(109 days)
Accell Evo3c™ is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the posterolateral spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
The Accell Evo3c™ is an extension to the Accell Family of products cleared under 510(k) K061880. The Accell Family of products, including Accell Evo3c™, contain human demineralized bone matrix (DBM) in particulate and dispersed forms. The Accell Evo3c™ is the same as Accell A2i, submitted under 510(k) K061880, with the exception of the inclusion of cancellous bone chips which are added as an osteoconductive scaffold. The Accell A2i is marketed under the brand name "Accell Evo3™," hence the "c" in Accell Evo3c™ denotes the inclusion of cancellous chips in the formulation.
This document is a 510(k) summary for the ACCELL EVO3C™ bone void filler, asserting its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI device would.
Instead, the "acceptance criteria" here refer to the regulatory requirements for demonstrating "substantial equivalence" of a new medical device to a predicate device, as per FDA's 510(k) pathway. The "study that proves the device meets the acceptance criteria" refers to the verification testing and characterization that supports this claim of substantial equivalence.
Here's an breakdown based on the provided text, recognizing that the context is a regulatory submission for a bone void filler, not an AI or diagnostic device:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is not a diagnostic AI device, there are no typical performance metrics like sensitivity, specificity, or AUC with corresponding acceptance criteria. Instead, the "acceptance criteria" are related to demonstrating substantial equivalence in terms of technical characteristics, safety, and functionality compared to predicate devices. The "reported device performance" refers to the results of various tests demonstrating these equivalencies.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same indications for use. | Accell Evo3c™ has the same intended use as predicate devices: "filling voids and gaps in the skeletal system... as a bone graft extender... or as a bone void filler..." |
| Principle of Operation Equivalence: Similar mechanism. | Accell Evo3c™ utilizes human demineralized bone matrix (DBM) in particulate and dispersed forms, similar to the Accell Family of products. The primary difference is the addition of cancellous bone chips for osteoconductivity, which does not alter the fundamental principle of operation as a resorbable bone void filler. |
| Technological Characteristics Equivalence: Similar materials, processing, and functional properties. | - Composition: Contains human demineralized bone matrix (DBM) and cancellous bone chips. This is an extension of the Accell Family (K061880), specifically Accell A2i, with the added cancellous chips. - Osteoinductive Potential: Each lot of DBM is tested using a quantitative in vitro assay validated to correlate with an athymic mouse osteoinductive potential assay. - Viral Inactivation Validation: Methods for processing DBM were evaluated for viral inactivation potential against a panel of viruses, demonstrating suitable inactivation. The cancellous bone component, while not demineralized, is processed in AATB-recommended antimicrobial, antiviral, and antiseptic solutions, and multiple safeguards (donor screening, serologic testing, tissue cleaning, terminal sterilization) are in place to mitigate viral transmission risk. |
| Safety and Effectiveness: No new questions of safety/efficacy. | "All necessary verification testing has been performed for the Accell Evo3c™ product to assure substantial equivalence to the predicate device." The viral inactivation validation demonstrates safety measures against potential pathogens. |
"Study That Proves the Device Meets the Acceptance Criteria":
The "study" cited is the sum of verification testing performed for the Accell Evo3c™ product, specifically mentioned under "5.5 Performance Data". This testing aimed to assure substantial equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
This is not applicable in the context of an AI device's test set for a 510(k) submission of a bone void filler.
- The "test set" here refers to the materials used in the specific verification tests (e.g., lots of DBM, samples of cancellous bone).
- For Osteoinductive Potential, each "lot of DBM" is tested. The specific number of lots or samples per lot is not provided. The testing involves an in vitro assay validated against an athymic mouse osteoinductive potential assay.
- For Viral Inactivation Validation, "a selected panel of viruses representing various virus types, sizes, shapes and genomes" was evaluated. The exact number of viruses or samples is not specified.
- Data Provenance: The human DBM is from human donors. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, as these are lab-based verification tests rather than clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. "Ground truth" in the context of this device refers to the established biological and material properties, rather than expert consensus on diagnostic imaging. The "truth" of osteoinductivity is determined by validated in vitro and in vivo (athymic mouse) assays. The efficacy of viral inactivation is determined by established microbiological validation methods.
4. Adjudication Method for the Test Set:
Not applicable. There is no expert adjudication for these types of material property tests. The tests themselves provide objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This is a bone void filler, not a diagnostic imaging device with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used:
- Osteoinductive Potential: The ground truth is established through a quantitative in vitro assay that has been "validated to correlate to an athymic mouse osteoinductive potential assay." So, an in vitro assay correlated to an animal model.
- Viral Inactivation Validation: The ground truth is the demonstrable reduction or inactivation of a "panel of viruses" by the processing methods, measured using standard microbiological validation techniques.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device (bone void filler) and not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of device.
