(148 days)
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.
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.
The provided document is a 510(k) summary for a medical device called PALACOS® R pro, a PMMA bone cement. It is a submission to the FDA for market clearance, asserting substantial equivalence to a predicate device. The information details non-clinical testing performed to demonstrate this equivalence, rather than a clinical study with acceptance criteria for device performance in human patients.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable within the context of this document, as it focuses on demonstrating bio-mechanical and material equivalence to an already approved device.
Here's an attempt to address your request based on the provided text, noting where information is not available or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are derived from the standards and tests applied to the predicate device and the reference device. The "reported device performance" indicates that PALACOS® R pro (or its relevant precursors) met these criteria, supporting substantial equivalence.
| Acceptance Criteria (Based on Predicate/Reference Device Standards) | Reported Device Performance (PALACOS® R pro / Reference Device) |
|---|---|
| Stability of liquid component (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Maximum temperature (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Setting time (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Intrusion (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Compressive strength (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Bending modulus (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Bending strength (per ISO 5833) | Characterized (met standards of predicate/reference) |
| Impact strength (per Dynstat test method) | Measured (for PALACOS® R+G pro, considered worst-case) |
| Bending strength (per Dynstat test method) | Measured (for PALACOS® R+G pro, considered worst-case) |
| EtO sterilization validation (per ISO 11135) | Validated |
| Biocompatibility: Cytotoxicity (per ISO 10993) | Performed (results valid for PALACOS® R pro) |
| Biocompatibility: Irritation (per ISO 10993) | Performed (results valid for PALACOS® R pro) |
| Biocompatibility: Sensitization (per ISO 10993) | Performed (results valid for PALACOS® R pro) |
| Biocompatibility: Acute systemic toxicity (per ISO 10993) | Performed (results valid for PALACOS® R pro) |
| Biocompatibility: Genotoxicity (per ISO 10993) | Performed (results valid for PALACOS® R pro) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the individual non-clinical tests (e.g., number of specimens for compressive strength testing). It states that the tests were performed "per ISO 5833" and "per ISO 10993," which would implicitly define testing protocols and sample sizes within those standards.
- Test set sample size: Not explicitly stated for each test, but implied by adherence to ISO standards.
- Data Provenance: The manufacturer, Heraeus Medical GmbH, is located in Wehrheim, Germany. The tests appear to be conducted as part of the product development and regulatory submission process, which is inherently prospective for demonstrating compliance. The data refers to non-clinical laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable here. The "ground truth" for these tests are the established parameters and thresholds defined by international standards (ISO 5833, ISO 11135, ISO 10993) for bone cement properties and sterilization/biocompatibility. These are objective measurements, not subjective expert assessments.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for reconciling differing expert opinions in clinical ground truth establishment. Here, the "truth" is determined by direct physical and chemical measurements against defined standard limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, this was not done. MRMC studies are associated with evaluating diagnostic imaging devices where human readers interpret results, often to assess AI's impact on reader performance. This document concerns a bone cement, which is a therapeutic device, not a diagnostic one.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a bone cement, a material used in surgery, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established international standards and measurement methodologies for material properties, sterilization efficacy, and biocompatibility. For instance, compressive strength has a defined physical measurement and an acceptable range per ISO 5833.
8. The Sample Size for the Training Set
Not applicable. This device is a material product, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as point 8.
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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)
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FOR FDA USE ONLY CONTRACTOR
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
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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 GmbHPhilipp-Reis-Straße 8/1361273 WehrheimGermany |
| Device trade name | PALACOS® R pro |
| Common name | PMMA Bone Cement |
| Classification | PMMA Bone Cement : Class II special control per 21 CFR 888.3027Cement Mixer for Clinical Use: Class I Exempt per 21 CFR 888.4210Cement Dispenser: Class I Exempt per 21 CFR 888.4200 |
| Classification name | Polymethylmethacrylate (PMMA) bone cement |
| Device code | LOD, KIH, JDZ |
| Identification of the marketeddevice to which equivalence isclaimed | PALACOS® R, K030902 |
| Reference device | PALACOS® R+G pro, K142157 |
| Description of the device | PALACOS® R pro is an acrylic bone cement for use inorthopedic surgery. It is formed from powder and liquid byexothermic polymerization. It secures the fixation of thegrafted artificial joint improving the transfer of forces at theinterface implant - bone. The bone cement powder andliquid of PALACOS® R pro are pre-packed in a vacuummixing and application system. This reduces the user stepsand processing time during mixing of the bone cement. Italso decreases the exposure to monomer fumes.PALACOS® R pro is available in one size: 75 g and is for |
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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-packedwith the bone cement powderOne ampoule of monomer liquid pre-packed in amonomer cartridgeAccessories: a nozzle, a femur pressurizer, avacuum sealed vacuum tube and in a separatebox, an adaptor ring for the use with bonecement gun. | |
| Indications for use | PALACOS® R pro is intended for use in arthroplasticprocedures of the hip, knee, and other joints for thefixation of polymer or metallic prosthetic implants toliving bone. |
| Comparison of technologicalcharacteristics | Bone cement is derived by mixing a powder componentand a monomer liquid. The only difference between thesubject and predicate device exists in a change to theprimary packaging into a pre-packed application device tosimplify the user handling of the components. |
| Discussion of nonclinical tests | For the predicate device PALACOS® R the stability ofliquid component, maximum temperature, setting time,intrusion, compressive strength, bending modulus andbending strength of was characterized per ISO 5833.The same tests were performed for the referencedevice PALACOS® R+G pro (K142157), which is theworst case product for pre-packed bone cement. Inaddition for PALACOS® R+G pro, impact and bendingstrength were measured according to Dynstat testmethod. EtO sterilization was validated per ISO 11135.Biocompatibility testing, including cytotoxicity, irritation, |
| Special 510(k) | 510(k) Summary |
| sensitization, acute systemic toxicity, and genotoxicitywas performed per ISO 10993. Because PALACOS®R+G pro can be regarded as worst case product, theresults are also valid for PALACOS® R pro. | |
| Clinical performance data | No clinical data was provided. |
| Conclusions from nonclinicaland clinical data | PALACOS® R pro is substantial equivalent toPALACOS® R. |
| Submitted by | Dr. Astrid MarxPhone: + 49 (0) 6181.35-2963Fax: + 49 (0) 6181.35-2916astrid.marx@heraeus.com |
| US contact information | ICON plc,62 Forest Street, Suite 300, Marlborough, MA 01752Tina 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.
§ 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.”