(408 days)
The Accell Family of products are intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
Accell DBM family of products are used for orthopaedic bone grafting procedures. They are osteoconductive human allogenic demineralized bone filling materials for use as fillers for gaps or voids that are not intrinsic to the stability of the bony structure.
Accell DBM family of products are products that are manufactured using human donor demineralized bone and may contain up to 70% poloxamer reverse phase medium carrier (RPM). The demineralized bone is derived from human ground, cortical allograft bone. Poloxamer RPM is an inactive product ingredient that is utilized as a containing agent for the demineralized bone and provides appropriate product handling characteristics for the products.
The products of the Accell DBM family are comprised of the same DBM and RPM components as found in DynaGraft II Gel, FDA cleared under 510(k) number K040419 and Connexus cleared under 510(k)'s K050690 and K052098. In addition, the Accell DBM family of products may contain up to a maximum of 70% of RPM carrier. This is the concentration of RPM already cleared in DynaGraft II gel.
Acceptance Criteria and Device Performance Study for IsoTis Accell DBM Family of Products (K061880)
This submission for the IsoTis Accell DBM Family of Products focuses on demonstrating substantial equivalence to predicate devices, primarily through material characterization and animal studies, rather than clinical efficacy against a specific set of performance criteria for human use.
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not outline specific numerical acceptance criteria for device performance. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices primarily through:
- Material Characterization: Ensuring the chemical composition, pH, and physical characteristics of the carrier (poloxamer RPM granules) are consistent with previously cleared products.
- Resorption Studies: Demonstrating suitable resorption rates of both the carrier and the DBM in animal models, comparable to the predicate.
- Osteoinductivity Potential: Verifying that each lot of DBM exhibits osteoinductive potential using an in vitro assay correlated to an athymic rat assay.
- Viral Inactivation: Confirming the processing methods effectively inactivate a panel of viruses.
- Safety and Performance in Animal Models: Demonstrating no safety or performance issues in animal studies (critical size defects, spinal fusion) compared to the predicate.
Given this, a table of acceptance criteria and reported device performance would look like this:
| Acceptance Criterion (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Carrier Characteristics | Analyzed for pH, physical characteristics, and appearance. Confirmed consistent with previously cleared products (DynaGraft II Gel). |
| Carrier Resorption | Resorption study performed in male adult rats to examine rate and extent of carrier elimination. |
| DBM Resorption | Demonstrated during rabbit animal studies (little DBM detected after 12 weeks, most remodeled). |
| Osteoinductive Potential | Each lot of DBM tested in vitro (cell culture assay) validated to correlate with an athymic rat osteoinductive potential assay. |
| Viral Inactivation | Methods for DBM processing evaluated with a panel of viruses, demonstrating suitable inactivation potential. |
| Safety and Performance in Animal Models | Rabbit tibial critical size defects and rabbit spinal fusion studies performed. Confirmed no safety or performance issues, substantially equivalent to DynaGraft II Gel. |
2. Sample Size for Test Set and Data Provenance
The provided document does not specify exact sample sizes for each animal study conducted for the Accell DBM family of products. It mentions:
- Carrier Resorption: "A resorption study has been performed to examine the rate and extent of carrier elimination in male adult rats." (No sample size provided)
- DBM Resorption: "Resorption of the DBM was demonstrated during rabbit animal studies." (No sample size provided)
- Specific Performance Studies: "These studies included rabbit tibial critical size defects and rabbit spinal fusion studies." (No sample size provided)
The data provenance is prospective animal studies conducted in rabbits and rats. There is no indication of country of origin for the data; typically, such studies would be conducted in the country of device manufacture or where the research facilities are located.
The document also references "Several animal studies were performed on both Connexus and DynaGraft II Gel and were submitted as part of their original 510(k) submissions (K050690 and K040419)." This suggests reliance on previously submitted data for predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission relies on animal models and laboratory testing (in vitro), not human clinical data with expert-established ground truth. Therefore, there were no human experts used to establish ground truth for a test set in the traditional sense involving clinical outcomes. The "ground truth" for the animal studies would be the physiological and histological observations made by veterinarians, pharmacologists, and histopathologists during the animal experiments, but their specific number and qualifications are not detailed.
For the in vitro osteoinductive potential assay, the validation to the athymic rat model serves as the ground truth correlation, established through laboratory methods rather than expert clinical consensus.
4. Adjudication Method for the Test Set
The concept of an adjudication method (e.g., 2+1, 3+1) is not applicable here as the studies are animal and in vitro based, not human clinical trials requiring consensus on clinical endpoints. The interpretation of animal study results would typically be done by the research team involved (e.g., veterinary pathologists, histologists) following standard scientific protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance is being evaluated for its impact on reader performance. This device is a bone void filler/graft extender, not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. This is not a software algorithm or AI device that operates independently. The "device" is a physical material (Demineralized Bone Matrix with a carrier).
7. Type of Ground Truth Used
The ground truth used was:
- Animal Outcomes/Histopathology: For resorption studies (in rats and rabbits) and safety/performance in animal models (tibial critical size defects, spinal fusion in rabbits). This involves observation of tissue remodeling, graft integration, and absence of adverse reactions.
