(183 days)
P810020
Not Found
No
The summary describes a traditional bone cement and does not mention any AI or ML components or functionalities.
Yes
Osteopal® is a bone cement used in arthroplastic procedures to fix prosthetic implants to bone, directly fulfilling a therapeutic purpose by securing medical devices within the body for functional restoration.
No
Explanation: Osteopal® is an acrylic bone cement used for the fixation of prosthetic implants to bone during arthroplastic procedures. It is a therapeutic device that aids in securing implants, not a device that diagnoses a condition or disease.
No
The device description clearly states it is an acrylic bone cement, which is a physical material used in surgery, not software.
Based on the provided information, Osteopal® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "fixation of polymer or metallic prosthetic implants to living bone" in surgical procedures. This is an in-vivo application (within the living body).
- Device Description: It's described as an "acrylic bone cement for use in orthopedic surgery," which is consistent with a surgical implant or accessory, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Osteopal®'s function is to physically secure implants within the body during surgery.
N/A
Intended Use / Indications for Use
Osteopal® is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixatio of polymer or metallic prosthetic implants to living bone.
Product codes
LOD
Device Description
Osteopal® is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, knee, and other joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgery
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)
OSTEOPAL® (or Palacos® E-flow, respectively) PMA (Merck and S.-P.) P810020 1998
Reference Device(s)
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
ふいいにているほどになるという
Osteopal®
SEP 2 3 2003
Image /page/0/Picture/3 description: The image shows the word "Heraeus" in a bold, sans-serif font at the top. Below the word "Heraeus", there is a handwritten-style alphanumeric string "KA30903". The text is black and the background is white.
510(k) Summary
| Applicant's name and address | Heraeus Kulzer GmbH & Co. KG
Grüner Weg 11
D-63450 Hanau |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact persons | Dr. K.-D. Kühn
phone: +49 6081 959-264
fax: +49 6081 959-288
klaus-dieter.kuehn@heraeus.com
Dr. C. Tuchscherer
phone: +49 6081 959-278
fax: +49 6081 959-288
christian.tuchscherer@heraeus.com |
| Date of summary | March 19th, 2003 |
| Device trade name | OSTEOPAL® |
| Classification name | Bone Cement |
| Identification of the marketed device Osteopal® to
which equivalence is claimed | OSTEOPAL® (or Palacos® E-flow, respectively)
PMA (Merck and S.-P.) P810020 1998 |
| Description of the device | Osteopal® is an acrylic bone cement for use in
orthopedic surgery. It is formed from powder and
liquid by exothermic polymerization. It secures the
fixation of the grafted artificial joint improving the
transfer of forces at the interface implant - bone. |
| Intended use | Fixation of prostheses in the bone (partial or total
hip joint replacement at the hip, knee or other
joints). |
| Comparison of technological characteristics | This is the known Osteopal® marketed by Merck
(as Palacos E-Flow marketed by S.-P.,
respectively). |
Image /page/0/Picture/7 description: The image shows the words "Heraeus Kulzer" stacked on top of each other. The text is white and the background is black. The words are in a sans-serif font and are slightly bolded.
1
Image /page/1/Picture/1 description: The image shows a black and white circular logo. The logo features a stylized image of an eagle or bird in flight, with three overlapping wing shapes suggesting motion. Encircling the bird image is text, which appears to be the name of an organization or agency. The text is arranged along the top and bottom curves of the circle.
SEP 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. K. D. Kühn Head of Department Heraeus Kulzer GmbH & Co. KG Grüner Weg 11 Hanau. Germany D-63450
Re: K030903 Trade/Device Name: OSTEOPAL® Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: June 25, 2003 Received: July 14, 2003
Dear Dr. Kühn:
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 (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 - Dr. K. D. Kühn
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). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millman
elia 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
3
Osteopal®
Image /page/3/Picture/2 description: The image shows the word "Heraeus" in a bold, sans-serif font. The letters are black and stand out against a white background. The word is horizontally oriented and appears to be a logo or brand name. The font is uniform in size and thickness.
Intended Use
Osteopal® is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixatio of polymer or metallic prosthetic implants to living bone.
Mark A. Melkerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
KO30903
510(k) Number -