(105 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.
Unfortunately, the provided text does not contain information about acceptance criteria or specific studies proving the device meets those criteria. The document is a 510(k) summary for a medical device (AVAflex Vertebral Balloon System, an Inflatable Bone Tamp) and it focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data.
Here's a breakdown of what is available in the provided text, and what is not in relation to your request:
What is present:
- Device Description and Intended Use: The AVAflex Vertebral Balloon System is an Inflatable Bone Tamp for balloon kyphoplasty, intended for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine.
- Predicate Device: CareFusion Inflatable Bone Tamps (K103064, K093463, K090211) and Radiopaque Bone Cement (K043518).
- Technological Characteristics Comparison to Predicate:
- Balloon inflation medium: 60% contrast recommended (New Device) vs. 60% contrast recommended (Predicate)
- Balloon and catheter materials: Polyurethane (New Device) vs. Polyurethane (Predicate)
- Wire mandrel material: Stainless steel (New Device) vs. Stainless steel (Predicate)
- Balloon shape: Cylindrical (New Device) vs. Cylindrical (Predicate)
- Maximum recommended inflation pressure: 400 psi (27 ATM) (New Device) vs. 400 psi (27 ATM) (Predicate)
- Maximum recommended inflation volume: 4 mL - 8 mL (New Device) vs. 4 mL - 6mL (Predicate)
- Performance Data (Non-Clinical Tests):
- Inflation pressure: Constrained burst test. Results Summary: The balloon catheters exceeded the requirements for the minimum burst pressure in a constrained environment.
- Inflation volume: Unconstrained burst test. Results Summary: The balloon catheters exceeded the requirements for the minimum burst volume in an unconstrained environment.
- Balloon double wall thickness: Calibrated measurement. Results Summary: The double wall thickness of the balloons was substantially equivalent to that of the predicate device.
- Conclusion from Non-Clinical Data: The new device meets performance requirements and is substantially equivalent to the predicate device.
- Clinical Tests: N/A - No clinical tests were conducted for this submission.
What is explicitly not present (and therefore cannot be provided from this text):
- A table of specific acceptance criteria and reported device performance against those criteria. The results summary states "exceeded the requirements" or "substantially equivalent," but does not define what those specific requirements (acceptance criteria) were in measurable terms (e.g., "minimum burst pressure must be X psi, device achieved Y psi").
- Sample sized used for the test set and the data provenance. While a burst test implies a sample, the specific number is not given and its origin (country, retrospective/prospective) is not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts. This information is typically relevant for studies involving human interpretation (e.g., image analysis), which are not present here.
- Adjudication method for the test set. Again, this is for studies involving human interpretation.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with/without AI assistance. This device is a physical medical device, not an AI/software device, so MRMC studies are not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. Not an AI/software device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.). For the non-clinical tests, the "ground truth" would be the established engineering/performance standards or the performance of the predicate device, but this is not explicitly detailed.
- The sample size for the training set. There isn't a "training set" in the context of this device's non-clinical testing.
- How the ground truth for the training set was established. Not applicable.
In summary, this 510(k) emphasizes that the new device is substantially equivalent to a previously approved predicate device based on non-clinical engineering performance benchmarks rather than a detailed study with explicit acceptance criteria and corresponding performance metrics. The specific numeric acceptance criteria for "minimum burst pressure" or "minimum burst volume" are not defined in the provided summary.
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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 |
| EstablishmentRegistration Number | 1423507 |
| OCT 0 3 2013 | |
| Name of contact person | Joy Greidanus |
| Date prepared | June 18, 2013 |
| NAME OF DEVICE | |
| Trade or proprietaryname | 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 marketeddevice(s) to whichequivalence is claimed | CareFusion Inflatable Bone Tamps, K103064, K093463, K090211Radiopaque 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. |
| 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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. . . . . . . . . . .
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPAREDTO THE PREDICATE DEVICE | ||
|---|---|---|
| Characteristic | New Device | Predicate |
| CareFusion Vertebral Balloon (K103064) | ||
| Balloon inflationmedium | 60% contrast recommended | 60% contrast recommended |
| Balloon and cathetermaterials | Polyurethane | Polyurethane |
| Wire mandrel material | Stainless steel | Stainless steel |
| Balloon shape | Cylindrical | Cylindrical |
| Maximumrecommended inflationpressure | 400 psi (27 ATM) | 400 psi (27 ATM) |
| Maximumrecommended inflationvolume | 4 mL - 8 mL | 4 mL - 6mL |
| 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 balloon catheters exceeded therequirements for the minimum burst pressure in aconstrained environment |
| Inflation volume | Unconstrained burst test | The balloon catheters exceeded therequirements for the minimum burst volume in anunconstrained environment |
| Balloon double wallthickness | Calibrated measurement | The double wall thickness of the balloons wassubstantially equivalent to that of the predicatedevice |
| 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 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
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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
§ 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.