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).

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.

AI/ML Overview

This document is a 510(k) summary for the HIGH V+ bone cement, which is a medical device for fixing vertebral fractures. The summary focuses on demonstrating the substantial equivalence of HIGH V+ to predicate devices (Vertecem and Spineplex) rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of submission. This 510(k) submission primarily relies on non-clinical (bench) testing to show equivalence in material properties and functional characteristics.

Here's the breakdown of the information that can be extracted from the document, and where the requested details are not present:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in the traditional sense of a clinical trial's primary endpoints. Instead, it presents various physical and chemical characteristics of the HIGH V+ and compares them to predicate devices and the ISO 5833 standard. The "acceptance" is implied by meeting or being comparable to these established benchmarks for bone cement.

Characteristic / Test	Acceptance Criteria (Implied by Predicate/Standard)	Reported Device Performance (HIGH V+)
Chemical Composition (Powder)
Polymethymethacrylate	Comparable to Vertecem (43.4% ± 1%) & Spineplex (11.5%)	63.1% ± 1%
Benzoyl peroxide	Comparable to Vertecem (0.5% ± 0.1%) & Spineplex (1.5%)	0.5% ± 0.1%
Barium sulfate	Comparable to Vertecem (30% +2% -3%) & Spineplex (30%)	27.3% +2.1% - 1.9%
Hydroxyapatite	Comparable to Vertecem (10% ± 1%)	9.1% +1.9% / -2.1%
Chemical Composition (Liquid)
Methylmethacrylate	Comparable to Vertecem (99.3% ± 1%) & Spineplex (97.4%)	98.5% ± 1%
Dimethyl-paratoluidine	Comparable to Vertecem (0.7% ± 0.1%) & Spineplex (2.6%)	1.5% ± 0.1%
Hydroquinone	Comparable to Vertecem (20ppm± 5ppm) & Spineplex (75ppm)	20ppm± 5ppm
Physical Characteristics
Molecular weights (Powder)	Comparable to Vertecem (222,518 g/mole)	534,511 g/mole
Cured cement	Comparable to Vertecem (394 552 g/mole)	646,966 g/mole
Working phases @ 20°C (Mixing)	Comparable to Vertecem (3 min)	0.5 min
Working phases @ 20°C (Waiting)	Comparable to Vertecem (11.5 min)	3 min
Working phases @ 20°C (Application)	Comparable to Vertecem (25 min)	9 min
Working phases @ 20°C (Setting time)	Comparable to Vertecem (30 min)	16 min
Compressive strength	Comparable to Vertecem (80.3 MPa)	81.91 MPa
Dynamic tension-compression mean fatigue	Comparable to Vertecem (4,317,676±1,237,780 cycles @ 7MPa) & Spineplex (3,799,425±1,990,989 cycles @ 7Mpa)	4,627,970±847,458 cycles @ 7Mpa
Bending strength	Comparable to Vertecem (52.6 MPa)	57.22 MPa
Bending modulus	Comparable to Vertecem (4173 MPa)	3338.82 MPa
Radiopacity	Equivalent radiopacity (Predicate)	Equivalent radiopacity
Monomer elution testing	Similar release profile to Vertecem	Increase release till 10 minutes after mixing, then stabilization
Compliance Standard	ISO 5833 "implants for surgery - acrylic resin cements"	In compliance with ISO 5833.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for each individual non-clinical test. The document states "Test data indicate that the final properties of HIGH V+ are in compliance..." but does not detail the number of samples tested for each property (e.g., number of specimens for compressive strength).
Data Provenance: The tests were conducted by Teknimed, SAS, located in L'Union, France. The data appears to be prospective as it's part of the premarket submission for a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a non-clinical (bench) study involving material properties, not diagnostic interpretation or clinical outcomes requiring expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a non-clinical (bench) study.

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

Not applicable. This is a non-clinical (bench) study about a bone cement, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a non-clinical (bench) study of a physical material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" or reference for comparison is the established performance of legally marketed predicate devices (Vertecem, Spineplex) and the chemical/physical requirements outlined in the international standard ISO 5833 "Implants for surgery - acrylic resin cements."

8. The sample size for the training set

Not applicable. This is a non-clinical study for a physical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device submission.

Summary

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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

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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)

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

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.

DeviceItems	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 methacrylatestyrene 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%
DeviceItems	HIGH V+	Vertecem	Spineplex
Dimethyl-paratoluidine	1.5% ± 0.1%	0.7% ± 0.1%	2.6%
Hydroquinone	20ppm± 5ppm	20ppm± 5ppm	75ppm
Physicalcharacteristics
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 meanfatigue	4,627,970±847,458cycles @ 7Mpa	4,317,676±1,237,780cycles @ 7Mpa	3,799,425±1,990,989cycles @ 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 till10 minutes aftermixing, thenstabilization	Increase release till10 minutes aftermixing, thenstabilization	--
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 (ISO11135-1)	Ethylene oxide (ISO11135-1)	Ethylene oxide (ISO11135-1)

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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.

Regulation Number and Section

§ 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.”