(29 days)
MicroPort hip instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Hip Systems in their cleared indications for use.
MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative ioint disease such as rheumatoid arthritis:
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
Rough grit blast surfaces and the hydroxyapatite and titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty. LINEAGE® and DYNASTY® modular shells with porous metal bead coating are intended only for uncemented arthroplasty.
PRIME shells are intended only for uncemented arthroplasty.
The device modification consists of an alteration to the sterilization instructions for FDAcleared MicroPort Orthopedics' (MPO) non-sterile hip orthopedic joint replacement instruments. The subject instruments are part of MicroPort Orthopedics' hip product lines and are required to facilitate total hip arthroplasty procedures. The modification will allow the option to sterilize the subject instruments using an FDA-cleared containment device. The subject devices will be placed in an FDA-cleared containment device, which will be wrapped in an FDA-cleared CSR wrap or similar type nonwoven, medical grade wrapping material, and then steam sterilized.
The modified sterilization process of the subject instruments was successfully challenged and validated through worst-case load configurations using an FDA-cleared containment device. The intended use and sterilization parameters, such as cycle, temperature, and exposure time, remain identical to the predicate devices.
The review document provides details on the 510(k) submission for MicroPort Orthopedics Inc.'s MPO Hip Instruments, focusing on a modification to their sterilization instructions.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Device withstands sterilization cycles and achieves sufficient sterility. | "MicroPort non-sterile orthopedic joint replacement instruments are able to withstand the reported sterilization cycles and achieve sufficient device sterility." |
| Steam Sterilization (Single-level tray) | Meets requirements of AAMI ST77:2013 | "Steam Sterilization Validation of MicroPort orthopedic joint replacement instruments using FDA-cleared containment device (single-level tray) per AAMI ST77:2013" - studies confirm that the device passed this validation. |
| Steam Sterilization (Double-level tray) | Meets requirements of AAMI ST79:2017 | "Steam Sterilization Validation of MicroPort orthopedic joint replacement instruments using FDA-cleared containment device (double-level tray) per AAMI ST79:2017" - studies confirm that the device passed this validation. |
| Vibration Test | Meets requirements of ISTA 2A | "Vibration Test of MicroPort orthopedic joint replacement instruments using FDA-cleared containment device per ISTA 2A." - studies confirm that the device passed this validation. |
| Intended Use | Remains consistent with predicate devices for total hip arthroplasty. | "The intended use and sterilization parameters, such as cycle, temperature, and exposure time, remain identical to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes (number of instruments) used for the sterilization validation or vibration testing. It refers to "worst-case load configurations" for the sterilization validation, implying that a representative selection of instruments was tested under challenging conditions. The data provenance is not specified, but it would typically be generated from internal testing conducted by MicroPort Orthopedics, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. The evaluations for sterilization validation and vibration testing rely on established standards (AAMI ST77, AAMI ST79, ISTA 2A), where "ground truth" is determined by meeting the specified physical and biological parameters within the standards, not by expert consensus in the typical sense of clinical image interpretation.
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are compliance-based (meeting standards) rather than requiring adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done. This device is an orthopedic instrument, and its effectiveness is not assessed through human interpretation of cases. The study focuses on the safety and efficacy of its reprocessing (sterilization).
6. Standalone Performance:
Standalone performance was implicitly assessed through the non-clinical testing. The instruments themselves, within the specified containment devices and sterilization cycles, directly underwent the validation tests to demonstrate their ability to achieve sterility and withstand integrity challenges. There is no "algorithm only without human-in-the-loop performance" as this is not an AI/software device.
7. Type of Ground Truth Used:
The ground truth used for these tests is based on accepted industry standards and scientific principles for sterilization and product integrity:
- Sterility: Achieved by demonstrating a Sterility Assurance Level (SAL) through biological indicators and physical parameters outlined in AAMI ST77 and AAMI ST79.
- Physical Integrity: Maintained by demonstrating the instrument's ability to withstand vibration during transit as per ISTA 2A.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of the reported studies. The modification is related to the reprocessing of physical instruments.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
{0}------------------------------------------------
January 5, 2022
Image /page/0/Picture/1 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below that.
MicroPort Orthopedics Inc. Gillen Gonzales Regulatory Affairs Specialist I 5677 Airline Road Arlington, Tennessee 38002
Re: K213816
Trade/Device Name: MPO Hip Instruments 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, JDI, LPH, MBL, KWL, KWY Dated: December 6, 2021 Received: December 7, 2021
Dear Gillen Gonzales:
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
{1}------------------------------------------------
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,
Limin Sun, Ph.D. Acting 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
{2}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
MPO Hip Instruments
Indications for Use (Describe)
MicroPort hip instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Hip Systems in their cleared indications for use.
MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative ioint disease such as rheumatoid arthritis:
-
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
Rough grit blast surfaces and the hydroxyapatite and titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty. LINEAGE® and DYNASTY® modular shells with porous metal bead coating are intended only for uncemented arthroplasty.
