(107 days)
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.
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 provided FDA 510(k) summary for the Kensey Nash Bone Void Filler XC (K120141) indicates that this device is claiming substantial equivalence to a predicate device, K060917 (Kensey Nash Bone Void Filler). Therefore, the study described is primarily focused on demonstrating this equivalence rather than establishing new performance criteria.
Here's an analysis based on the provided text:
Acceptance Criteria and Study for Kensey Nash Bone Void Filler XC (K120141)
The submission for K120141 does not detail new acceptance criteria or a new standalone study directly for the Kensey Nash Bone Void Filler XC. Instead, it relies on the performance data and established equivalence to its predicate device (K060917). The performance data cited are from the predicate device and are considered applicable to the new device because the technological characteristics are stated to be identical.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim based on the predicate device's existing data, specific quantitative acceptance criteria for this submission are not explicitly stated in the provided text. The performance is indirectly "accepted" by virtue of being identical to a previously cleared device.
| Performance Characteristic | Acceptance Criteria (from predicate K060917) | Reported Device Performance (K120141) |
|---|---|---|
| Biocompatibility | Met established standards for K060917 | Identical (due to identical technology) |
| Physical Properties | Met established standards for K060917 | Identical (due to identical technology) |
| Compressive Strength | Met established standards for K060917 | Identical (due to identical technology) |
| Animal Study | Demonstrated safety/effectiveness for K060917 | Identical (due to identical technology) |
2. Sample Size Used for the Test Set and Data Provenance
- The provided document does not specify the sample size for the test sets used in the biocompatibility, physical properties, compressive strength, or animal studies from the predicate device (K060917).
- The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). This information would typically be found in the actual predicate device's 510(k) submission (K060917).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The provided text does not mention the involvement of experts for establishing ground truth specifically for the performance data of the predicate device (K060917). This type of information is usually not relevant for a materials-based device in the context of biocompatibility, physical testing, and animal studies, where objective measurements and observations are typically used.
4. Adjudication Method for the Test Set
- The provided text does not describe any adjudication method. This is generally not applicable to the types of non-clinical tests (biocompatibility, physical properties, animal studies) typically employed for bone void fillers where objective laboratory measurements and animal observations are made.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This device is a bone void filler (a physical implant), not a diagnostic or AI-driven medical imaging device. Therefore, a study involving human readers or AI assistance is not relevant to its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No standalone algorithm performance study was done. This device is a physical implant and does not involve any algorithms or AI components.
7. The Type of Ground Truth Used
For the non-clinical testing referenced from the predicate device (K060917):
- Biocompatibility: Likely relies on established biological safety standards (e.g., ISO 10993 series) as ground truth, demonstrated through specific in vitro and in vivo tests.
- Physical Properties & Compressive Strength: Ground truth is based on engineering and material science standards, measured objectively (e.g., ASTM standards).
- Animal Study: Ground truth is established through histological analysis, radiography, and other objective observations of bone ingrowth and material resorption in an animal model, often reviewed by veterinary pathologists or other trained personnel.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve training sets as it is a physical implant, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, there is no ground truth established for one.
{0}------------------------------------------------
K120141(pg.iof2)
510(k) Summary
- 4 2012 MAY
| Submitted By: | Kensey Nash Corporation735 Pennsylvania Drive,Exton, PA 19341 |
|---|---|
| Contact Person: | Susan PileggiRegulatory SpecialistP: 484-713-2100F: 484-713-2903 |
| Date Prepared: | March 16, 2012 |
| 510(k): | K120141 |
| Device:Trade Name:Common/Usual Name:Proposed Classification: | Kensey Nash Bone Void Filler XCFiller, Bone Void, Calcium Compound21 CFR 888.3045MQVClass 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
Page 1 of 1
§ 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.