(29 days)
No
The summary describes a physical implant and associated instrumentation, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for use in the treatment of vertebral fractures, which is a therapeutic purpose.
No
Explanation: The device is an implant for treating vertebral fractures, designed for structural support rather than for diagnosing a condition.
No
The device description clearly states it is a physical implant made of polymer and tantalum, and is part of a system including other physical instruments. It is not software.
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 vertebral fractures in the thoracic and lumbar spine. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is an implantable medical device made of polymer and tantalum, designed to be placed within the vertebrae. This is a physical device used for structural support and treatment.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic or other information. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine. It is intended to be used in combination with Teknimed F20® bone cement.
Product codes
NDN, LOD
Device Description
V-STRUT© Vertebral Implant 4.5mm diameter is part of V-STRUT© Transpedicular Vertebral System.
V-STRUT© Transpedicular Vertebral System is composed of:
- V-STRUT© Vertebral Implant (K191709, Class II),
- V-STRUT© Guide Wire (Class I),
- V-STRUT© Instrumentation Set (Class I).
V-STRUT© Vertebral Implant 4.5mm diameter is a medical device to be placed in the vertebrae through a minimally invasive procedure.
Two devices are implanted in each vertebra to be treated. Each implant is introduced posteriorly through the pedicle up to the anterior
vertebral body wall.
The implant is made of radio transparent polymer, PEEK (Polyetheretherketone as per ASTM F2026) and includes two visualizing markers
made of tantalum (as per ASTM F560).
V-STRUT© Vertebral Implant 4.5mm diameter exists in different lengths to accommodate individual patient's anatomy of thoracic and/or
lumbar vertebrae. It is provided sterile. It is implanted using specific instrumentation provided with the implant (V-STRUT® Guide Wire
and V-STRUT© Instrumentation Set).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and lumbar spine
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)
V-STRUT© Vertebral Implant 4.5mm diameter substantial equivalence to the predicate device V-STRUT® Vertebral Implant (K191709) is supported by non-clinical mechanical testing (dynamic bending) and functional testing.
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
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
February 9, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue font.
Hyprevention Cecile Vienney CEO PTIB - Hopital Xavier Arnozan Avenue du Haut Leveque Pessac. 33604 France
Re: K240084
Trade/Device Name: V-STRUT® Vertebral Implant Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN, LOD Dated: January 3, 2024 Received: January 11, 2024
Dear Cecile Vienney:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Eileen
Digitally signed
by Eileen Cadel
S
Cadel -S Date: 2024.02.09
09:25:02-05'00'
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240084
Device Name V-STRUT® Vertebral Implant
Indications for Use (Describe)
V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine. It is intended to be used in combination with Teknimed F20® bone cement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| 510(k) Summary | Prepared on: 2024-02-09 | |
|---|---|---|
| -- | ---------------- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| ----------------- | --------------------- |
| Applicant Name | HYPREVENTION |
|---|---|
| Applicant Address | PTIB - Hopital Xavier Arnozan Avenue du Haut Leveque PESSAC 33604 |
| France | |
| Applicant Contact Telephone | 0017722283218 |
| Applicant Contact | Mrs. Cecile VIENNEY |
| Applicant Contact Email | c.vienney@hyprevention.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---|---|
| ------------- | --------------------- |
| Device Trade Name | V-STRUT® Vertebral Implant |
|---|---|
| Common Name | Polymethylmethacrylate (PMMA) bone cement |
| Classification Name | Cement, Bone, Vertebroplasty |
| Regulation Number | 888.3027 |
| Product Code(s) | NDN, LOD (CLASS 2) - BONE CEMENT |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K191709 | V-STRUT® Vertebral Implant | NDN |
Device Description Summary 21 CFR 807.92(a)(4)
V-STRUT© Vertebral Implant 4.5mm diameter is part of V-STRUT© Transpedicular Vertebral System.
V-STRUT© Transpedicular Vertebral System is composed of:
- V-STRUT© Vertebral Implant (K191709, Class II),
- V-STRUT© Guide Wire (Class I),
- V-STRUT© Instrumentation Set (Class I).
V-STRUT© Vertebral Implant 4.5mm diameter is a medical device to be placed in the vertebrae through a minimally invasive procedure.
Two devices are implanted in each vertebra to be treated. Each implant is introduced posteriorly through the pedicle up to the anterior
vertebral body wall.
The implant is made of radio transparent polymer, PEEK (Polyetheretherketone as per ASTM F2026) and includes two visualizing markers
made of tantalum (as per ASTM F560).
V-STRUT© Vertebral Implant 4.5mm diameter exists in different lengths to accommodate individual patient's anatomy of thoracic and/or
lumbar vertebrae. It is provided sterile. It is implanted using specific instrumentation provided with the implant (V-STRUT® Guide Wire
and V-STRUT© Instrumentation Set).
Intended Use/Indications for Use 21 CFR 807.92(a)(5)
V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine. It is intended to
4
be used in combination with Teknimed F20® bone cement.
Indications for Use Comparison
V-STRUT© Vertebral Implant 4.5mm diameter is intented for use in the treatment of vertebral fractures in the thoracic and lumbar spine, in combination with Teknimed F20® bone cement
The initial intended use in T9 to L5 levels (K191709) is extended to any thoracic or lumbar vertebra. It was demonstrated through non-clinical testing and functional testing that V-STRUT© Vertebral Implant 4.5mm diameter is at least equivalent to its predicate device in terms of safety and effectiveness. Thus, a conclusion of substantial equivalence to the predicate device V-STRUT© Vertebral Implant (K191709) is supported.
Technological Comparison
As its predicate device, V-STRUT® Vertebral Implant 4.5mm diameter is made of PEEK Polymer and implanted with the same instrumentation according to the same surgical steps.
V-STRUT© Vertebral Implant 4.5mm diameter is provided in new sizes. It was demonstrated through non-clinical testing and functional testing that the V-STRUT© Vertebral Implant 4.5mm diameter is substantially equivalent to the predicate device V-STRUT© Vertebral Implant (K191709).
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
V-STRUT© Vertebral Implant 4.5mm diameter substantial equivalence to the predicate device V-STRUT® Vertebral Implant (K191709) is supported by non-clinical mechanical testing (dynamic bending) and functional testing.