(106 days)
The OTI Bone Cement Plug is intended to allow bone cement pressurization in the intramedullary canal and preventing cement seepage distally. The Bone Plug is placed into the intramedullary canal of the femur at a set distance from the proximal end prior to placement of bone cement and Femoral Prosthesis.
OTI Bone Cement Plug - Line extension
The provided text is a 510(k) premarket notification letter from the FDA regarding the "OTI Bone Cement Plug." It does not contain any information about acceptance criteria, device performance data from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.
The document primarily focuses on:
- Device Identification: OTI Bone Cement Plug
- Regulatory Classification: Class II, Product Code JDK (Surgical mesh)
- Substantial Equivalence Determination: FDA has determined the device is substantially equivalent to legally marketed predicate devices.
- Limitations: A crucial warning is mandated: "WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED."
- Indications For Use: To allow bone cement pressurization in the intramedullary canal, preventing cement seepage distally, when placed at a set distance from the proximal end of the femur prior to bone cement and femoral prosthesis placement.
- General Controls: Mentions requirements for annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Therefore, I cannot fulfill your request for details on acceptance criteria and study information as these are not present in the provided text. This document is a regulatory clearance letter, not a study report or clinical trial summary.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sam Son Vice President, Technical Affairs OsteoImplant Technology Incorporated 11201 Pepper Road Hunt Valley, Maryland 21031-1201
JUN 1 2 2003
Re: K030608
Trade/Device Name: OTI Bone Cement Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: May 2, 2003 Received: May 5, 2003
Dear Mr. Son:
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 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:
WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.
THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.
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Page 2 - Mr. Sam Son
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.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
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,
David Shoebridge MP
Daniel Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name: OTI Bone Cement Plug - Line extension
Indications For Use:
The OTI Bone Cement Plug is intended to allow bone cement pressurization in the intramedullary canal and preventing cement seepage distally. The Bone Plug is placed into the intramedullary canal of the femur at a set distance from the proximal end prior to placement of bone cement and Femoral Prosthesis.
Mark N Milliman
(Division Sign-C Division of General, Restorative and Neurological Devices
510(k) Number K030646
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.