PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
Device Facts
| Record ID | K210607 |
|---|---|
| Device Name | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro |
| Applicant | Heraeus Medical GmbH |
| Product Code | LOD · Orthopedic |
| Decision Date | Jul 9, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3027 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
PALACOS® R 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 implants to living bone. PALACOS® R+G 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. PALACOS® MV+G 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.
Device Story
PALACOS® R pro, R+G pro, and MV+G pro are high/medium-viscosity, radiopaque, PMMA-based bone cements. Devices are pre-filled in a mixing and application system; prepared immediately before use by mixing polymer powder and monomer liquid. R+G and MV+G variants contain gentamicin to protect cured cement and contiguous tissue against sensitive bacteria. All variants contain zirconium dioxide as contrast medium and chlorophyll-copper-complex (E141) for visibility. Used in surgical settings by physicians for prosthetic implant fixation. Mixing can be performed with or without vacuum. Output is a ductile dough that sets in minutes, providing mechanical fixation of implants to bone.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity), mechanical/functional testing per FDA guidance for PMMA bone cement, sterilization validation (ISO 11135), and pyrogenicity testing (ANSI/AAMI ST72).
Technological Characteristics
PMMA-based bone cement; high or medium viscosity; radiopaque (zirconium dioxide); colored with chlorophyll-copper-complex (E141). Pre-filled mixing/application system. Sterilized via ethylene oxide (ISO 11135). Mechanical properties per ISO 5833 and ASTM F451. R+G and MV+G variants include gentamicin.
Indications for Use
Indicated for arthroplastic procedures of the hip, knee, and other joints for fixation of polymer or metallic prosthetic implants to living bone. PALACOS® R+G pro and PALACOS® MV+G pro are specifically indicated for use in the second stage of a two-stage revision for total joint arthroplasty after initial infection is cleared.
Regulatory Classification
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.
Special Controls
*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.”
Predicate Devices
Reference Devices
Submission Summary (Full Text)
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July 9, 2021
Heraeus Medical GmbH Ljuba Jaeckel Regulatory Affairs Manager Philipp-Reis-Str. 8/13 Wehrheim, Hessen 61273 Germany
Re: K210607
Trade/Device Name: PALACOS® R pro, PALACOS® R+G pro, PALACOS® MV+G pro Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD, MBB, KIH, JDZ Dated: June 7, 2021 Received: June 11, 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
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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 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 (OS) 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 Restorative, Repair and Trauma 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 Food and Drug Administration
### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K210607
Device Name PALACOS® R pro
Indications for Use (Describe)
PALACOS® R 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 (7/17)
Fic Rabbing Survey (Hil) Akkel 148
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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: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K210607
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)
> 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 (7/17)
PSC Publishing Survices (101) 443-6740 =
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Image /page/4/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is written in a large, bold, sans-serif font. Below the word "Heraeus" is the text "Heraeus Medical GmbH" in a smaller, bold, sans-serif font. The logo is simple and professional.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K210607
Device Name PALACOS® MV+G pro
Indications for Use (Describe)
PALACOS® MV+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)
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 (7/17)
15K Publishing Services (301) 445-6740 EF
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#### 7 510(k) Summary
| I. SUBMITTER | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Heraeus Medical GmbH<br>Philipp-Reis-Str. 8/13<br>61273 Wehrheim<br>Germany |
| Contact Person: | Ljuba Jaeckel<br>Manager Regulatory Affairs<br>Phone: +49 6181 35-3138<br>Email: ljuba.jaeckel@heraeus.com |
| Additional Contact Person: | Dr. Yannick Nils Hermanns<br>Manager Regulatory Affairs<br>Phone: +49 (6181) 35-2818<br>Email: yannicknils.hermanns@heraeus.com |
| Date Prepared: | February 26, 2021 |
| II. DEVICES | |
| Name of Device: | PALACOS® R pro<br>(PALACOS® R pro 40, PALACOS® R pro 80)<br>PALACOS® R+G pro<br>(PALACOS® R+G pro 40, PALACOS® R+G pro 80)<br>PALACOS® MV+G pro<br>(PALACOS® MV+G pro 40, PALACOS® MV+G pro 80) |
| Common Name: | Polymethylmethacrylate (PMMA) bone cement |
| Classification Name: | Bone cement (21 CFR 888.3027):<br>PALACOS® R pro<br>Bone cement, antibiotic (21 CFR 888.3027):<br>PALACOS® R+G pro, PALACOS® MV+G pro |
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Product Code:
LOD PALACOS® R pro MBB PALACOS® R+G pro, PALACOS® MV+G pro KIH. JDZ
Subsequent Product Code(s):
#### III. PREDICATE DEVICES
PALACOS® R pro PALACOS® R pro (K202475, Predicate device) PALACOS® R (K202475, Reference device)
PALACOS® R+G pro PALACOS® R+G pro (K202475, Predicate device) PALACOS® R+G (K202475, Reference device)
PALACOS® MV+G pro PALACOS® R+G pro (K202475, Predicate device) PALACOS® MV+G (K202475, Reference device)
#### IV. DEVICE DESCRIPTION
A bundled Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market PALACOS® R pro. PALACOS® R+G pro and PALACOS® MV+G pro.
