(110 days)
Not Found
No
The summary describes a mechanical device for vertebral augmentation and does not mention any AI or ML components or functions.
No
The device, the AVAflex Vertebral Augmentation Needle, is an instrument used during medical procedures (vertebroplasty and kyphoplasty) to prepare a fractured vertebral body for the injection of bone cement. It is a tool used in a therapeutic process, but it does not inherently provide a therapeutic effect itself; rather, it is used to facilitate the delivery of a therapeutic substance (bone cement) or to prepare the site for treatment.
No
The device is a surgical tool used to create a void in a fractured vertebral body and inject bone cement, which is a treatment procedure, not a diagnostic one.
No
The device description clearly states it is a "Vertebral Augmentation Needle," which is a physical, hardware-based medical device used in surgical procedures. There is no mention of software as the primary or sole component.
Based on the provided information, the AVAflex Vertebral Augmentation Needle 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- AVAflex Function: The AVAflex Vertebral Augmentation Needle is a surgical instrument used within the body during vertebroplasty and kyphoplasty procedures. Its purpose is to prepare the vertebral body and deliver bone cement. It does not analyze samples taken from the body.
The description clearly indicates the device is used for a surgical procedure to treat vertebral compression fractures, not for diagnostic testing of biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NDN, HXG, OAR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body, spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
All materials used in the fabrication of the Vertebral Augmentation Needle were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". These materials also were tested 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 curettes with regard to functional characteristics.
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.
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.
Not Found
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.”
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 Health
1430 Waukegan Road MPKB
McGaw 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 Vertebroplasty
Secondary - Tamp, Cement Dispenser |
| Device Class and
Requlation Number: | Class II per 21CFR §888.3027, Procode NDN
Class I per §888.4540, Procode HXG and §888.4200,
Procode OAR |
| Predicate Devices: | Cardinal Health Chroma-Line Cervical and Lumbar Spine
Curettes, Class I exempt
Kyphon, Inc., Kyphx Latitude Curette, Class I exempt
Medtronic Sofamor Danek, Arcuate Vertebral
Augmentation System, K063248 |
1
| Description: | 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. |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The AVAflex Vertebral Augmentation Needle is used
during a vertebroplasty to fill a fractured vertebral body
with Radiopaque Bone Cement manufactured by Cardina
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. |
| Summary of Technological
Characteristics: | The proposed device and the predicate device are
composed of the same or similar design, materials and
the manufacturing characteristics. |
| Summary of testing: | All materials used in the fabrication of the Vertebral
Augmentation Needle were evaluated through biological
qualification safety tests as outlined in ISO 10993 Part-1
"Biological Evaluation of Medical Devices". These
materials also were tested in accordance with industry
recognized test methods and were found to be
acceptable for the intended use. |
| Non-Clinical Testing: | Performance testing demonstrated that the proposed
device is substantially equivalent to the currently
marketed curettes with regard to functional
characteristics. |
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
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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