(655 days)
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No
The document describes a bone graft material and its testing, with no mention of AI or ML in its function or processing.
Yes
Explanation: The device is used to fill bony voids or gaps resulting from surgical or traumatic injury, and it is intended for transplantation and promotes osteoinductivity, all of which align with the definition of a therapeutic device.
No
The device is a bone void filler intended for transplantation to fill bony voids or gaps. It is not used to diagnose a medical condition.
No
The device description explicitly states that the product contains human tissue (allograft bone) and may contain porous ceramic granules, indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for filling bony voids and gaps in the body (extremities, pelvis, craniofacial). This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is described as containing human tissue (allograft bone) and a carrier, intended for transplantation. This is a medical device used for treatment, not for testing samples from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. The performance studies focus on viral inactivation and osteoinductive potential, which relate to the safety and efficacy of the bone graft material itself, not its use in diagnosing a disease.
In summary, the InterGro DBM product is a medical device used for bone grafting, which is a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
InterGro DBM products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. The device may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm². The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.
Product codes
MQV,GXP
Device Description
InterGro® DBM products contain human tissue (allograft bone) and are intended for transplantation. The allograft bone has been granulated, demineralized and provided in a lipid carrier. Some versions contain porous ceramic granules that are a composite of highly resorbable calcium carbonate with a slower resorbing 2 to 10 um outer layer of calcium phosphate.
InterGro DBM products have been processed aseptically and are ready to use. They do not require rehydration or any special preparation. InterGro DBM is intended for single patient use only.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
extremities, pelvis, craniofacial defects, craniotomies
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Viral Inactivation Validation: The methods for processing the DBM contained in InterGro® DBM were evaluated for their viral inactivation potential. A select panel of viruses representing various virus types, sizes, shapes, and genomes were evaluated. The viral inactivation testing demonstrated suitable viral inactivation potential of the processing methods for a wide range of potential human viruses.
- Osteoinductive Potential: Each lot of DBM incorporated into InterGro® DBM is assayed for its osteoinductive potential. The assay measures the proliferation of SAOS human osteosarcoma cells in the presence of human DBM compared to positive and negative controls (osteoinductive index). Results of the assay have been correlated with results from implantation of DBM into athymic rat muscle, which demonstrated a correlation coefficient of 0.850 (p0.20 and ≤0.20 (osteoinductive index) demonstrated a significant difference in healing as evaluated by radiography, 92% and 33% healing, respectively.
- Product Performance Testing: Performance of InterGro® DBM was evaluated in rabbit and sheep models by radiographic and histological methods.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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510(k) SUMMARY
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR $807.92.
| Submitted By: | Interpore Cross International
181 Technology Drive
Irvine, California 92618 |
|-----------------|-----------------------------------------------------------------------------------|
| Date: | December 16, 2003 |
| Contact Person: | Mark Loar
Manager, Regulatory and Clinical Affairs |
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Human Tissue Common/Usual Name: DBM Bone Graft Substitute Product Classification: Unclassified Proprietary Name: InterGro® DBM
PREDICATE DEVICE
Predicate device information is provided in this premarket notification.
DEVICE DESCRIPTION
InterGro® DBM products contain human tissue (allograft bone) and are intended for transplantation. The allograft bone has been granulated, demineralized and provided in a lipid carrier. Some versions contain porous ceramic granules that are a composite of highly resorbable calcium carbonate with a slower resorbing 2 to 10 um outer layer of calcium phosphate.
InterGro DBM products have been processed aseptically and are ready to use. They do not require rehydration or any special preparation. InterGro DBM is intended for single patient use only.
INDICATIONS-FOR-USE
InterGro DBM products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. The device may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm". The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.
1
SUBSTANTIAL EQUIVALENCE INFORMATION
InterGro® DBM was found to be substantially equivalent to the predicate devices. The safety and effectiveness of InterGro DBM is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.
. Viral Inactivation Validation
The methods for processing the DBM contained in InterGro® DBM were evaluated for their viral inactivation potential. A select panel of viruses representing various virus types, sizes, shapes, and genomes were evaluated. The viral inactivation testing demonstrated suitable viral inactivation potential of the processing methods for a wide range of potential human viruses.
- Osteoinductive Potential .
Each lot of DBM incorporated into InterGro® DBM is assayed for its osteoinductive potential. The assay measures the proliferation of SAOS human osteosarcoma cells in the presence of human DBM compared to positive and negative controls (osteoinductive index). Results of the assay have been correlated with results from implantation of DBM into athymic rat muscle, which demonstrated a correlation coefficient of 0.850 (p0.20 and ≤0.20 (osteoinductive index) demonstrated a significant difference in healing as evaluated by radiography, 92% and 33% healing, respectively.2
The combination of DBM, the carrier and, in some formulations, ceramic granules 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 of the DBM component. measured via the in-vitro "SAOS" bioassay will correlate with human clinical performance of InterGro DBM products.
- . Product Performance Testing Performance of InterGro® DBM was evaluated in rabbit and sheep models by radiographic and histological methods.
l Adkisson HD, Strauss-Schoenberger J, Gillis M, Wilkins R, Jackson M, and Hruska KA. Rapid Quantitiative Bioassay of Osteoinduction. J Ortho Res, 2000, 18:503-511.
י נ Wilkins RM, Clinical Effectiveness of Demineralized Bone Matrix Assayed in Human Cell Culture, Advances in Tissue Banking. 1999 3:113-124
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark Loar Manager, Regulatory and Clinical Affairs INTERPORE CROSS International 181 Technology Drive Irvine, California 92618
Re: K031399
Trade/Device Name: InterGro® DBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV,GXP Dated: December 16, 2004 Received: December 21, 2004
Dear Mr. Loar:
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 for assession 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 or any I 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 -- Mr. Mark Loar
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 premaince nedicate 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,
O. Mark N. Millikan
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): K031399
InterGro® DBM Device Name:
Indications-For-Use:
InterGro DBM products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. The device may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm². The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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, and Neurological Devices |
| 510(k) Number | K031399 |
|---|---|
| --------------- | --------- |
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