(84 days)
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).
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
The provided document describes the safety and effectiveness information for the CareFusion AVAmax Vertebral Balloon (Inflatable Bone Tamp). Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds against specific metrics for clinical performance. Instead, it presents summaries of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. The performance data is framed as meeting or exceeding requirements based on these tests.
| Characteristic | Standard/Test/FDA Guidance | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Inflation pressure | Constrained burst test | Exceed minimum burst pressure in a constrained environment | Exceeded the requirements for minimum burst pressure |
| Inflation volume | Unconstrained burst test | Exceed minimum burst volume in an unconstrained environment | Exceeded the requirements for minimum burst volume |
| Balloon double wallthickness | Calibrated measurement | Substantially equivalent to predicate device thickness | Substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and the Data Provenance
The document states, "N/A - No clinical tests were conducted for this submission." Therefore, there is no test set in the context of clinical data, no sample size, and no data provenance (country of origin, retrospective/prospective). The "test set" in this case refers to the physical devices subjected to non-clinical laboratory testing. The sample sizes for these engineering tests are not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical tests were conducted, no experts were used to establish ground truth for a clinical test set. The evaluation was based on engineering performance tests against established standards or internal requirements.
4. Adjudication Method for the Test Set
Not applicable, as no clinical tests were performed, and thus no expert adjudication was needed for clinical outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states, "N/A - No clinical tests were conducted for this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this device is a physical medical device (Inflatable Bone Tamp), not a software algorithm or AI-driven system.
7. The Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" was implicitly defined by engineering specifications, accepted standards for burst pressure/volume, and comparative measurements against predicate devices. There was no clinical ground truth (e.g., pathology, outcomes data).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or software system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set for an AI/software system.
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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 |
| EstablishmentRegistration Number | 1625685 |
| Name of contact person | Joy Greidanus |
| Date prepared | 10/28/2010 |
| NAME OF DEVICE | |
| Trade or proprietaryname | AVAmax Vertebral Balloon |
| Common or usual name | Inflatable Bone Tamp |
| Classification name | Primary: ArthroscopeSecondary: 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 marketeddevice(s) to whichequivalence isclaimed | CareFusion Inflatable Bone Tamp, K093463Kyphx Inflatable Bone Tamp, K041454, K981251Radiopaque 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 reducingthe fracture and preventing cement leakage, while still allowing for cementinterdigitation. The balloon catheter is the functional part of the device thatcreates a cavity and reduces the fracture. The balloon catheter provides aconduit through which the physician can inflate the balloon at the distal end ofthe catheter. The wire stiffener provides stiffness to the balloon catheter tofacilitate insertion through the access cannula |
| Intended use of thedevice | Intended for the reduction and fixation of fractures and/or creation of a void incancellous bone in the spine for kyphoplasty (for use with CareFusionRadiopaque Bone Cement) |
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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: VariableCareFusion: Cylindrical |
| Maximumrecommended inflationpressure | 400 psi (27 ATM) | 400 psi (27 ATM) |
| Maximumrecommended inflationvolume (15mm) | 4 mL | Kyphon: 5 mLCareFusion: 4 mL |
| Maximumrecommended inflationvolume (20mm) | 6 mL | Kyphon: No 20mm sizeCarefusion: 6 mL |
| PERFORMANCE DATA | ||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE | ||
| Performance Test Summary-New Device | ||
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Inflation pressure | Constrained burst test | The 15mm and 20mm balloon cathetersexceeded the requirements for the minimumburst pressure in a constrained environment |
| Inflation volume | Unconstrained burst test | The 15mm and 20mm balloon cathetersexceeded the requirements for the minimumburst volume in an unconstrained environment |
| Balloon double wallthickness | Calibrated measurement | The double wall thickness of the 15mm and20mm balloons was substantially equivalent tothat of the predicate devices |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION | ||
| N/A - No clinical tests were conducted for this submission | ||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATAThe 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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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
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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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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
§ 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.”