(84 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.
Yes.
The device is used to reduce and fix fractures and create a void in cancellous bone in the spine for kyphoplasty, which are therapeutic interventions.
No
The device description indicates that the Inflatable Bone Tamp is used for the "reduction and fixation of fractures and/or creation of a void in cancellous bone" and "creates a cavity and reduces the fracture." These actions are therapeutic interventions, not diagnostic ones. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description clearly outlines physical components like a balloon catheter and wire stiffener, indicating it is a hardware device used in a surgical procedure.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an "Inflatable Bone Tamp" used in "Balloon kyphoplasty" to create a cavity in bone and reduce fractures. This is a surgical procedure performed directly on the patient's body, not a test on a sample taken from the body.
- Intended Use: The intended use is for "reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine." This is a therapeutic and structural intervention, not a diagnostic test.
The device is a surgical tool used in a procedure, not a diagnostic test performed on a sample.
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. The wire stiffener provides stiffness to the balloon catheter to facilitate insertion through the access cannula
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
Physician
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
Characteristic: Inflation pressure
Standard/Test/FDA Guidance: Constrained burst test
Results Summary: The 15mm and 20mm 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 15mm and 20mm 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 15mm and 20mm balloons was substantially equivalent to that of the predicate devices
No clinical tests were conducted for this submission.
The results of the non-clinical tests show that the CareFusion 11G balloon catheters meet or exceed all performance requirements, and are substantially equivalent to the predicate devices.
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 Tamp, K093463, Kyphx Inflatable Bone Tamp, K041454, K981251
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
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Image /page/0/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a circular graphic on the left and the word "CareFusion" on the right. The graphic appears to be a stylized representation of hands or fingers forming a circle.
K103064
JAN 10 2011
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 | (847) 473-7990 |
| Establishment | |
| Registration Number | 1625685 |
| Name of contact person | Joy Greidanus |
| Date prepared | 10/28/2010 |
| NAME OF DEVICE | |
| Trade or proprietary | |
| name | AVAmax Vertebral Balloon |
| Common or usual name | Inflatable Bone Tamp |
| Classification name | Primary: Arthroscope |
| Secondary: Cement, Bone Vertebroplasty | |
| Classification panel | Orthopedic |
| Regulation | Class II per 21CFR §888.1100, Procode HRX: |
| Class II per 21CFR §888.3027, Procode NDN: | |
| Product Code(s) | VBT1115, VBT1120 |
| Legally marketed | |
| device(s) to which | |
| equivalence is | |
| claimed | CareFusion Inflatable Bone Tamp, K093463 |
| Kyphx Inflatable Bone Tamp, K041454, K981251 | |
| 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. The wire stiffener provides stiffness to the balloon catheter to | |
| facilitate insertion through the access cannula | |
| 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) |
1
CareFusion
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristic | New Device | Predicate |
|---|---|---|
| Compatible cannula size | 11G | 10G |
| 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 | Kyphon: Variable |
| CareFusion: Cylindrical | ||
| Maximum | ||
| recommended inflation | ||
| pressure | 400 psi (27 ATM) | 400 psi (27 ATM) |
| Maximum | ||
| recommended inflation | ||
| volume (15mm) | 4 mL | Kyphon: 5 mL |
| CareFusion: 4 mL | ||
| Maximum | ||
| recommended inflation | ||
| volume (20mm) | 6 mL | Kyphon: No 20mm size |
| Carefusion: 6 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 15mm and 20mm balloon catheters |
| exceeded the requirements for the minimum | ||
| burst pressure in a constrained environment | ||
| Inflation volume | Unconstrained burst test | The 15mm and 20mm 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 15mm and |
| 20mm balloons was substantially equivalent to | ||
| that of the predicate devices | ||
| 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 11G balloon catheters meet or exceed all |
performance requirements, and are substantially equivalent to the predicate devices.
一
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird with outstretched wings, depicted in a simple, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
CareFusion % Ms. Joy Greidanus Manager, Regulatory Affairs 1 500 Waukegan Road McGaw Park, Illinois 60085
JAN 1 0 201
Re: K103064
Trade Name: Inflatable Bone Tamp Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: December 13, 2010 Received: December 14, 2010
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 Foond, Or ug 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 provisiops 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 Part 801); medical device reporting (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 Pari 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/ucm11188017/php/fact/ 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" (216FR Previ 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
For
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical. Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/4/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a circular icon on the left and the word "CareFusion" on the right. The icon appears to be a globe with a stylized heart shape inside. The text is in a bold, sans-serif font.
『、 i
K103064
JAN 10 2011
CareFusion 1500 Waukegan Road AcGaw Park, Illinois 60085-6787
Indication for Use
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 X
Over-The Counter Use or
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division S Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103064
000035