(99 days)
No
The summary describes a mechanical hip implant component and its material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a component of a total hip replacement system, which is used to treat severely disabled and/or painful hip joints, aligning with the definition of a therapeutic device.
No
The device description clearly states it is a non-cemented hip prosthesis, a replacement for physical function. Its intended use is to correct physical conditions resulting from various joint diseases and fractures, not to diagnose them.
No
The device description clearly states it is a physical hip prosthesis component (acetabular liner) and the performance studies are focused on material and mechanical properties, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "reconstruction of the articulating surface of femoral and/or acetabular portions of the hip." This is a surgical implant used within the body.
- Device Description: The description details a "non-cemented hip prosthesis" consisting of components like a femoral head, acetabular liner, and acetabular shell. These are physical implants.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens.
The information provided describes a medical device intended for surgical implantation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
NovoHip Vitamin E liners are intended for use with the NovoSource NovoHip Total Hip System. NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acctabular portions of the hip that are severely disabled and/or very painful as a result of:
- Non-inflammatory degencrative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis or traumatic arthritis
- Correction of functional deformity
- Non-union femoral neck fracture
- · Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
OQG, LPH, LZO
Device Description
The NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral head, acetabular liner, and acetabular shell components. The femoral head component articulates within the poly acetabular component. The acetabular liner snaps into the acetabular shell component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.
The NovoHip Vitamin E liners are components to be used with the NovoHip Total Hip System, previously cleared via K132158. The Vitamin E poly acetabular component snaps into the metal acetabular components that were previously cleared with the NovoHip Total Hip System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Non-Clinical Performance Data Summary:
- Thermal Properties (DSC) Test
- Small Punch Testing
- Oxidation Index Analysis
- Density Testing
- Trans-Vinylene Yield Index Analysis
- In Situ Determination of Network Parameters
- Tensile Property Test
- Izod Impact Test
- Residual Free Radical Content
- Compressive Modulus
- Fatigue Crack Propagation
- Poisson's Ratio
- Exhaustive Extraction
- Consolidation Assessment
- Post-Wear Analysis
- Fatigue Crack Propagation
- Analysis of Extraction Residue
- Orbital Hip Wear
- Wear Particle Analysis at 1,000,000 Cycles
- Locking Mechanism Strength Evaluation
- Lever-Out Test
- Torque-Out Test
- Push-In Test
- Push-Out Test
- Rotational Stability Test
- Torsional Strength of Metallic Bone Screws
- Driving Torque of Metallic Bone Screws
- Axial Pullout Strength of Metallic Bone Screws
Clinical Performance Data Summary:
No clinical testing was required.
Non-Clinical and Clinical Performance Data Conclusions:
Based on testing results and the comparisons provided, the NovoHip Vitamin E liner is considered substantially equivalent to the Zimmer Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, DePuy Pinnacle Acetabular System, and Wright Medical Lineage Acetabular System in material, construction, and performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Zimmer Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners (K120370), DePuy Pinnacle Acetabular System (K001534), Wright Medical Lineage Acetabular System (K002149)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
K140701 (pg 1/3)
510(k) Summary NovoHip Vitamin E Liners NovoSource Inc.
JUN 2 7 2014
510(k) Summary
Submitter Information
Applicant/Sponsor: NovoSource, Inc. 714 E Monument Ave, Suite 220 Dayton, OH 45402
Contact Person: Allison Scott, RAC 317-228-8719 Allison.Scott@Navigant.com
Date of Preparation: June 27, 2014
Trade Name: NovoHip Vitamin E liner
Common Name: Hip prosthesis
Classification Name(s): Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis + Additive porous uncemented per 21 CFR 888.3358
Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis per 21 CFR 888.3358
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis per 21 CFR 888.3353
Device Produce Code(s): OQG, LPH, LZO Predicate Devices:
NovoHip Total Hip System (K132158)
Zimmer Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners (K120370)
DePuy Pinnacle Acetabular System (K001534)
Wright Medical Lineage Acetabular System (K002149)
1
510(k) Summary NovoHip Vitamin E Liners NovoSource Inc.
