(126 days)
PROCOTYL® PRIME hip system is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
-
non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli. and painful hip dysplasia:
-
inflammatory degenerative joint disease such as rheumatoid arthritis;
-
correction of functional deformity; and,
-
revision procedures where other treatments or devices have failed.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
The PROCOTYL® PRIME E-CLASS™ XLPE Liner is an additional liner option for MicroPort Orthopedics' PROCOTYL® PRIME Acetabular Cup System (K170444). The design features are summarized below:
- Manufactured from E-CLASS™ vitamin E blended highly crosslinked ultra high . molecular weight polyethylene (VEXLPE) conforming to ASTM F2695-12
- Available in Standard, Lipped, or Face-Changing Lateralized Configurations .
- Inner Diameter sizes 22mm to 44mm o
The provided text describes a 510(k) premarket notification for a medical device, the PROCOTYL® PRIME E-CLASS™ XLPE Liner. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials with specific acceptance criteria as might be seen for a novel device. Therefore, the response will focus on the non-clinical testing performed to establish this substantial equivalence.
1. Table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the "acceptance criteria" are generally implied to be meeting the performance of existing, legally marketed predicate devices and established standards (ASTM, ISO). The "reported device performance" refers to the results of the non-clinical tests that demonstrate this equivalence.
| Performance Test (simulated surrogate for acceptance criteria) | Reference Standard / Basis for Acceptance | Reported Device Performance |
|---|---|---|
| Material Properties Testing | Comparison to currently marketed UHMWPE | Subject Acetabular Liner underwent material properties testing to compare its properties to those of currently marketed UHMWPE. (Implied: results were comparable, supporting substantial equivalence) |
| Bacterial Endotoxins | USP endotoxin limit of 20 EU/device | Found to be less than the USP endotoxin limit of 20 EU/device. |
| Pre- and Post-fatigue Push-out, Lever-out, and Torque-out Testing | Evaluation of lock detail | Subject Acetabular Liner underwent pre- and post-fatigue push-out, lever-out, and torque-out testing to evaluate its lock detail. (Implied: results indicated satisfactory lock detail, supporting substantial equivalence) |
| Frictional Torque Testing | Evaluation of properties under pinch-loading conditions | Subject Acetabular Liner underwent frictional torque testing to evaluate properties under pinch-loading conditions. (Implied: results demonstrated satisfactory frictional torque properties, supporting substantial equivalence) |
| Long Term Axial Cyclic Loading | Evaluation of mechanical integrity and fatigue resistance | Subject Acetabular Liner underwent complete long term axial cyclic loading to evaluate the subject Acetabular Liner's mechanical integrity and fatigue resistance properties. (Implied: results demonstrated adequate mechanical integrity and fatigue resistance for its intended use, supporting substantial equivalence) |
| Impingement Testing | Evaluation of mechanical integrity during lip impingement in a fatigue loading profile | Subject Acetabular Liner underwent impingement testing to evaluate its mechanical integrity during lip impingement in a fatigue loading profile. (Implied: results demonstrated adequate mechanical integrity under impingement, supporting substantial equivalence) |
| Wear Testing | Determination of wear rate | Subject Acetabular Liner underwent wear testing to determine the wear rate. A wear particle analysis was performed on the wear debris. (Implied: wear rate and particle analysis were comparable to predicate devices or acceptable for the intended use, supporting substantial equivalence) |
| Range of Motion Study | Performed for the PROCOTYL® PRIME Acetabular Cup System (K170444) | A range of motion study was performed for the PROCOTYL® PRIME Acetabular Cup System, originally submitted as part of K170444. (Since the liner is an additional option for this system, presumably the range of motion is maintained or comparable.) |
| Extractables Study (E-CLASS™ material) | Determine irritant potential and compare to currently marketed Vitamin E UHMWPE | The E-CLASS™ material underwent an extractables study to determine its irritant potential and to compare this potential to currently marketed Vitamin E UHMWPE. (Implied: irritant potential was comparable or acceptable, supporting biocompatibility and substantial equivalence) |
| Cytotoxicity Testing (E-CLASS™ material) | Determine irritant potential using cell monolayers | The E-CLASS™ material underwent cytotoxicity testing, performed using cell monolayers, to determine the irritant potential of the material. (Implied: irritant potential was acceptable, supporting biocompatibility) |
| Irritation and Sensitization Studies (E-CLASS™ material) | Determine irritant and allergenic potential on animal specimens | The E-CLASS™ material underwent irritation and sensitization studies, performed on animal specimens, to determine the irritant and allergenic potential of the material. (Implied: irritation and allergenic potential were acceptable, supporting biocompatibility) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of test specimens) for each non-clinical test. It generally states that "testing was performed" or "underwent testing." The data provenance is internal to MicroPort Orthopedics, Inc. and is generated through their non-clinical testing. This is typically prospective in nature for these types of bench and animal studies. No country of origin of the data is explicitly mentioned beyond the company's location in Arlington, Tennessee.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to a non-clinical 510(k) submission focused on demonstrating substantial equivalence through bench and animal testing. "Ground truth" established by experts is typically relevant for clinical studies, particularly those involving diagnostic accuracy or human interpretation.
