(192 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use and indications for a total hip arthroplasty device.
Yes
The device is indicated for the reduction or relief of pain and improved hip function, which are therapeutic outcomes.
No
The provided "Intended Use / Indications for Use" describes a device used for treatment (total hip arthroplasty for pain reduction and improved function), not for diagnosing a condition.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. Without this information, it's impossible to ascertain if the device includes hardware components or is purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in a surgical procedure (total hip arthroplasty) to treat conditions affecting the hip joint. This is a therapeutic intervention performed directly on the patient's body.
- 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 outside the body to analyze samples and provide diagnostic information. This device is clearly used inside the body for a surgical procedure.
N/A
Intended Use / Indications for Use
Indication: for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following:
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- Non-inflammatory degenerative joint disease including: osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia,
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- Inflammatory degenerative joint disease including rheumatoid arthritis;
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- Correction of functional deformity;
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- Revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Product codes
JDI, LWJ, LZO
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but in this case, it is a more abstract design featuring three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2001
Mr. Steven L. Mandell President Orthopedic Source, Inc. P.O. Box 307 Loomis, California 95650
Re: K011887
Trade/Device Name: Avalon Cup System Regulation Number: 21 CFR 888.3350; 888.3353 Regulation Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented and Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented Regulatory Class: Class II Product Code: JDI, LWJ, LZO Dated: October 30, 2001 Received: November 7, 2001
Dear Mr. Mandell:
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 such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Steven L. Mandell
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you'll finding of substantial equivalence of your device to a legally premaired notification. "The suits 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 11 you desire specific art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 211 ) 594-4659. Additionally, for questions on the promotion and advertising of Compinatee at (301) 59 - 4 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark n-Mullins
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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page 1 of 1
510(k) Number (if known):
Device Name: The Avalon Cup System
Indication for Use:
Indication: for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following: