(91 days)
Not Found
No
The description focuses on the material properties and surgical application of a bone substitute, with no mention of AI or ML.
Yes
The device is an implantable bone graft intended for the filling, repair, reconstruction, and augmentation of defects in craniofacial bones, which constitutes a therapeutic purpose.
No
The intended use and device description state that this device is an implantable bone graft material used for filling, repairing, reconstructing, and augmenting bone defects. It does not mention any function related to diagnosing a disease or condition.
No
The device description clearly describes a physical, synthetic bone graft material that is mixed and applied as a paste, which then hardens. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "filling, repair, reconstruction and augmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones." This describes a surgical implant used directly on the patient's body for structural repair.
- Device Description: The description details a material that is mixed and applied as a paste to harden in situ, becoming an osteoconductive material that is resorbed and replaced by natural bone. This is a description of a medical device used for tissue repair and regeneration within the body.
- Lack of Diagnostic Purpose: There is no mention of this device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a therapeutic implant used for structural repair.
N/A
Intended Use / Indications for Use
CaP Bone Substitute Material is an implantable bone graft, that is a synthetic, calcium phosphate, hydroxyapatite material intended for use in the filling, repair, reconstruction and auqmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas, with a surface area no larger than 25cm².
Product codes
87 GXP
Device Description
Calcium Phosphate (CaP) Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. It is intended for use in cranial-maxillo-facial surgical repair applications. At the time of use, the CaP product material is combined with the mixing liquid (U.S.P. Sodium Chloride, 0.9%) in the elastomeric mixing bulb, and is mixed, using a kneading technique, to form a paste. The paste can be administered to the treatment site by manual application, and be shaped in situ or into a desired form prior to implantation. After applying the paste to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order and has a similar chemical identity and crystalline structure to that of natural bone. CaP Bone Substitute Material is an osteoconductive material that is 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
craniofacial bones including fronto-orbital, malar and mental areas
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).
0
OCT 2 4 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| SPONSOR: | ETEX Corporation |
|---|---|
| 38 Sidney Street, 3rd Floor | |
| Cambridge, MA 02139 | |
| Phone: (617) 577-7270 x236 | |
| Fax: (617) 577-7170 | |
| 510(k) CONTACT: | Kristine Canavan |
| Manager, Regulatory Affairs | |
| TRADE NAME: | CaP Bone Substitute Material |
| COMMON NAME: | Bone Graft Material |
| Bone Substitute Material | |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | 21 CFR 882.5300 |
| Methyl Methacrylate for Cranioplasty | |
| PRODUCT CODE: | 87 GXP |
| PREDICATE DEVICES: | a-BSM® Bone Substitute Material |
| 510(k) No.: K983009, ETEX Corporation |
DEVICE DESCRIPTION:
Calcium Phosphate (CaP) Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. It is intended for use in cranial-maxillo-facial surgical repair applications. At the time of use, the CaP product material is combined with the mixing liquid (U.S.P. Sodium Chloride, 0.9%) in the elastomeric mixing bulb, and is mixed, using a kneading technique, to form a paste. The paste can be administered to the treatment site by manual application, and be shaped in situ or into a desired form prior to implantation. After applying the
1
Image /page/1/Picture/0 description: The image shows handwritten text, including the alphanumeric string "K032307" and "20F2". Below these strings, the word "CONFIDENTIAL" is printed in bold and underlined. The text appears to be part of a document or label, possibly indicating a classification level or identification code.
paste to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order and has a similar chemical identity and crystalline structure to that of natural bone. CaP Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
INDICATIONS FOR USE:
CaP Bone Substitute Material is an implantable bone graft, that is a synthetic, calcium phosphate, hydroxyapatite material intended for use in the filling, repair, reconstruction and auqmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas, with a surface area no larger than 25cm².
BASIS OF SUBSTANTIAL EQUIVALENCE:
CaP Bone Substitute Material is a synthetic bone graft substitute material substantially equivalent to α-BSM Bone Substitute Material (OMF). Both materials are provided sterile and as single patient, single use kits and are identical in intended use (i.e., cranio-maxillo-facial indications). CaP Bone Substitute Material is also similar to α-BSM Bone Substitute Material (OMF) in material properties and in product performance characteristics. Differences between the CaP and a-BSM products do not raise any new questions of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
OCT 2 4 2003
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle's head and neck, represented by three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kristine Canavan Manager, Regulatory Affairs ETEX Corporation University Park at MIT 38 Sidney Street Cambridge, MA 02139
Re: K032307
Trade Name: CaP Bone Substitute Material Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate for Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: July 24, 2003 Received: July 28, 2003
Dear Ms. Canavan:
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 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
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Page 2 - Ms. Kristine Canavan
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 (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 vours.
Sincerely yours,
Mark A. Millam
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known)
Device Name: CaP Bone Substitute Material
Indications for Use:
CaP Bone Substitute Material is an implantable bone graft, that is a synthetic calcium phosphate hydroxyapatitic material intended to be implanted for use in the filling, repair, reconstruction and augmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas with a surface area no larger than 25cm .
Concurrence of CDRH, Office of Device Evaluation
イズモデルティースイエステーマーニーニーニーニーニーニーニーニーニーニー・ホームニーニーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
for Mark N. Millburn
vision Sign-Off) Frision of General, Restorative and Neurological Devices
Number K03 2307