(97 days)
K-961526
Not Found
No
The summary describes a mechanical implant (acetabular cup) and its biomechanical testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No.
The device is an acetabular cup, which is an implant used in hip replacement surgery, not a therapeutic device in the sense of delivering treatment or therapy directly to a patient. Its purpose is to replace a damaged anatomical structure.
No
The device description indicates it is a cementless acetabular cup designed for joint replacement, not for identifying or assessing medical conditions. Its function is to replace, not diagnose.
No
The device description clearly states it is a "cementless acetabular cup," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating hip joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a cementless acetabular cup designed for surgical implantation.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
- Biomechanical Testing: The performance studies focus on the mechanical properties and stability of the implant, which are relevant to surgical devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PLUS EPF Acetabular Cup is intended for all types of arthrosis. such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.
Product codes
LWJ
Device Description
The PLUS EPF Cup is a cementless acetabular cup, which was designed with a triple-radius profile. The advantages are 1) minimal bone resection, 2) press-fit with physiological load transfer through the peripheral zone of the acetabulum, thus ensuring good primary stability without the need for screw fixation and 3) optimal osseous integration due to good primary stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, acetabulum, femoral head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon / 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)
The following three biomechanical tests were performed comparing four cups of other leading manufacturers to the PLUS EPF Cup: out force necessary to unseat the titanium cup from the acetabulum, 2) the push-out force necessary to push the polyethylene liner out of the cup, and 3) the force required to seat the acetabular cups into a block of foam that simulated the reamed acetabulum. In all tests the PLUS EPF Cup was comparable to, or exceeded, cementless competitive acetabular cups.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K-961526
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
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510(k) Summary of Safety and Effectiveness Information
(as required by 807.92c), prepared by Hartmut Loch, President of HHL Consulting for PLUS Orthopedics in San Diego, California August 6, 1997
NOV 1 3 1997
Trade name: PLUS EPF Acetabular Cup
Common name: Cementless Total Hip Prosthesis, Acetabular Component
Classification name: Hip joint metal/polymer/metal semi constrained porous coated uncemented prosthesis
Equivalence: We are claiming substantial equivalency to the cementless Press-fit Cup, marketed by Encore Orthopedics, Austin, Texas (K-961526).
Characteristics: The PLUS EPF Cup is a cementless acetabular cup, which was designed with a triple-radius profile. The advantages are 1) minimal bone resection, 2) press-fit with physiological load transfer through the peripheral zone of the acetabulum, thus ensuring good primary stability without the need for screw fixation and 3) optimal osseous integration due to good primary stability.
The PLUS EPF Cup is intended for all types of arthrosis, such as Indications: advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.
Contraindications: Contraindications include acute or chronic infections (local or systemic), serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.
The following three biomechanical tests were performed Performance data: comparing four cups of other leading manufacturers to the PLUS EPF Cup: out force necessary to unseat the titanium cup from the acetabulum, 2) the push-out force necessary to push the polyethylene liner out of the cup, and 3) the force required to seat the acetabular cups into a block of foam that simulated the reamed acetabulum. In all tests the PLUS EPF Cup was comparable to, or exceeded, cementless competitive acetabular cups.
☎ 415.572.0100 fax 415.572.0901 pager 415.202.6680
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hartmut Loch ·President HHL Consulting Representing Plus Orthopedics 835 Cortez Lane Foster City, California 94404
v. 13, 1997
K972931 Re: Plus EPF Acetabular Cup Trade Name: Requlatory Class: II Product Code: LWJ Dated: October 27, 1997 October 27, 1997 Received:
Dear Mr. Loch:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Hartmut Loch
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _1__of____1
(97293 510(k) Number (if known): K-972931
Device Name: PLUS EPF ACETABULAR CUP
Indications for Use:
The PLUS EPF Acetabular Cup is intended for all types of arthrosis. such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109)
.. *
OR
Over-The-Counter Use
(Optional Format 1-2-96