(28 days)
Not Found
No
The summary describes a physical implant (femoral stem) and its associated instruments. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is a femoral stem used in hip arthroplasties to treat degenerative and inflammatory arthritis, trauma, and avascular necrosis, indicating a therapeutic purpose.
No
The device is a femoral stem (an implant) used in hip arthroplasties to treat various conditions, not to diagnose them.
No
The device description clearly states it is a physical femoral stem and associated instruments, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation in the hip joint to treat various conditions like arthritis, trauma, and failed hip replacements. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (femoral stem) and associated instruments for surgical implantation. This is consistent with a medical device used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ESOP® HA Femoral Stem is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.
Product codes
MEH
Device Description
The ESOP® HA Femoral Stem consists of left and right configuration metaphysis parts in various size diameters, and diaphysis parts in various sizes. The ESOP® HA Femoral Stem instrument system is used for proper implantation of the device. The ESOP® HA Femoral Stem design includes: 10 left and right configuration metaphysis parts in various sizes diameters and cone angles, and 7 diaphysis parts of various sizes which are to be screwed into the extremity of the metaphysis part.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, femoral neck
Indicated Patient Age Range
Not Found
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
Verification/validation and design control activities Performance Data: demonstrate the safety and effectiveness of the ESOP® HA Femoral Stem.
Key Metrics
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
Sponsor: Pro-Active
MAY 0-3 2002
ESOP® HA Femoral Stem Special 510(k) Premarket Notification
K021108
page 1 of 2
510(k) SUMMARY – ESOP® HA Femoral Stem
| Submitter Name: | Fournitures Hospitalieres Industrie |
|---|---|
| Submitter Address: | 6 rue Nobel, Z.I. de Kernevez |
| Quimper, France 29000 | |
| Contact Person: | Christine Quendez |
| Phone Number: | + 33 2 98 55 68 95 |
| Fax Number: | +33 2 98 53 42 13 |
| Date Prepared: | 22 March 2002 |
| Device Trade Name: | ESOP® HA Femoral Stem |
| Device Common Name: | Femoral Stem |
| Classification Name: | Prosthesis, Hip, Femoral Component |
| Predicate Devices: | ● FHI ESOP® S/C Femoral Stem, K964878 |
| ● Landos CORAIL Femoral Stem, K953111 | |
| Device Description: | The ESOP® HA Femoral Stem consists of left and right |
| configuration metaphysis parts in various size diameters, | |
| and diaphysis parts in various sizes. The ESOP® HA | |
| Femoral Stem instrument system is used for proper | |
| implantation of the device. The ESOP® HA Femoral | |
| Stem design includes: 10 left and right configuration | |
| metaphysis parts in various sizes diameters and cone | |
| angles, and 7 diaphysis parts of various sizes which are | |
| to be screwed into the extremity of the metaphysis part. | |
| Device Technological | |
| Characteristics and | |
| Comparison to | |
| Predicate Device(s): | The ESOP® HA Femoral Stem is made of similar |
| materials, is available in similar diameters and lengths, has | |
| a similar design, and the same indications for use as the | |
| predicate devices and other currently marketed femoral | |
| stems. |
1
Verification/validation and design control activities Performance Data: demonstrate the safety and effectiveness of the ESOP® HA Femoral Stem.
Sponsor:
Pro-Active
Conclusion: The ESOP® HA Femoral Stem is substantially equivalent to the claimed predicate devices and other currently marketed femoral stems.
2
Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 3 2002
Fournitures Hospitalieres Industrie c/o Dr. Andre Weith Director, Pro-Active Healthcare c/o PharmaNet, Inc. 815 Connecticut Avenue NW, Suite 800 Washington, D.C. 20006
Re: K021108
Trade/Device Name: ESOP® HA Femoral Stem Regulation Number: 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Regulatory Class: II Product Code: MEH Dated: April 5, 2002 Received: April 5, 2002
Dear Dr. Weith:
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
3
Page 2 - Dr. Andre Weith
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.
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 and additionally 21 CFR Part 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" (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,
L. Mark N. Millburn
Celia Witten. Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Sponsor: Pro-Active
ESOP® HA Femoral Stem Special 510(k) Premarket Notification
510(k) Number (if known):
page 1 of 1
Device Name:
ESOP® HA Femoral Stem
Indications for Use:
The ESOP® HA Femoral Stem is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH; Office of Device Evaluation (ODE) | for Mark N Melhuish (Division Sign-Off) Division of General, Restorative and Neurological Devices |
|---|---|
| 510(k) Number | K021108 |
| Prescription Use | |
| (Per 21 CFR 801.109) | OR Over-The-Counter Use |
(Optional Format 1-2-96)