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5.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | IsoTis OrthoBiologics, Inc. | |
|---|---|---|
| TRADE NAME: | ACCELL EVO3C™ | |
| COMMON NAME: | Bone Void Filler | |
| CLASSIFICATIONNAME: | Resorbable calcium salt bone void filler | AUG 10 2009 |
| DEVICECLASSIFICATION: | Class II | |
| PRODUCT CODE | MQV, MBP | |
| PREDICATE DEVICES: | Accell Family of products - K061880 (Accell DBM100,Accell TBM®, Accell A2i and Accell Connexus®),DYNAGRAFT® II - K040419, ORTHOBLAST® II |
K050642 , DBX DBM Mix - K063676, Grafton DBM Orthoblend - K051195
5.1 Substantially Equivalent To:
The Accell Evo3c™ is substantially equivalent in intended use, principal of operation and technological characteristics to the current Accell Family of products (Accell DBM100, Accell TBM®, Accell A2i and Accell Connexus®); 510(k) - K061880, DYNAGRAFT® II; 510(k) -K040419, ORTHOBLAST® II; 510(k) – K050642, DBX DBM Mix; 510(k) – K063676, and Grafton DBM Orthoblend 510(k) – K051195.
5.2 Description of the Device Subject to Premarket Notification:
The Accell Evo3c™ is an extension to the Accell Family of products cleared under 510(k) K061880. The Accell Family of products, including Accell Evo3c™, contain human demineralized bone matrix (DBM) in particulate and dispersed forms. The Accell Evo3c™ is the same as Accell A2i, submitted under 510(k) K061880, with the exception of the inclusion of cancellous bone chips which are added as an osteoconductive scaffold. The Accell A2i is marketed under the brand name "Accell Evo3™," hence the "c" in Accell Evo3c™ denotes the inclusion of cancellous chips in the formulation.
5.3 Indication for Use:
Accell Evo3c™ is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the posterolateral spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
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5.4 Technical Characteristics:
The Accell Evo3c™ and Accell Family of products (K061880) utilize ground and demineralized, human cortical bone (DBM) in the formulation of the product. The Accell Evo3c™ includes cancellous chips which act as an osteoconductive scaffold. The DBM component exhibits osteoinductive potential in validated animal and/or in vitro models. It is unknown how the osteoinductive potential, measured in these validated models, will correlate with clinical performance in human subjects.
5.5 Performance Data:
All necessary verification testing has been performed for the Accell Evo3c™ product to assure substantial equivalence to the predicate device.
5.6 Osteoinductive Potential
Each lot of DBM used to manufacture the Accell Evo3c™ and the Accell Family of products is tested for osteoinductive potential using a quantitative in vitro assay. The in vitro assay has been validated to correlate to an athymic mouse osteoinductive potential assay. It is unknown how osteoinductive potential measured via the in vitro or athymic mouse assays will correlate with human clinical performance.
5.7 Viral Inactivation Validation
The methods for processing of the DBM contained in Accell Evo3c™ and the Accell Family of products were evaluated for their viral inactivation potential. A selected panel of viruses representing various virus types, sizes, shapes and genomes were evaluated. The viral inactivation testing demonstrated suitable inactivation potential of the processing methods for a wide range of potential viruses.
Viral Inactivation Validation: The methods for processing of the DBM contained in Accell Evo3c were evaluated for their viral inactivation potential. A selected panel of viruses representing various virus types, sizes, shapes and genomes were evaluated. The viral inactivation testing demonstrated suitable inactivation potential of the processing methods for a wide range of potential viruses. . The Evo3c product contains cancellous bone which has been added to the demineralized bone matrix. Since the cancellous bone chips are not demineralized, the degree of viral inactivation of this component is not fully known The cancellous bone has been processed in antimicrobial, antiviral, and antiseptic solutions which are recommended by the American Association of Tissue Banks (AATB) to reduce the risk of transmissible viral diseases from human tissue products. The risk of disease transmission with the cancellous bone component remains low due to multiple safeguards including donor screening, serologic testing, tissue cleaning process, and terminal sterilization of the finished device.
5.8 Basis for Determination of Substantial Equivalence:
Upon reviewing the safety and efficacy information provided in this submission and comparing
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intended use, principle of operation and overall technological characteristics, the Accell Evo3c™, has been determined by IsoTis OrthoBiologics to be substantially equivalent to an existing legally marketed device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
IsoTis OrthoBiologics, Inc. Division of Integra LifeSciences Corporation % Ms. Carroll Councilman Director Quality Assurance and Regulatory Affairs 2 Goodyear, Suite A Irvine, California 92618
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2009
Re: K091193
Trade/Device Name: Accell Evo3cTM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: II Product Code: MQV, MBP Dated: June 2, 2009 Received: June 3, 2009
Dear Ms. Councilman :
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 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); 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.
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Page 2 - Ms. Carroll Councilman
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Сваловкин
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K091193
Device Name:
Accell Evo3c™
Indications for Use:
Accell Evo3c™ is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. Accell Evo3c is indicated for use as a bone graft extender in the posterolateral spine, extremities and pelvis, or as a bone void filler in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|---|
| (Optional Format 1-2-96) | |||
| (Division Sign-Off) | Page 1 of 1 | ||
| Division of Surgical, Orthopedic, and Restorative Devices | |||
| 510(k) Number | K091193 |
CONFIDENTIALISOTIS ORTHOBIOLOGICS, INC. ACCELL EVO3C™
§ 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.