(37 days)
The SpineMedica Paradis Vaso Shield™ is indicated as a cover for vessels following anterior vertebral surgery.
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.
The provided 510(k) summary for the SpineMedica Paradís Vaso Shield™ indicates that performance standards were met and testing was performed to demonstrate substantial equivalence to predicate devices. However, the document does not describe specific acceptance criteria or a detailed study that proves the device meets those criteria with quantitative results.
Instead, the submission relies on the concept of "substantial equivalence" to previously cleared devices. This means the device is considered safe and effective because it has the same indications for use, design, function, and/or materials as legally marketed predicate devices. The 510(k) summary explicitly states: "Testing performed indicates the SpineMedica Paradis Vaso Shield™ is substantially equivalent to predicate devices."
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I answer questions about sample sizes, expert ground truth establishment, or specific study methodologies (like MRMC or standalone performance) because these details are not present in the provided document.
The 510(k) process for this device did not involve presenting new clinical or performance data against specific acceptance criteria in the same way a de novo or PMA submission might. The FDA's letter (K093551) confirms substantial equivalence and primarily focuses on labeling requirements and limitations regarding claims not established (e.g., reducing adhesion formation).
Summary of what can be inferred from the document:
The 510(k) submission for the "SpineMedica Paradís Vaso Shield™" demonstrates substantial equivalence to predicate devices rather than presenting a study with explicit acceptance criteria and corresponding performance data. The document does not contain the detailed information necessary to answer the questions posed regarding specific acceptance criteria, study methodology, sample sizes, expert qualifications, or ground truth establishment.
The FDA's review concluded that the device is substantially equivalent based on its stated indications for use, design, function, and materials being similar to pre-existing, legally marketed devices. The FDA's letter primarily focused on clarifying labeling requirements and limitations, especially concerning unproven claims.
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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.
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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.
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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
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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 |
§ 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).