(112 days)
Intended for the reduction and fixation of fractures 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 text is a 510(k) summary for the CareFusion Inflatable Bone Tamp. It describes the device, its intended use, and states that performance testing demonstrated substantial equivalence to predicate devices. However, the document does not contain the detailed information necessary to answer the specific questions about acceptance criteria, a comprehensive study design, or specific performance metrics.
Here's what can be extracted and what is missing based on your template:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly states that the device was evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 and in accordance with industry-recognized test methods, and "were found to be acceptable for the intended use." Performance testing "demonstrated that the proposed device is substantially equivalent to the currently marketed predicate devices with regard to functional characteristics."
- Reported Device Performance: No specific performance metrics (e.g., success rates, precision, accuracy, sensitivity, specificity, etc.) are provided. The only "performance" reported is meeting the safety standards and achieving substantial equivalence to predicates.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no human-expert-reviewed test sets are mentioned. The testing described focuses on material and functional characteristics, not diagnostic or interpretive tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device for a surgical procedure (Inflatable Bone Tamp), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the biological and functional testing, the "ground truth" would be established by the ISO standards and industry-recognized test methods themselves (e.g., material property specifications, inflation/pressure limits, leakage tests against defined benchmarks).
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Study Information Available in the Document:
The study described in this 510(k) pertains to the non-clinical testing of the Inflatable Bone Tamp.
- Type of Study: Non-clinical (bench testing) to assess material safety and functional characteristics.
- Objective: To demonstrate substantial equivalence of the proposed device to predicate devices.
- Methods:
- Biological Qualification Safety Tests: As outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices."
- Other Performance Testing: Evaluated in accordance with industry-recognized test methods. These tests focused on ensuring the device shares similar design, materials, and manufacturing characteristics, and functional performance, with legally marketed predicate devices.
- Results: All materials and performance testing were found to be acceptable for the intended use and demonstrated substantial equivalence to the predicate devices.
- Predicates: Cardinal Health Inflatable Bone Tamp (K090211), Kyphx Inflatable Bone Tamp (K041454, K981251), and Radiopaque Bone Cement (K043518).
In conclusion, this document primarily serves as a regulatory submission demonstrating substantial equivalence for a physical medical device, not an AI/software device. Therefore, many of the requested details related to clinical studies, AI performance metrics, and human reader-contributed data are not present nor relevant to this type of device submission.
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K0934663-
Image /page/0/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a stylized letter C inside of a shield on the left, and the word "CareFusion" in bold sans-serif font on the right. The logo is black and white.
FEB 2 S 2010
CareFusion 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847,578 6610 FAX: 847.785.2506
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Inflatable Bone Tamp
CareFusion Sponsor: 1500 Waukegan Road MPWM McGaw Park, IL 60085 Regulatory Affairs: Contact Sharon Nichols Telephone: (847) 578-6610 Date Summary Prepared: November 2009 Common Name: Inflatable Bone Tamp Regulation Description: Primary - Arthroscope Secondary - Cement, bone, vertebroplasty Device Class and Class II per 21CFR §888.1100, Procode Regulation Number: HRX: Class II per 21CFR §888.3027, Procode NDN: Cardinal Health Inflatable Bone Tamp, Predicate Devices: K090211 Kyphx Inflatable Bone Tamp, K041454, K981251 Radiopaque Bone Cement, K043518
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Description:
Intended Use:
Characteristics:
Summary of Technological
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 for the reduction and fixation of fractures in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).
The proposed device and the predicate devices are composed of the same or similar design, materials and manufacturing characteristics.
All materials used in the fabrication of the Inflatable Bone Tamp were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". These materials also were evaluated in accordance with industry recognized test methods and were found to be acceptable for the intended use.
Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate devices with regard to functional characteristics.
Non-Clinical Testing:
Summary of testing:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS) and the General Services Administration (GSA). The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - GSA" around the top half. Inside the circle is the symbol of HHS, which is a stylized caduceus with a human figure in the center.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
CareFusion % Ms. Sharon Nichols Regulatory Affairs Manager 1500 Waukegan Road McGaw Park, Illinois 60085
FEB 2 3 2010
Re: K093463
Trade/Device Name: Inflatable Bone Tamp Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, HRX Dated: February 3, 2010 Received: February 4, 2010
Dear Ms. Nichols:
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 Part 801); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set 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.
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Page 2 - Ms. Sharon Nichols
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/ucm115809.htm for 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" (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.goy/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,
Arbane buchn
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 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 stylized shield or emblem with a checkmark-like shape inside. The text "CareFusion" is in a bold, sans-serif font.
CareFusion 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 FAX: 847.785.2506
Indication for Use
510(k) Number (if known):
Device Name:
Indications For Use:
unknown at this time
Inflatable Bone Tamp
Intended for the reduction and fixation of fractures in cancellous bone in the spine for kyphoplasty (for use with CareFusion Radiopaque Bone Cement).
Prescription Use X
Over-The Counter Use
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
OF
Concurrence of CDRH, Office of Device Evaluation (ODE)
thull D. FOR M. MELKERSON
(Division Sign-Off) (Øivision Sign-Childer, Ørthopedic, Division of Surgices Division of Sale
and Restorative Devices
510(k) Number K093
000028
§ 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.”