(148 days)
No
The device description and performance studies focus on the material properties and mechanical performance of bone cement, with no mention of AI or ML.
Yes
Explanation: The device is an acrylic bone cement used for the fixation of prosthetic implants to living bone during arthroplastic procedures, which directly addresses a medical condition to improve health.
No
Explanation: The device is an acrylic bone cement used for surgical fixation of prosthetic implants to bone, not for diagnosis.
No
The device description clearly states it is an acrylic bone cement and includes physical components like powder, liquid, a mixing and application device, and accessories. It is a physical material used for fixation, 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 prosthetic implants to bone during surgical procedures. This is a direct surgical application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a bone cement used to secure implants. It is applied directly to the bone during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Anatomical Site: The anatomical sites (hip, knee, other joints) are where the surgical procedure takes place, not where samples are collected for in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
PALACOS® R pro 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.
Product codes
LOD, KIH, JDZ
Device Description
PALACOS® R 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 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 pro is available in one size: 75 g and is for single use. The PALACOS® R 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
hip, knee, and other joints
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
Nonclinical tests were performed.
For the predicate device PALACOS® R the stability of liquid component, maximum temperature, setting time, intrusion, compressive strength, bending modulus and bending strength of was characterized per ISO 5833.
The same tests were performed for the reference device PALACOS® R+G pro (K142157), which is the worst case product for pre-packed bone cement. In addition for PALACOS® R+G pro, 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, and genotoxicity was performed per ISO 10993.
No clinical data was provided.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces suggesting community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
Heraeus Medical GmbH % Ms. Tina Wu-Murphy ICON plc 62 Forest Street. Suite 300 Marlborough, Massachusetts 01752
Re: K150119
Trade/Device Name: PALACOS® R pro Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD, KIH, JDZ Dated: June 3, 2015 Received: June 5, 2015
Dear Ms. Wu-Murphy:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Tina Wu-Murphy
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 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.
Lori A. Wiggins -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150119
Device Name
PALACOS® R pro
Indications for Use (Describe)
PALACOS® R pro 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY CONTRACTOR
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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PALACOS® R pro
Heraeus
Heraeus Medical GmbH 61273 Wehrheim, Germany
Radiopaque bone cement
| Special 510(k) | 510(k) Summary |
|---|---|
| Date of summary | January 5th, 2015 |
|---|---|
| Applicant's name and address | Heraeus Medical GmbH |
| Philipp-Reis-Straße 8/13 | |
| 61273 Wehrheim | |
| Germany | |
| Device trade name | PALACOS® R 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, KIH, JDZ |
| Identification of the marketed | |
| device to which equivalence is | |
| claimed | PALACOS® R, K030902 |
| Reference device | PALACOS® R+G pro, K142157 |
| Description of the device | PALACOS® R 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 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 pro is available in one size: 75 g and is for |
4
PALACOS® R pro
Image /page/4/Picture/1 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold font at the top of the image. Below that is the text "Heraeus Medical GmbH" followed by the address "61273 Wehrheim, Germany".
Radiopaque bone cement
| Special 510(k) | 510(k) Summary |
|---|---|
| single use. The PALACOS® R pro device includes: | |
| The mixing and application device pre-packed | |
| with the bone cement powderOne ampoule of monomer liquid pre-packed in a | |
| monomer cartridgeAccessories: 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 pro 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. | |
| 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 | For the predicate device PALACOS® R the stability of |
| liquid component, maximum temperature, setting time, | |
| intrusion, compressive strength, bending modulus and | |
| bending strength of was characterized per ISO 5833. | |
| The same tests were performed for the reference | |
| device PALACOS® R+G pro (K142157), which is the | |
| worst case product for pre-packed bone cement. In | |
| addition for PALACOS® R+G pro, impact and bending | |
| strength were measured according to Dynstat test | |
| method. EtO sterilization was validated per ISO 11135. | |
| Biocompatibility testing, including cytotoxicity, irritation, | |
| Special 510(k) | 510(k) Summary |
| sensitization, acute systemic toxicity, and genotoxicity | |
| was performed per ISO 10993. Because PALACOS® | |
| R+G pro can be regarded as worst case product, the | |
| results are also valid for PALACOS® R pro. | |
| Clinical performance data | No clinical data was provided. |
| Conclusions from nonclinical | |
| and clinical data | PALACOS® R pro is substantial equivalent to |
| PALACOS® R. | |
| Submitted by | Dr. Astrid Marx |
| Phone: + 49 (0) 6181.35-2963 | |
| Fax: + 49 (0) 6181.35-2916 | |
| astrid.marx@heraeus.com | |
| US contact information | ICON plc, |
| 62 Forest Street, Suite 300, Marlborough, MA 01752 | |
| Tina Wu-Murphy | |
| (Phone: +1 443 352 3909, | |
| Tina.Wu-Murphy@iconplc.com) |
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Image /page/5/Picture/0 description: The image shows the text "PALACOS® R pro" in a bold, sans-serif font. The word "PALACOS" is followed by the registered trademark symbol. The text is horizontally aligned and appears to be a logo or brand name.
Image /page/5/Picture/1 description: The image shows the logo for Heraeus Medical GmbH, located in 61273 Wehrheim, Germany. The logo is a simple, bold typeface with the word "Heraeus" in a larger font size on the top line. The company name and address are printed in a smaller font size below the logo.