(275 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical equivalence of a bone cement, with no mention of AI or ML technologies.
Yes.
This device, Mendec Spine, is a bone cement used in vertebroplasty or kyphoplasty procedures to treat pathological fractures of the vertebral body, such as those resulting from osteoporosis, hemangioma, or metastatic cancers, which directly addresses a medical condition and aims to restore function or alleviate symptoms.
No
This device, Mendec Spine, is a bone cement used for treating pathological fractures of the vertebral body through vertebroplasty or kyphoplasty procedures. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a two-component acrylic resin system (powder and liquid) used in a medical procedure, indicating it is a physical material, 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 pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is an acrylic resin used as a bone cement. This is a material implanted into the body.
- 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 information. Mendec Spine is used in vivo (inside the body) as a therapeutic implant.
N/A
Intended Use / Indications for Use
Mendec Spine is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, bening lesions (hemangioma), and malignant lesions (metastatic cancers, mylema)
Product codes (comma separated list FDA assigned to the subject device)
NDN, LOD
Device Description
Like the predicate devices. Mendec Spine acrylic resin is provided as a two-component system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabiliser and N.N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebral body / Vertebrae
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)
Mechanical tests: Mendec Spine acrylic resin was tested in direct comparison to the predicate device and verified substantially equivalent, as defined by ISO 5833:2002, "Implants for Sugery - Acrylic resin cements".
Non-clinical test results: Performance testing demonstrated that Mendec Spine is substantially equivalent to the Kyphx HV-R with regard to functional characteristics.
Clinical results; Clinical information demonstrates that the intended use is substantially equivalent to the predicate indication for the treatment of pathological vertebral body fractures and does not adversely impact safety and effectiveness.
Biocompatibility: The materials used in Mendee Spine complies with ASTM F 451-99 point 10 and ISO 10993.
Sterilization: The Mendee Spine acrylic resin is sterile and non-pyrogenic. The solid components are sterilised with ethylene oxide (EO) gas to a Sterility Assurance Level (SAL) of 10th. The liquid components are sterilized with filtration methods to a SAL of 102. The outer packaging containing the liquid component is sterifised with ethylene oxide (EO) gas. The acrylic resin is intended for single use only.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K033801: Kyphx HV-R Bone Cement (Kyphon Inc.), K041584: Kyphx HV-R Bone Cement (Kyphon Inc.), K032945: Stryker Spineplex Radiopaque Bone Cement (Stryker)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K042415
JUN 9 – 2005
ﺎ
. : Mendec Spine
Company confidential
」
r
Traditional 510(k)
Summary of Safety and Effectiveness
| Official Correspondent: | Christine Brauer, Ph.D.
Regulatory Affairs Consultant
One Democracy Plaza
6701 Democracy Boulevard, Suite 700
Bethesda, MD 20817
tel: 301-545-1990
fax: 301-545-1992
E-MAIL: chrisbrauer@earthlink.net | | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Trade Name: | Mendec Spine | | |
| Common Name: | Bone Cement | | |
| Classification Name: | Bone Cement, 888.3027 | | |
| Device code: | NDN, LOD | | |
| Manufacturer/Submitter: | TECRES S.p.A FDA Owner number: 9033624
Via Andrea Doria 10,
37066 Sommacampagna, Verona, Italia
Phone: +39 045 9217311
Fax: +39 045 9217330 | | |
| Contact person: | Massimo Grazioli, General Manager | | |
| Predicate device: | K033801: Kyphx HV-R Bone Cement (Kyphon Inc.).
K041584: Kyphx HV-R Bone Cement (Kyphon Inc.).
