(210 days)
Not Found
No
The device description and performance studies focus on mechanical properties and function, with no mention of AI or ML.
Yes
The device is used to reduce and fix fractures in the spine and creates a void for bone cement, directly treating a medical condition.
No
The device is intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone, which are therapeutic actions, not diagnostic ones.
No
The device description clearly describes a physical medical device (Inflatable Bone Tamp, balloon catheter) used for a surgical procedure (kyphoplasty) and includes performance studies related to the physical properties of the device (burst pressure, burst volume, wall thickness). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device, the Inflatable Bone Tamp (IBT), is a surgical tool used directly within the body during a procedure (kyphoplasty) to create a cavity and reduce fractures in the spine. It does not analyze biological samples.
- Intended Use: The intended use clearly states "reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty." This is a surgical intervention, not a diagnostic test performed on a sample.
Therefore, the Inflatable Bone Tamp is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).
Product codes (comma separated list FDA assigned to the subject device)
HRX, NDN
Device Description
The Inflatable Bone Tamp (IBT) was designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (vertebral body)
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)
Performance Test Summary-New Device:
- Inflation pressure: Constrained burst test. Results: The balloon catheters exceeded the requirements for the minimum burst pressure in a constrained environment.
- Inflation volume: Unconstrained burst test. Results: The balloon catheters exceeded the requirements for the minimum burst volume in an unconstrained environment.
- Balloon double wall thickness: Calibrated measurement. Results: The double wall thickness of the balloons was substantially equivalent to that of the predicate device.
- Simulated use: Cadaver. Results: Cadaveric simulated use testing demonstrated substantial equivalence in performance.
N/A - No clinical tests were conducted for 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
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
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Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2015
CareFusion Ms. Jov Greidanus Manager, Regulatory Affairs 75 North Fairway Drive Vernon Hills, Illinois 60061
Re: K151125
Trade/Device Name: AVAflex Vertebral Balloon System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, NDN Dated: September 30, 2015 Received: October 2, 2015
Dear Ms. Greidanus:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved OMB No 0910-0120
Expiration Date January 31, 2017
See PRA Statement below
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) Unknown K151125
Device Name
AVAflex Vertebral Balloon System
Indications for Use (Describe)
Intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) SUMMARY K151125
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | |||
|---|---|---|---|
| Name | CareFusion | ||
| Address | 75 North Fairway Drive, Vernon Hills IL 60061 USA | ||
| Phone number | (847) 362-8103 | ||
| Fax number | (312) 949-0583 | ||
| Establishment | |||
| Registration Number | 1423507 | ||
| Name of contact person | Joy Greidanus | ||
| Date prepared | September 30, 2015 | ||
| NAME OF DEVICE | |||
| Trade or proprietary | |||
| name | AVAflex Vertebral Balloon System | ||
| Common or usual name | Inflatable Bone Tamp | ||
| Classification name | Arthroscope | ||
| Classification panel | Orthopedic | ||
| Regulation | Class II per 21CFR §888.1100, Procode HRX | ||
| Class II per 21CFR §888.3027, Procode NDN | |||
| Legally marketed | |||
| device(s) to which | |||
| equivalence is claimed | CareFusion Inflatable Bone Tamps, K131824 | ||
| Radiopaque Bone Cement, K043518 | |||
| Reason for 510(k) | |||
| submission | Modifications to device | ||
| Device description | The Inflatable Bone Tamp (IBT) was designed for use in balloon kyphoplasty. | ||
| The balloon serves to create a cavity in the vertebral body, thereby reducing | |||
| the fracture and preventing cement leakage, while still allowing for cement | |||
| interdigitation. The balloon catheter is the functional part of the device that | |||
| creates a cavity and reduces the fracture. The balloon catheter provides a | |||
| conduit through which the physician can inflate the balloon at the distal end of | |||
| the catheter. | |||
| Intended use of the | |||
| device | Intended for the reduction and fixation of fractures and/or creation of a void in | ||
| cancellous bone in the spine for kyphoplasty (for use with CareFusion | |||
| Radiopaque Bone Cement). |
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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristic | New Device | Predicate
CareFusion Vertebral Balloon K131824 |
|----------------------------------------------|--------------------------|---------------------------------------------------|
| Compatible cannula
size | 11G | 10G |
| Balloon inflation
medium | 60% contrast recommended | 60% contrast recommended |
| Markers | Radiopaque | Radiopaque |
| Balloon shape | Cylindrical | Cylindrical |
| Maximum
recommended inflation
pressure | 400 psi (27 ATM) | 400 psi (27 ATM) |
| Maximum
recommended inflation
volume | 3-6 mL | 4-8 mL |
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
|---|---|---|
| Inflation pressure | Constrained burst test | The balloon catheters exceeded the |
| requirements for the minimum burst pressure in a | ||
| constrained environment. | ||
| Inflation volume | Unconstrained burst test | The balloon catheters exceeded the |
| requirements for the minimum burst volume in an | ||
| unconstrained environment. | ||
| Balloon double wall | ||
| thickness | Calibrated measurement | The double wall thickness of the balloons was |
| substantially equivalent to that of the predicate | ||
| device. | ||
| Simulated use | Cadaver | Cadaveric simulated use testing demonstrated |
| substantial equivalence in performance. |
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
N/A - No clinical tests were conducted for this submission.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The results of the non-clinical tests show that the CareFusion Flexible IBT System meets or exceeds all performance requirements, and is substantially equivalent to the predicate device.