(88 days)
Not Found
No
The document describes a mechanical vertebral augmentation system with no mention of AI or ML components.
Yes
The device is indicated for the "treatment of painful pathological fractures of the vertebral body," which is a therapeutic intervention.
No.
The device is intended for the treatment of painful pathological fractures of the vertebral body, specifically for vertebral augmentation, which is a therapeutic procedure involving the use of instruments to prepare and inject bone cement. It is not described as diagnosing a condition.
No
The device description explicitly lists multiple hardware components, including cutting instruments, cannulas, trocars, a hand drill, and cement delivery tubes. The performance studies also focus on the mechanical properties and performance of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of painful pathological fractures of the vertebral body. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The components listed are instruments used for a surgical procedure (cutting, inserting, delivering cement) within the vertebral body.
- Anatomical Site: The device is used within the vertebral body, which is part of the patient's anatomy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (within the body) for a therapeutic intervention.
N/A
Intended Use / Indications for Use
The Acu-Cut Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma. It is intended to be used in combination with Ascendx Cement.
Product codes
NDN, KIH
Device Description
The Acu-Cut Vertebral Augmentation System consists of:
- the Acu-Cut Cutting Instrument .
- 2 Cannulas
- 1 Tri-Point Tip Trocar
- 1 Bevel Tip Trocar
- 1 Hand Drill
- 5 Cement Delivery Tubes with Plungers
- A previously FDA cleared bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vertebral body
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
Comprehensive bench and clinical testing of the Acu-Cut Vertebral Augmentation System was conducted. Testing included:
- Bench testing for the Acu-Cut Cutting Instrument .
- Cutting torque testing in osteoporotic vertebrae and sawbones
- Tensile strength testing of Cutting Instrument band
- Cutting Instrument flex cable weld strength testing
- Bench testing for the Trocars, Cannulas, Hand Drills and Cement Delivery Devices
- Insertion testing
- Trocar Handle Strength Testing
- Torque and Tensile Strength Testing
- Cement Delivery Instrument Testing
- Removal Force Testing
- Sterilization Validation
- Packaging and Shipping Validations
- Biocompatibility Testing
- Clinical Testing Ascendx VCF Repair System IDE study
- Accelerated and Real Time Aging Testing .
The testing demonstrated that the System conforms to its design specifications. The testing also demonstrated the Acu-Cut System's ability to mechanically withstand insertion and deployment within a vertebral body. In all instances, the Acu-Cut System functioned as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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K113452
PAGE 1 of 2
510(k) SUMMARY for K113452
Ascendx Spine, Inc.'s Acu-Cut Vertebral Augmentation System FEB 17 2012
Submitter
Ascendx Spine, Inc. 7079 University Blvd Winter Park FL 32792
Phone: (321) 280-4800 Facsimile: (321) 280-4801 Contact Person: Teresa Cherry Date Prepared: July 16, 2012 (12/15ed)
Name of Device
Acu-Cut Vertebral Augmentation System
Classification Name
Vertebroplasty, Cement, Bone
Predicate Devices
Medtronic USA, Inc.'s Arcuate Vertebral Augmentation System (K070527)
Intended Use / Indications for Use
The Acu-Cut Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma. It is intended to be used in combination with Ascendx Cement.
Technological Characteristics
The Acu-Cut Vertebral Augmentation System consists of:
- the Acu-Cut Cutting Instrument .
- . 2 Cannulas
- 1 Tri-Point Tip Trocar .
- 1 Bevel Tip Trocar ●
- 1 Hand Drill ●
1
Page 2 of 2
- · 5 Cement Delivery Tubes with Plungers
- · A previously FDA cleared bone cement.
Performance Data
Comprehensive bench and clinical testing of the Acu-Cut Vertebral Augmentation System was conducted. Testing included:
- Bench testing for the Acu-Cut Cutting Instrument .
- Cutting torque testing in osteoporotic vertebrae and sawbones o
- Tensile strength testing of Cutting Instrument band o
- Cutting Instrument flex cable weld strength testing o
- Bench testing for the Trocars, Cannulas, Hand Drills and Cement Delivery ● Devices
- o Insertion testing
- Trocar Handle Strength Testing 0
- Torque and Tensile Strength Testing O
- Cement Delivery Instrument Testing O
- o Removal Force Testing
- Sterilization Validation ●
- Packaging and Shipping Validations .
- Biocompatibility Testing ●
- Clinical Testing Ascendx VCF Repair System IDE study ●
- Accelerated and Real Time Aging Testing .
The testing demonstrated that the System conforms to its design specifications. The testing also demonstrated the Acu-Cut System's ability to mechanically withstand insertion and deployment within a vertebral body. In all instances, the Acu-Cut System functioned as intended.
Substantial Equivalence
The Acu-Cut Vertebral Augmentation System is substantially equivalent to the predicate device. The Acu-Cut Vertebral Augmentation System has the same intended uses and indications as the predicate Arcuate Vertebral Augmentation System. Both systems include a cutting device that is used to create a cavity by cutting cancellous bone within the vertebral body. Both systems include Class I instruments for gaining access to the vertebral body and for delivering previously cleared bone cement. The technological characteristics and principles of operation of the Acu-Cut System are also similar to the predicate. The minor technological differences between the Acu-Cut Vertebral Augmentation System and its predicate device, e.g., with respect to dimensions, etc., raise no new issues of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is composed of three curved lines that form the body, wings, and tail feathers.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 17 2012
Ascendx Spine, Incorporated % Hogan LovellsUS LLP Ms. Janice M. Hogan Regulatory Counsel 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K113452
Trade/Device Name: Acu-Cut Vertebral Augmentation System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, KIH Dated: November 21, 2011 Received: November 21, 2011
Dear Ms. Hogan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars) and enough the Medical Device Amendments, or to connineres phot to May 20, 1978, are encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, increasing market the act include requirements for annual registration, listing of gencial controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Thease note: OD10 : 0010 : abeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (300 acree, insisting major regulations affecting your device can be may be subject to additions, 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 that IDA has made a accornmancir in administered by other Federal agencies. You must or any rederal statutes and regulations annualing, but not limited to: registration and listing (21 Comply with an the For 8 requirements (1); medical device reporting (reporting of medical CrK Fall 607), laocing (21 OFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Janice M. Hogan
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 n you active spothio ad 1100 corpor JDA/Centers Offices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Somer 10. BOTTess and ing by reference to premarket notification" (21CFR Part note the 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 I ou may 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,
Eind Keith
~ Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: Acu-Cut Vertebral Augmentation System
Indications for Use:
The Acu-Cut Vertebral Augmentation System is indicated for the treatment of painful pathological fractures of the vertebral body. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancers and myeloma. It is intended to be used in combination with Ascendx Cement.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-(Division Sign-Sign-Sical, Orthopedic, and Restorative Devices
510(k) Number
Page I of i
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