(183 days)
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.
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.
This document is a 510(k) summary for the medical device OSTEOPAL®, a bone cement. The purpose of a 510(k) summary is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on comparing the new device's technological characteristics, indications for use, and performance to an existing device rather than presenting extensive de novo clinical trials to establish acceptance criteria and prove its meeting.
Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the format typically found for AI/ML device submissions. Specifically, it lacks:
- A table of acceptance criteria and reported device performance: This document explicitly states that the new device, Osteopal®, is the known Osteopal® marketed by Merck (or Palacos E-Flow by S.-P.) and refers to an existing PMA (P810020). This implies equivalence to a previously approved device, not validation against new performance criteria.
- Sample size, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study results, standalone performance, type of ground truth, training set sample size, and ground truth establishment for the training set: These are all elements typically found in studies for novel devices, especially those incorporating AI/ML, where performance metrics like sensitivity, specificity, or AUC are evaluated against a defined ground truth derived from expert review or pathology. Since this is a 510(k) for a bone cement claiming equivalence, such detailed performance studies with human interpretation or AI assistance are not part of this submission.
In summary, the provided 510(k) summary for OSTEOPAL® is a regulatory submission for a traditional medical device (bone cement) claiming substantial equivalence to a predicate device. It is not an AI/ML device submission and therefore does not contain the information requested about acceptance criteria and associated performance studies as typically understood for such technologies.
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ふいいにているほどになるという
Osteopal®
SEP 2 3 2003
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510(k) Summary
| Applicant's name and address | Heraeus Kulzer GmbH & Co. KGGrüner Weg 11D-63450 Hanau |
|---|---|
| Contact persons | Dr. K.-D. Kühnphone: +49 6081 959-264fax: +49 6081 959-288klaus-dieter.kuehn@heraeus.comDr. C. Tuchschererphone: +49 6081 959-278fax: +49 6081 959-288christian.tuchscherer@heraeus.com |
| Date of summary | March 19th, 2003 |
| Device trade name | OSTEOPAL® |
| Classification name | Bone Cement |
| Identification of the marketed device Osteopal® towhich 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 inorthopedic surgery. It is formed from powder andliquid by exothermic polymerization. It secures thefixation of the grafted artificial joint improving thetransfer of forces at the interface implant - bone. |
| Intended use | Fixation of prostheses in the bone (partial or totalhip joint replacement at the hip, knee or otherjoints). |
| Comparison of technological characteristics | This is the known Osteopal® marketed by Merck(as Palacos E-Flow marketed by S.-P.,respectively). |
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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.
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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
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Osteopal®
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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 -
§ 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.”