(171 days)
No
The 510(k) summary describes a passive bone void filler material and does not mention any computational or analytical functions that would involve AI or ML.
Yes
The device is described as a "bone void filler" that facilitates healing by being "resorbed and replaced with bone." This indicates a therapeutic function of aiding the body's repair process.
No
The device is a bone void filler intended for use in the extremities and pelvis to fill gaps caused by trauma or surgery. It is a material that resorbs and is replaced by bone during healing, and does not perform any diagnostic function.
No
The device description clearly states it is a mixture of physical materials (beta tricalcium phosphate, polylactic acid, Type I bovine collagen) provided in various physical forms (cylinders, granules, cubes, blocks). This indicates a physical medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Intended Use: The Kensey Nash Bone Void Filler is intended to be implanted into the body to fill bony voids. It is a surgical implant, not a device used for testing specimens.
- Device Description: The description details the materials and form of the implant, not components for analyzing biological samples.
Therefore, based on the provided information, the Kensey Nash Bone Void Filler is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Kensey Nash Bone Void Filler is intended to be gently packed into the bony voids or gaps of the extremities and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood or bone marrow aspirate. The addition of these autogenous blood products does not alter the performance of the device.
Product codes
MQV
Device Description
Kensey Nash Bone Void Filler is a mixture of beta tricalcium phosphate, polylactic acid and Type I bovine collagen. The product will be provided gamma sterilized for one-time use in a variety of shapes ranging from pre-formed cylinders, granules, cubes and blocks with sizes ranging up to 25 mm in diameter and up to 30 cc in volume.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities and pelvis
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
Non-Clinical Testing: Kensey Nash BVF has undergone non-clinical testing that provides reasonable assurance of safety and effectiveness for its intended use. Testing included biocompatibility, physical properties testing, compressive strength and an animal study.
Key Metrics
Not Found
Predicate Device(s)
K040047, K033707, K033679, K051386
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K0600917
510(k) Summary
SEP 2 2 2006
Submitted by: Kensey Nash Corporation 735 Pennsylvania Drive Exton, PA 19341 Contact Person: Jennifer J. Bosley, MBA, RAC Regulatory Affairs Specialist Ph: (484) 713-2173 Fax: (484) 713-2903 Date Prepared: September 14, 2006 510(k) #: K060917 Device Trade Name: Kensey Nash Bone Void Filler Common/Usual Name: Bone Void Filler Proposed Classification: Resorbable Calcium Salt Bone Void Filler Device 21CFR8888.3045 Class II, MQV-87Orthopedics
Device Description:
Kensey Nash Bone Void Filler is a mixture of beta tricalcium phosphate, polylactic acid and Type I bovine collagen. The product will be provided gamma sterilized for one-time use in a variety of shapes ranging from pre-formed cylinders, granules, cubes and blocks with sizes ranging up to 25 mm in diameter and up to 30 cc in volume.
Intended Use:
The Kensey Nash Bone Void Filler is intended to be gently packed into the bony voids or gaps of the extremities and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood or bone marrow aspirate. The addition of these autogenous blood products does not alter the performance of the device.
Predicate Devices:
| MANUFACTURER | DEVICE | 510(k) # |
|---|---|---|
| OsteoBiologics | PolyGraft™ BGS | K040047 |
| OsteoBiologics | PolyGraft™ TCP | K033707 |
| Kensey Nash [Centerpulse Spine-Tech] | CopiOs™ Bone Void Filler | K033679 |
| Medtronic | MasterGraft® Putty | K051386 |
Substantial Equivalence:
Kensey Nash BVF is substantially equivalent to the legally marketed predicate devices with regard to intended use, materials, physical structure, principle of operation and technological characteristics. Results of in vivo and in viro comparison testing demonstrate that Kensey Nash BVF is substantially equivalent to PolyGrafi™ BGS.
Non-Clinical Testing:
Kensey Nash BVF has undergone non-clinical testing that provides reasonable assurance of safety and effectiveness for its intended use. Testing included biocompatibility, physical properties testing, compressive strength and an animal study.
1-800-524-1984
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 2006
Kensey Nash Corporation % Ms. Jennifer J. Bosley Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341
Re: K060917
Trade/Device Name: Kensey Nash Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 21, 2006 Received: August 22, 2006
Dear Ms. Bosley:
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.
2
Page 2 - Ms. Jennifer Bosley
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 Houracturers; International and Consumer-Assistance at its toll-free-number (809)-638-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Joulau Bucheno
Mark N. Melkerso Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use Statement
K060917 510(k) Number:
Kensey Nash Bone Void Filler Device Name:
Indications For Use:
The Kensey Nash Bone Void Filler is intended to be gently packed into the bony voids or - and gape of the extremities and pelvis that are caused by trauma or surgery-and are not intrinsic to the stability of the bony structure. These defects may be created from traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood or bone marrow aspirate. The addition of these autogenous products does not alter the performance of the device.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Burchum for mkm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K0140917
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