(29 days)
Not Found
No
The summary describes a physical implant made of PMMA and stainless steel with gentamicin, and the performance testing focuses on mechanical properties and endotoxin limits. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is implanted to treat a septic process in patients undergoing total hip replacement, and it releases gentamicin, an antibiotic, to reduce bacterial colonization.
No
The device is a temporary hip replacement used in a two-stage procedure due to a septic process, and it contains gentamicin to reduce the risk of bacterial colonization. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a physical implant made of polymethylmethacrylate and stainless steel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a temporary implant for use in a surgical procedure (total hip replacement) due to a septic process. It is inserted into the body.
- Device Description: The device is described as a temporary hip spacer implant made of PMMA and stainless steel, containing gentamicin. This is a physical implant, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are used outside the body to examine specimens. This device is an implant used inside the body.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
KWY, KWL
Device Description
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral medullary canal and acetabular cavity
Indicated Patient Age Range
skeletally mature patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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 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
2
Indications for Use
510(k) Number (if known) K220492
Device Name COPAL® exchange G hip spacer
Indications for Use (Describe)
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a bold, sans-serif font in gray. Below it, in a smaller, black, sans-serif font, is the text "Heraeus Medical GmbH."
| 7 | 510(k) Summary |
|---|---|
| --- | ---------------- |
| 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)
4
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 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).
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)
5
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