COPAL® exchange G hip spacer (polymethylmethacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip spacer is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, canes) throughout the implantation period.

Device Description

COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile.

COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. The mass used in the filling of the molds (the PMMA unformed resin) is prepared from a powder component and a liguid component. It contains the X-ray contrast medium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).

COPAL® exchange G hip spacer will be used with COPAL® exchange G hip trials (510(k) exempt devices).

AI/ML Overview

This response analyzes FDA K220492 for "COPAL® exchange G hip spacer." It is important to note that this device is a physical medical implant, not an AI/ML powered software device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., ground truth establishment, expert adjudication, MRMC studies) are not applicable to this submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device (hip spacer) and not an AI/ML powered device, the "acceptance criteria" are not based on metrics like accuracy, sensitivity, or specificity. Instead, they relate to mechanical performance, material properties, and biocompatibility. The provided document indicates that the acceptance criteria for the modified device were the same as those for the original predicate device (K191016).

Criterion	Original Device Standard	Reported Device Performance (K220492)
Fatigue Performance	ISO 7206-6 (same protocol as K191016)	Meets acceptance criteria (same as original device)
Endotoxin Limits	Not explicitly stated, but implied to be standard limits.	Meets endotoxin limits
Risk Analysis	DIN EN ISO 14971	Demonstrated no new worst-case scenario compared to predicate; deemed as safe and effective.
Material Composition	Polymethylmethacrylate (radiopaque PMMA with gentamicin) and inner stainless steel (AISI 316L) reinforcing structure	Unchanged from predicate, except for modified dimension
Biocompatibility	Not explicitly detailed but implied by material unchanged from predicate	Implied to be acceptable as materials are retained from predicate.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of an AI/ML test set. For physical device testing, the sample size would refer to the number of devices or components tested. The document does not specify the exact number of spacers tested for fatigue or endotoxin, but states that "COPAL® exchange G hip spacer meets endotoxin limits" and "The fatigue performance testing as per ISO 7206-6 was performed... The acceptance criteria were not altered...". This implies that standard testing was conducted on an appropriate number of samples to demonstrate compliance.
Data Provenance: Not applicable in the context of clinical data for AI/ML. The performance data is generated from laboratory mechanical and material testing. The document states the manufacturer is Heraeus Medical GmbH, located in Germany, implying the testing was conducted under their control.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. For a physical device, "ground truth" is established by engineering specifications, material standards, and validated testing methodologies, not by expert consensus on clinical images or patient data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data for AI/ML models.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical implant, not a diagnostic AI tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical device, so there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, international standards (e.g., ISO 7206-6, DIN EN ISO 14971), and validated laboratory testing results for mechanical properties (fatigue), material composition, and biological safety (endotoxin).

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no AI/ML model, there's no training set or ground truth establishment for it.

Summary

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March 23, 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

Heraeus Medical GmbH Heike Gustke Senior Manager Regulatory Affairs Philipp-Reis-Str. 8/13 Wehrheim, Hessen 61273 Germany

Re: K220492

Trade/Device Name: COPAL® exchange G hip spacer Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY, KWL Dated: February 14, 2022 Received: February 22, 2022

Dear Heike Gustke:

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 medical devices and radiation-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.

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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Indications for Use

510(k) Number (if known) K220492

Device Name COPAL® exchange G hip spacer

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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7	510(k) Summary
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I.	SUBMITTER
Manufacturer:	Heraeus Medical GmbH
	Philipp-Reis-Str. 8/13
	61273 Wehrheim
	Germany
Contact Person:	Dr. Heike Gustke
	Senior Manager Regulatory Affairs
	Phone: +49 (6181) 35-2942
	Email: heike.gustke@heraeus.com
	Additional Email: Regulatory_HM@heraeus.com
Date Prepared:	March 21, 2022

II.	DEVICES
Name of Device:	COPAL® exchange G hip spacer
Device Common Name:	KWL: Prosthesis, Hip, Hemi-, Femoral, Metal
	KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented or Uncemented
Regulation Description:	KWL: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
	KWY: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
Regulation Number:	KWL: 21 CFR 888.3360
	KWY: 21 CFR 888.3390
Regulatory Class:	Class II
Product Code(s):	KWL, KWY

PREDICATE DEVICES lll.

COPAL® exchange G hip and knee spacers (K191016)

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Image /page/4/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font, and it is in gray. Below the word "Heraeus" is the text "Heraeus Medical GmbH" in a smaller, black, sans-serif font.

DEVICE DESCRIPTION IV.

A Special 510(k) submission is being supplied to the U.S. FDA to gain clearance for a modification to the existing COPAL® exchange G hip spacer previously cleared in K191016. The change includes a modified dimension of COPAL® exchange G hip spacer.

The intended use and indications for use of existing COPAL® exchange G hip spacer previously cleared in K191016 remain unchanged.

COPAL® exchange G hip spacer will be used with COPAL® exchange G hip trials (510(k) exempt devices).

INDICATIONS FOR USE >

COPAL® exchange G hip spacer (polymethylmethacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients underqoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). COPAL® exchange G hip spacer is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.q. crutches, walkers, canes) throughout the implantation period.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE

Device comparison demonstrated that COPAL® exchange G hip spacer is substantially equivalent to the previously cleared COPAL® exchange G hip spacer (K191016) regarding intended use, indications for use, technological characteristics (design features, material, and performance) as well as operating principle.

At a high level, the subject device and predicate devices are based on the following same technological elements:

Temporary joint prostheses
. Preformed PMMA hip spacer containing gentamicin with an inner stainless-steel core
Spacer design (diameter and shape)

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Image /page/5/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font and is colored in gray. Below the word "Heraeus" is the text "Heraeus Medical GmbH" in a smaller, bold, sans-serif font and is colored in black.

The following technological differences exist between the subject and predicate devices:

Spacer design (length) o

PERFORMANCE DATA VII.

The submitter of this Special 510(k) is the manufacturer of the predicate device.

A risk analysis was performed as per DIN EN ISO 14971 to assess the impact of the modification on the device. The records of risk analysis process are retained in design history file. The evaluation demonstrated that the subject device did not present a new worst case and that the same verification and validation methods were applied to the subject device in comparison to the previously cleared predicate device (K191016). The risk analysis demonstrated that the subject device is as safe and effective as the predicate device.

The fatigue performance testing as per ISO 7206-6 was performed to address the modified dimension of COPAL® exchange G hip spacer. The same protocol as the original submission was used for collecting and assessing the data. The acceptance criteria were not altered from those used for the original device. COPAL® exchange G hip spacer meets endotoxin limits. It has been indicated that the subject device is as safe and effective as the predicate device.

CLINICAL TESTING VIII.

No clinical testing of COPAL® exchange G hip spacer has been conducted.

IX. CONCLUSION

COPAL® exchange G hip spacer is substantially equivalent to the predicate device (COPAL® exchange G hip spacer (K191016)) identified in this premarket notification

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.