PRIME shells are intended only for uncemented arthroplasty.
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 reqarding 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."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a white circle inside, containing a red diamond shape. To the right of the icon is the text "MicroPort" in a bold, blue font, with the word "Orthopedics" underneath in a smaller font.
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 Safety and Effectiveness for MPO Hip Instruments Reprocessing Change.
| Submitted by: | MicroPort Orthopedics Inc.5677 Airline Road, Arlington, TN 38002Phone: 866-872-0211Fax: 855-446-2247 |
|---|---|
| Date: | January 4, 2022 |
| Contact Person: | Gillen GonzalesRegulatory Affairs Specialist I |
| Proprietary Name: | MPO Hip Instruments |
| Common Name: | Orthopedic Surgical Instruments |
| Classification Name andReference: | 21 CFR 888.3353 Hip joint metal/ceramic/polymersemi constrained cemented or nonporous, uncementedprosthesis - Class II (Primary) |
| 21 CFR 888.3350 Hip joint metal/polymer semi-constrainedcemented prosthesis- Class II | |
| 21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis - Class II | |
| 21 CFR 888.3360 Hip joint femoral (hemi-hip) metalliccemented or uncemented prosthesis - Class II | |
| 21 CFR 888.3390 Hip joint femoral (hemi-hip)metal/polymer cemented or uncemented prosthesis - ClassII | |
| Subject Product Code andPanel Code: | Orthopedics/87/ LZO (Primary), JDI, LPH, MBL, KWL,KWY |
| Primary Predicate Device: | PROFEMUR® TL CLASSIC LONG NECK HIP STEMS(K140676) |
| Predicate Devices: | PROFEMUR® RENAISSANCE® CLASSIC LONGNECK HIP STEMS (K141235)PROFEMUR® Preserve Size 1-3 Hip Stems (K150133) |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a white circle inside, containing a red four-pointed star. To the right of the square is the text "MicroPort" in a larger, bold blue font, with the word "Orthopedics" underneath in a smaller blue font.
PROFEMUR® Preserve Classic Stem (K150302) Prime Acetabular Cup System (K170444) MicroPort CoCr Femoral Heads (K190123) PROFEMUR® TL2 Stems (K191632) PROFEMUR® GLADIATOR® Cemented Classic Stem (K201519)
DEVICE INFORMATION
A. Device Description
The device modification consists of an alteration to the sterilization instructions for FDAcleared MicroPort Orthopedics' (MPO) non-sterile hip orthopedic joint replacement instruments. The subject instruments are part of MicroPort Orthopedics' hip product lines and are required to facilitate total hip arthroplasty procedures. The modification will allow the option to sterilize the subject instruments using an FDA-cleared containment device. The subject devices will be placed in an FDA-cleared containment device, which will be wrapped in an FDA-cleared CSR wrap or similar type nonwoven, medical grade wrapping material, and then steam sterilized.
The modified sterilization process of the subject instruments was successfully challenged and validated through worst-case load configurations using an FDA-cleared containment device. The intended use and sterilization parameters, such as cycle, temperature, and exposure time, remain identical to the predicate devices.
B. Intended Use
MicroPort hip instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Hip Systems in their cleared indications for use.
MicroPort total hip systems are 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, ankylosis, protrusio 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
Rough grit blast surfaces and the hydroxyapatite and titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image is a 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 blue underneath it.
Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.
LINEAGE® and DYNASTY® modular shells with porous metal bead coating are intended only for uncemented arthroplasty.
PRIME shells are intended only for uncemented arthroplasty.
C. Technological Characteristics Comparison
MicroPort non-sterile hip orthopedic joint replacement instruments were successfully validated and sterilized using an FDA-cleared containment device. MicroPort non-sterile orthopedic joint replacement instruments are able to withstand the reported sterilization cycles and achieve sufficient device sterility.
D. Nonclinical Testing
Provided below are the non-clinical tests that were performed using the subject device. The result demonstrated that the subject device nonclinical test results met the acceptance criteria of the standards.
- Steam Sterilization Validation of MicroPort orthopedic joint replacement instruments using FDA-cleared containment device (single-level tray) per AAMI ST77:2013
- Steam Sterilization Validation of MicroPort orthopedic joint replacement instruments using FDA-cleared containment device (double-level tray) per AAMI ST79:2017
- Vibration Test of MicroPort orthopedic joint replacement instruments using FDA-● cleared containment device per ISTA 2A.
E. Clinical and Animal Testing
No clinical or animal testing were required.
F. Conclusions
The sterilization of the subject devices is substantially equivalent to the predicate devices. The safety and effectiveness of the modified sterilization method of the subject devices is adequately supported by the substantial equivalence information, materials information, and design control summaries data provided within this Premarket Notification. Validation testing and analysis data adequately support the substantial equivalence of MPO Hip Instruments Reprocessing Change.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.