(357 days)
No
The description focuses on the material properties and intended use of bone cement for vertebral fracture fixation, with no mention of AI or ML technologies.
No
The device, HIGH V+, is a bone cement used for the fixation of pathological fractures. While it provides pain relief by stabilizing the vertebral body, its primary function is structural support and fixation, not direct therapeutic treatment of a disease or condition in the way a drug or a therapy device would. It's an implantable material that aids in the mechanical restoration of the vertebral body.
No.
The device is a bone cement used for the fixation of pathological fractures, not for diagnosing medical conditions.
No
The device description clearly states it is a bone cement made of physical components (powder and liquid monomer) intended for injection into the vertebral body. It is a physical medical device, 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 fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a bone cement injected into the vertebral body. This is a material implanted or used within the body, not a reagent or instrument used to examine specimens taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is structural support and pain relief through physical fixation.
IVD devices are used in vitro (outside the living body) to examine specimens and provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the living body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The HIGH V+ is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Product codes
NDN
Device Description
HIGH V+ is a self-hardening and ready to use Poly Methylmethacrylatebone cement with 36.4% of radiopaque agentsfor the treatment of painfulvertebral fractures based on the predicate devices Spineplex. Vertecem. It can be injected directly into the fractured vertebral body by either Vertebroplasty or Kylphoplasty procedures to relieve pain. HIGH V+ allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The HIGH V+ cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.
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
Non-clinical tests were conducted:
- Powder morphology
- Molecular weights
- Monomer elution testing
- Viscosity vs. temperature
- Setting time vs. temperature
- Handling times
- Compressive strength
- Bending strength
- Bending modulus
- Dynamic tension-compression fatigue test
- Radiopacity
- Glass transition
- Bacterial Endotoxins Test (BET) to establish non-pyrogenicity
No clinical studies were performed.
Key Metrics
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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 12, 2017
Teknimed, SAS % Mr. J.D. Webb Authorized Contact Person The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock. Texas 78681
Re: K161114
Trade/Device Name: HIGH V+ Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: April 10, 2017 Received: April 11, 2017
Dear Mr. Webb:
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 (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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161114
Device Name
HIGH V+
Indications for Use (Describe)
The HIGH V+ is used for the fixation of pathological fractures of the vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lessons (hemangiona), or malignant lesions (metastatic cancers, myeloma).
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
।
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510(k) Summary for the HIGH V+ Bone cement
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the HIGH V+.
1. GENERAL INFORMATION
| Date Prepared: | November 11, 2016 |
|---|---|
| ---------------- | ------------------- |
Trade Name: HIGH V+
Common Name: Polymethylmethacrylate (PMMA) bone cement
Classification Name: Cement, Bone, Vertebroplasty
Class: II
Product Code: NDN
CFR section: 21 CFR section 888.3027
Device panel: Orthopedic
PrimaryLegally Vertecem, K090435 Marketed Predicate Device:
Secondary Legally Spineplex K032945 Marketed Predicate Device:
- Submitter: Teknimed, SAS 11, rue d'Apollo 31240 L'Union France
- Contact: J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199 Tele 512-692-3699 Fax e-mail: jdwebb@orthomedix.net
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2. DEVICE DESCRIPTION
HIGH V+ is a self-hardening and ready to use Poly Methylmethacrylatebone cement with 36.4% of radiopaque agentsfor the treatment of painfulvertebral fractures based on the predicate devices Spineplex. Vertecem. It can be injected directly into the fractured vertebral body by either Vertebroplasty or Kylphoplasty procedures to relieve pain. HIGH V+ allows an excellent consolidation of the vertebral body and an effective and rapid pain relief. The HIGH V+ cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.
Material:
The liquid component is mainly composed of methyl methacrylate. The major powder components are polymethylmethacrylate (PMMA), hydroxyapatite and barium sulfate.Benzoyl peroxide which initiates the polymerization is included in the polymer powder.
Function:
The HIGH V+ bone cement allows stabilization of the vertebral body and a rapid pain relief.
