(107 days)
Not Found
No
The summary describes a bone void filler material and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
Explanation: The device is intended to fill bone voids caused by trauma or surgery and assists in the healing process by providing a scaffold for new bone growth, which is a therapeutic function.
No
The device is a bone void filler intended for surgical repair, not for diagnosing conditions.
No
The device description clearly states it is a mixture of physical materials (beta tricalcium phosphate and polylactic acid) provided in various shapes and volumes, indicating a physical implantable device, not software.
Based on the provided information, the Kensey Nash Bone Void Filler XC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to be gently packed into the bony voids or gaps of the extremities and pelvis that are caused by trauma or surgery." This describes a device used in vivo (within the body) for structural support and bone regeneration.
- Device Description: The description details the composition (beta tricalcium phosphate and polylactic acid) and physical forms (cylinders, granules, etc.) of a material intended for implantation or filling within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The Kensey Nash Bone Void Filler XC is a medical device used inside the body for a therapeutic purpose (bone void filling and regeneration).
N/A
Intended Use / Indications for Use
The Kensey Nash Bone Void Filler XC 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. 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 the autogenous products does not alter the performance of the device.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
The Kensey Nash Bone Void Filler XC is a mixture of beta tricalcium phosphate and polylactic acid. The product will be provided gamma sterilized for one time use in a healthcare facility. The products are supplied in a variety of shapes ranging from pre-formed cylinders, granules, cubes, blocks, and wedges ranging up to 25mm in diameter and up to 30cc 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
healthcare facility
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)
The non-clinical testing submitted in the predicate device (K060917) included biocompatibility, physical properties testing, compressive strength, and an animal study. This testing remains applicable to this submission.
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
K120141(pg.iof2)
510(k) Summary
- 4 2012 MAY
| Submitted By: | Kensey Nash Corporation
735 Pennsylvania Drive,
Exton, PA 19341 |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Susan Pileggi
Regulatory Specialist
P: 484-713-2100
F: 484-713-2903 |
| Date Prepared: | March 16, 2012 |
| 510(k): | K120141 |
| Device:
Trade Name:
Common/Usual Name:
Proposed Classification: | Kensey Nash Bone Void Filler XC
Filler, Bone Void, Calcium Compound
21 CFR 888.3045
MQV
Class II |
| Predicate Device: | K060917: Kensey Nash Bone Void Filler |
Device Description:
The Kensey Nash Bone Void Filler XC is a mixture of beta tricalcium phosphate and polylactic acid. The product will be provided gamma sterilized for one time use in a healthcare facility. The products are supplied in a variety of shapes ranging from pre-formed cylinders, granules, cubes, blocks, and wedges ranging up to 25mm in diameter and up to 30cc in volume.
The safety and effectiveness of this device for use in chondral defects have not been established. This device is not intended for the replacement of articular cartilage.
Intended Use:
The Kensey Nash Bone Void Filler XC 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. 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 the autogenous products does not alter the performance of the device.
1
Carmin 1 Marie
Technological Characteristics:
The technological characteristics of Kensey Nash Bone Void Filler XC are identical to the Kensey Nash Bone Void Filler cleared per K060917. The device and predicate are designed to be gently packed into defect sites and used as non-structural scaffolds for the body's natural healing and bone regeneration process. There are no new design changes that could affect the safety or effectiveness of the device.
Performance Data:
The non-clinical testing submitted in the predicate device (K060917) included biocompatibility, physical properties testing, compressive strength, and an animal study. This testing remains applicable to this submission.
Substantial Equivalence:
The Kensey Nash Bone Void Filler XC is substantially equivalent to the predicate device with regard to intended use, indications for use, operating principle, design, materials, packaging, sterilization, and manufacturing process.
2
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 features a stylized eagle-like bird symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring; MD 20993-0002
Kensey Nash Corporation % Ms. Susan Pileggi Regulatory Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341
4 2012 MAY
Re: K120141
Trade/Device Name: Kensey Nash Bone Void Filler XC Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: March 19, 2012 Received: March 20, 2012
Dear Ms. Pileggi
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the device's labeling:
"The safety and effectiveness of this device for use in chondral and osteochondral defects have not been established. This device is not intended for the replacement of articular cartilage."
3
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
4
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Christs foreman Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KASSA INDEX LISTA
Indications For Use Statement
510(k) Number: K120141
Device Name: Kensey Nash Bone Void Filler XC
Indications For Use:
The Kensey Nash Bone Void Filler XC 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. 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 the autogenous products does not alter the performance of the device.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Per 21 CFR 801 Subpart D) Over-The-Counter Use (Per 21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
AND/OR
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120141
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