(70 days)
No
The device description and the absence of mentions of AI, DNN, or ML, along with the lack of information on training/test sets or performance metrics typically associated with AI/ML, indicate that this device does not incorporate AI or ML.
Yes
The device is indicated for the "treatment of painful pathological fractures of the vertebral body," which is a therapeutic purpose. It delivers bone cement to improve patient health.
No
The device is a system for delivering bone cement to treat vertebral fractures, not for diagnosing them. It is indicated for the "treatment of painful pathological fractures."
No
The device description explicitly states it consists of "manual instruments" and is a "system" for delivering bone cement, indicating it is a hardware-based medical device.
No, this device 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ARCUATE™ Vertebral Augmentation System is a system of manual instruments used to deliver bone cement directly into the patient's body (specifically, the spine) during a surgical procedure.
- Intended Use: The intended use is to treat painful vertebral fractures by augmenting the bone with cement, which is a therapeutic intervention, not a diagnostic test.
The device is a surgical system used for a therapeutic procedure, not for analyzing samples outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ARCUATE™ 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.
Product codes
NDN, KIH
Device Description
The purpose of this application is to include additional instruments to the previously cleared ARCUATE™ Vertebral Augmentation System (K063248). The ARCUATE™ Vertebral Augmentation System consists of a variety of manual instruments which provides physicians with a means to percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the spine in vertebroplasty procedures. The ARCUATE™ Vertebral Augmentation System kits are packaged with VISIOPLAST™ Spine Cement, which has been previously cleared by the FDA for use in the treatment of painful vertebral compression fractures.
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
Physicians
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K063248, K040483, K062452, K060148, K042691, K062424
Reference Device(s)
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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ARCUATE™ Vertebral Augmentation System 510(k) Summary April 2007
| I. | Company: | Medtronic Sofamor Danek USA, Inc. |
|---|---|---|
| 1800 Pyramid Place | ||
| Memphis, TN 38132 |
MAY - 4 2007
- Christine Scifert Contact: Group Director, Regulatory Affairs (901) 396-3133
- ARCUATE™ Vertebral Augmentation System Proposed Proprietary Trade Name: II. Classification Name: Methyl Methacrylate for Vertebroplasty Orthopedic Cement Delivery System NDN. KIH Product Code: 888.3027 and 888.4200 Regulation No .:
Product Description/Purpose of Application III.
The purpose of this application is to include additional instruments to the previously cleared ARCUATE™ Vertebral Augmentation System (K063248). The ARCUATE™ Vertebral Augmentation System consists of a variety of manual instruments which provides physicians with a means to percutaneously deliver polymethylmethacrylate (PMMA) bone cement to the spine in vertebroplasty procedures. The ARCUATE™ Vertebral Augmentation System kits are packaged with VISIOPLAST™ Spine Cement, which has been previously cleared by the FDA for use in the treatment of painful vertebral compression fractures.
IV. Indications
The ARCUATE™ 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.
V. Substantial Equivalence
Documentation was provided which demonstrated the subject ARCUATE™ instruments to be substantially equivalent to previously cleared systems such as the ARCUATE™ Vertebral Augmentation System (K063248, SE 03/13/07, the EQUESTRA™ Fluid Delivery System, (K040483, SE 06/23/04), the Kit Mendec Spine and Delivery System (Tecres SpA, K062452, SE 09/21/06), the EBI Vertebroplasty System (K060148, SE 03/16/06), the Vertefix® Vertebroplasty Procedure Set (K042691, SE 11/08/05) and the Disco-O-Tech CONFIDENCE Cement System (K062424, SE 0914/06). The VISIOPLAST™ Spine Cement packaged with this
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system was cleared by the agency for use in the treatment of painful vertebral compression fractures in K042415, SE 06/09/05.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three overlapping wings, symbolizing health, services, and security. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AY = 4 7007
Medtronic Sofamor Danek % Ms. Christine Scifert Director, Regulatory Affairs 1800 Pvramid Place Memphis, Tennessee 38132
Re: K070527
Trade/Device Name: ARCUATE™ Vertebral Augmentation System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN, KIH Dated: February 22, 2007 Received: February 23, 2007
Dear Ms. Scifert:
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 ass outted in also encreat 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 n your at 110 to 11 also 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.
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Page 2 - Ms. Christine Scifert
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
barbara Buend
TS
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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April - 2007
510(k) Number_
Device Name:
Indications for Use: The ARCUATE™ 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sebeart BuelsingBaxm
(Division Sign) Division of General, Restorative, and Neurological Devices
510(k) Number K070527