(57 days)
No
The description focuses on the chemical composition and physical properties of a bone cement, with no mention of AI or ML.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is a bone cement used to fix prosthetic implants in bones, which is a supportive material for a surgical procedure rather than a direct therapeutic agent.
No
This device is a bone cement used for fixation of prosthetic implants to bone during surgical procedures, not for diagnosing diseases or conditions.
No
The device description clearly states it is a poly(methyl methacrylate)-based (PMMA) bone cement, which 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 "fixation of polymer or metallic prosthetic implants to living bone" during surgical procedures. This is a direct interaction with the patient's body during surgery, not an in vitro test performed on samples outside the body.
- Device Description: The device is a bone cement, a material used to physically bond implants to bone. This is a therapeutic/surgical material, not a diagnostic reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on in vitro analysis.
Therefore, PALACOS® MV pro is a surgical material used in orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PALACOS® MV pro is indicated 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® MV pro is a standard-setting, medium viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyllcopper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.
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
Biocompatibility testing: A biocompatibility evaluation for PALACOS® MV pro was performed on PALACOS® R (K202475), which is representative of the subject device in accordance with the FDA Guidance document Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on September 4th, 2020 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-mediated Pyrogenicity, Genotoxicity, Hemocompatibility, Implantation. Additionally, cytotoxicity testing was performed on the PALACOS MV® pro (subject device) and PALACOS® R pro (predicate device) after preparation aseptically with the mixing and application system.
Mechanical and functional testing: Mechanical tests were conducted in order to demonstrate that the PALACOS® MV pro functions as intended and is safe and effective for its intended use. The mechanical and functional testing was performed alongside the FDA Guidance document Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement -Guidance for Industry and FDA, issued on July 17th, 2002. The testing according to Annex I and Annex II of prior named FDA Guidance document provided data to state the substantial equivalence of the subject device to the predicate device.
Sterilization: Validation of the sterilization was performed in accordance to ISO 11135. The sterilization is carried out by gassing with ethylene oxide. The sterilization cycle is designed to deliver sterile units, starting with a defined bioburden and ending with a sterility assurance level (SAL) of 10-6.
Pyrogenicity: PALACOS® MV pro has been tested for the presence of bacterial endotoxins using the LAL test (known as the Limulus amebocyte lysate test) according to ANSI/AAMI ST72. The subject device meets the endotoxin limit specification of ≤ 20 EU/device.
Clinical testing: No clinical testing of the PALACOS® MV pro has been conducted.
Key Metrics
Not Found
Predicate Device(s)
PALACOS® R pro (K210607)
Reference Device(s)
Not Found
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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February 2, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Heraeus Medical GmbH Ljuba Jaeckel Regulatory Affairs Manager Philipp-Reis-Str. 8/13 Wehrheim, Hessen 61273 Germany
Re: K213812
Trade/Device Name: PALACOS® MV pro Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD, KIH, JDZ Dated: December 2, 2021 Received: December 7, 2021
Dear Ljuba Jaeckel:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Laura C. Rose. Ph.D. Assistant Director DHT6C: Division of Stereotaxic. Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2023 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) |
Device Name PALACOS® MV pro
Indications for Use (Describe)
PALACOS® MV pro is indicated 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
PSC Publishing Services (301) 443-6740 EF
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Traditional 510(k) Premarket Notification PALACOS® MV pro
510(k) Summary - K213812
| I. SUBMITTER | |
|---|---|
| Manufacturer: | Heraeus Medical GmbH |
| Philipp-Reis-Str. 8/13 | |
| 61273 Wehrheim | |
| Germany | |
| Contact Person: | Ljuba Jaeckel |
| Manager Regulatory Affairs | |
| Phone: +49 6181 35-3138 | |
| Email: ljuba.jaeckel@heraeus.com | |
| Additional Contact Person: | Alexander Peczka |
| Senior Regulatory Affairs Manager | |
| Phone: +49 (6181) 35-2964 | |
| Email: alexander.peczka@heraeus.com | |
| Date Prepared: | December 03, 2021 |
| II. DEVICES | |
| Name of Device: | PALACOS® MV pro |
| (PALACOS® MV pro 40, PALACOS® MV pro 80) | |
| Common Name: | Polymethylmethacrylate (PMMA) bone cement |
| Classification Name: | Bone cement (21 CFR 888.3027) |
| Regulatory Class: | Class II |
LOD
KIH, JDZ
Product Code: Subsequent Product Code(s):
= PREDICATE DEVICES
PALACOS® R pro (K210607)
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IV. DEVICE DESCRIPTION
A Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market PALACOS® MV pro.
