(195 days)
No
The summary describes a bone cement and its physical and mechanical properties, with no mention of AI or ML in its function or development.
Yes
The device, TRAUMACEM™ V+ Injectable Bone Cement, is indicated for "augmentation of the TFN-ADVANCED® Proximal Femoral Nailing System through cannulated implants and instruments for patients with poor bone quality (e.g., osteoporosis)," directly acting to treat a condition (poor bone quality/osteoporosis) and improve patient outcome following a fracture. This falls under the definition of a therapeutic device.
No
The device is an injectable bone cement used for augmentation, which is a treatment or therapy, not a diagnostic procedure. Its purpose is to physically strengthen bone, not to identify or characterize medical conditions.
No
The device description clearly states it consists of sterile packed powder and liquid components, which are physical materials, not software. The performance studies also focus on material properties and biomechanical performance, further indicating it is a physical device.
Based on the provided information, the TRAUMACEM™ V+ Injectable Bone Cement is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "augmentation of the TFN-ADVANCED® Proximal Femoral Nailing System through cannulated implants and instruments for patients with poor bone quality". This describes a surgical procedure performed in vivo (within the living body) to improve the stability of a bone fracture fixation.
- Device Description: The description details a bone cement that is mixed and injected into the bone. This is a material used directly in a surgical procedure on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
In summary, the TRAUMACEM™ V+ Injectable Bone Cement is a medical device used in vivo during surgery, not an IVD used for testing samples in vitro.
N/A
Intended Use / Indications for Use
The TRAUMACEM™ V+ Injectable Bone Cement is indicated for augmentation of the TFN-ADVANCED® Proximal Femoral Nailing System through cannulated implants and instruments for patients with poor bone quality (e.g., osteoporosis).
Product codes (comma separated list FDA assigned to the subject device)
LOD
Device Description
TRAUMACEM™ V+ Injectable Bone Cement consists of sterile packed powder and liquid components to create radiopaque TRAUMACEM™ V+ Injectable Bone Cement. The powder component is pre-packed in the mixer. The liquid component is stored in a glass ampoule. A transfer lid for the mixing and transfer of the bone cement in the application system is also contained in the kit. Mixing the two sterile components produces the injectable bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal Femoral
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)
- Biomechanical evaluation of cut-out resistance
- Cadaveric evaluation of cut-out resistance
- Cannulated implant removal evaluation
- Radiopacity comparison
- Cytotoxicity
- Irritation
- Sensitization
- Material mediated pyrogenicity
- Genotoxicity (in vitro and in vivo)
- Implantation
- Chemical characterization.
Summary of Clinical Evidence
Three clinical studies conducted outside the US were presented in support of the subject device. One was a prospective, multicenter, randomized, postmarket study comparing outcomes in patients with unstable trochanteric fractures that were treated with or without Traumacem V+ Injectable Bone Cement Augmentation. Two were summaries of peer-reviewed publications summarizing the short-term and long-term outcomes of patients with trochanteric fractures who were treated with cephalomedullary nail augmentation with PMMA bone cements. The three studies were evaluated with respect to clinical indications, method of use and patient populations, which were confirmed to align with the intended use of the subject device. No cases of cut-out were observed. Potential risks associated with augmentation (e.g., cement leakage) had a low rate of occurrence. These data correlated well with presented real-world market experience on the use of Traumacem V+ Injectable Bone Cement outside the United States.
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.
Simplex P (K062553)
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.