4. Adjudication method for the test set
This information is not applicable to the non-clinical testing described. Adjudication methods (like 2+1, 3+1) are used in clinical studies to resolve discrepancies in expert interpretations or assessments.
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
No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical data was not provided for the subject devices." This implies that no human reader studies (with or without AI assistance) were conducted as part of this submission. The device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given that "Clinical data was not provided," there is no "ground truth" in the sense of clinical outcomes or expert diagnoses from human patients. The "ground truth" for the non-clinical tests would be the established scientific principles, engineering standards (e.g., ASTM F2695-12 for the material), and performance characteristics of predicate devices against which the new liner's properties are compared.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is a physical medical device, not an AI algorithm requiring a training dataset.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set."
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MicroPort Orthopedics, Inc. Ms. Sarah Stroupe Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
August 13, 2019
Re: K171181
Trade/Device Name: PROCOTYL® PRIME E-CLASS™ XLPE Liner Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, OQI, LPH, OQG Dated: July 28, 2017 Received: August 1, 2017
Dear Ms. Stroupe:
This letter corrects our substantially equivalent letter of August 28, 2017.
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.
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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 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.
Vesa Vuniqi Date: 2019.08.13 -S - - -15:02:35 -04'00'
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty 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)
Device Name PROCOTYL® PRIME E-CLASS™ XLPE Liner
Indications for Use (Describe)
PROCOTYL® PRIME hip system is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
-
non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli. and painful hip dysplasia:
-
inflammatory degenerative joint disease such as rheumatoid arthritis;
-
correction of functional deformity; and,
-
revision procedures where other treatments or devices have failed.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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/1 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the word "MicroPort" in blue, with the word "Orthopedics" in red underneath. Below that is the phrase "Full Function, Faster" in blue.
510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Substantial Equivalence for the PROCOTYL® PRIME E-CLASS™ XLPE Liner.
| Submitted by: | MicroPort Orthopedics Inc.5677 Airline Rd, Arlington TN, 38002Phone: 866-872-0211Fax: 855-446-2247 |
|---|---|
| Date: | August 25, 2017 |
| Contact Person: | Sarah Evonne StroupeRegulatory Affairs Specialist II |
| Proprietary Name: | PROCOTYL® PRIME E-CLASS™ XLPE Liner |
| Common Name: | Acetabular Liner |
| Classification Name and Reference: | 21 CFR 888.3353 LZO/OQIHip joint metal/ceramic/polymer semi constrainedcemented or nonporous, uncemented prosthesisClass II |
| Classification Name and Reference: | 21 CFR 888.3358 LPH/OQGHip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesisClass II |
| Subject Product Code and Panel Code: | Orthopedics/87/LZO/LPH/OQG/OQI |
| Primary Predicate Device: | PROCOTYL® PRIME AcetabularCupSystem (K170444) |
| Additional Predicate Devices: | LINEAGE® Acetabular System (K002149 andK052026) |
| Additional Predicate Devices: | DYNASTY® Acetabular System (K082924,K061547, and K070785) |
| Reference Device: | StelKast's EXp Acetabular Liner (K094035, ModelsSC3342 Non-Hooded 28mm, SC3343 Hooded28mm) |
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Image /page/4/Picture/1 description: The image shows the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle containing a red four-pointed star. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Below that is the text "Full Function, Faster" in blue.
DEVICE INFORMATION
A. Intended Use
The PROCOTYL® PRIME E-CLASS™ XLPE Liner is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. This device is indicated for the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
B. Device Description
The PROCOTYL® PRIME E-CLASS™ XLPE Liner is an additional liner option for MicroPort Orthopedics' PROCOTYL® PRIME Acetabular Cup System (K170444). The design features are summarized below:
- Manufactured from E-CLASS™ vitamin E blended highly crosslinked ultra high . molecular weight polyethylene (VEXLPE) conforming to ASTM F2695-12
- Available in Standard, Lipped, or Face-Changing Lateralized Configurations .
- Inner Diameter sizes 22mm to 44mm o
C. Substantial Equivalence Information
The design features and materials of the subject devices are substantially equivalent to those of the predicate and reference devices. The indications for use are identical to the predicate and reference devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate and reference devices. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
D. Nonclinical Testing
The following nonclinical testing was performed to evaluate the E-CLASS™ material and design of the finished product.
