(105 days)
No
The device description and performance studies focus on the mechanical properties and function of an inflatable bone tamp for kyphoplasty, with no mention of AI or ML capabilities.
Yes.
The device is described as creating a cavity and reducing fractures in the spine, which are actions intended to alleviate or treat a medical condition.
No
The device description indicates its purpose is for "reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty." This describes a therapeutic, rather than a diagnostic, function.
No
The device description clearly describes a physical medical device (Inflatable Bone Tamp) with a balloon catheter, designed for a surgical procedure (kyphoplasty). The performance studies focus on physical properties like burst pressure and volume, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine for kyphoplasty. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an Inflatable Bone Tamp used in balloon kyphoplasty. It is a physical tool used to create a cavity and reduce fractures within the vertebral body.
- Lack of Diagnostic Function: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such diagnostic function. It is a therapeutic device used during a surgical procedure.
The information provided clearly describes a surgical instrument used for treatment, not a device used for in vitro diagnostic testing.
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)
NDN, HRX
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
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)
The results of the non-clinical tests show that the CareFusion Flexible IBT System meets performance requirements, and is substantially equivalent to the predicate device.
Performance Test Summary-New Device:
- Characteristic: Inflation pressure; Standard/Test/FDA Guidance: Constrained burst test; Results Summary: The balloon catheters exceeded the requirements for the minimum burst pressure in a constrained environment
- Characteristic: Inflation volume; Standard/Test/FDA Guidance: Unconstrained burst test; Results Summary: The balloon catheters exceeded the requirements for the minimum burst volume in an unconstrained environment
- Characteristic: Balloon double wall thickness; Standard/Test/FDA Guidance: Calibrated measurement; Results Summary: The double wall thickness of the balloons was substantially equivalent to that of the predicate device
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.
CareFusion Inflatable Bone Tamps, K103064, K093463, K090211
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.
Radiopaque Bone Cement, K043518
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.
0
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | |
|---|---|
| Name | CareFusion |
| Address | 1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA |
| Phone number | (847) 473-7404 |
| Fax number | (312) 949-0583 |
| Establishment | |
| Registration Number | 1423507 |
| OCT 0 3 2013 | |
| Name of contact person | Joy Greidanus |
| Date prepared | June 18, 2013 |
| 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: | |
| Product Code(s) | TBD |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | CareFusion Inflatable Bone Tamps, K103064, K093463, K090211 |
| Radiopaque Bone Cement, K043518 | |
| Reason for 510(k) | |
| submission | New 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 (K103064) | ||
| Balloon inflation | ||
| medium | 60% contrast recommended | 60% contrast recommended |
| Balloon and catheter | ||
| materials | Polyurethane | Polyurethane |
| Wire mandrel material | Stainless steel | Stainless steel |
| Balloon shape | Cylindrical | Cylindrical |
| Maximum | ||
| recommended inflation | ||
| pressure | 400 psi (27 ATM) | 400 psi (27 ATM) |
| Maximum | ||
| recommended inflation | ||
| volume | 4 mL - 8 mL | 4 mL - 6mL |
| 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 | ||
| 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
performance requirements, and is substantially equivalent to the predicate device.
.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
October 3, 2013
CareFusion Ms: Joy Greidanus Manager, Regulatory Affairs 75 North Fairway Drive Vernon Hills, Illinois 60061
Rc: K131824
Trade/Device Name: Intlatable Bone Tamp Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN. HRX Dated: August 28. 2013 Received: August 29, 2013
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 docs 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 of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set
3
Page 2 - Ms. Joy Greidanus
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/dcfault.htm for the CDRI/'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 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.
Erin lị Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CareFusion - June 2013 - Traditional 510(k): Flexible Inflatable Bone Tamp System
Image /page/4/Picture/2 description: The image contains the logo for CareFusion. The logo consists of a circular graphic on the left and the word "CareFusion" on the right. The circular graphic appears to contain a stylized design, possibly representing a heart or a leaf.
1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.7404 FAX: 847.473.7790
510(k) Number (if known):
Unknown at this time
Inflatable Bone Tamp
Device Name:
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).
Prescription Use ____ (Per 21 CFR 801 Subpart D) ---------- (Per 21 CFR 807 Subpart C) And/Or Over-The Counter Use_ (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laurence D. Coyne -S
(Division Sign-Off) Division of Orthopedie Devices 510(k) Number: K131824