(45 days)
OSMOSYS is intended for use as a bone void filler to fill bony void gaps of the skeletal system (i.e. the extremities, spine and pelvis) resulting from surgery or trauma that are not intrinsic to the stability of the bony structure. OSMOSYS is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Following placement in the bony voids or gap, OSMOSYS resorbs and is replaced with bone during the healing process.
OSMOSYS is a synthetic bone substitute composed of a mixture of hydroxyapatic (HA) and tricalcium phosphate (TCP). The resulting product is a biphasic macro-porous bio-ceramic designed to fill bony void gaps of the skeletal system (i.e., the extremities, spine and polvis) resulting from surgery or trauma that are not intrinsic to the stability of the bony structure. Analysis by pycnometry reveals the presence of pores representing on average 70% of the volume of the material. The pores are between 300um and 500μm, correlating well with the values from optic microscopy. OSMOSYS is available in the form of irregular granules (2-3 mm) and sticks (5x5x20 mm). OSMOSYS is in conformity with the specifications of ASTM F1088-1987 and ASTM F1185-2003.
The provided text is a 510(k) summary for the OSMOSYS Calcium Phosphate Ceramic Bone Filler, which describes a medical device, its intended use, and its equivalence to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through clinical trials or algorithm performance metrics.
The document discusses the device's composition, porosity, pore size, and resorption, stating that it is "similar to the predicate device in terms of composition, porosity, pore size, and resorption." It also mentions that "OSMOSYS is in conformity with the specifications of ASTM F1088-1987 and ASTM F1185-2003," which are material standards and not performance criteria for a diagnostic algorithm.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample size for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for test sets.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This is a regulatory submission for a physical medical device (bone void filler), not a diagnostic or AI-driven device, so the criteria and study types requested (e.g., related to AI, diagnostic accuracy, human reader performance) are not applicable to the content provided.
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OSMOSYS Bone Substitute 510(k) Summarv April 4, 2005
| Submitter | MEDICREA TECHNOLOGIESZI Chef de Baie17000 La RochelleFrance |
|---|---|
| Contact person | J.D. Webb1001 Oakwood BlvdRound Rock. TX 78681512-388-0199 |
| Trade Name | OSMOSYS Calcium Phosphate Ceramic Bone Filler |
| Common name | Bone void filler |
| Classification name | Filler, calcium sulfate, preformed pelletsClass II per 21 CFR section 888.3045 |
| Product Code | MQV |
| Equivalent Device | Calcigen (K030178) (Biomet - Warsaw, IN)Mastergraft Resorbable Ceramic (K020986) (Medtronic Sofamor Danek -Memphis, TN). |
| Device Description |
OSMOSYS is a synthetic bone substitute composed of a mixture of hydroxyapatic (HA) and tricalcium phosphate (TCP). The resulting product is a biphasic macro-porous bio-ceramic designed to fill bony void gaps of the skeletal system (i.e., the extremities, spine and polvis) resulting from surgery or trauma that are not intrinsic to the stability of the bony structure.
Analysis by pycnometry reveals the presence of pores representing on average 70% of the volume of the material. The pores are between 300um and 500μm, correlating well with the values from optic microscopy. OSMOSYS is available in the form of irregular granules (2-3 mm) and sticks (5x5x20 mm).
OSMOSYS is in conformity with the specifications of ASTM F1088-1987 and ASTM F1185-2003.
Intended Use
OSMOSYS is intended for use as a bone void filler to fill bony void gaps of the skeletal system (i.e. the extremities, spine and pelvis) resulting from surgery or trauma that are not intrinsic to the stability of the bony structure. OSMOSYS is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Following placement in the bony voids or gap, OSMOSYS resorbs and is replaced with bone during the healing process.
Summary Nonclinical Tests
OSMOSYS is similar to the predicate device in terms of composition, porosity, pore size, and resorption.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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APR 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDICREA TECHNOLOGIES C/o Mr. J.D. Webb OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K050490
Trade/Device Name: OSMOSYS Calcium Phosphate Ceramic Bone Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: February 21, 2005 Received: March 02, 2005
Dear Mr. Webb:
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 docs 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- Mr. J.D. Webb
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 (240) 276-0120 . 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/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Kipt Clurda
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K050490
Device Name: OSMOSYS Calcium Phosphate Ceramic Bone Filler
Indications for Use:
OSMOSYS is intended for use as a bone void filler to fill bony void gaps of the skeletal system (i.e. the extremities, spine and pelvis) resulting from surgery or trauma that are wa in the system (t.e. the extremities). spine and perviol readers is indicated for use in the not mirmsic to the stability of the bony information or osseous defects created from traimatic treatment of surgically created osseous deroces or easy OSMOSYS resorbs and is replaced with bone during the healing process.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styk Plodr
(Division Division of General Beatherstiv and Neurological a conce
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50490
510(k) Number
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.