K032945: Stryker Spineplex Radiopaque Bone Cement (Stryker) | | |
| Indications for use: | Mendec Spine is indicated for the treatment of pathological
fractures of the vertebral body using a vertebroplasty or
kyphoplasty procedure. Painful vertebral compression fractures
may result from osteoporosis, bening lesions (hemangioma), and
malignant lesions (metastatic cancers, mylema) | | |
| Device Description: | Like the predicate devices. Mendec Spine acrylic resin is provided
as a two-component system. The powder component consists of a
PMMA-styrene copolymer with barium sulphate as a radiopacifier
and benzoyl peroxide as an initiator. The liquid component consists
of methylmethacrylate monomer, with the addition of
hydroquinone as a stabiliser and N.N-dimethyl-p-toluidine as
promoter. The powder and liquid components are mixed prior to
Section 4
Page 1/2 | | |
1
Company confidential
Traditional 510(k)
Mendec Spine
Summary of Safety and Effectiveness
Table 4-1 compares the chemical composition of Mendec use. Spine to the predicate device.
Table 4-1 Chemical composition of Mendec Spine and Kyphx HV-R
| Chemical composition | KyphX HV-R
#K033801
#K041584 | Spineplex
#K032945 | Mendec Spine |
|------------------------------|------------------------------------|-----------------------|--------------|
| Powder | 20 g | 20 g | 20 g |
| Polymethymethacrylate | $68,0% w/w$ | $68,50% w/w$ | $67,50% w/w$ |
| Barium sulphate | $30,0% w/w$ | $30,0% w/w$ | $30,0% w/w$ |
| Benzoyl peroxide | $2,0% w/w$ | $1,5% w/w$ | $2.5% w/w$ |
| Liquid | 9 g | 9.96 ml (9.05 g) | 9.4 g |
| Methylmethacrylate (monomer) | $99,1% w/w$ | $97,4% w/w$ | $99.1% w/w$ |
| N.N-dimethyl-p-toluidine | $0,90% w/w$ | $2,60% w/w$ | $0,90% w/w$ |
| Hydroquinone | 75 ppm | 75 ppm | 75 ppm |
Mechanical tests: Mendec Spine acrylic resin was tested in direct comparison to the predicate device and verified substantially equivalent, as defined by ISO 5833:2002, "Implants for Sugery - Acrylic resin cements" Non-clinical test results: Performance testing demonstrated that Mendec Spine is substantially equivalent to the Kyphx HV-R with regard to functional characteristics Clinical results; Clinical information demonstrates that the intended use is substantially equivalent to the predicate indication for the treatment of pathological vertebral body fractures and does not adversely impact safety and effectiveness. Biocompatibility:
The materials used in Mendee Spine complies with ASTM F 451-99 point 10 and ISO 10993
Sterilization: The Mendee Spine acrylic resin is sterile and non-pyrogenic. The solid components are sterilised with ethylene oxide (EO) gas to a Sterility Assurance Level (SAL) of 10th. The liquid components are sterilized with filtration methods to a SAL of 102. The outer packaging containing the liquid component is sterifised with ethylene oxide (EO) gas. The acrylic resin is intended for single use only.
Section 4 Page 2/3
2
K042415
Mendec Spine
Company confidential
LONGLAND REPRENTWERSON ..... ... ... ... ... .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Traditional 510(k)
INSUL INCLUSION IN MARKET PURGE
BARRE BL. GELLERS AND AND AND BELLER
consistences ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Summary of Safety and Effectiveness
Substantial Equivalence: The chemical constituents in Mendec Spine acrylic resin are substantially equivalent to those in the predicates Kyphx HR-V (#K033801; #K041584) and in the predicate Spineplex (#K032945).
Section 4 Page 3/3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 9 - 2005
Tecres Spa C/o Christine L. Brauer, Ph.D Regulatory Affairs Consultant Brauer Device Consultants, LLC One Democracy Plaza 6701 Democracy Boulevard, Suite 700 Bethesda, Maryland 20817
Re: K042415
Trade/Device Name: Mendec Spine Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: May 18, 2005 Received: May 18, 2005
Dear Dr. Brauer:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as sct
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 -Christine L. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
H.A. Chuds
- Miriam Provost, Ph.D.
Miriam Prov st. Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K042415
Device Name: Mendec Spine
Indications For Use:
Mendec Spine is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporesis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Prescription Use ﺮ ﺍﻟﻤﺮﺍﺟﻊ (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
H. Curtis
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number