(160 days)
No
The device description and performance studies focus on the mechanical properties and compatibility of a hip implant component, with no mention of AI/ML technology.
Yes
The device, OMNI Skirted Heads, is intended for total hip replacement, which is a medical procedure to treat conditions like osteoarthritis and femoral neck fracture. This falls under the definition of a therapeutic device as it treats or alleviates a disease or injury.
No
The device description clearly states "The OMNI Skirted Heads are intended to be used in the primary/revision total hip replacement procedures." This indicates it is a therapeutic device (a prosthetic component for hip replacement), not a diagnostic one. Its purpose is to treat conditions like osteoarthritis and femoral neck fracture, not to identify or assess them.
No
The device description clearly states the device is a physical implant (femoral heads) made of cobalt chromium, intended for surgical use in total hip replacement. It is a hardware device, 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 states that the OMNI Skirted Heads are for use in total hip replacement procedures. This is a surgical intervention performed directly on the patient's body.
- Device Description: The device is described as a femoral head made of cobalt chromium, designed to be used with an acetabular cup and a femoral stem. These are all components of a hip implant, which is an implantable medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is designed to be implanted within the body.
N/A
Intended Use / Indications for Use
The OMNI Skirted Heads are intended for use in combination with the NOVAE® Dual Mobility Acetabular Cup and are indicated for total hip replacement, which includes:
. Osteoarthritis
. Femoral neck fracture
. Dislocation risk
. Osteonecrosis of the femoral head
. Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH
Device Description
The OMNI Skirted Heads are intended to be used in the primary/revision total hip replacement procedures in combination with the SERF Dual Mobility Acetabular Cup. These femoral heads are manufactured from cobalt chromium (CoCr) and are designed to be used with the SERF Dual Mobility Acetabular cup. These heads offer a skirted feature and when used with the Dual Mobility cups, the skirt extends over the exposed femoral taper and reduces the contact between the SERF polyethylene liner and machined surface of the K1 stem trunnion. SERF obtained clearance to use the OMNI K1 stem with its Dual Mobility NOVAE Acetabular Cup under K111572. In this submission, OMNI proposes two sizes for these skirted heads – 28mm+7 and 22mm+3.5 diameter and neck length respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Range of Motion testing was conducted to demonstrate the compatibility of the SERF Dual Mobility cups and proposed OMNI skirted heads. The results of testing met the requirements for Range of Motion per ISO 21535.
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.
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without 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 a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2016
OMNIlife Science Incorporated Ms. Christina Flores Manager, Regulatory Affairs 50 O'Connell Way, Suite 10 East Taunton, Massachusetts 02718
Re: K152919 Trade/Device Name: OMNI Skirted Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, MEH Dated: December 16, 2015 Received: December 17, 2015
Dear Ms. Flores:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152919
Device Name OMNI Skirted Heads
Indications for Use (Describe)
The OMNI Skirted Heads are intended for use in combination with the NOVAE® Dual Mobility Acetabular Cup and are indicated for total hip replacement, which includes:
- . Osteoarthritis
- . Femoral neck fracture
- . Dislocation risk
- . Osteonecrosis of the femoral head
- . Revision procedures where other treatments or devices have failed and if bone reconstruction so permits
SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| TABLE 1: 510(k) SUMMARY | |
|---|---|
| Date Summary Prepared | 03/09/2016 |
| Manufacturer/Distributor/Sponsor | OMNIlife Science |
| 50 O'Connell Way | |
| Suite 10 | |
| East Taunton, MA 02718 | |
| 510(k) Contact | Christina Flores |
| Manager, Regulatory Affairs | |
| OMNIlife Science | |
| 50 O'Connell Way | |
| East Taunton, MA 02718 | |
| Telephone: (774)-226-1835 | |
| Fax: (508)-822-6030 | |
| Email: cflores@omnils.com | |
| Trade Name | OMNI Skirted Heads |
| Common Name | Hip joint metal/ceramic/polymer semi-constrained |
| cemented or nonporous uncemented prosthesis. | |
| Classification | Class II per 21 CFR §888.3353 Hip joint |
| metal/ceramic/polymer semi-constrained cemented or | |
| nonporous uncemented prosthesis. | |
| Product Code LZO, MEH | |
| Predicate Device | K111572 NOVAE® Dual Mobility Acetabular Cup |
| Reference Predicate: | |
| K000788 OMNI (formerly APEX) Modular Hip Stem | |
| K101575 OMNI (formerly APEX) Modular Heads | |
| Purpose of Submission | This traditional 510(k) premarket notification is being |
| submitted to obtain clearance for the OMNI Skirted | |
| Heads for use with the SERF Dual Mobility Acetabular | |
| Cups (K111572). |
4
| Device Description | The OMNI Skirted Heads are intended to be used in the primary/revision total hip replacement procedures in combination with the SERF Dual Mobility Acetabular Cup. These femoral heads are manufactured from cobalt chromium (CoCr) and are designed to be used with the SERF Dual Mobility Acetabular cup. These heads offer a skirted feature and when used with the Dual Mobility cups, the skirt extends over the exposed femoral taper and reduces the contact between the SERF polyethylene liner and machined surface of the K1 stem trunnion. SERF obtained clearance to use the OMNI K1 stem with its Dual Mobility NOVAE Acetabular Cup under K111572. In this submission, OMNI proposes two sizes for these skirted heads – 28mm+7 and 22mm+3.5 diameter and neck length respectively. |
|---|---|
| Intended Use/Indications for use | The OMNI Skirted Heads are intended for use in combination with the NOVAE® Dual Mobility Acetabular Cup and are indicated for total hip replacement, which includes: |
| • Osteoarthritis | |
| • Femoral neck fracture | |
| • Dislocation risk | |
| • Osteonecrosis of the femoral head | |
| • Revision procedures where other treatments or devices have failed and if bone reconstruction so permits. |
SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use. |
| Substantial Equivalence Summary | The proposed OMNI Skirted Heads are substantially equivalent to the predicate NOVAE Dual Mobility Acetabular Cup (K111572) in terms of the fundamental scientific technology and intended uses and the reference predicate (K101575) in terms of design and materials. Any differences between the proposed and the predicates are considered minor and do not raise any new concerns regarding safety and effectiveness. |
5
| The proposed skirted head is similar in design to the |
|---|
| skirted heads cleared in the reference predicate K101575 |
| and the same size, 22mm and 28mm heads, as those |
| cleared in K000788. The proposed skirted head is |
| composed of cobalt chromium (CoCr), this material is |
| identical to the OMNI skirted heads cleared in K101575. |
| SERF obtained clearance to use OMNI heads (with |
| diameter 22.2 and 28mm) with their Dual Mobility Cup |
| in K111572. |
| Range of Motion testing was conducted to demonstrate |
| the compatibility of the SERF Dual Mobility cups and |
| proposed OMNI skirted heads. The results of testing met |
| the requirements for Range of Motion per ISO 21535. |
| Based on the similar intended use, technological |
| characteristics, material and testing, OMNIlife science |
| believes the proposed introduction of skirted heads to be |
| substantially equivalent to the legally marketed |
| predicates. |