(183 days)
Palamed* 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.
Palamed® 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 a bone cement device (PALAMED®), rather than a study report describing acceptance criteria and device performance based on a study. Therefore, most of the requested information cannot be extracted from the provided text.
The document states that the PALAMED® device is "substantially equivalent" to a legally marketed predicate device (PALAMED® 510k (Merck) K010586). This substantial equivalence is based on the comparison of technological characteristics, implying that the device's performance is expected to be similar to the predicate device, which has already met regulatory requirements.
Here's what can be extracted based on the nature of the document:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the 510(k) summary. The summary focuses on substantiating equivalence to a predicate device rather than detailing specific acceptance criteria and reporting performance against them. For bone cement, acceptance criteria would typically involve various mechanical, physical, and chemical properties (e.g., setting time, strength, porosity, biocompatibility), but these specific values are not listed here. The "reported device performance" in this context is implicitly that it performs equivalently to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable to this document. The 510(k) summary does not describe a new study with a test set in the way a clinical trial or a performance study would. It relies on the equivalence to an already marketed device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. There's no test set in the described context for which ground truth was established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not a study involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (bone cement), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of establishing ground truth for a new algorithm or diagnostic test. For bone cement, the "ground truth" would be established by validated test methods for its physical, chemical, and mechanical properties, and its safe and effective clinical use as demonstrated by historical data on the predicate device.
8. The sample size for the training set:
Not applicable. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established:
Not applicable. This document does not describe a machine learning algorithm or a training set.
In summary, the provided text is a regulatory submission for device clearance based on substantial equivalence, not a detailed study report demonstrating performance against specific acceptance criteria for a new device design.
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(גוויר מחום מחום חשובות מחו
SEP 2 3 2003
Image /page/0/Picture/3 description: The image shows the word "Heraeus" in a bold, sans-serif font. Below the word "Heraeus" is the alphanumeric code "K030904" in a handwritten-style font. The text is black against a white background. The image appears to be a label or identifier.
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 | PALAMED® |
| Classification name | Bone Cement |
| Identification of the marketed device Palamed® towhich equivalence is claimed | PALAMED®510k (Merck) K010586 |
| Description of the device | Palamed® 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 already known Palamed® marketed byMerck. |
Image /page/0/Picture/7 description: The image contains the text "Heraeus Kulzer" stacked on top of each other. The text is in a serif font and is white against a black background. The word "Heraeus" is on top, and "Kulzer" is below it.
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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features a stylized image of a bird with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is text that reads "INSTITUTE OF HEALTH & HUMAN SERVICES - USA". The text is arranged along the perimeter of the circle.
Public Health Service
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: K030904 Trade/Device Name: PALAMED® 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,
Sincerely yours,
Mark N. Milkman
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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Palamed®
ાડ
Intended Use
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Palamed* 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.
Mark N. Milliman
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K030904 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.”