(21 days)
IGNITE® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE® Putty is 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.
The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site
The IGNITE® product combines existing Wright Medical products into a kit configuration: ALLOMATRIX® Injectable Putty (K020895, K041168), and accessory Bone Graft Syringe (K023088) with accessory components which are exempt from 510(k) requirements pursuant to 21 CFR 878.4800. The IGNITE® convenience kit provides surgeons the option of mixing the ALLOMATRIX® powder with sterile water or mixing with autologous bone marrow aspirate (BMA).
This document describes the IGNITE® Kit, a bone void filler. The provided text outlines the device's indications for use, description, materials, and substantial equivalence, along with details regarding its osteoinductivity potential and viral inactivation validation.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the IGNITE® Kit are primarily based on its osteoinductive potential and viral inactivation effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Osteoinductivity Potential: | |
| - In vitro assay correlation: | The DBM (Demineralized Bone Matrix) incorporated into IGNITE® Kits showed a correlation coefficient of 0.850 (p<0.0005) between its in vitro osteoinductivity bioassay (using Saos human osteosarcoma cells) and in vivo implantation in athymic rat muscle. This accurately predicted the in vivo osteoinductivity of 99 of 101 donor lots. |
| - Clinical healing correlation: | Clinical results demonstrated a significant difference in healing as evaluated by radiography: 92% healing for DBM with >0.20 osteoinductivity index versus 33% healing for DBM with <0.20 osteoinductivity index. |
| - In vivo osteoinductivity: | IGNITE® Kit was assayed in vivo in the rat muscle pouch model and found to be osteoinductive. Each lot of IGNITE® Kit is assayed in vivo in the athymic rat muscle pouch to ensure the osteoinductivity potential of the final product. The product is considered osteoinductive if one specimen (explant) contains new bone (i.e. bone occupied with lamellae), cartilage, and/or chondrocytes. |
| Viral Inactivation Validation: | |
| - Processing method effectiveness: | The method for processing the DBM and CBM (presumably CBM also refers to a component of the kit, likely another form of bone matrix) contained in IGNITE® Kits demonstrated suitable viral inactivation potential for a wide spectrum of potential human viruses. This was evaluated using a panel of model potential human viruses representing various virus types, sizes, shapes, and genomes. |
| Substantial Equivalence (General): | The intended use, material composition, and design features of the IGNITE® Kit are substantially equivalent to the previously submitted and cleared ALLOMATRIX® product (K020895, K041168). The safety and effectiveness are supported by substantial equivalence information, materials data, and testing results. |
2. Sample Size Used for the Test Set and Data Provenance
- Osteoinductivity (In vitro/In vivo correlation):
- The study correlating in vitro bioassay with in vivo rat muscle implantation utilized 101 donor lots. Data provenance is not explicitly stated but implies laboratory testing results.
- Osteoinductivity (Clinical healing correlation):
- The sample size for the clinical study comparing healing rates for DBM with different osteoinductivity indices is not explicitly stated, only the percentage of healing observed (92% vs 33%). Data provenance is clinical, as it refers to "clinical results."
- Osteoinductivity (In vivo rat muscle pouch model):
- This is an in-house quality control measure; each lot of IGNITE® Kit is assayed. The specific sample size for a "test set" from a regulatory perspective for this specific assay is not provided, beyond stating it's performed for "each lot." The data provenance is laboratory testing.
- Viral Inactivation:
- A "panel of model potential human viruses" was used. The exact number of virus types is not specified, nor is the specific "sample size" in terms of replicates or experimental units. The data provenance is laboratory testing/validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not explicitly state the number or qualifications of experts used to establish "ground truth" in the traditional sense for these studies.
- For osteoinductivity, the "ground truth" (or reference standard) in the correlation study was the in vivo implantation in athymic rat muscle, and in the clinical study, it was "healing as evaluated by radiography." These evaluations would involve expertise (e.g., veterinary pathologists for rat studies, radiologists/orthopedic surgeons for clinical radiography), but the document does not detail their numbers or qualifications.
- For viral inactivation, the "ground truth" is the observed viral reduction/inactivation, which would be assessed by virology experts, but their numbers and qualifications are not mentioned.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication methods (like 2+1 or 3+1 consensus) for the test sets mentioned. The assessment of osteoinductivity in the rat model specifies a single criterion ("if one specimen (explant) contains new bone..."). Clinical radiography assessments would likely be standard medical practice, but no specific adjudication is detailed for the purpose of these studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study involving human readers with and without AI assistance is mentioned. The device described, IGNITE® Kit, is a bone void filler product, not an AI-powered diagnostic or decision support system.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- This question is not applicable as the IGNITE® Kit is a medical device (bone void filler) and not an algorithm or AI system.