3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
HIGH V+ has similar technological characteristics as the predicate devices as shown in the detailed side by side comparison in the following table.
| Device
| Items | HIGH V+ | Vertecem | Spineplex |
|---|---|---|---|
| Sponsor | Teknimed | Teknimed | Stryker |
| 510(k) Number | -- | K090435 | K032945 |
| Product Code | NDN | NDN | NDN |
| Indications for Use | [2] below table | [1] below table | [3] below table |
| Chemical composition | |||
| Powder (% w/w) | 20g ± 0.4g | 21g ± 0.4g | 20g |
| Polymethymethacrylate | 63.1% ± 1% | 43.4% ± 1% | 11.5% |
| Methyl methacrylate | |||
| styrene copolymer | -- | 16.1% ± 1% | 57% |
| Benzoyl peroxide | 0.5% ± 0.1% | 0.5% ± 0.1% | 1.5% |
| Barium sulfate | 27.3% +2.1% - 1.9% | 30% +2% -3% | 30% |
| Hydroxyapatite | 9.1% +1.9% / -2.1% | 10% ± 1% | -- |
| Liquid (% w/w) | 8.6g ± 0.2g | 9.2 ± 0.2g | 9.4g |
| Methylmethacrylate | 98.5% ± 1% | 99.3% ± 1% | 97.4% |
| Device | |||
| Items | HIGH V+ | Vertecem | Spineplex |
| Dimethyl-paratoluidine | 1.5% ± 0.1% | 0.7% ± 0.1% | 2.6% |
| Hydroquinone | 20ppm± 5ppm | 20ppm± 5ppm | 75ppm |
| Physical | |||
| characteristics | |||
| Molecular weights: | |||
| Powder | 534,511 g/mole | 222,518 g/mole | -- |
| Cured cement | 646,966 g/mole | 394 552 g/mole | |
| Working phases @ 20°C | Mixing: 0.5 min | ||
| • Waiting: 3 min | |||
| • Application: 9 min | |||
| • Setting time: 16min | Mixing: 3 min | ||
| • Waiting: 11.5 min | |||
| • Application: 25 min | |||
| • Setting time: 30min | |||
| Compressive strength | 81.91 MPa | 80.3 MPa | -- |
| Dynamic tension- | |||
| compression mean | |||
| fatigue | 4,627,970±847,458 | ||
| cycles @ 7Mpa | 4,317,676±1,237,780 | ||
| cycles @ 7Mpa | 3,799,425±1,990,989 | ||
| cycles @ 7Mpa | |||
| Bending strength | 57.22 MPa | 52.6 MPa | -- |
| Bending modulus | 3338.82 | 4173 MPa | -- |
| Radiopacity | Equivalent radiopacity | Equivalent radiopacity | Equivalent radiopacity |
| Monomer elution testing | Increase release till | ||
| 10 minutes after | |||
| mixing, then | |||
| stabilization | Increase release till | ||
| 10 minutes after | |||
| mixing, then | |||
| stabilization | -- | ||
| Sterilization method | |||
| Powder | Gamma radiation | ||
| (ISO 11137) | Gamma radiation | ||
| (ISO 11137) | Gamma radiation | ||
| (ISO 11137) | |||
| Liquid | Filtration (ISO 13408) | Filtration (ISO 13408) | Filtration (ISO 13408) |
| Inner Blister | Ethylene oxide (ISO | ||
| 11135-1) | Ethylene oxide (ISO | ||
| 11135-1) | Ethylene oxide (ISO | ||
| 11135-1) |
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4. INTENDED USE
The HIGH V+ is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
5. NON-CLINICAL TEST SUMMARY
The following tests were conducted:
- · Powder morphology
- · Molecular weights
- . Monomer elution testing
- . Viscosity vs. temperature
- . Setting time vs. temperature
- Handling times .
- . Compressive strength
- Bending strength .
- Bending modulus .
- Dynamic tension-compression fatigue test .
- · Radiopacity
- Glass transition .
- Bacterial Endotoxins Test (BET) to establish non-pyrogenicity .
Test data indicate that the final properties of HIGH V+ are in compliance with the standard reference for bone cement: ISO 5833 "implants for surgery - acrylic resin cements" and are substantially equivalent to those of predicate devices.
6. CLINICAL TEST SUMMARY
No clinical studies were performed.
7. CONCLUSIONS NONCLINICAL AND CLINICAL
This summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that HGH V+ bone cement is as safe, as effective, and perform as well as the predicate devices.