(30 days)
No
The description focuses on the material properties and delivery system of a bone cement, with no mention of AI/ML capabilities or data processing.
Yes
The device is used to secure the fixation of grafted artificial joints, improving force transfer at the implant-bone interface, which is a therapeutic function.
No
This device is an acrylic bone cement used to secure artificial joint fixation during orthopedic surgery, not to diagnose a condition.
No
The device description clearly outlines physical components including bone cement powder, liquid, a mixing and application device, and various accessories. The performance studies also focus on material properties and sterilization, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for securing the fixation of artificial joints in orthopedic surgery. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is an acrylic bone cement used to physically fix an implant to bone. It's a material used in the body during surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test a sample from the human body to provide information about a physiological state, disease, or condition.
IVD devices are used to perform tests on samples (like blood, urine, tissue) taken from the body to diagnose or monitor a condition. This bone cement is a material implanted into the body.
N/A
Intended Use / Indications for Use
PALACOS® R+G pro is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.
Product codes (comma separated list FDA assigned to the subject device)
LOD, MBB, KIH, JDZ
Device Description
PALACOS® R+G pro is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. The bone cement powder and liquid of PALACOS® R+G pro are pre-packed in a vacuum mixing and application system. This reduces the user steps and processing time during mixing of the bone cement. It also decreases the exposure to monomer fumes. PALACOS® R+G pro is available in one size: 75 g and is for single use. The PALACOS® R+G pro device includes: The mixing and application device pre-packed with the bone cement powder One ampoule of monomer liquid pre-packed in a monomer cartridge Accessories: a nozzle, a femur pressurizer, a vacuum sealed vacuum tube and in a separate box, an adaptor ring for the use with bone cement gun
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The stability of liquid component, maximum temperature, setting time, intrusion, compressive strength, bending modulus and bending strength of PALACOS® R+G pro was characterized per ISO 5833. In addition, impact and bending strength were measured according to Dynstat test method. EtO sterilization was validated per ISO 11135. Biocompatibility testing, including cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation, genotoxicity and chemical characterization was performed per ISO 10993. No clinical data was provided.
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.
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.
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.”
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5, 2014
Heraeus Medical GmbH Dr. Astrid Marx Junior Regulatory Affairs Manager Philipp-Reis-Straße 8/13 61273 Wehrheim Germany
Re: K142157
Trade/Device Name: PALACOS® R+G pro Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD, MBB, KIH, JDZ Dated: July 25, 2014 Received: August 6, 2014
Dear Dr. Marx
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
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142157
Device Name PALACOS® R+G pro
Indications for Use (Describe)
PALACOS® R+G pro is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is written in a bold, sans-serif font in gray color. Below the logo, the words "Heraeus Medical GmbH" are written in a smaller, sans-serif font in black color.
61273 Wehrheim, Germany
PALACOS® R+G pro
Radiopaque bone cement with gentamicin
| Special 510(k) | 510(k) Summary |
|---|---|
| Date of summary | July 25th, 2014 |
| Applicant's name and address | Heraeus Medical GmbH |
| Philipp-Reis-Straße 8/13 | |
| 61273 Wehrheim | |
| Germany | |
| Device trade name | PALACOS® R+G pro |
| Common name | PMMA Bone Cement |
| Classification | PMMA Bone Cement : Class II special control per 21 CFR |
| 888.3027 | |
| Cement Mixer for Clinical Use: Class I Exempt per 21 CFR | |
| 888.4210 | |
| Cement Dispenser: Class I Exempt per 21 CFR 888.4200 | |
| Classification name | Polymethylmethacrylate (PMMA) bone cement |
| Device code | LOD, MBB, KIH, JDZ |
| Identification of the marketed | |
| device to which equivalence is | |
| claimed | PALACOS® R+G, K031673 |
| Reference device | SmartMix Cemvac Pre-filled with SmartSet GHV |
| Gentamicin bone cement, K053445 | |
| Description of the device | PALACOS® R+G pro is an acrylic bone cement for use in |
| orthopedic surgery. It is formed from powder and liquid by | |
| exothermic polymerization. It secures the fixation of the | |
| grafted artificial joint improving the transfer of forces at the | |
| interface implant - bone. The bone cement powder and | |
| liquid of PALACOS® R+G pro are pre-packed in a vacuum | |
| mixing and application system. This reduces the user steps | |
| and processing time during mixing of the bone cement. It | |
| also decreases the exposure to monomer fumes. | |
| PALACOS® R+G pro is available in one size: 75 g and is | |
| Special 510(k) | 510(k) Summary |
| for single use. The PALACOS® R+G pro device includes: | |
| The mixing and application device pre-packed with the bone cement powder One ampoule of monomer liquid pre-packed in a monomer cartridge Accessories: a nozzle, a femur pressurizer, a vacuum sealed vacuum tube and in a separate box, an adaptor ring for the use with bone cement gun | |
| Indications for use | PALACOS® R+G pro is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared. |
| Comparison of technological | |
| characteristics | Bone cement is derived by mixing a powder component and a monomer liquid. The only difference between the subject and predicate device exists in a change to the primary packaging into a pre-packed application device to simplify the user handling of the components. |
| Discussion of nonclinical tests | The stability of liquid component, maximum temperature, setting time, intrusion, compressive strength, bending modulus and bending strength of PALACOS® R+G pro was characterized per ISO 5833. In addition, impact and bending strength were measured according to Dynstat test method. EtO sterilization was validated per ISO 11135. Biocompatibility testing, including cytotoxicity, irritation, sensitization, acute systemic toxicity, implantation, genotoxicity and chemical characterization was performed per ISO 10993. |
| Clinical performance data | No clinical data was provided. |
| Special 510(k) | 510(k) Summary |
| Conclusions from nonclinical | |
| and clinical data | PALACOS® R+G pro is substantial equivalent to |
| PALACOS® R+G. | |
| Submitted by | Dr. Astrid Marx |
| Phone: + 49 (0) 6181.35-2963 | |
| Fax: + 49 (0) 6181.35-2910 | |
| astrid.marx@heraeus.com | |
| US contact information | Aptiv Solutions, |
| 62 Forest Street, Suite 300, Marlborough, MA 01752, | |
| Tina Wu (Phone: +1 443.352.3909, | |
| tina.wu@aptivsolutions.com) |
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Image /page/4/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a bold, sans-serif font in a dark gray color. Below the logo is the text "Heraeus Medical GmbH" in a smaller, black font. There is a thin black line underneath the text.
61273 Wehrheim, Germany
PALACOS® R+G pro
Radiopaque bone cement with gentamicin
Special 510(k) – 510(k) Summary, Page 2
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Heraeus
Heraeus Medical GmbH
61273 Wehrheim, Germany
PALACOS® R+G pro
Radiopaque bone cement with gentamicin
25 July 2014
Special 510(k) – 510(k) Summary, Page 3