Device Description
The NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral head, acetabular liner, and acetabular shell components. The femoral head component articulates within the poly acetabular component. The acetabular liner snaps into the acetabular shell component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.
The NovoHip Vitamin E liners are components to be used with the NovoHip Total Hip System, previously cleared via K132158. The Vitamin E poly acetabular component snaps into the metal acetabular components that were previously cleared with the NovoHip Total Hip System.
Intended Use(s)
NovoHip Vitamin E liners are intended for use with the NovoSource NovoHip Total Hip System. NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:
-
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
Rheumatoid arthritis or traumatic arthritis
-
Correction of functional deformity
-
Non-union femoral neck fracture
-
Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.
Technological Characteristics
The NovoHip Total Hip System and NovoHip Vitamin E liner have the same intended use as the predicate devices. The NovoHip Total Hip System and NovoHip Vitamin-E liner have similar indications for use as the predicate devices. The NovoHip Vitamin E liner is manufactured from the same materials as the predicate devices. The range of sizes of the NovoHip Vitamin E liner is similar to the predicate devices.
2
510(k) Summary NovoHip Vitamin E Liners · NovoSource Inc.
K140701 (pg 3/3)
Non-Clinical Performance Data Summary
-
- Thermal Properties (DSC) Test
-
- Small Punch Testing
-
- Oxidation Index Analysis
-
- Density Testing
-
- Trans-Vinylene Yield Index Analysis
-
- In Situ Determination of Network Parameters
-
- Tensile Property Test
-
- Izod Impact Test
-
- Residual Free Radical Content
-
- Compressive Modulus
-
- Fatigue Crack Propagation
-
- Poisson's Ratio
-
- Exhaustive Extraction
-
- Consolidation Assessment
-
- Post-Wear Analysis
-
- Fatigue Crack Propagation
-
- Analysis of Extraction Residue
-
- Orbital Hip Wear
-
- Wear Particle Analysis at 1,000,000 Cycles
-
- Locking Mechanism Strength Evaluation
-
- Lever-Out Test
-
- Torque-Out Test
-
- Push-In Test
-
- Push-Out Test
-
- Rotational Stability Test
-
- Torsional Strength of Metallic Bone Screws
-
- Driving Torque of Metallic Bone Screws
-
- Axial Pullout Strength of Metallic Bone Screws
Clinical Performance Data Summary
No clinical testing was required.
Non-Clinical and Clinical Performance Data Conclusions
Based on testing results and the comparisons provided, the NovoHip Vitamin E liner is considered substantially equivalent to the Zimmer Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, DePuy Pinnacle Acetabular System, and Wright Medical Lineage Acetabular System in material, construction, and performance characteristics.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
June 27, 2014
NovoSource, Incorporated Navigant Consulting, Incorporated % Allison Scott, RAC Senior Consultant 9001 Weslevan Road, Suite 200 Indianapolis, Indiana 46268
Re: K140701
Trade/Device Name: NovoHip Vitamin E Liner Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis Regulatory Class: Class II Product Code: OQG, LPH, LZO Dated: May 27, 2014 Received: May 28, 2014
Dear Ms. Scott:
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 (21
4
Page 2 - Ms. Allison Scott
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (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/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/McdicalDevices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K140701 (pg 1/1)
Device Name
NovoSource NovoHip Total Hip System
Indications for Use (Describe)
NovoHip Vitamin E liners are intended for use with the NovoSource NovoHip Total Hip System. NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acctabular portions of the hip that are severely disabled and/or very painful as a result of:
-
Non-inflammatory degencrative joint disease including osteoarthritis and avascular necrosis
-
Rheumatoid arthritis or traumatic arthritis
-
Correction of functional deformity
-
Non-union femoral neck fracture
-
· Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabet际上 - Frank - S
Division of Orthopedic Devices
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