Court, Suite B | |
| Marietta, GA 30067 | |
| Classification: | 21 CFR 870.3470, Vessel Guard |
| Class: | II |
| Product Code: | OMR |
Indications For Use:
The SpineMedica Paradís Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.
Device Description:
The SpineMedica Paradis Vaso Shield™ is a flexible sheet of 30 Wt.1% polyvinyl alcohol (PVA) material with dimensions of 60 ±6 mm X 100 ±10 mm and a thickness of 1.0 ±0.2 mm. The corners of the sheet are rounded. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated in saline solution.
Predicate Device(s):
The SpineMedica Paradis Vaso Shield™ was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and/or materials.
Performance Standards:
Testing performed indicates the SpineMedica Paradis Vaso Shield™ is substantially equivalent to predicate devices.
Summary of Safety and Effectiveness:
As part of the Special 510(k) submission, additional shelf life expiration date information is submitted.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's emblem, which is a stylized depiction of a bird or eagle with outstretched wings. The emblem is positioned to the right of the text, which is arranged in a circular pattern around the emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
SpineMedica, LLC c/o Sally Thorsen Director, Quality and Regulatory Affairs 811 Livingston Court, Suite B
DEC 2 4 2009
Re: K093551 Trade Name: SpineMedica Paradís Vaso Shield™ Regulation Number: 870.3470 Regulation Name: Intracardiac patch or pledget
Regulatory Class: II Product Code: OMR Dated: November 13, 2009 Received: November 17, 2009
Dear Ms. Thorsen:
Marietta, GA 30067
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 10 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 with a 12 month shelf life, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling and any promotional materials:
The safety and effectiveness of this device for reducing the incidence, severity, and extent of post-operative adhesion formation have not been established.
Furthermore, the indication for use as a cover for vessels following anterior vertebral surgery must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
2
Page 2 – Ms. Sally Thorsen
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code 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 complies 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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Nee Tillman
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): ' .
Device Name: SpineMedica Paradís Vaso Shield™
The SpineMedica Paradis Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.
Prescription Use ﮯ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division of Cardiovascular Devices | |
|---|---|
| 510(k) Number | K093551 |