(266 days)
CarriGen Porous Bone Substitute is an injectable, self setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation / placement); sinus lifts; cystic defects; and oral and maxillofacial augmentation. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
CarriGen Porous Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, nano-crystalline hydroxyapatite (NCHA); is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Here's an analysis of the provided text regarding the CarriGen Bone Grafting Material and its acceptance criteria, structured as requested.
Important Note: The provided document is a 510(k) Summary and an FDA 510(k) clearance letter. It describes the device, its intended use, and substantial equivalence to predicate devices. It explicitly mentions "Testing data meeting the requirements of Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted." However, the document itself does NOT contain the detailed acceptance criteria, the specific study design, or the performance results of such studies. It confirms that such data was submitted and found acceptable for 510(k) clearance, but the data itself is not presented here.
Therefore, for many of the requested points, the answer will be that the information is "Not Available in the provided document."
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available in the provided document. The document states that "Testing data meeting the requirements of Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted." This implies specific performance criteria were met, but these criteria and the detailed performance results are not enumerated in this 510(k) summary or the clearance letter. | Not Available in the provided document. The document does not provide specific quantitative performance metrics beyond stating that testing data was submitted and accepted. |
Study Details
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not Available in the provided document. -
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 Available in the provided document. The type of testing submitted would likely be animal studies or mechanical/chemical bench testing, rather than expert evaluation of images, given it's a bone grafting material. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not Available in the provided document. This type of adjudication is typically for image-based diagnostic AI, which is not applicable to this physical bone grafting material. -
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. The CarriGen Porous Bone Substitute Material is a physical bone grafting material, not an AI or imaging diagnostic device. Therefore, MRMC studies involving human readers and AI assistance are not relevant. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. As a physical bone grafting material, this device does not have an "algorithm-only" or "human-in-the-loop" performance. Its performance is related to its osteoconductive properties, resorption rate, and replacement by natural bone. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not Available in the provided document. For a bone grafting material, ground truth would typically be established through histological analysis (pathology) of tissue samples from animal or human studies to assess new bone formation, material resorption, and integration. -
The sample size for the training set:
Not Applicable / Not Available. For a physical medical device like a bone graft, there isn't a "training set" in the context of machine learning or AI. Performance data would come from pre-clinical (e.g., animal) and potentially clinical studies. -
How the ground truth for the training set was established:
Not Applicable / Not Available. As above, the concept of a training set ground truth is not relevant for this type of device.
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Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be a mix of letters and numbers. The string starts with the letter 'K', followed by the number '100', and then the numbers '883'. The handwriting is somewhat stylized, with the numbers and letters having a rounded appearance.
Traditional 510(k) Submission – CarriGen Bone Grafting Material
5. 510(k) Summary
| Submitter: | DEC 21 2010ETEX Corporation38 Sidney StreetCambridge, MA 02139Registration No.: 1225112Owner/Operator No.: 9014709 |
|---|---|
| Contact Person: | Christopher KlaczykRegulatory Affairs ManagerOffice: (617) 577-7270 x160Mobile: (617) 710-8091Fax: (617) 577-7170E-Mail: cklaczyk@etexcorp.com |
| Date Prepared: | March 19, 2010 |
| Product Code(s): | LYC (21 CFR 872.3930) |
| Device Class: | II (21 CFR 872.3930) |
| Classification Panel: Dental Devices | |
| Classification Name: Bone Grafting Material, Synthetic (21 CFR 872.3930) | |
| Proprietary Name: | CarriGen Porous Bone Substitute Material |
| Predicate Device(s): | Alpha-bsm Bone Substitute Material (ETEX Corp.,K091729)Beta-bsm Injectable Bone Substitute Material (ETEXCorp., K091729)Gamma-bsm Moldable Bone Substitute Material (ETEXCorp., K091729)EquivaBone Osteoinductive Bone Graft Substitute (ETEXCorp., K091729) |
| Device Description: | CarriGen Porous Bone Substitute Material is a synthetic,biocompatible bone graft substitute material. At the time ofuse, the powder component is combined with a specifiedvolume of mixing solution and mixed to form a putty. Theresulting putty is administered to the treatment site bymanual application. The material can be shaped into adesired form in-situ prior to implantation. After the puttyis applied to the treatment site, it hardens at bodytemperature and converts to an apatitic calcium phosphatematerial. The end product, nano-crystalline hydroxyapatite |
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(NCHA); is-of-low-crystalline-order-with-a-similar-chemical_ and crystalline structure to that of natural bone minerals. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
Intended Use: CarriGen Porous Bone Substitute is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, apicoectomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation / placement); sinus lifts; cystic defects; and oral and maxillofacial augmentation. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Synthetic calcium phosphate, sodium carboxymethyl Materials: cellulose and EfferSoda (a commercial formulation of 88% sodium bicarbonate and 12% sodium carbonate)
- Testing data meeting the requirements of Class II Special Performance Data: Controls Guidance Document: Dental Bone Grafting Material Devices (dated April 28, 2005) has been submitted.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Christopher Klaczyk Regulatory Affairs Manager Etex Corporation 38 Sidney Street Cambridge, Massachusetts 02139
DEC2 1 2010
: .
Re: K100883
Trade/Device Name: CarriGen Porous Bone Substitute Material Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: December 7, 2010 Received: December 8, 2010
Dear Mr. Klaczyk:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
.
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Page 2- Mr. Klaczyk
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Kunrei
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications For Use
510(k) Number (if known):
Device Name:
CarriGen Porous Bone Substitute Material
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Indications for Use:
CarriGen Porous Bone Substitute is an injectable, self setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended to be used in bony voids or gaps to fill and/or augment dental intraosseous, intraoral and maxillofacial defects. These defects include periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, apicoectorny, cystectomy); dental extraction sites (ridge maintenance, implant preparation / placement); sinus lifts; cystic defects; and oral and maxillofacial augmentation. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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 Anesthesiology, General Hospital |
| Infection Control, Dental Devices |
| 510(k) Number: | K100883 |
|---|---|
| ---------------- | --------- |
ETEX Corporation
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.