7. Type of Ground Truth Used
- Osteoinductivity:
- For the in vitro/in vivo correlation, the ground truth for osteoinductivity was obtained from in vivo implantation into athymic rat muscle and subsequent histological assessment (presence of new bone, cartilage, and/or chondrocytes).
- For clinical correlation, the ground truth was radiographic evaluation of healing.
- Viral Inactivation:
- The ground truth for viral inactivation was the measured reduction of viral titers after exposure to the processing method, using a panel of model viruses.
8. Sample Size for the Training Set
- The concept of a "training set" is not applicable here as the IGNITE® Kit is not an AI/ML model that requires training data. The studies performed are performance evaluations for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable, as there is no training set for an AI/ML model for this device.
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NOV - 7 2005
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A Wright Medical Group Company
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the IGNITE® Kit.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | October 14, 2005 |
| Contact Person: | Ehab M EsmailDirector, Regulatory AffairsPhone: 901-867-120 Fax: 901-867 4630 |
| Proprietary Name: | IGNITE® Kit |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Filler, calcium sulfate preformed pellets |
| Device Product Code and Panel Code: | Orthopedics/87/MOV |
DEVICE INFORMATION
INTENDED USES/ INDICATIONS A.
IGNITE® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE® Putty is 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.
The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site
B. DEVICE DESCRIPTION
The IGNITE® product combines existing Wright Medical products into a kit configuration: ALLOMATRIX® Injectable Putty (K020895, K041168), and accessory
Image /page/0/Picture/12 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company".
Image /page/0/Picture/13 description: The image shows a black and white drawing of a planet. The planet has a rough, textured surface with dark and light areas. There is a ring around the planet, and a small object is visible below it. The drawing is simple and lacks detail, giving it a somewhat abstract appearance.
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Bone Graft Syringe (K023088) with accessory components which are exempt from 510(k) requirements pursuant to 21 CFR 878.4800. The IGNITE® convenience kit provides surgeons the option of mixing the ALLOMATRIX® powder with sterile water or mixing with autologous bone marrow aspirate (BMA).
C. MATERIALS
The implant materials used for the IGNITE® Kit are substantially equivalent to the previously submitted and cleared ALLOMATRIX® implant materials.
D. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, material composition, and design features of the IGNITE® Kit are substantially equivalent to the previously submitted and cleared ALLOMATRIX® product. The safety and effectiveness of the IGNITE® Kit is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.
Osteoinductivity Potential
The DBM incorporated into IGNITE® Kits is assayed in vitro for its osteoinductive potential. The bioassay measures the proliferation of Saos human osteosarcoma cells in the presence of human DBM compared to positive and negative controls (osteoinductivity index). Results from the bioassay were correlated with results from implantation of DBM into athymic rat muscle", which demonstrated a correlation coefficient of 0.850 (p<0.0005) and accurately predicted the in vivo osteoinductivity of 99 of 101 donor lots. Additionally, clinical results using DBM with >0.20 and <0.20 demonstrated a significant difference in healing as evaluated by radiography, 92% and 33% healing, respectively.3
IGNITE® Kit were assayed in vivo in the rat muscle pouch model- and found to be osteoinductive. Each lot of IGNITE® Kit is assayed in vivo in the athymic rat muscle pouch to ensure the osteoinductivity potential of the final product.
Adkisson HD, Strauss-Schoenberger J, Gillis M, Wilkins R, Jackson M, and Hruska KA. Rapid Quantitative 1 Bioassay of Osteoinduction, J Ortho Res, 2000, 18:503-511.
Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in composite grafts of 2 bone marrow and bone matrix, Clin Orthop 1980 Jul-Aug;(150):288-300. Note: The product is considered osteoinductive if one specimen (explant) contains new bone (i.e. bone occupied with lamellae), cartilage, and/or chondrocytes.
3 Wilkins RM, Clinical Effectiveness of Demineralized Bone Matrix Assayed in Human Cell Culture, Advances in Tissue Banking. 1999 3:113-124
Viral Inactivation Validation
The method for processing the DBM and CBM contained in IGNITE® Kits 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.
Image /page/1/Picture/14 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the words is a horizontal line, and below that is the text "A Wright Medical Group Company".
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NOV - 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ehab M. Esmail Director, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K052913
Trade/Device Name: IGNITE® KIT Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: October 14, 2005 Received: October 17, 2005
Dear Mr. Esmail:
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 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 –Ehab. M. Esmail
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Mark N. Melkerson, Acting 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: K052913
IGNITE® KIT Device Name:
Indications For Use:
IGNITE® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE® Putty is 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.
The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.
Prescription Use V (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)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K052913
§ 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.