(86 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on the material, design, and mechanical testing of a hip stem.
Yes
The device is indicated for the reduction or relief of pain and improved hip function, which are therapeutic outcomes.
No
This device is a hip stem intended for total hip arthroplasty, which is a treatment (surgical implant) rather than a diagnostic tool. Its purpose is to alleviate pain and improve hip function in patients with certain conditions, not to identify or diagnose those conditions.
No
The device description explicitly states it is a "Hip Stem manufactured from cobalt chrome alloy," which is a physical implant, 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 describes a surgical implant for total hip arthroplasty to treat various hip conditions. This is a therapeutic device implanted in the body.
- Device Description: The device is a hip stem manufactured from cobalt chrome alloy, designed for use with bone cement. This is a physical implant.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a replacement joint component.
N/A
Intended Use / Indications for Use
This device is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:
-
- inflammatory degenerative joint disease such as rheumatoid arthritis:
-
- correction of functional deformity:
-
- revision procedures where other treatments or devices have failed; and,
-
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Product codes (comma separated list FDA assigned to the subject device)
JDI
Device Description
The Dual Offset PERFECTA® IMC Hip Stem is manufactured from cobalt chrome alloy (ASTM F 799). The stem is available in standard and long lengths and features a collar. The stem is designed to be used with bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip (specifically proximal femur)
Indicated Patient Age Range
skeletally mature patients
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)
Submitted testing indicates that the device should withstand a load of 2300N for at least 5 million cycles at 10 hertz.
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.
PERFECTA® IMC Hip Stem manufactured by Wright Medical Technology, Inc.
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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OCT - 9 1997
page 1 of 1
Image /page/0/Picture/3 description: The image shows a stylized letter "W" logo. The "W" is formed by three thick, black, triangular shapes that are arranged to create the letter's form. A registered trademark symbol is located to the bottom right of the "W".
Contact Person: Kim Tompkins July 14, 1997 Date:
510(k) Summary
| Trade Name: | Dual Offset PERFECTA® IMC Hip Stem, product line extension to
the PERFECTA® IMC Hip System |
|-------------------|-----------------------------------------------------------------------------------------------|
| Common Name: | Femoral Hip Stem |
| Classification: | Class II |
| Predicate Device: | PERFECTA® IMC Hip Stem manufactured by Wright Medical
Technology, Inc. |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Description/Intended Use
The Dual Offset PERFECTA® IMC Hip Stem is manufactured from cobalt chrome alloy (ASTM F 799). The stem is available in standard and long lengths and features a collar. The stem is designed to be used with bone cement.
This device is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:
-
- inflammatory degenerative joint disease such as rheumatoid arthritis:
-
- correction of functional deformity:
-
- revision procedures where other treatments or devices have failed; and,
-
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Testina
Submitted testing indicates that the device should withstand a load of 2300N for at least 5 million cycles at 10 hertz.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three lines forming its body and wings, giving it a sense of motion. The overall design is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 1997
Ms. Kim Tompkins Director, Clinical and Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K972641 Dual Offset PERFECTA® IMC Hip Stem Trade Name: Requlatory Class: II Product Code: JDI Dated: July 14, 1997 Received: July 15, 1997
Dear Ms. Tompkins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
2
Page 2 - Ms. Kim Tompkins
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. Gale M. Whitten, Ph.D., M.
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
C. Indications for Use of the Device
Page 1 of 1
| 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ | K972641 | |||
|---|---|---|---|---|
| . |
Device Name: Dual Offset PERFECTA® IMC Hip Stem
Indications for Use:
This device is indicated in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- 1 . Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- Inflammatory degenerative joint disease such as rheumatoid arthritis:
-
- Correction of function deformity:
- Revision procedures where other treatments or devices have 4. failed; and
-
- Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
This device is intended for use with bone cement.
(Please do not write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
t. ceele
(Division Sign-Off) (Division Signi-On)
Division of General Restorative Devices 510(k) Number_12322641
Prescription Use X (Per 21 CFR 801.109)
Or
Over-the-Counter Use (Optional Format 1-2-96)