(293 days)
Not Found
No
The summary describes a physical medical device (acetabular liner) and its intended use, without mentioning any software, algorithms, or data processing capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is a joint replacement for patients suffering from disability due to degenerative joint disease, rheumatoid arthritis, functional deformity, or femoral fracture, all of which aim to treat or alleviate a disease, injury, or condition.
No
Explanation: The provided text describes a joint replacement device, specifically an acetabular liner, intended for the treatment of various joint diseases and fractures. Its purpose is to replace parts of a joint, which is a therapeutic intervention, not a diagnostic one. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description clearly describes a physical component (polyethylene acetabular liner) intended for surgical implantation, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for joint replacement, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical implant (acetabular liner) made of polyethylene. IVDs are typically reagents, kits, instruments, or software used to examine specimens from the human body.
- 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.
IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device's purpose is to replace a damaged joint, which is a treatment, not a diagnosis.
N/A
Intended Use / Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis;
- correction of functional deformity; ●
- femoral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This device is intended for cementless use only
Product codes (comma separated list FDA assigned to the subject device)
OQG, LPH
Device Description
A highly cross linked polyethylene acetabular liner infused with pure liquid pharmaceutical grade alpha-tocopheral. This application is for the addition of size 32 ID, with neutral, 10° and 20° hooded configurations available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Testing The 32 mm liner does not create a new worst-case for mechanical testing compared to the predicate devices.
Clinical Testing: None provided.
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.
K973119, K974093, K974095, K130365
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6. 2014
Encore Medical, L.P. Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K140130
Trade/Device Name: X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E 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 Dated: September 12, 204 Received: September 15, 2014
Dear Ms. Hutto:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
Page 2 – Ms. Teffany Hutto
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/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 Small Manufacturers, International and Consumer Assistance 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 yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): _ K140130
Device Name: X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E
Indications for Use:
X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular ● necrosis of the natural femoral head;
- rheumatoid arthritis; ●
- correction of functional deformity; ●
- femoral fracture. ●
This device may also be indicated in the salvage of previously failed surgical attempts.
This device is intended for cementless use only
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
3
510(k) Summary
Date: November 4, 2014
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djoglobal.com
| Product | Classification | Product Code |
|---|---|---|
| X-alt™ Highly Cross Linked | ||
| Acetabular Liner with Vitamin E | Class II | LPH - Hip joint metal/polymer/metal semi-constrained |
| porous-coated uncemented prosthesis per 21 CFR | ||
| 888.3358 | ||
| OQG - Hip prosthesis, semi-constrained, cemented, | ||
| metal/polymer, + additive, porous, uncemented per 21 | ||
| CFR 888.3358 |
Description: A highly cross linked polyethylene acetabular liner infused with pure liquid pharmaceutical grade alpha-tocopheral. This application is for the addition of size 32 ID, with neutral, 10° and 20° hooded configurations available.
Indications for Use:
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis;
- correction of functional deformity; ●
- femoral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended for cementless use only
Predicate Device:
- K973119, K974093, K974095 DJO Surgical FMP Acetabular Shells with Standard Poly Liner ● (Spiked, Hemispherical, Flared Shells)
- K130365 DJO Surgical X-alt Highly Cross Linked Acetabular Liners with Vitamin E ●
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials, indications, sterilization, packaging, and intended use.
Non-Clinical Testing The 32 mm liner does not create a new worst-case for mechanical testing compared to the predicate devices.