(17 days)
Not Found
No
The document describes a mechanical implant (hip liner) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on mechanical testing and literature review, not algorithmic performance metrics.
Yes
The device is a component of a total hip prosthesis intended to replace a hip joint and manage high risk of dislocation, which are therapeutic actions.
No
Explanation: The device is a component of a total hip prosthesis intended to replace a hip joint in patients at high risk of dislocation. It is a treatment device, not a diagnostic one.
No
The device description clearly states that the device is a physical polyethylene liner, a hardware component of a total hip prosthesis.
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 device is a component of a total hip prosthesis intended to replace a hip joint in patients at high risk of dislocation. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as polyethylene liners with a retaining ring, designed to be implanted in the hip joint. This is consistent with a medical device for surgical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro testing.
Therefore, the Freedom™ Constrained Liners are a medical device for surgical implantation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Freedom™ Constrained Liners are intended to replace a hip joint. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Product codes
KWZ
Device Description
The Freedom™ Constrained Acetabular Liners are polyethylene liners that will come pre-assembled with a retaining ring already in place. The liners will be available in five different styles. All the liners allow for the same range of motion. The locking mechanism and profile of that mechanism remain the same throughout the series.
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)
Non-Clinical Testing: Mechanical testing, published medical literature, and engineering justifications determined that the Freedom™ Constrained Liner presented no new unacceptable risks and is, therefore, substantially equivalent to the predicate device.
Clinical Testing: None provided as a basis for substantial equivalence.
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
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
0
JAN 2 3 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant or Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, IN 46581-0587 |
|-----------------------|-------------------------------------------------------------------|
| Contact Person: | Max T. Hebel
Telephone: (219) 267-6639 |
| Proprietary Name: | FreedomTM Constrained Liners |
| Common Name: | Constrained Acetabular Insert |
Classification: Prosthesis, hip, constrained, metal/polymer (CFR 888.3310).
Device Classification: Class II
Legally Marketed Device to which Substantially Equivalence is Claimed: Ringloc® II Constrained Liners (K021728)
Device Description: The Freedom™ Constrained Acetabular Liners are polyethylene liners that will come pre-assembled with a retaining ring already in place. The liners will be available in five different styles. All the liners allow for the same range of motion. The locking mechanism and profile of that mechanism remain the same throughout the series.
Indications for Use: The Freedom™ Constrained Liners are indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.
Summary of Technologies: The Freedom™ Constrained Liners-the materials, design, sizing, and indications are similar or identical to the predicate devices.
Non-Clinical Testing: Mechanical testing, published medical literature, and engineering justifications determined that the Freedom™ Constrained Liner presented no new unacceptable risks and is, therefore, substantially equivalent to the predicate device.
Clinical Testing: None provided as a basis for substantial equivalence.
1.007 1.5
MAILING ADDRESS SHIPPING ADDRESS 120. Box 587 56 E. Bell Drive Warsaw, IN 46581-0587 Warsaw, IN 46582 ースアスター(アステスティ) FAX - FAX
『 FAX OFFICE 1:-MAIL (한 574.267.6639 biomet@biomet.com
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2003
Mr. Max T. Hebel Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw. Indiana 46581-0587
Re: K030047
Trade Name: Freedom™ Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: January 2, 2003 Received: January 6, 2003
Dear Mr. Hebel:
We have reviewed your Section 510(k) premarket 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) 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 (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.
2
Page 2 – Mr. Max T. Hebel
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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 of Small Manufacturers, 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 vours,
Sincerely yours,
Mark A. Melkersen
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 01.
510(k) Number (if known): Device Name: Freedom™ Constrained Liners Indications for Use:
The Freedom™ Constrained Liners are intended to replace a hip joint. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
le Mark N Mellen
(Division Sign-Off)
Division of General. . . rative
and Neurological D. . . es
510(k) Number K030047
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)