(30 days)
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).
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.
This 510(k) premarket notification (K062452) describes the "Kit Mendec Spine and Delivery System," a convenience kit for percutaneous vertebroplasty. This submission is a "Special 510(k)," indicating that it likely relies on its substantial equivalence to a previously cleared predicate device, the "Mendec Spine" (K042415), and that any modifications are minor and do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary (and the full submission, by its nature as a Special 510(k)) does not specify quantifiable acceptance criteria or detailed device performance metrics in the format typically seen with clinical studies for novel devices or significant modifications. Instead, the document focuses on demonstrating substantial equivalence to a predicate device.
For a Special 510(k), the acceptance criteria are implicitly that the new device performs "as intended" and is "substantially equivalent" to the predicate, meaning it has the same intended use, technological characteristics, and raises no new safety or effectiveness concerns. Performance is generally demonstrated through comparisons to the predicate, often involving:
- Materials comparison: Demonstrating that the materials used in the new device are the same as or equivalent to those in the predicate, or are well-established for this application.
- Design comparison: Showing that the design features are either identical or that any changes do not adversely affect performance or safety.
- Performance testing (if applicable to changes): For a Special 510(k), this typically involves bench testing to ensure modified components meet established standards or perform comparably to the predicate. Clinical studies are rare for Special 510(k)s unless a significant change warranted it.
Based on the provided information, typical "acceptance criteria" and "reported device performance" in the sense of clinical accuracy or outcome rates are not present, as the submission relies on substantial equivalence and non-clinical demonstrations.
| Acceptance Criteria (Implied for Special 510(k)) | Reported Device Performance (Summary of Submission) |
|---|---|
| Intended Use: Same as the predicate device (treatment of pathological fractures of the vertebral body using a vertebroplasty procedure). | 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)." (This is identical to the predicate's intended use, as verified by the FDA's clearance letter and the Indications for Use statement in Attachment 2). |
| Technological Characteristics: Materials, design, and operating principles are the same as or equivalent to the predicate, or differences do not raise new safety/effectiveness questions. | 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." The submission states: "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." |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to the predicate device. | Demonstrated by comparison to the predicate device (Mendec Spine, K042415) and by providing adequate documentation (likely including bench testing, biocompatibility, and sterilization validation, though not detailed in this summary) to show that any proposed changes do not adversely impact safety or effectiveness. The FDA's clearance letter confirms: "We have reviewed your Section 510(k) premarket notification of intent to market the device [...] and found the device is substantially equivalent..." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. For a Special 510(k) demonstrating substantial equivalence, a traditional "test set" with patient data (as one would use for AI performance evaluation) is not typically required or described. The evaluation relies on demonstrating equivalence to the predicate through materials, design, and performance testing data (e.g., mechanical, biocompatibility, sterilization studies), which are not clinical test sets.
- Data Provenance: Not applicable for a clinical test set. The data supporting this submission would primarily be non-clinical (bench testing, material characterization, design specifications) provided by the manufacturer (Tecres S.p.A., Italy).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a medical device (acrylic resin and delivery system), not an AI diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study assessing diagnostic performance against a ground truth established by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a vertebroplasty kit, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. This is a physical medical device. The "ground truth" for its safety and effectiveness is established through adherence to standards, biocompatibility testing, mechanical testing, and comparison to the predicate device's established performance, rather than an expert consensus on patient data.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
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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 LLC1700 Research Boulevard, Suite 220Rockville, Maryland 20850Phone: 301-545-1990Fax: 301-545-1992Contact: Christine L. Brauer, Ph.D. |
|---|---|
| Manufacturer: | Tecres S.p.A.Via Andrea Doria37066 SommacampagnaVerona - ItalyFDA Owner/Operator ID #: 9033624 |
| Date: | August 22, 2006 |
Attachment 4
:
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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 percutaneousvertebroplasty |
| Regulation Number: | 888.3027888.4200 |
| 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
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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.
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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
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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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§ 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.”