BonOs Inject (K090460), Vertecem (K090435), Vertecem II (K121876)
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that they resemble a bird in flight. The profiles are connected and flow into each other, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) Products, LLC Christopher J. Medberry, Ph.D. Project Leader, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380 September 28, 2017
Re: K170802
Trade/Device Name: TRAUMACEM™ V+ Injectable Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD Dated: August 25, 2017 Received: August 25, 2017
Dear Dr. Medberry:
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 of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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 (DICE) 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 (DICE) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170802
Device Name
TRAUMACEM™ V+ Injectable Bone Cement
Indications for Use (Describe)
The TRAUMACEM™ V+ Injectable Bone Cement is indicated for augmentation of the TFN-ADVANCED® Proximal Femoral Nailing System through cannulated implants and instruments for patients with poor bone quality (e.g., osteoporosis).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
escription OSC (Part 21 CFR 801 Subpart D)
Use (21 CFR 801 Subpart C)
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| K170802 510(k) Summary | |
|---|---|
| Sponsor: | Synthes (USA) Products, LLC |
| Primary Contact: | |
| Christopher J. Medberry, Ph.D. | |
| Project Leader, Regulatory Affairs | |
| Synthes (USA) Products, LLC | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 Phone: | |
| (610) 719- 6806 | |
| cmedberr@its.jnj.com | |
| Alternate Contact: | |
| Stacey Bonnell | |
| Associate Director, Regulatory Affairs | |
| Synthes (USA) Products, LLC | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| Phone: (610) 719-5895 | |
| sbonnell@its.jnj.com | |
| Date | |
| Prepared: | September 28th, 2017 |
| Proprietary | |
| Name: | TRAUMACEM™ V+ Injectable Bone Cement |
| Classification: | Classification: 888.3027 |
| Product Code: LOD | |
| Predicate | |
| Device: | Simplex P (K062553) - primary |
| Reference | |
| Devices: | BonOs Inject (K090460), Vertecem (K090435), Vertecem II |
| (K121876) | |
| Device | |
| Description: | TRAUMACEM™ V+ Injectable Bone Cement consists of sterile |
| packed powder and liquid components to create radiopaque | |
| TRAUMACEM™ V+ Injectable Bone Cement. The powder component | |
| is pre-packed in the mixer. The liquid component is stored in a glass | |
| ampoule. A transfer lid for the mixing and transfer of the bone cement | |
| in the application system is also contained in the kit. Mixing the two | |
| sterile components produces the injectable bone cement. | |
| Indications | |
| for Use: | The TRAUMACEM™ V+ Injectable Bone Cement is indicated for |
| augmentation of the TFN-ADVANCED® Proximal Femoral Nailing | |
| System through cannulated implants and instruments for patients with | |
| poor bone quality (e.g., osteoporosis). | |
| Substantial | |
| Equivalence: | The proposed TRAUMACEM™ V+ Injectable Bone Cement has |
| comparable indications, design characteristics, materials, and | |
| performance characteristics in comparison to the predicate device. |
4
Summary Comparison of Technological Characteristics In specific, the subject, predicate, and reference devices are selfpolymerizing two-component systems comprising a powder and a liquid that polymerize at room temperature immediately after they are mixed together in an exothermic reaction. The major powder component of the subject and predicate devices is acrylic polymer. The indications for the TRAUMACEM™ V+ Injectable Bone Cement are highly similar to a subset of the indications for predicate device Simplex P (K062553) and utilized in the same patient population (e.g., patients with poor bone quality or loss of bone substance). Both TRAUMACEM™ V+ Injectable Bone Cement and Simplex P (K062553) meet the requirements of ASTM F451-08/ISO 5833:2002 (apart from setting and dough time). The major differences between the subiect and predicate cement are radiopacity and handling properties. TRAUMACEM™ V+ Injectable Bone Cement was designed to have increased radiopacity and working time to facilitate delivery through cannulated implants and instruments. As these differences influence physical and chemical properties, the subject device was then compared to reference devices BonOs Inject (K090460) and Vertecem (K090435) to demonstrate compliance with the Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA (dated July 17th, 2002). Reference device Vertecem II (K121876) was also included as a material reference in support of the biological risk evaluation. The following performance tests have also been provided in support of this 510(k):
- Biomechanical evaluation of cut-out resistance ●
- Cadaveric evaluation of cut-out resistance ●
- Cannulated implant removal evaluation ●
- Radiopacity comparison ●
- Cytotoxicity ●
- Irritation ●
- 0 Sensitization
- Material mediated pyrogenicity ●
- Genotoxicity (in vitro and in vivo) ●
- Implantation ●
- Chemical characterization. ●
Summary of Clinical Evidence
Three clinical studies conducted outside the US were presented in support of the subject device. One was a prospective, multicenter, randomized, postmarket study comparing outcomes in patients with unstable trochanteric fractures that were treated with or without Traumacem V+ Injectable Bone Cement Augmentation. Two were
5
| summaries of peer-reviewed publications summarizing the short-term
and long-term outcomes of patients with trochanteric fractures who
were treated with cephalomedullary nail augmentation with PMMA
bone cements. The three studies were evaluated with respect to
clinical indications, method of use and patient populations, which
were confirmed to align with the intended use of the subject device.
No cases of cut-out were observed. Potential risks associated with
augmentation (e.g., cement leakage) had a low rate of occurrence.
These data correlated well with presented real-world market
experience on the use of Traumacem V+ Injectable Bone Cement
| outside the United States. |
|---|
| Conclusions |
| Overall, the performance testing and clinical evidence from the |
| postmarket randomized study, postmarket case series, and outside |
| the US market experience support that the benefits of using |
| Traumacem V+ Injectable Bone Cement outweigh the potential risks |
| when utilized in accordance with its indications for use and supports |
| the substantial equivalence of the subject device. |