(266 days)
No
The device description and intended use focus on the material properties and physical application of a bone graft substitute, with no mention of AI or ML technologies.
Yes.
The device is intended to be used as a bone graft substitute material to fill and/or augment dental and maxillofacial defects, indicating a medical purpose to treat or alleviate a condition.
No
The device is a bone graft substitute material intended to fill and/or augment bony voids or gaps; it is not described as diagnosing or detecting diseases or conditions.
No
The device is a physical bone graft substitute material, not software. The description details its composition, preparation, and application as a putty that hardens in the body.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that CarriGen Porous Bone Substitute is a material used to fill and/or augment bony voids or gaps within the body (dental intraosseous, intraoral, and maxillofacial defects).
- Device Description: The description details a material that is mixed and applied to a surgical site and hardens at body temperature. It is a bone graft substitute that is resorbed and replaced by natural bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a material implanted into the body for structural support and bone regeneration.
N/A
Intended Use / Indications for 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.
Product codes
LYC
Device Description
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 resorbed and replaced by natural bone over time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental intraosseous, intraoral and maxillofacial defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Alpha-bsm Bone Substitute Material (ETEX Corp., K091729), Beta-bsm Injectable Bone Substitute Material (ETEX Corp., K091729), Gamma-bsm Moldable Bone Substitute Material (ETEX Corp., K091729), EquivaBone Osteoinductive Bone Graft Substitute (ETEX Corp., K091729)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 2010
ETEX Corporation
38 Sidney Street
Cambridge, MA 02139
Registration No.: 1225112
Owner/Operator No.: 9014709 |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher Klaczyk
Regulatory Affairs Manager
Office: (617) 577-7270 x160
Mobile: (617) 710-8091
Fax: (617) 577-7170
E-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 (ETEX
Corp., K091729)
Gamma-bsm Moldable Bone Substitute Material (ETEX
Corp., K091729)
EquivaBone Osteoinductive Bone Graft Substitute (ETEX
Corp., K091729) |
| Device Description: | 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 |
1
(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.
2
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
4
4. Indications For Use
510(k) Number (if known):
Device Name:
CarriGen Porous Bone Substitute Material
ー・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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