PALACOS® MV pro is a standard-setting, medium viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyllcopper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.
V. INTENDED USE
PALACOS® MV pro is a PMMA bone cement 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.
VI. INDICATIONS FOR USE
PALACOS® MV pro is indicated for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Device comparison demonstrated that the PALACOS® MV pro is substantially equivalent to the previously cleared PALACOS® R pro (K210607) regarding intended use, technological characteristics (device design, material and performance) as well as operating principle.
Both the subject and predicate device are PMMA bone cements that are intended for use in arthroplastic procedures. They consist of two components that are already prefilled in a mixing and application system and are prepared immediately before use by mixing the polymer powder with the monomer liquid.
At a high level, the subject device and predicate device are based on the following same technological elements:
- -PMMA bone cement.
- -Chemical composition,
- -Sterilized with an established method (ethylene oxide) as per DIN EN ISO 11135 and DIN EN ISO 10993-7
- -Mechanical characteristics as per ISO 5833 and ASTM F451,
- -Mixing and application properties, and
- -Clinical use of the devices including the anatomical location, duration of exposure, and intended use population.
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The following technological difference exist between the subject and predicate devices:
- Ratio of material constituents in polymer powder differs and therefore setting time is extended.
VIII. PERFORMANCE DATA
The submitter of this Traditional 510(k) Premarket Notification is the manufacturer of the predicate device.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
A biocompatibility evaluation for PALACOS® MV pro was performed on PALACOS® R (K202475), which is representative of the subject device in accordance with the FDA Guidance document Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on September 4th, 2020 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation ●
- Acute Systemic Toxicity
- Material-mediated Pyrogenicity ●
- Genotoxicity
- Hemocompatibility
- Implantation
The bone cements of PALACOS® MV pro and the test article are identical in their qualitative components and differ only in the slightly different quantitative compositions. The formulation change does not alter the chemical or physical properties of the medical device in its final finished form, and therefore, results from the test article can be applied to the proposed medical device in its final finished form.
In Addition, cytotoxicity testing was performed on the PALACOS MV® pro (subject device) and PALACOS® R pro (predicate device) after preparation aseptically with the mixing and application system.
The PALACOS® MV pro is categorized as: implant medical device, intended to be used for long term contact duration (> 30 d) in tissue / bone.
Accessories of PALACOS® MV pro are categorized as: implant medical device, intended to be used for limited contact duration (≤ 24 h) in tissue / bone.
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Mechanical and functional testing
Mechanical tests were conducted in order to demonstrate that the PALACOS® MV pro functions as intended and is safe and effective for its intended use.
The mechanical and functional testing was performed alongside the FDA Guidance document Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement -Guidance for Industry and FDA, issued on July 17th, 2002. The testing according to Annex I and Annex II of prior named FDA Guidance document provided data to state the substantial equivalence of the subject device to the predicate device.
Sterilization
Validation of the sterilization was performed in accordance to ISO 11135. The sterilization is carried out by gassing with ethylene oxide. The sterilization cycle is designed to deliver sterile units, starting with a defined bioburden and ending with a sterility assurance level (SAL) of 10°.
Based on the tests performed and the results obtained, the chosen sterilization process can be considered as valid and PALACOS® MV pro shows equivalence to the predicate device.
Pyrogenicity
PALACOS® MV pro has been tested for the presence of bacterial endotoxins using the LAL test (known as the Limulus amebocyte lysate test) according to ANSI/AAMI ST72. The subject device meets the endotoxin limit specification of ≤ 20 EU/device and shows equivalence to the predicate device.
IX. CLINICAL TESTING
No clinical testing of the PALACOS® MV pro has been conducted.
X. CONCLUSIONS
The PALACOS® MV pro is substantially equivalent to the predicate device (PALACOS® R pro. K210607) identified in this premarket notification. Substantial equivalence has been demonstrated through a comparison of intended use, technological characteristics (device design, material and performance) as well as operating principle. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device.