- In Vitro Assay Correlation: For osteoinductive potential, where an in vitro cell culture assay was validated to correlate with an athymic rat osteoinductive potential assay.
- Laboratory Characterization: For chemical composition, pH, and physical characteristics of the carrier, confirmed through analytical testing.
- Viral Inactivation Assays: For demonstrating the efficacy of processing methods against a panel of viruses.
8. Sample Size for the Training Set
The concept of a "training set" in the context of machine learning or AI is not applicable to this submission. The device is a medical material, and its development and testing involve traditional biological and material science studies, not AI model training. Therefore, there is no training set as typically defined for AI/ML products.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the AI/ML sense, this question is not applicable. The "ground truth" for the various performance aspects of the material (as described in point 7) was established through established scientific methodologies in animal research, in vitro assays, and chemical characterization.
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KO61880
AUG 1 5 2007
510(K) SUMMARY
IsoTis Accell DBM Family of Products
SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED
IsoTis OrthoBiologics, Inc. 2 Goodvear Irvine CA 92618 U.S.A.
- (949) 855-7168 PHONE:
- Contact Person: Karon Morell
- Date Prepared: August 10, 2007
NAME OF DEVICE:
Accell Family of Products (Accell DBM 100, Accell TBM, A2i, and Accell Connexus)
Common or Usual Name
Bone Void Filler
CLASSIFICATION NAME
21 C.F.R. § 888.3045 Resorbable calcium salt bone void filler device
PREDICATE DEVICES
DynaGraft II Paste and Putty (K040419) AlloMatrix ® DBM Putty with inert carrier Sodium Carboxymethylcellulouse (K040980) InterGro® DBM with inert carrier Lecithin (K031399) Osteofil Paste DBM with inert carrier Porcine Collagen (K043420)
INTENDED USE/INDICATIONS
The Accell Family of products are intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers 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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DEVICE DESCRIPTION
Accell DBM family of products are used for orthopaedic bone grafting procedures. They are osteoconductive human allogenic demineralized bone filling materials for use as fillers for gaps or voids that are not intrinsic to the stability of the bony structure.
Accell DBM family of products are products that are manufactured using human donor demineralized bone and may contain up to 70% poloxamer reverse phase medium carrier (RPM). The demineralized bone is derived from human ground, cortical allograft bone. Poloxamer RPM is an inactive product ingredient that is utilized as a containing agent for the demineralized bone and provides appropriate product handling characteristics for the products.
The products of the Accell DBM family are comprised of the same DBM and RPM components as found in DynaGraft II Gel, FDA cleared under 510(k) number K040419 and Connexus cleared under 510(k)'s K050690 and K052098. In addition, the Accell DBM family of products may contain up to a maximum of 70% of RPM carrier. This is the concentration of RPM already cleared in DynaGraft II gel.
SUMMARY OF PERFORMANCE TESTING
The poloxamer RPM granules used to prepare the carrier in two of the Accell DBM family of products are characterized to confirm the chemical composition. The carrier is analyzed for pH, physical characteristics and appearance. A resorption study has been performed to examine the rate and extent of carrier elimination in male adult rats.
Resorption of the DBM was demonstrated during rabbit animal studies. After 12 weeks, very little of the DBM could be detected and most had been remodeled.
Viral inactivation studies have been performed for the demineralization process in combination with terminal sterilization processing.
Several animal studies were performed on both Connexus and DynaGraft II Gel and were submitted as part of their original 510(k) submissions (K050690 and K040419). Additional animal studies have been performed and previously submitted in the 510(k) supplements, for the Accell DBM family of products. These studies included rabbit tibial critical size defects and rabbit spinal fusion studies.
These studies confirmed that the Accell products raised no safety or performance issues and are substantially equivalent to the predicate device, DynaGraft II Gel Demineralized Bone Matrix.
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Osteoinducitive Potential
Each lot of DBM used to manufacture the Accell DBM family of products is tested for osteoinductive potential using an in vitro cell culture test. The in vitro cell culture assay has been validated to correlate to an athymic rat osteoinductive potential assay. It is unknown how osteoinductivity potential, measured via the in vitro cell culture or athymic rat assays, will correlate with human clinical performance.
VIRAL INACTIVATION VALIDATION
The methods for processing of the DBM contained in 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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 15 2007
IsoTis OrthoBiologics, Inc. c/o Ms. Karen Morell Director Ouality Assurance and Regulatory Affairs 2 Goodyear Irvine, CA 92618
Re: K061880
Trade Name: Accell Family of Products (Accell DBM 100, Accell TBM, A2i, and Accell Connexus) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MBP, MOV Dated: May 28, 2007 Received: May 30, 2007
Dear Ms. Morell:
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
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Page 2 - Ms. Karen Morell
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.
Sincerely vours.
Barbara Buell
Mark N. Melkerson Director Division of General, Restorative and Neurological 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): K061880
Accell Family of Products (Accell DBM 100, Accell TBM, A2i, and Accell Device Name: Connexus)
Indications for Use:
The Accell Family of products are intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders in the spine, extremities and pelvis, or as bone void fillers in the extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.
Prescription Use ✔ (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sarbare Buell
Division of General, Restorative and Neurological Devices
510(k) Number K0 6 1880
Page 1 of 1
11DC - 088BB4/000001 - 25B5505 vl
§ 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.