(110 days)
The AVAflex Vertebral Augmentation Needle is used during a vertebroplasty to fill a fractured vertebral body with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.
The AVAflex Vertebral Augmentation Needle is used during a kyphoplasty to scrape and score bone in the spine to create a void within a fractured vertebral body and fill the void with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.
The AVAflex Vertebral Augmentation Needle is a device used to disrupt cancellous bone by scraping and scoring the bone as and creating a void within a vertebral body. After the bone is disrupted, Radiopaque Bone Cement is injected through the AVAflex Vertebral Augmentation Needle to fill the previously created void.
This is a 510(k) premarket notification for a medical device, the AVAflex Vertebral Augmentation Needle, from 2007. It is not an AI/ML device, and therefore, many of the requested criteria (like ground truth, expert opinions, AI assistance, etc.) are not applicable. The study described focuses on non-clinical performance and biological safety.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". | Materials were evaluated and found to be "acceptable for the intended use." |
| Functional Characteristics | Performance testing demonstrating substantial equivalence to currently marketed curettes. | Performance testing demonstrated that the proposed device is "substantially equivalent to the currently marketed curettes with regard to functional characteristics." |
| Material Properties | Industry-recognized test methods for materials. | Materials were tested and found to be "acceptable for the intended use." |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical laboratory testing of the device itself (materials, performance), not a study on human or clinical data. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical or image data are not applicable. The "test set" here refers to the actual physical devices or materials undergoing laboratory evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable for a non-clinical device performance and biocompatibility study. "Ground truth" in this context refers to established standards and test methodologies (e.g., ISO 10993 for biocompatibility) rather than expert consensus on medical findings.
4. Adjudication Method for the Test Set
This is not applicable as the study involves objective laboratory testing against established standards, not human interpretation or a need for adjudication.
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
No, an MRMC study was not done. This device is a surgical tool, not an AI diagnostic/imaging device. Therefore, the concept of AI assistance for human readers is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" was established
by international standards such as ISO 10993 Part-1.
For functional characteristics, the "ground truth" was established by comparison to predicate devices and industry-recognized test methods.
8. The Sample Size for the Training Set
This is not applicable as this is not an AI/ML device and therefore does not have a "training set" in the computational sense. The "training" for such a device would involve engineering design, prototyping, and iterative physical testing, for which sample sizes are determined by engineering and quality assurance standards.
9. How the Ground Truth for the Training Set was Established
This is not applicable as this is not an AI/ML device. The "ground truth" for the development of such a device is rooted in engineering principles, material science, and established medical requirements for surgical tools.
{0}------------------------------------------------
CardinalHealth
Cardinal Health 1430 Waukegan Road
McGaw Park, Illinois 60085-6787 847.578.6610 FAX: 847.785.2506
NOV 2 0 2007
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS AVAflex Vertebral Augmentation Needle
| Sponsor: | Cardinal Health1430 Waukegan Road MPKBMcGaw Park, IL 60085 |
|---|---|
| Regulatory Affairs:Contact | Sharon Nichols |
| Telephone: | (847) 578-6610 |
| Date Summary Prepared: | November 2007 |
| Common Name: | AVAflex Vertebral Augmentation Needle |
| Regulation Description: | Primary - Cement, Bone VertebroplastySecondary - Tamp, Cement Dispenser |
| Device Class andRequlation Number: | Class II per 21CFR §888.3027, Procode NDNClass I per §888.4540, Procode HXG and §888.4200,Procode OAR |
| Predicate Devices: | Cardinal Health Chroma-Line Cervical and Lumbar SpineCurettes, Class I exemptKyphon, Inc., Kyphx Latitude Curette, Class I exemptMedtronic Sofamor Danek, Arcuate VertebralAugmentation System, K063248 |
{1}------------------------------------------------
| Description: | The AVAflex Vertebral Augmentation Needle is a deviceused to disrupt cancellous bone by scraping and scoringthe bone as and creating a void within a vertebral body.After the bone is disrupted, Radiopaque Bone Cement isinjected through the AVAflex Vertebral AugmentationNeedle to fill the previously created void. |
|---|---|
| Intended Use: | The AVAflex Vertebral Augmentation Needle is usedduring a vertebroplasty to fill a fractured vertebral bodywith Radiopaque Bone Cement manufactured by CardinaHealth. The painful pathological vertebral bodycompression fractures may result from osteoporosis,benign or malignant lesions such as metastatic cancersand myeloma.. |
| The AVAflex Vertebral Augmentation Needle is usedduring a kyphoplasty to scrape and score bone in thespine to create a void within a fractured vertebral bodyand fill the void with Radiopaque Bone Cementmanufactured by Cardinal Health. The painfulpathological vertebral body compression fractures mayresult from osteoporosis, benign or malignant lesionssuch as metastatic cancers and myeloma. | |
| Summary of TechnologicalCharacteristics: | The proposed device and the predicate device arecomposed of the same or similar design, materials andthe manufacturing characteristics. |
| Summary of testing: | All materials used in the fabrication of the VertebralAugmentation Needle were evaluated through biologicalqualification safety tests as outlined in ISO 10993 Part-1"Biological Evaluation of Medical Devices". Thesematerials also were tested in accordance with industryrecognized test methods and were found to beacceptable for the intended use. |
| Non-Clinical Testing: | Performance testing demonstrated that the proposeddevice is substantially equivalent to the currentlymarketed curettes with regard to functionalcharacteristics. |
{2}------------------------------------------------
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2007
CardinalHealth % Ms. Sharon Nichols Regulatory Affairs 1430 Waukegan Road McGwa Park, IL 60085-6787
Re: K072133
Trade/Device Name: AVAflex Vertebral Augmentation Needle Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, HXG, OAR Dated: October 25, 2007 Received: October 26, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
{3}------------------------------------------------
Page 2 - Ms. Sharon Nichols
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-3464. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The company name, "CardinalHealth", is written in a simple, sans-serif font.
Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6610 FAX: 847.785.2506
Indication for Use
510(k) Number (if known): K072133
Device Name: AVAflex Vertebral Augmentation Needle
Indications For Use:
The AVAflex Vertebral Augmentation Needle is used during a vertebroplasty to fill a fractured vertebral body with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.
The AVAflex Vertebral Augmentation Needle is used during a kyphoplasty to scrape and score bone in the spine to create a void within a fractured vertebral body and fill the void with Radiopaque Bone Cement manufactured by Cardinal Health. The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.
Prescription Use X or (Per 21 CFR 801.109)
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchner
Division of General, Restorative, and Neurological Devices
510(k) Number K072133
§ 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.”