BIOGENNIX RPC by BIOGENNIX, LLC | FDA 510(k) Summary

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 the healing process.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the Biogennix RPC bone void filler, which is a medical device. This type of regulatory document focuses on establishing substantial equivalence to a predicate device, rather than defining novel acceptance criteria and conducting a new study to prove it.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted directly from this specific document, as they pertain to the evaluation of a new device's performance against predefined criteria, a Multi-Reader Multi-Case (MRMC) study, or a standalone algorithm performance study.

Here's the information that can be extracted and a clear indication of what is not applicable based on the provided text:

Acceptance Criteria and Device Performance

The "acceptance criteria" for a 510(k) submission like this are primarily demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The device performance relates to its ability to meet the characteristics of the predicate device.

Acceptance Criteria (Demonstrates Substantial Equivalence)	Reported Device Performance (Biogennix RPC)
Same Intended Use as the predicate device.	Biogennix RPC has the same intended use: filling bony voids or gaps not intrinsic to bony structure stability, and as a bone graft extender for posterolateral spine fusion when mixed with autogenous bone graft.
Same Technological Characteristics or differences do not raise new questions of safety or effectiveness.	Biogennix RPC has the same technological characteristics (osteoconductive, open cell, resorbable ceramic, composite of calcium salts, provides space for bone/vascular ingrowth, resorbs and replaced by bone). Bench testing (x-ray diffraction, FTIR, IPS-MS, biomechanical, morphometry, in vitro dissolution, biocompatibility) and animal implantation studies demonstrated substantial equivalence to the predicate device (Pro Osteon 500R).
Conformity to Applicable Standards (e.g., biocompatibility, sterilization).	Conforms to ISO 10993 series (Biological evaluation of medical devices) and ANSI/AAMI/ISO 11137 (Sterilization of Health Care Products for Radiation Sterilization).
Biocompatibility consistent with legally marketed devices.	Biocompatibility testing was included in the studies demonstrating substantial equivalence.
Mechanical Properties (e.g., structural integrity, handling) comparable to predicate.	Biomechanical and morphometry studies were conducted to demonstrate substantial equivalence.
Resorption and Bone Replacement characteristics (for resorbable materials).	In vitro dissolution and animal implantation in long bone defects and posterolateral spine demonstrated the device's resorption and replacement with bone during the healing process, consistent with the predicate.

Study Information

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable in this context. This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a predicate device through various tests (bench, animal) rather than a clinical "test set" in the context of diagnostic performance. The studies mentioned are:
  - x-ray diffraction, FTIR, IPS-MS, biomechanical, morphometry, in vitro dissolution (likely laboratory-based, not involving human subjects for a "test set").
  - Biocompatibility (likely in vitro and animal studies).
  - Animal implantation (in long bone defects and posterolateral spine).
- Details on the sample sizes for these specific tests (e.g., number of animals, number of specimens for bench tests) are not provided in this summary.
- Data provenance (country of origin, retrospective/prospective) is not specified.
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 Applicable. As this is not a diagnostic device submission focusing on human interpretation of data, there is no "ground truth" established by experts in the sense of image interpretation or clinical diagnosis. The "truth" in this context is the performance of the device in various physical, chemical, and animal models.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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 device is a bone void filler (a physical implant), not a diagnostic tool or AI software that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device is a physical bone void filler, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the established scientific and engineering principles for material performance, biocompatibility, and biological response in animal models. For example, for biomechanical tests, the ground truth would be the measured physical properties; for animal studies, it would be histological analysis of bone ingrowth and resorption. This is not "expert consensus" on diagnostic findings or patient outcomes in a clinical trial, but rather expert assessment of experimental results.
The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that would require a "training set."
How the ground truth for the training set was established:
- Not Applicable. See point 7.

Summary

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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 NameAddress:	Biogennix, Inc19200 Von Karman AvenueSuite 400Irvine, CA 92612	JUL 29 201
	Phone:Fax:	949-274-1700866-832-7879
	Contact:	Edwin Clayton Shors
2. DeviceName:
	Trade Name:Common Name:	Biogennix RPCBone Void Filler
	Classification Name:	Filler, bone void, calcium compound
3. Device Class
	Regulatory ClassProduct Code	IIMQV
	Panel	Orthopedic
	Regulation Number:	21CFR 888.3045
4. PredicateDevice		Pro Osteon 500R (K990131), marketed by Interpore Cross
5. DeviceDescription		Biogennix RPC is an osteoconductive, open cell, resorbable ceramic. Theceramic is a composite of calcium salts. The open pores and porosityprovide space and structure for bone and vascular ingrowth. The calciumsalts resorb over time. The product is available in block and granular forms.
6. IntendedUse:		Biogennix RPC is indicated only for bony voids or gaps that are not intrinsic tothe stability of the bony structure. Biogennix RPC is indicated to be gentlypacked into bony voids or gaps of the skeletal system (i.e., the extremities,spine and pelvis). These defects may be surgically created osseous defectsor osseous defects created from traumatic injury to the bone. Biogennix RPCbone void filler may be used as a bone graft extender for posterolateral spinefusion when mixed in a one to one ratio with autogenous bone graft. Theproduct provides bone void filler that resorbs and is replaced with bone during
7. PerformanceSummary	Comparative testing consistent with Class II Special Control GuidanceDocument: Resorbable Calcium Salt Bone Void filler Device: Guidance forIndustry and FDA Staff (dated June 2, 2003) has been submitted to showthat 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 inlong bone defects and posterolateral spine. These studies demonstrated

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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

1. 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.

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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

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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

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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

Regulation Number and Section

§ 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.