(56 days)
No
The document describes a mechanical hip implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to replace a damaged hip joint, which directly addresses a medical condition (severe hip pain and disability) by restoring function and alleviating symptoms.
No
Explanation: The device is an MSA Hip System, which is a modular hip replacement system. Its intended use is to replace a hip joint, not to diagnose a condition or disease.
No
The device description clearly states it is a modular hip system consisting of physical components made of materials like Ti-6AI-4V and CoCr alloy, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a hip implant system intended to replace a hip joint within the body. It is a surgical implant, not a device that analyzes samples taken from the body.
The description focuses on the materials, components, and surgical application of the device, which are characteristic of an implantable medical device, not an IVD.
N/A
Intended Use / Indications for Use
The MSA Hip System is indicated for cementless use and is intended to replace a hip joint.
The device is intended for:
- · skeletally mature individuals undergoing primary surgery for total hip replacement
- · patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fracture of the femur.
- · patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis
- · patients suffering from disability due to previous fusion
- · patients with acute femoral neck fractures
Product codes
MEH, LZO
Device Description
The MSA Hip System is a modular hip system consisting of a short stem which mates with a modular neck. The hip stems are made of Ti-6AI-4V (ASTM F136) with a commercially pure titanium plasma spray coating (ASTM F1580) on the proximal end. The stems are available with and without a hydroxyapatite coating. The modular necks are made of CoCr alloy (ASTM F1537). The MSA Hip System can be mated with metal or ceramic femoral heads and acetabular components.
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
skeletally mature individuals
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)
The company performed burst strength testing of the ceramic femoral head. The test results demonstrate that the pre-determined acceptance criteria identified in the Design Control Activities Summary were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 1 5 2011
K113107 (pg 1/2)
5. 510(k) Summary
| Contact: | Mr. Steve Banks
Director |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street, NW, 12th Floor
Washington, DC 20005
Phone: (202) 552-5800
Fax: (202) 552-5798 |
| Date Prepared: | October 19, 2011 |
| Device Trade Name: | MSA Hip System |
| Manufacturer: | Global Manufacturing Technology
8-10 Resolution Drive
Unanderra NSW 2526
AUSTRALIA
Phone: (011) 61 (2) 8887 0100 |
| Classification: | 21 CFR 888.3353 |
| | Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis |
| | Class II |
| Product Code: | MEH, LZO |
Reason for Special 510(k) Submission:
The purpose of this Special 510(k) is to add ceramic femoral heads to the MSA Hip System. There have been no changes to the intended use of the device or its fundamental scientific technology.
Indications For Use:
The MSA Hip System is indicated for cementless use and is intended to replace a hip joint.
The device is intended for:
- · skeletally mature individuals undergoing primary surgery for total hip replacement
- · patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fracture of the femur.
1
- · patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis
- · patients suffering from disability due to previous fusion
- · patients with acute femoral neck fractures
Device Description:
The MSA Hip System is a modular hip system consisting of a short stem which mates with a modular neck. The hip stems are made of Ti-6AI-4V (ASTM F136) with a commercially pure titanium plasma spray coating (ASTM F1580) on the proximal end. The stems are available with and without a hydroxyapatite coating. The modular necks are made of CoCr alloy (ASTM F1537). The MSA Hip System can be mated with metal or ceramic femoral heads and acetabular components.
Predicate Devices:
The modified MSA Hip System is substantially equivalent to the predicate MSA Hip System (K102172) with respect to indications, design, and function.
Substantial Equivalence:
The company performed burst strength testing of the ceramic femoral head. The test results demonstrate that the pre-determined acceptance criteria identified in the Design Control Activities Summary were met.
Conclusion
The MSA Hip System when mated with a ceramic femoral head is substantially equivalent to previously cleared devices with respect to its indications for use, design, and function.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Global Manufacturing Technology % Musculoskeletal Clinical Regulatory Advisers, LLC Ms. Hollace Rhodes Director, Orthopaedic Regulatory Affairs 1331 H St Northwest Washington, DC 20005
DEC 1 5 2011
Re: K113107
Trade/Device Name: MSA Hip System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
porous uncemented prosthesis
Regulatory Class: Class II Product Code: MEH, LZO Dated: November 16, 2011 Received: November 17, 2011
Dear Ms. Rhodes:
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
3
Page 2 - Ms. Hollace Rhodes
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 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
incerely yours,
for Peter Vrooman
Mark N. Melkerson
Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 4.
510(k) Number (if known): 长川3107 (pg ١/١)
Device Name: MSA Hip System
The MSA Hip System is indicated for cementless use and is intended to replace a hip joint.
The device is intended for:
- skeletally mature individuals undergoing primary surgery for total hip . replacement
- patients suffering from severe hip pain and disability due to rheumatoid arthritis, ● osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fracture of the femur.
- patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital . femoral epiphysis
- patients suffering from disability due to previous fusion .
- . patients with acute femoral neck fractures
イ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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)
for MxM
(Division Sign-Off)
Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113107