(49 days)
Ceraform Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Ceraform Bone Void Filler is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Ceraform Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontancously.
Ceraform Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Ceraform Bone Void Filler is an osseo-conductive macroporous implant made of synthetic beta tri-calcium phosphate(30% - 40%) and hydroxyapatite (60% - 70%). It has a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. The porosity is 60% - 85% and the size of pores is 150 - 400μπ. Ceraform implant slowly resorbs during the remodelling and bone defect repair process and is progressively replaced with bone.
Ceraform is available in 5 gram, 10 gram and 15 grams dosages of granules that are approximately 3mm X 3mm in size, and sticks of packages of 5 and 10 units that are 5mm X 5mm X 20mm in size.
This document describes a medical device, Ceraform Bone Void Filler, and its regulatory clearance. It is a 510(k) submission, which means it asserts substantial equivalence to a predicate device. This type of submission does not typically include a study proving acceptance criteria for device performance in the same way a Premarket Approval (PMA) application would for novel devices.
Therefore, many of the requested sections (2-7, 9) regarding a study proving acceptance criteria or details about ground truth, expert consensus, and multi-reader studies are not applicable to this document. The document focuses on demonstrating that the Ceraform Bone Void Filler is substantially equivalent to an already legally marketed device (Teknimed's TRIHA+ Bone Void Filler, K031826) based on technological characteristics and intended use.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, there are no explicit "acceptance criteria" presented in the document in the format of a performance study with defined numerical targets and results against those targets. Instead, the "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence to a predicate device. The "reported device performance" is essentially that its characteristics are similar to the predicate.
| Characteristic | Acceptance Criteria (Substantial Equivalence to Predicate) | Reported Ceraform Performance |
|---|---|---|
| Composition | Similar to predicate (synthetic beta tri-calcium phosphate (30% - 40%) and hydroxyapatite (60% - 70%)) | Synthetic beta tri-calcium phosphate (30% - 40%) and hydroxyapatite (60% - 70%) |
| Porosity | Similar to predicate (60% - 85%) | 60% - 85% |
| Pore Size | Similar to predicate (150 - 400µm) | 150 - 400µm |
| Resorption | Similar to predicate (slowly resorbs during remodeling and bone defect repair) | Slowly resorbs during remodeling and bone defect repair and is progressively replaced with bone. |
| Intended Use | Similar to predicate (bone void filler for non-load-bearing voids, in extremities, spine, and pelvis; not for large defects that would fail to heal spontaneously) | "Ceraform Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure... indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone... Ceraform Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Ceraform Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis)." |
| Mechanism of Action | Similar to predicate (calcium phosphate scaffold resorbs and is replaced with bone during healing) | "Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process." |
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. This is a 510(k) submission for substantial equivalence. It does not contain a "test set" or a clinical study for performance in the typical sense. Data provenance regarding clinical performance is not provided as a study was not conducted as part of this submission. The submission relies on the established safety and effectiveness of the predicate device (TRIHA+ Bone Void Filler).
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 is no "test set" and no "ground truth" derived from expert review presented in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or expert adjudication is described.
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 device is a bone void filler, not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of medical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth data from an independent study is presented in this 510(k) submission.
8. The sample size for the training set
Not applicable. This is not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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Date March 9, 2004
Submitter
Teknimed, S.A. 11 rue Apollo 31240 L'Union FRANCE
Contact person
J.D. Wcbb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name Bone void filler
Classification name
Filler, calcium sulfate, preformed pellets per 21 CFR Sec. 888.3045
Equivalent Device
Ceraform Bone Void Filler is a modification to Teknimed's TRIHA+ Bone Void Filler (K031826).
MAY - 3 2004
Device Description
Ceraform Bone Void Filler is an osseo-conductive macroporous implant made of synthetic beta tri-calcium phosphate(30% - 40%) and hydroxyapatite (60% - 70%). It has a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. The porosity is 60% - 85% and the size of pores is 150 - 400μπ. Ceraform implant slowly resorbs during the remodelling and bone defect repair process and is progressively replaced with bone.
Ceraform is available in 5 gram, 10 gram and 15 grams dosages of granules that are approximately 3mm X 3mm in size, and sticks of packages of 5 and 10 units that are 5mm X 5mm X 20mm in size.
Intended Use
Ceraform Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Ceraform Bone Void Filler is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Ceraform Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Ceraform Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Summary of Technological Characteristics Compared to Predicate Device
Ceraform is similar to the predicate device in terms of composition, porosity, pore size, and resorption.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle. The eagle is facing to the right and has its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 3 2004
Teknimed, S.A. C/o Mr. J. D. Webb The Orthomedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K040669
Trade/Device Name: Ceraform Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: April 20, 2004 Received: April 22, 2004
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 cnactment 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 r ou may, aroney interest 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 Fedcral 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 elcctronic 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) I mo letet 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,
L. Mark A. Millman
Celia M. Witten, PhD, MD 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): K040669
Device Name: Ceraform Bone Void Filler
Indications for Use:
Ceraform Bone Void Filler is intended for use only as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Ceraform Bone Void Filler is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to bone. Ceraform Bone Void Filler should not be used to treat large defects that in the surgeon's opinion would fail to heal spontancously.
Ceraform Bone Void Filler is intended to be gently packed into voids or gaps in the skeletal system (i.e. extremities, spine, and pelvis). Following placement in the bony voids or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Countor 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)
Mark N. Millerson
ion-()f Division of General, Restorative, and Neurological Devices
510(k) Number K040669
§ 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.