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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called PALACOS® MV pro, a polymethylmethacrylate (PMMA) bone cement. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

The information provided does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML powered device, or any diagnostic device subject to performance metrics like sensitivity, specificity, AUC, etc. Instead, it focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway.

Therefore, many of the requested items (e.g., performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or mentioned in this document.

Here's an analysis based on the information provided in the document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state acceptance criteria in terms of specific numerical thresholds for performance metrics commonly associated with AI/ML or diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" for demonstrating substantial equivalence are based on matching the predicate device's intended use, technological characteristics, and operating principle. The "reported device performance" is demonstrated through various tests designed to show that the subject device functions as intended and is safe and effective, aligning with the predicate.

Acceptance Criteria Category (Implied by SE)	Reported Device "Performance" (Meeting Criteria)
Intended Use	PALACOS® MV pro has the same intended use as the predicate (PALACOS® R pro, K210607): fixation of polymer or metallic prosthetic implants to living bone in arthroplastic procedures of the hip, knee, and other joints.
Technological Characteristics (Device Design, Material, Operating Principle)	Both devices are PMMA bone cements, consist of two pre-filled components, and are prepared immediately before use by mixing polymer powder with monomer liquid.
Chemical Composition	The subject and predicate devices share the same chemical composition at a high level.
Sterilization Method	Both are sterilized with ethylene oxide as per DIN EN ISO 11135 and DIN EN ISO 10993-7. The sterilization process for PALACOS® MV pro was validated according to ISO 11135 to achieve an SAL of 10^-6.
Mechanical Characteristics	Mechanical testing performed according to ISO 5833 and ASTM F451 demonstrated equivalence to the predicate.
Mixing and Application Properties	These properties were considered equivalent to the predicate.
Clinical Use, Anatomical Location, Duration of Exposure, Intended Use Population	These aspects are equivalent to the predicate device.
Biocompatibility	Evaluations (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-mediated Pyrogenicity, Genotoxicity, Hemocompatibility, Implantation) were performed on a representative device (PALACOS® R, K202475) and deemed applicable due to identical qualitative components and minor quantitative differences not altering chemical/physical properties. Additionally, cytotoxicity testing was performed on PALACOS® MV pro and PALACOS® R pro.
Pyrogenicity	PALACOS® MV pro was tested for bacterial endotoxins using the LAL test (ANSI/AAMI ST72) and meets the specification of ≤ 20 EU/device, showing equivalence to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Test Set Sample Size: Not applicable in the context of an AI/ML test set. The document refers to various engineering and biological tests conducted on the device itself or representative materials. The 'sample size' for these tests would refer to the number of units tested, but this is not specified for each test.
Data Provenance: Not applicable in the context of an AI/ML test set. The tests are laboratory-based and follow international standards. The manufacturer is Heraeus Medical GmbH, located in Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is not a diagnostic device or an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for this device's performance is established through adherence to recognized international standards and laboratory testing for physical, mechanical, chemical, and biological properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There is no expert adjudication process described, as it's not relevant for this type of device and submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a bone cement, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a PMMA bone cement, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device's safety and effectiveness, in the context of substantial equivalence, is rooted in:

International Standards: Adherence to established mechanical (ISO 5833, ASTM F451), sterilization (ISO 11135), biocompatibility (ISO 10993-1), and pyrogenicity (ANSI/AAMI ST72) standards.
Predicate Device Performance: The demonstrated safe and effective use of the predicate device (PALACOS® R pro) acts as a benchmark. The subject device is shown to be equivalent in its properties to this predicate.
Laboratory Testing Results: Direct measurements of physical, chemical, and biological properties in controlled laboratory settings.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. There is no "training set" or associated ground truth establishment process for this device as it is not an AI/ML product.

Summary

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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

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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)

K213812

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.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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 GmbHPhilipp-Reis-Str. 8/1361273 WehrheimGermany
Contact Person:	Ljuba JaeckelManager Regulatory AffairsPhone: +49 6181 35-3138Email: ljuba.jaeckel@heraeus.com
Additional Contact Person:	Alexander PeczkaSenior Regulatory Affairs ManagerPhone: +49 (6181) 35-2964Email: 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.

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.

Regulation Number and Section

§ 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.”