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Image /page/5/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Underneath the company name is the tagline "Full Function, Faster" in a smaller, blue font.
The subject Acetabular Liner underwent material properties testing to compare its properties to those of currently marketed UHMWPE.
The subject Acetabular Liner was evaluated for bacterial endotoxins and found to be less than the USP endotoxin limit of 20 EU/device.
The subject Acetabular Liner underwent pre- and post-fatigue push-out, lever-out, and torque-out testing to evaluate its lock detail.
The subject Acetabular Liner underwent frictional torque testing to evaluate properties under pinch-loading conditions.
The subject Acetabular Liner complete long term axial cyclic loading to evaluate the subject Acetabular Liner's mechanical integrity and fatigue resistance properties.
The subject Acetabular Liner underwent impingement testing to evaluate its mechanical integrity during lip impingement in a fatigue loading profile.
The subject Acetabular Liner underwent wear testing to determine the wear rate. A wear particle analysis was performed on the wear debris.
Additionally, a range of motion study was performed for the PROCOTYL® PRIME Acetabular Cup System, originally submitted as part of K170444.
E. Clinical Testing
Clinical data was not provided for the subject devices.
F. Biocompatibility
Both bench and animal studies were performed to evaluate the biocompatibility of the E-CLASS™ material.
The E-CLASS™ material underwent an extractables study to determine it's the irritant potential of the material and to compare this potential to currently marketed Vitamin E UHMWPE.
The E-CLASS™ material underwent cytotoxicity testing, performed using cell monolayers, to determine the irritant potential of the material.
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Image /page/6/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the word "MicroPort" in a large, bold, blue font. Below that is the word "Orthopedics" in a smaller, red font, and below that is the phrase "Full Function, Faster" in a smaller, blue font.
The E-CLASS™ material underwent irritation and sensitization studies, performed on animal specimens, to determine the irritant and allergenic potential of the material.
No biocompatibility testing was performed for the associated instrumentation, as all associated instruments have been previously cleared.
G. Component and Accessory Compatibility
The PROCOTYL® PRIME E-CLASS™ XLPE Liner may be used with PROCOTYL® PRIME Acetabular Cup System Acetabular Shells and Instrumentation (K170444).
The PROCOTYL® PRIME E-CLASS™ XLPE Liners may be used with previously cleared MicroPort Femoral Heads.
Table 1 shows the compatibility of the subject Acetabular Liner with previously cleared MicroPort Orthopedics products.
| 510(k) | Intended Combinations |
|---|---|
| with Femoral Heads (up to 44mm) | |
| K893685 | Ceramic-Polyethylene with ID 28-36mm** |
| K920593 | Ceramic-Polyethylene, OD 28mm |
| K925512 | Ceramic-Polyethylene, OD 28mm |
| K932222 | Metal-Polyethylene, OD 28mm XXL |
| K002149 | Metal-Polyethylene with ID 22-32mm |
| K021349* | Metal-Polyethylene with ID 38-56mm |
| K004043* | Metal-Polyethylene with ID 28-36mm |
| K051348* | Metal-Polyethylene with ID 38-56mm |
| K072656 | Ceramic-Polyethylene with ID 38-46mm with neck sleeves |
| K130376 | Ceramic-Polyethylene with ID 32-40mm |
| K140043 | Ceramic-Polyethylene with ID 28mm |
| with Acetabular Shells | |
| K170444 | Quad and Solid Acetabular Shells |
| with Instrumentation | |
| K170444 | Acetabular Liner Trials |
Table 1: Subject Acetabular Liners Compatibility
*Metal femoral heads in K021349, K004043 and K051348 were originally cleared for use with metal-metal bearings, and later cleared for compatibility with DYNASTY® A-CLASS® polyethylene liners in K070785.
**36mm Forte Ceramic heads were originally cleared for use in PMA P030027, and later cleared for compatibility with PROCOTYL® L / O Acetabular System in K142119.
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Image /page/7/Picture/0 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red star-like shape. To the right of the square is the word "MicroPort" in blue, with the word "Orthopedics" in red underneath. Below that is the phrase "Full Function. Faster."
H. Conclusion
The indications for use and fundamental scientific technology of the PROCOTYL® PRIME E-CLASS™ XLPE Liner are similar to the predicate and reference devices. The materials of the subject device are considered to be substantially equivalent to the predicate and reference devices. The design features, materials information, predicate and subject testing, and analysis provided in the Master File support the substantial equivalence of the PROCOTYL® PRIME E-CLASS™ XLPE Liner.
MicroPort Orthopedics BV Hoogoorddreef 5, 1101 BA Amsterdam, The Netherlands +31 20 545 01 00
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.