(109 days)
Total hip replacement or hip arthroplasty is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Certain cases of ankylosis.
Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
- Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
- Avascular necrosis of the femoral head.
- Non-union of femoral neck fractures.
- Certain high subcapital and femoral neck fractures in the elderly.
- Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
- Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.
The DePuy Actis DuoFix Hip Prosthesis is indicated for cementless use only.
The DePuy Actis DuoFix Hip prostheses are manufactured from forged titanium alloy (Ti6Al4V) and have a sintered commercially pure titanium bead porous coating (Porocoat®) and thin layer of plasma-sprayed hydroxyapatite (HA) coating. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hemi-arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty.
This document describes the DePuy Actis DuoFix Hip Prosthesis, a hip implant. The submission is a 510(k) premarket notification for a line extension (an additional smaller size hip stem) of an already cleared device (K150862).
Here's an analysis of the acceptance criteria and study data provided:
1. A table of acceptance criteria and the reported device performance
For a medical device like a hip prosthesis, "acceptance criteria" usually refer to meeting specific performance standards in mechanical testing. Since this is a line extension of an existing device, the acceptance criteria would be for the new, smaller size stem to perform equivalently to the predicate devices and meet relevant ISO standards for hip prostheses.
The document states that the subject device (new smaller stem) is substantially equivalent to the predicate device (existing DePuy Actis DuoFix Hip Prosthesis). This implies that the new stem meets the same performance criteria as the previously cleared larger stems.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: - Neck fatigue testing in accordance with ISO 7206-6:2013 | Met Neck fatigue testing in accordance with ISO 7206-6:2013 |
| - Distal fatigue testing in accordance with ISO 7206-4:2010 | Met Distal fatigue testing in accordance with ISO 7206-4:2010 |
| Biocompatibility/Sterility: - Pyrogenicity testing standards | Met Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST-72:2011 |
| Material: - Use of Ti6AL4V with Porocoat and plasma sprayed HA coating | Ti6AL4V with Porocoat and plasma sprayed HA coating (Same as predicate) |
| Fixation: - Uncemented | Uncemented (Same as predicate) |
| Sterile Method: - Gamma sterilization | Gamma (Same as predicate) |
| Packaging: - Inner nylon pouch and outer PETG blister with Tyvek peel lid | Inner nylon pouch and outer PETG blister with Tyvek peel lid (Same as predicate) |
| Shelf Life: - 10 years | 10 years (Same as predicate) |
| Overall: - Substantial Equivalence to predicate device | Conclusion: "The subject devices are substantially equivalent to the predicate DePuy Actis DuoFix Hip Prosthesis." (This is the ultimate acceptance criterion for 510(k)). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to non-clinical (bench) testing for mechanical and biocompatibility assessments. Therefore, the "sample size" for the test set would refer to the number of prostheses or components tested in each specific mechanical and pyrogenicity test. This information (e.g., how many stems were subjected to fatigue testing) is not explicitly provided in the summary.
The data provenance is not mentioned in terms of country of origin, but it is non-clinical laboratory data, likely generated internally by DePuy or by contract testing organizations. It would be considered prospective in the sense that the tests were designed and executed specifically for this submission.
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)
This question is not applicable to this type of device submission. The "ground truth" for hip prostheses in a 510(k) for a line extension is established through adherence to recognized performance standards (e.g., ISO standards) and comparison to the predicate device's established performance. This does not involve expert consensus on clinical cases or image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations of clinical data or images. Since no clinical trials or expert interpretations of such data were conducted for this 510(k) submission, there is no adjudication method.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices often involving artificial intelligence (AI), not for hip prostheses which are mechanical implants.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance evaluation was not done. This device is a mechanical implant and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on:
- Adherence to internationally recognized standards: Specifically, ISO 7206-6:2013 for neck fatigue and ISO 7206-4:2010 for distal fatigue, and ANSI/AAMI ST-72:2011 for pyrogenicity. These standards define the acceptable performance limits and test methodologies.
- Demonstration of equivalence to a legally marketed predicate device: The predicate device (K150862) had already established its safety and effectiveness through similar performance data. The new device's ground truth is that it performs similarly to the predicate.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is a mechanical device, not an AI/machine learning algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2016
DePuy (Ireland) % Ms. Correne Ramy Project Leader, Regulatory Affairs Depuy Orthopaedics, Incorporated 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K160907 Trade/Device Name: DePuy Actis DuoFix Hip Prosthesis 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: MEH, LPH, KWL, KWY Dated: June 10, 2016 Received: June 13, 2016
Dear Ms. Ramy:
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. 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
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(21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4: Indications for Use Statement
K160907 510 (k) Number (if known): _
Device Name: DePuy Actis DuoFix Hip Prosthesis
Indications for Use:
Total hip replacement or hip arthroplasty is indicated in the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Certain cases of ankylosis.
Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:
-
- Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
-
- Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
-
- Avascular necrosis of the femoral head.
