(196 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use and indications for a hip arthroplasty device.
Yes
The device is intended for cemented use in hip arthroplasty applications to treat various hip joint impairments, fractures, and tumors, which are therapeutic interventions.
No
This device is described as an implant (for hip arthroplasty) intended for cemented use, not for diagnosing conditions. Its indications for use list various hip joint impairments and fractures that it is used to treat, not to diagnose.
No
The intended use describes a device for hip arthroplasty, which is a surgical procedure involving the implantation of a physical prosthesis. The description does not mention any software component, and the intended use is clearly related to a physical implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and indications for this device clearly describe its use in hip arthroplasty, which is a surgical procedure involving the hip joint itself, not the analysis of bodily fluids or tissues in vitro (outside the body).
- The indications relate to conditions of the hip joint. The listed indications (osteoarthritis, fractures, tumors, etc.) are conditions affecting the physical structure and function of the hip joint, which are treated surgically with this device.
- There is no mention of analyzing samples. The description focuses on the device's application within the body during surgery.
Therefore, this device is a surgical implant intended for use in hip replacement procedures, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended for cemented use only. The device is intended for use in hip arthroplasty applications whose indications include:
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- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic Notably inpullion acetabuli and painful hip dysplasia.
- Previously failed surgery.
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- Proximal femoral neck fractures or dislocation.
-
- Idiopathic avascular necrosis of the femoral head.
-
- Non-union of proximal femoral neck fractures.
-
- Treatment or fractures that uro as nations in the structural Benigh of manghant bone tumore, congenital as spanish seat the prosthesis.
abnormalities where sufficient bone stock exists to properly seat the prosthesis.
- Treatment or fractures that uro as nations in the structural Benigh of manghant bone tumore, congenital as spanish seat the prosthesis.
Product codes
JDI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
hip joint, femoral head, proximal femoral neck
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the snake-like figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.
SEP 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William J. Griffin Regulatory and Clinical Affairs Manager Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020
Re: K050637
Trade/Device Name: Encompass™ Cemented Hip System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: September 2, 2005 Received: September 7, 2005
Dear Mr. Griffin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(t) press. In substantially equivalent (for the indications felerenced above and nave acterifically marketed predicate devices marketed in interstate for use stated in the enclosure) to regars actual to the Medical Device Americal Partic commerce prof to May 26, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuired in actre approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merciole, market the act res, cost include requirements for annual registration, listing of general controls provisions of the riot labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sociation major regulations affecting your device can
may be subject to such additional controls. Existing major hiay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I casta singerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of a station of the requirements of the Act that I DA has made a decorminations administered by other Federal agencies. You must or any redelal statutes and regulations annuding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, more and CFK Fart 607), fabeing (21 CFR Part 820); and 1f applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (2001) - 10 mm (2006) - 10 your Section 510(k) This letter will anow you to ocgin maneting your and equivalence of your device to a legally
1
Page 2– Mr. William J. Griffin
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), please If you desire specific advice for your ac not to a control of the regulation entitled, colliati the Office of Comphane as (21 notification" (21CFR Part 807.97). You may obtain " Misoranuning by relevelee to premainters in the Act from the Division of Small other general information on your responsive Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
- of 1 N. Valli
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K050637 510(k) Number (if known):
Device Name: Encompass™ Cemented Hip System
Indications for Use
The device is intended for cemented use only. The device is intended for use in hip arthroplasty applications whose indications include:
-
- Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic Notably inpullion acetabuli and painful hip dysplasia.
- Previously failed surgery. 2.
-
- Proximal femoral neck fractures or dislocation.
-
- Idiopathic avascular necrosis of the femoral head.
-
- Non-union of proximal femoral neck fractures.
-
- Nori-union of proximal lomeral inmanageable using other forms of theraly.
-
- Treatment or fractures that uro as nations in the structural Benigh of manghant bone tumore, congenital as spanish seat the prosthesis.
abnormalities where sufficient bone stock exists to properly seat the prosthesis.
- Treatment or fractures that uro as nations in the structural Benigh of manghant bone tumore, congenital as spanish seat the prosthesis.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
202
Sign-Off) (Division Division of General, Restorative, and Neurological Devices
510(k) Number 1050637