(276 days)
Not Found
No
The summary describes a resorbable ceramic bone void filler and its performance studies, with no mention of AI or ML technology.
Yes
The device is a bone void filler that resorbs and is replaced with bone during the healing process, indicating its use in treating bone defects and promoting healing.
No
This device is described as a "bone void filler" and is used in a surgical context to help bone heal. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a ceramic material available in block and granular forms, indicating a physical, hardware-based medical device.
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 Biogennix RPC is a bone void filler used to pack into bony voids or gaps in the skeletal system. This is a therapeutic and structural application within the body.
- Device Description: The description details a ceramic material designed for osteoconduction and resorption within the body, facilitating bone growth.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. Biogennix RPC is implanted within the body to aid in bone healing.
N/A
Intended Use / Indications for Use
Biogennix RPC is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Biogennix RPC is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the home. Biogennix PRC may be used as a bone graft extender in posterolateral spine fusion when mixed in a one to one ratio with autogenous bone graft. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
Biogennix RPC is an osteoconductive, open cell, resorbable ceramic. The ceramic is a composite of calcium salts. The open pores and porosity provide space and structure for bone and vascular ingrowth. The calcium salts resorb over time. The product is available in block and granular forms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities, spine and 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
Comparative testing consistent with Class II Special Control Guidance Document: Resorbable Calcium Salt Bone Void filler Device: Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the Biogennix RPC is substantially equivalent to the predicate dice. Studies included x-ray diffraction, FTIR, IPS-MS, biomechanical, morphometry, in vitro dissolution, biocompatibility, and animal implantation in long bone defects and posterolateral spine. These studies demonstrated that Biogennix RPC performed substantially equivalent to the predicate device. In addition, the device conforms to applicable standards , including ISO 10993 series: Biological evaluation of medical devices, ANSVAAM/ISO 11137 Sterilization of Health Care Products for Radiation Sterilization
Key Metrics
Not Found
Predicate Device(s)
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
Section: 510k Summary 510k Notification #K093342 :
This summary of 510k safety and effectiveness information being submitting in accordance with the requirement of SMDA and 21 CFR 807.92
| 1. Submitted by: | |||||
|---|---|---|---|---|---|
| Submitter's Name | |||||
| Address: | Biogennix, Inc | ||||
| 19200 Von Karman Avenue | |||||
| Suite 400 | |||||
| Irvine, CA 92612 | JUL 29 201 | ||||
| Phone: | |||||
| Fax: | 949-274-1700 | ||||
| 866-832-7879 | |||||
| Contact: | Edwin Clayton Shors | ||||
| 2. Device | |||||
| Name: | |||||
| Trade Name: | |||||
| Common Name: | Biogennix RPC | ||||
| Bone Void Filler | |||||
| Classification Name: | Filler, bone void, calcium compound | ||||
| 3. Device Class | |||||
| Regulatory Class | |||||
| Product Code | II | ||||
| MQV | |||||
| Panel | Orthopedic | ||||
| Regulation Number: | 21CFR 888.3045 | ||||
| 4. Predicate | |||||
| Device | Pro Osteon 500R (K990131), marketed by Interpore Cross | ||||
| 5. Device | |||||
| Description | Biogennix RPC is an osteoconductive, open cell, resorbable ceramic. The | ||||
| ceramic is a composite of calcium salts. The open pores and porosity | |||||
| provide space and structure for bone and vascular ingrowth. The calcium | |||||
| salts resorb over time. The product is available in block and granular forms. | |||||
| 6. Intended | |||||
| Use: | Biogennix RPC is indicated only for bony voids or gaps that are not intrinsic to | ||||
| the stability of the bony structure. Biogennix RPC is indicated to be gently | |||||
| packed into bony voids or gaps of the skeletal system (i.e., the extremities, | |||||
| spine and pelvis). These defects may be surgically created osseous defects | |||||
| or osseous defects created from traumatic injury to the bone. Biogennix RPC | |||||
| bone void filler may be used as a bone graft extender for posterolateral spine | |||||
| fusion when mixed in a one to one ratio with autogenous bone graft. The | |||||
| product provides bone void filler that resorbs and is replaced with bone during | |||||
| 7. Performance | |||||
| Summary | Comparative testing consistent with Class II Special Control Guidance | ||||
| Document: Resorbable Calcium Salt Bone Void filler Device: Guidance for | |||||
| Industry and FDA Staff (dated June 2, 2003) has been submitted to show | |||||
| that the Biogennix RPC is substantially equivalent to the predicate dice. | |||||
| Studies included x-ray diffraction, FTIR, IPS-MS, biomechanical, | |||||
| morphometry, in vitro dissolution, biocompatibility, and animal implantation in | |||||
| long bone defects and posterolateral spine. These studies demonstrated |
1
that Biogennix RPC performed substantially equivalent to the predicate device. In addition, the device conforms to applicable standards , including ISO 10993 series: Biological evaluation of medical devices, ANSVAAM/ISO 11137 Sterilization of Health Care Products for Radiation Sterilization
-
- Conclusions: Biogennix RPC has the same intended use and technological characteristics as the predicate device. Moreover, bench testing contained. In this submission demonstrated that any differences in their technologic characteristics do not raise any new questions of safely or effectiveness. Thus, Biogennix RPC is substantial equivalent to the predicate device.
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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biogennix, LLC % Mr. Edwin C. Shors President 19200 Von Karman Avenue - Suite 400 Irvine, California 92612
JUL 2 5 2010
Re: K093342
Trade/Device Name: Biogennix RPC Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: July 13, 2010 Received: July 14, 2010
Dear Mr. Shors:
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.
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
3
Page 2 - Mr. Edwin C. Shors
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 (OS) 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,
Carlare Muehl
Mark N. Melke Director Division of Surgical. Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use Statement
510K Number K093342:
JUL 2 5 2010
DEVICE NAME: Biogennix RPC
INDICATION FOR USE
Biogennix RPC is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Biogennix RPC is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the home. Biogennix PRC may be used as a bone graft extender in posterolateral spine fusion when mixed in a one to one ratio with autogenous bone graft. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
| Prescription Use
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | AND/OR | Over the Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D | ?1 CFR 801 Subpart し |
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Pevice Evaluation (ODE)
rthonedic.
510(k) Number K093342