(160 days)
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.
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.
This is not an AI/ML device and as a result, the acceptance criteria and study information points outlined in the request are not applicable. The device is the OMNI Skirted Heads, which are part of a hip joint prosthesis. The provided document is a 510(k) premarket notification for this medical device, demonstrating its substantial equivalence to previously marketed devices.
However, I can extract information relevant to the device's performance testing and justification for substantial equivalence.
Here's a summary of the available information:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Range of Motion (ROM) per ISO 21535 requirements | Results of testing met the requirements for Range of Motion per ISO 21535. |
| Compatibility with SERF Dual Mobility Acetabular Cups | Demonstrated through Range of Motion testing. |
| Material: Cobalt Chromium (CoCr) | The device is manufactured from Cobalt Chromium (CoCr), which is identical to the skirted heads cleared in the predicate device (K101575). |
| Design Similarity to Predicate Devices (K101575, K000788) | The proposed skirted head is similar in design to skirted heads cleared in the reference predicate K101575 and the same size (22mm and 28mm heads) as those cleared in K000788. |
2. Sample size used for the test set and the data provenance:
- Test Set: The document mentions "Range of Motion testing was conducted." It does not specify the exact sample size for this testing.
- Data Provenance: Not explicitly stated, but it's internal testing conducted by the manufacturer (OMNIlife Science) to support their 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/provided. This device is a mechanical implant, and its performance criteria are based on engineering and material standards (e.g., ISO 21535), not expert interpretation of outputs.
4. Adjudication method for the test set:
- Not applicable. Performance is based on objective measurements against engineering standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, this type of study is not applicable as this is a mechanical medical device, not an AI/ML-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used:
- Engineering Standards and Specifications: The "ground truth" for this device appears to be the requirements of relevant ISO standards (e.g., ISO 21535 for Range of Motion) and the performance characteristics of predicate devices.
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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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
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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
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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 Science50 O'Connell WaySuite 10East Taunton, MA 02718 |
| 510(k) Contact | Christina FloresManager, Regulatory AffairsOMNIlife Science50 O'Connell WayEast Taunton, MA 02718Telephone: (774)-226-1835Fax: (508)-822-6030Email: cflores@omnils.com |
| Trade Name | OMNI Skirted Heads |
| Common Name | Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis. |
| Classification | Class II per 21 CFR §888.3353 Hip jointmetal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis.Product Code LZO, MEH |
| Predicate Device | K111572 NOVAE® Dual Mobility Acetabular CupReference Predicate:K000788 OMNI (formerly APEX) Modular Hip StemK101575 OMNI (formerly APEX) Modular Heads |
| Purpose of Submission | This traditional 510(k) premarket notification is beingsubmitted to obtain clearance for the OMNI SkirtedHeads for use with the SERF Dual Mobility AcetabularCups (K111572). |
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| 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. |
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| 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. |
§ 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.