(84 days)
No
The 510(k) summary describes a bone graft material and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is described as a bone void filler and graft extender, which assists in bone formation rather than directly treating a disease or condition.
No
Explanation: The device, Accell Evo3, is a moldable putty used to fill voids and gaps in the skeletal system (bone graft extender/bone void filler). Its purpose is therapeutic or reparative, not diagnostic.
No
The device description clearly states that Accell Evo3 is a "moldable putty" containing physical components like de-mineralized bone matrix and a poloxamer medium, packaged in a syringe. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill voids and gaps in the skeletal system and act as a bone graft extender or bone void filler. This is a therapeutic and structural function within the body.
- Device Description: The device is a moldable putty containing de-mineralized bone matrix and a poloxamer medium. This is a material intended for implantation or placement 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 treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. Accell Evo3 is used within the body for structural support and bone regeneration.
N/A
Intended Use / Indications for Use
Accell Evo3 is intended to fill voids and gaps in the skeletal system that are not intrinsic to the bony structure. The product is indicated for use as a bone graft extender in the spine, extremities and pelvis. Accell Evo3 may also be used as a bone void filler in the posterolateral spine, extremittes and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
Product codes
MQV, MBP
Device Description
Accell Evo3 is a moldable putty that contains ground, cortical de-mineralized bone marrix (DBM) in particulate and solubilized forms as well as a poloxamer reverse phase medium for proper handling. The device is packaged in a prefiled open-bore polycarbonate syringe and terminally sterilized by e-beam radiation. The DBM used to manufacture Accell Evo3 is only obtained from AATB-accredited facilities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system, spine, extremities, 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
Accell Evo3 demonstrated effective bone formation through fusion when tested in the postero-lateral rabbit spine model. Radiographic, histological and biomechanical evidence of the device's equivalence to autograft The in vivo and in vitro tests performed on Accell Evo3 demonstrate substantial equivalence in terms of controls. intended use, technological characteristics and performance to its predicate devices.
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
510(k) SUMMARY
Date of Preparation December 20, 2010
Company Integra LifeSciences 2 Goodyear Irvine, CA 92618
Contact
Jenny Fam Director of Regulatory Affairs Integra Orthobiologics 949-595-8710
Proprietary Name Accell Evo3
Common Name
Bone Void Filler
Classification
21 CFR 888.3045; Resorbable calcium salt bone void filler
Product Codes
MQV: Filler, Bone Void, Calcium Compound MBP: Filler, Bone Void, Osteoinduction (Without Human Growth Factor)
Predicate Devices
The device is substantially equivalent to Integra Accell DBM Family (K061880) and Ostectech Grafton DBM Putty (K051195).
Indications for Use
Accell Evo3 is intended to fill voids and gaps in the skeletal system that are not intrinsic to the bony structure. The product is indicated for use as a bone graft extender in the spine, extremities and pelvis. Accell Evo3 may also be used as a bone void filler in the posterolateral spine, extremittes and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
Device Description
Accell Evo3 is a moldable putty that contains ground, cortical de-mineralized bone marrix (DBM) in particulate and solubilized forms as well as a poloxamer reverse phase medium for proper handling. The device is packaged in a prefiled open-bore polycarbonate syringe and terminally sterilized by e-beam radiation. The DBM used to manufacture Accell Evo3 is only obtained from AATB-accredited facilities.
Device Performance
Accell Evo3 is an osteoconductive bone void filler. The device is resorbed over time and provides a favorable environment that stimulates bone growth and remodeling. Accell Evo3 has been assayed in vitro for bone morphogenetic protein-2. The in vitro assay has been validated to an in vivo (athymic mouse) osteoinductive assay. It is unknown how osteoinductive polential measured via the in vivo assays will correlate with human clinical performance.
Viral Inactivation
The methods for processing the DBM contained in Accell Evo3 have been evaluated for viral inactivation potential. A panel of model potential human viruses representing various wirus types and genomes were evaluated. The DBM processing methods have been determined to provide significant viral inactivation for a wide range of potential viruses.
Determination of Substantial Equivalence
Accell Evo3 demonstrated effective bone formation through fusion when tested in the postero-lateral rabbit spine model. Radiographic, histological and biomechanical evidence of the device's equivalence to autograft The in vivo and in vitro tests performed on Accell Evo3 demonstrate substantial equivalence in terms of controls. intended use, technological characteristics and performance to its predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Integra LifeSciences IsoTis Orthobiologics % Ms. Jenny Fam Director of Regulatory Affairs 2 Goodyear Irvine, California 92672
MAR 1 7 2011
Re: K103742
Trade/Device Name: Accell Evo36 Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MBP, MQV Dated: December 20, 2010 Received: December 28, 2010
Dear Ms. Fam:
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.
2
Page 2 - Ms. Jenny Fam
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 vours.
Az. B. M. h
Mark N. Melkerson Director Division of Surgical. Orthonedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number:
Device Name: Accell Evo38
Indications for Use:
Accell Evo3 is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use as a bone graft extender in the spine, extremities and pelvis. Accell Evo3 may also be used as a bone void filler in the posterolateral spine, extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
Prescription Use X (Part 21 CFR 801 Sub-part D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Sub-part C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign Off
(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic.
Division torotive Devices Division of Surgical
and Restorative Devices
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510(k) Number K103742