(81 days)
Not Found
No
The summary describes a bone graft substitute material and its composition. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
This device is a bone graft substitute intended to fill bone voids and defects, aiding in the healing process by being replaced with new bone, which aligns with the definition of a therapeutic device.
No
The device, CaP Plus, is described as a bone graft substitute material intended for filling bone voids or defects. It reseorbs and is replaced by new bone during the healing process. Its function is to facilitate healing and replacement of bone tissue, not to diagnose a condition.
No
The device description clearly states it is a "bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM)" which is a physical material, not software.
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 CaP Plus is for "filling bone voids or defects of the skeletal system". This is a therapeutic use, directly applied to the patient's body to aid in bone healing.
- Device Description: The description details a material implanted into the body that hardens, resorbs, and remodels. This is consistent with a medical device used for treatment or repair within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. CaP Plus is used inside the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
CaP Plus is intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine, and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Product codes
MQV, MBP
Device Description
CaP Plus is a hiocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). After implantation, the product hardens at body temperature; then resorbs and remodels during the healing process. Each lot of DBM supplied with CaP Plus is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of CaP Plus osteoinductivity in humans.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (such as the extremities, spine, and the pelvis)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
CaP Plus Bone Substitute Material (K063050), CaP3 Bone Substitute Material (K033138), Optium DBMTM Gel & Putty (K053098)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
ETEX Corporation Medical Device 510(k) Submission CaP Plus
510(k) SUMMARY AS REQUIRED UNDER 21 CFR 807.87(H) 8.
. →
SUMMARY OF SAFETY AND EFFECTIVENESS
APR 2 8 2008
| SPONSOR: | ETEX Corporation
University Park at MIT
38 Sidney Street, 3rd Floor
Cambridge, MA 02139
Phone: (617) 577-7270
Fax: (617) 577-7170 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Pamela W. Adams, RAC
Senior Vice President and Chief Operating Officer |
| TRADE NAME: | CaP Plus
Equivabone
CaP/DBM |
| COMMON NAME: | Bone Void Filler
Bone Graft Material
Bone Substitute Material |
| CLASSIFICATION: | Class II |
| CLASSIFICATION NAME: | 21 CFR 888.3045
Resorbable Calcium Salt Bone Void Filler Device |
| PRODUCT CODE: | MQV, MBP |
| PREDICATE DEVICE(S): | CaP Plus Bone Substitute Material (K063050)
CaP3 Bone Substitute Material (K033138)
Optium DBMTM Gel & Putty (K053098) |
1
ETEX Corporation Medical Device 510(k) Submission CaP Plus
Device Description:
CaP Plus is a hiocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). After implantation, the product hardens at body temperature; then resorbs and remodels during the healing process. Each lot of DBM supplied with CaP Plus is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of CaP Plus osteoinductivity in humans.
Indications for Use:
Intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine, and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Basis of Substantial Equivalence:
CaP Plus shares the same function and intended use as the predicate devices. CaP Plus was found to be substantially equivalent to the predicate devices. The safety and effectiveness of CaP Plus is adequately supported by the substantial equivalence data and test results provided with this premarket notification.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing the human services aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2008
ETEX Corporation % Ms. Pamela W. Adams, RAC Senior Vice President and Chief Operating Officer University Park at MIT 38 Sidney Street, 3rd Floor Cambridge, MA 02139
K080329 Re:
Trade/Device Name: CaP Plus Regulation Number: CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: January 31, 2008 Received: February 11, 2008
Dear Ms. Adams:
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.
3
Page 2 - Ms. Pamela W Adams
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ETEX Corporation Medical Device 510(k) Submission CaP Plus
510(k) Number (if known)
CaP Plus Device Name:
Indications for Use:
CaP Plus is intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine, and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Prescription Use X
Over-The Counter Use
(Per 21 CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation
OR
Neil RR Ogle for
nxn
Division Sign-Off
Division of General, Restorative. and Neurological Devices
510(k) Number K080329
ETEX Corporation 510(k) CaP Plus Submission
01/31/2008