This submission encompasses multiple devices that have an identical intended use and similar indications for use as well as rely on similar data.
# PALACOS® R pro
PALACOS® R pro is a standard-setting, high-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 chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder (= powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.
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Image /page/7/Picture/1 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a larger, bold, sans-serif font on the top line. Below it, in a smaller, bold, sans-serif font, is the text "Heraeus Medical GmbH".
# PALACOS® R+G pro
PALACOS® R+G pro is a standard-setting, high-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 aminoglycoside antibiotic gentamicin to protect the cured bone cement and contiguous tissue against colonization by bacteria that are sensitive to gentamicin. It contains the X-ray contrast medium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder (= powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.
# PALACOS® MV+G pro
PALACOS® MV+G 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 aminoglycoside antibiotic gentamicin to protect the cured bone cement and contiguous tissue against colonization by bacteria that are sensitive to gentamicin. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder (= powder) with the monomer liquid). A ductile dough forms that sets within a few minutes.
#### V. INTENDED USE
# PALACOS® R pro
PALACOS® R 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 implants to living bone.
# PALACOS® R+G pro
PALACOS® R+G 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.
# PALACOS® MV+G pro
PALACOS® MV+G 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.
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Image /page/8/Picture/1 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font and is gray in color. Below it, in a smaller, black, sans-serif font, is the text "Heraeus Medical GmbH".
#### VI. INDICATIONS FOR USE
### PALACOS® R pro
PALACOS® R 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.
# PALACOS® R+G pro
PALACOS® R+G pro is indicated for use in the second stage of a two-stage revision for total ioint arthroplasty after the initial infection has been cleared.
## PALACOS® MV+G pro
PALACOS® MV+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.
### VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
### PALACOS® R pro
Device comparison demonstrated that the PALACOS® R pro is substantially equivalent to the previously cleared PALACOS® R pro (K202475) 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 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.
The following technological differences exist between the subject and predicate devices:
- -Two types of mixing are available. Mixing of bone cement can be done with or without vacuum with the same mixing and application system.
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Image /page/9/Picture/1 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, sans-serif font and is gray in color. Below it, in a smaller, black, sans-serif font, is the text "Heraeus Medical GmbH."
# PALACOS® R+G pro
Device comparison demonstrated that the PALACOS® R+G pro is substantially equivalent to the previously cleared PALACOS® R+G pro (K202475) 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 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 of exposure, and intended use population.
The following technological differences exist between the subject and predicate devices:
- -Two types of mixing are available. Mixing of bone cement can be done with or without vacuum with the same mixing and application system.
# PALACOS® MV+G pro
Device comparison demonstrated that the PALACOS® MV+G pro is substantially equivalent to the previously cleared PALACOS® R+G pro (K202475) 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,
- -Materials,
- -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 of exposure, and intended use population
The following technological differences exist between the subject and predicate devices:
- -Ratio of material constituents in polymer powder differs and therefore setting time is extended.
- -Two types of mixing are available. Mixing of bone cement can be done with or without vacuum with the same mixing and application system.
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Image /page/10/Picture/1 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font and is gray in color. Below it, in a smaller, black, sans-serif font, is the text "Heraeus Medical GmbH".
