(30 days)
Not Found
No
The summary describes a bone cement and delivery system for vertebroplasty, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
Yes
The device is indicated for the "treatment of pathological fractures of the vertebral body using a vertebroplasty procedure," which is a therapeutic intervention.
No
The device is described as a treatment for pathological fractures of the vertebral body using a vertebroplasty procedure, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly details physical components like acrylic resin, a syringe-like device, extension tubes, and a needle, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is an acrylic resin and a delivery system used to inject the resin into the vertebral body. This is a surgical/interventional device.
- 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.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
The Kit Mendec Spine and delivery system is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Product codes
NDN, LOD; KIH
Device Description
Kit Mendec Spine and delivery system contains an acrylic resin for vertebroplasty and a delivery system. The acrylic resin consists of exportion of acryic Tosh 101 vercent. The delivery system consists of a syringe-like device with a "gun-system", an Extension tube, an Extension tube and may include, depending on the variant, a Needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
Special 510(k) Kit Mendec Spine and delivery system
ATTACHMENT 4
SEP 2 1 2006
510(k) Summary
510(k) Summary
| Official Correspondent: | Brauer Device Consultants LLC
1700 Research Boulevard, Suite 220
Rockville, Maryland 20850
Phone: 301-545-1990
Fax: 301-545-1992
Contact: Christine L. Brauer, Ph.D. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Tecres S.p.A.
Via Andrea Doria
37066 Sommacampagna
Verona - Italy
FDA Owner/Operator ID #: 9033624 |
| Date: | August 22, 2006 |
Attachment 4
:
1
Special 510(k) Kit Mendec Spine and delivery system
510(k) Summary
| Trade/Proprietary Name: | Kit Mendec Spine and delivery system |
|---|---|
| Common Name: | Convenience Kit for percutaneous |
| vertebroplasty | |
| Regulation Number: | 888.3027 |
| 888.4200 | |
| Device Class: | II |
| Classification Panel: | Orthopedic |
| Classification Product Code: | NDN, LOD; KIH |
Intended Use:
The Kit Mendec Spine and delivery system is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedures for the nodinall of painting may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (may myeloma).
Predicate Device Information
The predicate device is Mendec Spine (K042415).
Device Description
Kit Mendec Spine and delivery system contains an acrylic resin for vertebroplasty and a delivery system. The acrylic resin consists of exportion of acryic Tosh 101 vercent. The delivery system consists of a syringe-like device with a "gun-system", an Extension tube, an Extension tube and may include, depending on the variant, a Needle.
Substantial Equivalence
The components of the Kit Mendec Spine and delivery system are either exempt from premarket notification or have been found to be substantially equivalent through the premarket notification process for the use for which the sit is to be intended. Any difference that may exist do not significantly affect the substantial equivalence of the device.
Attachment 4
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2006
Tecres S.p.A % Christine Brauer, Ph.D. Brauer Device Consultants 1700 Research Boulevard, Suite 220 Rockville, Maryland 20850
Re: K062452
Trade/Device Name: Kit Mendec Spine and Delivery System Regulation Number: 21 CFR 888.3027 Regulation Name: Methyl methacrylate for vertebroplasty Regulatory Class: Class II Product Code: NDN Dated: August 22, 2006 Received: August 22, 2006
Dear Dr. Brauer:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the entributes of the enactment date of the Medical Device Amendments, or to conniner of the 114) 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mailes of the Act include requirements for annual registration, listing of general controls provision 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 If your device is blassified (600 a00 roy als. Existing major regulations affecting your device can inay of subject to suble additions, 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 I tease oc advised that I Dry Prosum that your device complies with other requirements of the Act that I Dri has made a sond regulations administered by other Federal agencies. You must of any I edetar studited and egginements, including, but not limited to: registration and listing (21 Comply with an the 11ct 31equirements, 01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Christine Brauer, Ph.D.
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 240-276-0120. 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.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k) Kit Mendec Spine and delivery system
ATTACHMENT 2
Indications for Use
510(k) Number (if known):
Device Name: Kit Mendec Spine and delivery system
Indications for Use: The Kit Mendec Spine and delivery system is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
K06 2452 Barbara Budup
(Division Sign-Off) Page _ of _
Division of General, Restorative, and Neurological Devices
510(k) Number (0624
p 1/1
Attachment 2
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