(90 days)
ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP, and ALLOMATRIX® PLUS CBM are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM come in the form of a kit with a premeasured powder, TCP and/or CBM chips, premeasured mixing solution, and the tools necessary to mix the components. emps, premeasured himmy all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.
The provided text describes a 510(k) summary for ALLOMATRIX® Putty Products, which are bone void fillers. The submission focuses on demonstrating substantial equivalence to predicate devices and includes information on product performance testing.
Here's an analysis of the acceptance criteria and study data based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance | Study Type/Evidence |
|---|---|---|---|
| Osteoinductivity Potential | DBM in product possesses osteoinductive potential. | Each lot of DBM is assayed in vitro for a native protein (surrogate marker) correlated to the athymic rat model. This assures only DBM with osteoinductivity potential is used. | In vitro immunoassay and correlation to athymic rat model (for DBM alone and ALLOMATRIX Putty Products). |
| Viral Inactivation | Processing method effectively inactivates potential human viruses. | Processing method demonstrated suitable viral inactivation potential for a wide spectrum of model human viruses. | Viral inactivation validation study of the processing method. |
| Product Performance | Device exhibits expected performance in a biological model (e.g., bone formation, integration). | Evaluated in a canine model using radiographic and histological methods. | In vivo canine model study. |
| Substantial Equivalence | Device is as safe and effective as identified predicate devices. | Found to be substantially equivalent to predicate devices. Supported by substantial equivalence info, materials data, and testing results. | Comparison to predicate devices, materials data, and various testing (including those listed above). |
2. Sample Sizes and Data Provenance
- Osteoinductivity: "Each lot of DBM" is tested. The athymic rat model (Lindholm & Urist, 1980) is referenced, likely for validation of the surrogate marker, but specific sample sizes for this correlation study within the submission are not provided. The study by Lindholm and Urist itself would describe its sample sizes and methodology.
- Viral Inactivation: A "panel of model potential human viruses" was evaluated. Specific sample sizes (e.g., number of replicates, viral titers) are not provided.
- Product Performance Testing (Canine Model): The document states "evaluated in a canine model." No specific sample size (number of canines or defect sites) is mentioned.
- Data Provenance: The document implies the studies were conducted by or for Wright Medical Technology, Inc. ("Data on file at Wright Medical Technology, Inc."). The canine model is an in vivo animal study, and the osteoinductivity and viral inactivation tests are laboratory-based studies. All studies appear to be prospective in nature, designed to evaluate the product.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of human experts to establish ground truth for a test set in the context of an AI/algorithm-based device. The ALLOMATRIX® Putty Products are physical medical devices, and their performance is assessed through biological and laboratory testing, not through interpretation of digital data by human readers.
4. Adjudication Method
Not applicable, as this is not a study involving human readers or interpretation of data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI/software device that would involve human readers making diagnoses or assessments. It is a bone void filler, and its effectiveness is determined through biological performance.
6. Standalone (Algorithm Only) Performance Study
No. This is not an AI/algorithm device.
7. Type of Ground Truth Used
- Osteoinductivity: The ground truth for osteoinductivity potential is established by correlating the in vitro immunoassay results to the athymic rat model, which is a widely accepted in vivo model for evaluating bone formation and osteoinduction. The immunoassay itself serves as a surrogate for this biological activity.
- Viral Inactivation: The ground truth is the actual viral inactivation observed in the laboratory setting using model viruses and the processing method.
- Product Performance (Canine Model): The ground truth for bone healing and integration is established through radiographic and histological analysis of the treated bone defects in the canine model. These are direct biological observations.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set." The product undergoes manufacturing quality control and specific performance testing.
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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K041663 1/2
SEP 1 6 2004
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe in accordance with the Food and Drag Formance with 21 CRF 807, this information serves as a
Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information o Medical Devices Act of 1970 and in ven the use of ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP, and ALLOMATRIX® PLUS CBM.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | September 15, 2004 |
| Contact Person: | Brian YoungDirector, Regulatory Affairs |
| Proprietary Name: | ALLOMATRIX® TCP, ALLOMATRIX® w/CaSO4 Filled TCP, and ALLOMATRIX® PLUSCBM |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Filler, Calcium Sulfate Preformed Pellets - Class II888.3045 |
| Device Product Code and Panel Code: | Orthopedics/MQV |
DEVICE INFORMATION
INTENDED USE A.
INTENDED USE ADDOMIXTRIA - 15-15-14-11-11-11-11-11-11-11-11-11-11-11-11-11-11-11-2017-11-11 of the bony structure. ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
DEVICE DESCRIPTION B.
DEVICE DESCREAT TOT!
ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM come in the form of a kit with a premeasured powder, TCP and/or CBM chips, premeasured mixing solution, and the tools necessary to mix the components. emps, premeasured himmy all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.
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C. SUBSTANTIAL EQUIVALENCE INFORMATION
ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM were found to be substantially equivalent to the predicate devices. The safety and effectiveness of ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.
Osteoinductivity Potential
Each lot of DBM incorporated into ALLOMATRIX® TCP, ALLOMATRIX® with CaSO4 Filled TCP and ALLOMATRIX® Plus CBM (hereafter ALLOMATRIX® Putty Products) is assayed in vitro for a native protein as a surrogate test marker for osteoinductive potential. Results from this immunoassay were correlated to the athymic rat model for the DBM alone and the ALLOMATRIX Putty Products.2 Testing each lot of DBM with this immunoassay assures that only DBM with osteoinductivity potential is used in the ALLOMATRIX® Putty Products. Although only one native protein is used as the test marker, it is the combination of various proteins in the DBM that is responsible for its osteoinductivity potential. The combination of DBM, and binding medium has not been evaluated for osteoinductivity; therefore, it is unknown to what extent the formulation components may alter the osteoinductive character of the DBM. Additionally, it is unknown how osteoinductivity potential. measured by this surrogate immunoassay, will correlate with human clinical performance of the Allomatrix Putty Products.
- l Data on file at Wright Medical Technology, Inc.
- 2 Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in compositive grafts of bone marrow and bone matrix, Clin Orthop 1980 Jul-Aug;(150):288-300.
Viral Inactivation Validation
The method for processing the DBM and CBM contained in ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes, and genomes were evaluated. The viral inactivation testing demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses.
Product Performance Testing
Performance of ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM were evaluated in a canine model by radiographic and histological methods.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an emblem of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2004
Mr. Brian J. Young Director, Regulatory Affairs Wright Medical Technology 5677 Airline Road Arlington, Tennessee 38002
Re: K041663
ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP, and ALLOMATRIX® PLUS CBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MQV Dated: June 14, 2004 Received: June 18, 2004
Dear Mr. Young:
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 macketed 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 aqencies. 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 pregetive
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Page 2 - Mr. Brian J. Young
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.
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. 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
510(K) Number (if known):_K04 (663
ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and Device Name: ALLOMATRIX® PLUS CBM
Indications for Use:
ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP, and ALLOMATRIX® PLUS CBM are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® TCP, ALLOMATRIX® w/ CaSO4 Filled TCP and ALLOMATRIX® PLUS CBM are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Prescription Use X (Per21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K041663 510(k) Number_
§ 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.