#### VIII. PERFORMANCE DATA
The submitter of this Traditional 510(k) Premarket Notification is the manufacturer of the predicate and reference devices.
The following performance data were provided in support of the substantial equivalence determination.
## PALACOS® R pro
### Biocompatibility testing
A biological risk assessment for PALACOS® R pro was conducted 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 4*, 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.
As there is no change in the bone cement itself (formulation or manufacturing) between the predicate and subject device, the focus of the biological risk assessment is therefore the change in the mixing/application system and the accessories as well as any process related influences. All material changes are addressed in detail and it is determined whether or not the changes could affect the subject device from a biocompatibility perspective. It is concluded that the possible transfer of leachables from the mixing and application system or accessories into the bone cement is low. A cytotoxicity test was performed to support this conclusion. It is not estimated that the changes introduced in the subject device would have a negative impact on the subject device s biocompatibility profile.
## Mechanical and functional testing
Mechanical tests were conducted in order to demonstrate that the PALACOS® R 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® R pro shows equivalence to the predicate device.
## Pvrogenicitv
PALACOS® R pro has been tested for the presence of bacterial endotoxins using the LAL test (known as the Limulus amebocyte Iysate 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.
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Image /page/11/Picture/1 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font in gray color. Below it, in a smaller, black, sans-serif font, is the text "Heraeus Medical GmbH".
# PALACOS® R+G pro
# Biocompatibility testing
The biocompatibility evaluation for PALACOS® R+G pro was conducted 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 4", 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.
As there is no change in the bone cement itself (formulation or manufacturing) between the predicate and subject device, the focus of the biological risk assessment is therefore the change in the mixing/application system and the accessories as well as any process related influences. All material changes are addressed in detail and it is determined whether or not the changes could affect the subject device from a biocompatibility perspective. It is concluded that the possible transfer of leachables from the mixing and application system or accessories into the bone cement is low. A cytotoxicity test was performed to support this conclusion. It is not estimated that the changes introduced in the subject device would have a negative impact on the subject device s biocompatibility profile.
## Mechanical and functional testing
Mechanical tests were conducted in order to demonstrate that the PALACOS® R+G 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® R+G pro shows equivalence to the predicate device.
## Pyrogenicity
PALACOS® R+G pro has been tested for the presence of bacterial endotoxins using the LAL test (known as the Limulus amebocyte Iysate 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.
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Image /page/12/Picture/1 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 word "Heraeus", the words "Heraeus Medical GmbH" are written in a smaller, bold, sans-serif font in black color.
# PALACOS® MV+G pro
# Biocompatibility testing
The biocompatibility evaluation for PALACOS® MV+G pro was conducted 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 4", 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.
As there is no change in the bone cement itself (formulation or manufacturing) between the predicate and subject device. the focus of the biological risk assessment is therefore the change in the mixing/application system and the accessories as well as any process related influences. All material changes are addressed in detail and it is determined whether or not the changes could affect the subject device from a biocompatibility perspective. It is concluded that the possible transfer of leachables from the mixing and application system or accessories into the bone cement is low. A cytotoxicity test was performed to support this conclusion. It is not estimated that the changes introduced in the subject device would have a negative impact on the subject device s biocompatibility profile.
## Mechanical and functional testing
Mechanical tests were conducted in order to demonstrate that the PALACOS® MV+G 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+G pro shows equivalence to the predicate device.
## Pyrogenicity
PALACOS® MV+G 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.
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#### IX. CLINICAL TESTING
# PALACOS® R pro
No clinical testing of the PALACOS® R pro has been conducted.
# PALACOS® R+G pro
No clinical testing of the PALACOS® R+G pro has been conducted.
# PALACOS® MV+G pro
No clinical testing of the PALACOS® MV+G pro has been conducted.
#### X. CONCLUSIONS
## PALACOS® R pro
The PALACOS® R pro is substantially equivalent to the predicate device (PALACOS® R pro, K202475) 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.
## PALACOS® R+G pro
The PALACOS® R+G pro is substantially equivalent to the predicate device (PALACOS® R+G pro. K202475) 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.
## PALACOS® MV+G pro
The PALACOS® MV+G pro is substantially equivalent to the predicate device (PALACOS® R+G pro, K202475) 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.
