(585 days)
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No
The document describes a bone void filler made of calcium sulfate and DBM, with no mention of AI or ML technology in its description, intended use, or performance studies.
No
The device is a bone void filler and is not described as treating or preventing a disease, but rather aiding in the repair of bone defects.
No
Explanation: The device, OSTEOSET® DBM Pellets, is described as a material used to fill bony voids and gaps, indicating a therapeutic or reparative function rather than a diagnostic one.
No
The device description clearly states it is made of physical materials (calcium sulfate, DBM, stearic acid) and is provided as preformed pellets, indicating a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for filling bony voids or gaps in the skeletal system. This is a therapeutic and structural application within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a material (calcium sulfate and DBM) designed to be implanted into bone defects. This is consistent with a medical device used for treatment or repair, not for diagnosing a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
OSTEOSET® DBM Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. OSTEOSET® DBM Pellets are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Product codes (comma separated list FDA assigned to the subject device)
MQV, MBP
Device Description
OSTEOSET® DBM Pellets are made of surgical grade calcium sulfate incorporating Human Demineralized Bone Matrix (DBM) and stearic acid as a tableting aid. OSTEOSET® DBM Pellets are provided as preformed 3.0 mm or 4.8 mm pellets. The biodegradable, radiopaque pellets are used to fill bone voids and are resorbed in approximately 30-60 days when used according to labeling. This product is supplied sterile for single patient use.
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
Bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis).
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
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)
The DBM incorporated into OSTEOSET® DBM Pellets 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 muscle2, which demonstrated a correlation coefficient of 0.850 (p0.20 and ≤0.20 demonstrated a significant difference in healing as evaluated by radiography, 92% and 33% healing, respectively.3
The method for processing the DBM contained in OSTEOSET® DBM Pellets 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.
Performance of OSTEOSET® DBM Pellets was compared to the predicate device in a canine model by radiographic, mechanical, histological and quantification of new bone formation. There was no difference in radiographic, mechanical, histological and quantification of new bone formation at the end of the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
K'022828
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 use of OSTEOSET® DBM Pellets.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | February 16, 2004 |
| Contact Person: | Roger D. Brown |
| Sr. Director, Clinical and Regulatory Affairs | |
| Proprietary Name: | OSTEOSET® DBM Pellets |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Filler, Calcium Sulfate Preformed Pellets - Class II |
| 888.3045 | |
| Device Product Code and Panel Code: | Orthopedics/MOV |
DEVICE INFORMATION
A. INTENDED USE
OSTEOSET® DBM Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. OSTEOSET® DBM Pellets are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
B. DEVICE DESCRIPTION
OSTEOSET® DBM Pellets are made of surgical grade calcium sulfate incorporating Human Demineralized Bone Matrix (DBM) and stearic acid as a tableting aid. OSTEOSET® DBM Pellets are provided as preformed 3.0 mm or 4.8 mm pellets. The biodegradable, radiopaque pellets are used to fill bone voids and are resorbed in approximately 30-60 days when used according to labeling. This product is supplied sterile for single patient use.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, materials, and mode of action of OSTEOSET® DBM Pellets are substantially equivalent to the predicate device. The safety and effectiveness of OSTEOSET® DBM Pellets is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.
1
DBM Osteoinductivity Potential Testing
The DBM incorporated into OSTEOSET® DBM Pellets 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 muscle2, which demonstrated a correlation coefficient of 0.850 (p0.20 and ≤0.20 demonstrated a significant difference in healing as evaluated by radiography, 92% and 33% healing, respectively.3
- Adkisson HD. Strauss-Schoonberger J. Gillis M. Wilkins R. Jackson M. and Hruska KA. Rapid Quantitative 1 Bioassay of Osteoinduction, J Ortho Res, 2000, 18:503-511.
- 2 Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in composite grafts of bone marrow and bone matrix, Clin Orthop 1980 Jul-Aug (150):288-300.
- 3 Wilkins RM, Clinical Effectiveness of Denineralized Bone Matrix Assayed in Human Cell Culture, Advances in Tissue Banking. 1999 3:113-124
The osteoinductivity of the OSTEOSET® DBM Pellets has not been established and it is unknown how osteoinductivity of the DBM component, measured via the in vitro bioassay, will correlate with human clinical performance of Osteoset DBM Pellets.
Viral Inactivation Potential
The method for processing the DBM contained in OSTEOSET® DBM Pellets 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 OSTEOSET® DBM Pellets was compared to the predicate device in a canine model by radiographic, mechanical, histological and quantification of new bone formation. There was no difference in radiographic, mechanical, histological and quantification of new bone formation at the end of the study.
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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2004
Roger D. Brown Director, Regulatory Affairs Wright Medical Technology 5677 Airline Road Arlington, Tennessee 38002
Re: K022828 Trade Name: OSTEOSET DBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: January 6, 2004 Received: January 7, 2004
Dear Mr. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 madc 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
3
Page 2 - Mr. Roger D. Brown
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.
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.
/ Mark H. Milliken
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 STATEMENT
510(K) Number (if known): K022828
OSTEOSET® DBM Pellets Device Name: ______________
Indications for Use:
OSTEOSET® DBM Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. OSTEOSET® DBM Pellets are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, 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)
Mark N Milburn
ral. Restorative, and Neurological Devices
510(k) Number K02
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