(67 days)
Not Found
No
The 510(k) summary describes a mechanical implant (acetabular cup) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is an acetabular cup for total hip replacement, which is a medical procedure aimed at treating joint diseases and restoring function. This directly serves a therapeutic purpose by alleviating symptoms and correcting anatomical issues.
No
The device is an acetabular system used in total hip replacement procedures, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states the device is composed of titanium alloy and includes physical components like shells, screws, and plastic inserts. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in total hip replacement procedures. This is a surgical procedure performed on a patient's body.
- Device Description: The device is described as an acetabular shell and plastic inserts made of materials like titanium alloy and UHMWPE. These are physical implants designed to be placed within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
Therefore, the Apex Interface™ Acetabular System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Apex Interface™ Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for uncemented fixation and single use implantation, and may be used for the following conditions, as appropriate:
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The Interface Acetabular System, Acetabular Shell is composed of titanium alloy (ASTM F136), coated with sintered unalloyed titanium beads. The shells are designed for cementless use. The two versions of the shells include a "no hole" and a "3 hole" version (plus an apical hole in both versions). The cup system includes titanium alloy cancellous bone screws (in separate sterile packaging) for optional supplemental fixation of the "3 hole" shell. The Shell uses plastic inserts manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648-00), machined from compression molded sheet, and sterilized using ethylene oxide.
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)
No additional testing required per dFMEA.
No clinical studies were performed.
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.
K031110 Apex Modular Acetabular Cup
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.
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Apex Interface Acetabular System, Acetabular Shell
26 October, 2011
| Submitter | OMNIlife science, Inc.
50 O'Connell Way
E. Taunton MA 02718 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Christine Nassif
Director, Regulatory Affairs
774-226-1871
(508) 822-6030 (fax) |
| Preparation Date | 26 October, 2011 |
| Device Name | Apex Interface Acetabular System, Acetabular Shell |
| Sizes | Standard sizes, 46-76mm and x-sizes, 48x-58x mm.
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. |
| Common name/Classification | Class II per 21 CFR § 888.3358 |
| Regulatory Class | LPH |
| Product Code | |
| Legally Marketed Predicate Device(s) | K031110 Apex Modular Acetabular Cup, May 22, 2003 |
| Device Description | The Interface Acetabular System, Acetabular Shell is composed of titanium alloy (ASTM F136), coated with sintered unalloyed titanium beads. The shells are designed for cementless use. The two versions of the shells include a "no hole" and a "3 hole" version (plus an apical hole in both versions). The cup system includes titanium alloy cancellous bone screws (in separate sterile packaging) for optional supplemental fixation of the "3 hole" shell. The Shell uses plastic inserts manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648-00), machined from compression molded sheet, and sterilized using ethylene oxide. |
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| Indications for Use | The Apex Interface™ Acetabular System is intended for use in combination with the Apex
Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to
articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis
is intended for uncemented fixation and single use implantation, and may be used for the
following conditions, as appropriate:
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device
Comparison | The Apex Interface Acetabular System is manufactured, packaged, and sterilized using
equivalent materials and processes. The subject device(s) is also substantially equivalent to
its predicate(s) based on comparison of design features, intended use, and indications for
use. The fundamental scientific technology of the modified device(s) has not changed
relative to the predicate device(s). The safety and effectiveness of the devices has not
changed relative to the predicate devices. The safety and effectiveness of the Interface
Acetabular System is adequately supported by the substantial equivalence information,
materials information, and analysis data provided within this Premarket Notification. |
| Non-Clinical Test
Summary | No additional testing required per dFMEA. |
| Clinical Test
Summary | No clinical studies were performed. |
| Conclusions | In summary, the Interface Acetabular System, Acetabular Shell, in our opinion, is substantially
equivalent to the predicate device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters and is arranged in a circular fashion to match the shape of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Omni Life Science, Inc. % Chrstine Nassif 50 O'Connell Way Suite 10 East Taunton, MA 02718
·DEC - 2 2011
Re: K112779
Trade/Device Name: Apex Interface Acctabular System, Acetabular Shell 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: LPH Dated: October 26, 2011 Received: November 2, 2011
Dear Ms. Nassif:
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Christine Nassif
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin L. Keith
S Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
: K112779-S1 Apex Interface Acetabular Sys-Shell
510(k) Numbe
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
and Restorative Devices
AND/OR Over-The-Counter Use
on of Surgical, Orthopedic,
(21 CFR 801 Subpart C)
Prescription Use
(Part 21 CFR 801 Subpart D)
OMNIlife science, Inc.
.
Part 21 CFR 801 Subpart D)
Rheumatoid arthritis;
Correction of functional deformity;
Congenital dislocation;
Revision procedures where other treatments or devices have failed;
Femoral neck and trochanteric fractures of the proximal femur.
Device Name: Apex Interface Acetabular System, Acetabular Shell
510(k) Number (if known): 丝绸2779 (pg ١/١٦)
Indications for Use
The Apex Interface™ Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for uncemented fixation and single use implantation, and may be used for the following conditions, as appropriate:
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;