-
- Non-union of femoral neck fractures.
-
- Certain high subcapital and femoral neck fractures in the elderly.
-
- Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
-
- Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.
The DePuy Actis DuoFix Hip Prosthesis is indicated for cementless use only.
Prescription Use Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(Please do not write below this line. Continue on another page if needed.)
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Section 5: 510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | ||
|---|---|---|
| Name | DePuy Orthopaedics | |
| Address | 700 Orthopedic DriveWarsaw, IN 46582 | |
| Phone number | 574-371-4981 | |
| Fax number | 574-371-4987 | |
| Establishment RegistrationNumber | 1818910 | |
| Name of contact person | Correne Ramy | |
| Date prepared | March 31, 2016 | |
| Name of device | ||
| Trade or proprietary name | DePuy Actis DuoFix Hip Prosthesis | |
| Common or usual name | MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphateLPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncementedKWL - prosthesis, hip, hemi-, femoral, metalKWY - prosthesis, hip, hemi-, femoral, metal/polymer, cemented oruncemented | |
| Classification name | MEH - Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesisLPH - Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesisKWL - Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesisKWY - Hip joint femoral (hemi-hip) metal/polymer cemented or uncementedprosthesis | |
| Class | II | |
| Classification panel | 87 Orthopedics | |
| Regulation | 21 CFR 888.3353, 888.3358, 888.3360, 888.3390 | |
| Product Code(s) | MEH, LPH, KWL, KWY | |
| Legally marketed device(s) towhich equivalence is claimed | DePuy Actis DuoFix Hip Prosthesis (K150862, cleared September 25, 2015) | |
| Reason for 510(k) submission | Line extension of an additional smaller size hip stem | |
| Device description | The DePuy Actis DuoFix Hip prostheses are manufactured from forged | |
| titanium alloy (Ti6Al4V) and have a sintered commercially pure titanium bead | ||
| porous coating (Porocoat®) and thin layer of plasma-sprayed hydroxyapatite(HA) coating. The stem consists of a wide range of stem neck designs and sizes | ||
| allowing an accurate anatomical match for each patient. The stems are | ||
| compatible with both unipolar and bipolar heads intended for hemi-arthroplasty | ||
| and with modular metal and ceramic femoral heads intended for total hip | ||
| arthroplasty. | ||
| Intended use of the device | Total hip arthroplasty and hemi-hip arthroplasty | |
| Indications for use | Total hip replacement or hip arthroplasty is indicated in the followingconditions: | |
| 1. A severely painful and/or disabled joint from osteoarthritis,traumatic arthritis, rheumatoid arthritis, or congenital hipdysplasia. | ||
| 2. Avascular necrosis of the femoral head. | ||
| 3. Acute traumatic fracture of the femoral head or neck. | ||
| 4. Certain cases of ankylosis. | ||
| Partial hip replacement or hip hemi-arthroplasty is indicated in thefollowing conditions: | ||
| 1. Acute fracture of the femoral head or neck that cannot beappropriately reduced and treated with internal fixation. | ||
| 2. Fracture dislocation of the hip that cannot be appropriatelyreduced and treated with internal fixation. | ||
| 3. Avascular necrosis of the femoral head. | ||
| 4. Non-union of femoral neck fractures. | ||
| 5. Certain high subcapital and femoral neck fractures in theelderly. | ||
| 6. Degenerative arthritis involving only the femoral head in whichthe acetabulum does not require replacement. | ||
| 7. Pathology involving only the femoral head/neck and/orproximal femur that can be adequately treated by hip hemi-arthroplasty. | ||
| The DePuy Actis DuoFix Hip Prosthesis is indicated for cementless useonly. |
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| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THEPREDICATE DEVICE | ||
|---|---|---|
| Characteristics | Subject Device: | Predicate Device: |
| DePuy Actis DuoFix Hip Prosthesis | DePuy Actis DuoFix Hip Prosthesis(K150862) | |
| Intended Use | Total Hip Arthroplasty, Hemi-HipArthroplasty | Same |
| Material | Ti6AL4V with Porocoat and plasma sprayedHA coating | Same |
| Fixation | Uncemented | Same |
| Stem Size | 0 | 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
| Neck Offset | Standard, High | Same |
| Collar | Collared | Same |
| Sterile Method | Gamma | Same |
| Packaging | Inner nylon pouch and outer PETG blisterwith Tyvek peel lid | Same |
| Shelf Life | 10 years | Same |
| PERFORMANCE DATA | ||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE | ||
| Neck fatigue testing in accordance with ISO 7206-6:2013 | ||
| Distal fatigue testing in accordance with ISO 7206-4:2010 | ||
| Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST-72:2011 | ||
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION | ||
| No clinical tests were conducted to demonstrate substantial equivalence. |
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CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject devices are substantially equivalent to the predicate DePuy Actis DuoFix Hip Prosthesis.
§ 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.