(31 days)
Not Found
No
The summary describes a bone void filler and manual surgical instruments, with no mention of AI or ML capabilities.
Yes
The device is a kit used in core decompression procedures, providing a bone void filler that resorbs and is replaced by bone during healing, indicating its role in treating a medical condition.
No
The PRO-DENSE™ Core Decompression Procedure Kit is described as a bone void filler and surgical instruments used during core decompression procedures, indicating its therapeutic rather than diagnostic function. It is intended to be replaced by bone during healing, not to provide diagnostic information.
No
The device description explicitly states it consists of a bone void filler (a material) and manual surgical instruments (hardware). It also mentions an implant material. These are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for a "core decompression procedure" and involves a "bone void filler" and "manual surgical instruments." This describes a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The description details a "calcium sulfate - calcium phosphate composite bone void filler" that is mixed and injected or packed into bony defects. This is a material implanted into the body to aid in bone healing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant and associated instruments used directly in a surgical procedure.
N/A
Intended Use / Indications for Use
The PRO-DENSE™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
Product codes
MQV
Device Description
The design features of the PRO-DENSE™ Core Decompression Procedure Kit are substantially equivalent to the design features of the PRO-DENSE Bone Void Filler submission (510(k); K070437). The implant material of the PRO-DENSE™ Core Decompression Procedure Kit is exactly the same as the predicate above. The PRO-DENSE Core Decompression Procedure Kit includes Class I and Class II (premarket notification exempt) instrumentation to facilitate a standard core decompression procedure. PRO-DENSE™ consists of a calcium sulfate - calcium phosphate composite bone void filler consisting of a powder component and an aqueous mixing solution. When the two components are mixed, according to directions, an injectable paste is formed which subsequently hardens via hydration reactions. The paste can be injected and cured in situ or formed into pellets which can be gently packed into bony defects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
00115 2007
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 PRO-DENSE™ Core Decompression Procedure Kit.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | June 21, 2007 |
| Contact Person: | Ryan M. Belaney |
| Regulatory Affairs Specialist II | |
| Proprietary Name: | PRO-DENSE™ Core Decompression Procedure Kit |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | 21 CFR 888.3045 -- Resorbable Calcium Salt Bone Void |
| Filler Device - Class II | |
| Device Product Code and Panel Code: | Orthopedic/87/MQV |
DEVICE INFORMATION
A. INTENDED USE
The PRO-DENSE™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
B. DEVICE DESCRIPTION
The design features of the PRO-DENSE™ Core Decompression Procedure Kit are substantially equivalent to the design features of the PRO-DENSE Bone Void Filler submission (510(k); K070437). The implant material of the PRO-DENSE™ Core Decompression Procedure Kit is exactly the same as the predicate above. The PRO-DENSE Core Decompression Procedure Kit includes Class I and Class II (premarket notification exempt) instrumentation to facilitate a standard core decompression procedure. A brief description of the PRO-DENSE™ implant is provided below.
IMPLANT DESCRIPTION
PRO-DENSE™ consists of a calcium sulfate - calcium phosphate composite bone void filler consisting of a powder component and an aqueous mixing solution. When the two components are mixed, according to directions, an injectable paste is formed which subsequently hardens via hydration reactions. The paste can be injected and cured in situ or formed into pellets which can be gently packed into bony defects.
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C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, type of interface, operating principles, shelf life, and design features of the PRO-DENSE™ Core Decompression Procedure Kit are substantially equivalent to the previously cleared PRO-DENSE™ Bone Void Filler 510(k): K070437. Additionally, the safety and effectiveness of the PRO-DENSE™ Core Decompression Procedure Kit is adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. Mr. Ryan M. Belaney Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
OCT 1 5 2007
K072597 Re:
Trade/Device Name: PRO-DENSE™ Core Decompression Procedure Kit Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: June 27, 2007 Received: September 14, 2007
Dear Mr. Belaney:
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 - Mr. Ryan M. Belaney
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buell ND
for
Mark N. Melk 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: K072597 Device Name: PRO-DENSE™ Core Decompression Procedure Kit Indications For Use:
The PRO-DENSE™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.
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)
Barbara Buchius fox MKL
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number K072597