(157 days)
No
The device description and intended use focus on mechanical components for vertebral access and cement delivery, with no mention of AI or ML capabilities.
No.
The device is an access system for delivering cement in vertebroplasty, not the therapeutic agent itself. It facilitates a therapeutic procedure but is not inherently therapeutic.
No
Explanation: The device is intended for the fixation of vertebral body fractures using vertebroplasty, which is a treatment procedure, not a diagnostic one. Its predicate devices are also for biopsy and cement delivery.
No
The device description explicitly states it consists of a reusable Power Driver and a disposable sterile needle set, which are 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 "fixation of fractures of the vertebral body using vertebroplasty." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of a power driver and a needle set used for accessing the vertebral body. These are instruments used in a surgical context.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The device is clearly intended for a surgical intervention, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain cement.
Product codes
OAR, MOQ
Device Description
The Vertebral Access System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve, 1 beveled needle set and 2 sharps protectors. The Vertebral Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The 11 gauge, 152mm needle set is identical in gauge and length to the predicate devices: OnControl™ Bone Marrow Biopsy System (cleared via K072045) and the Parallax EZFlow Cement Delivery System (cleared via K051820). The powered driver is identical to the predicate driver cleared via K072045.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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5. 510(k) Summary
Image /page/0/Picture/2 description: The image shows the word "vidcare" in a stylized font. The letters are outlined and filled with a pattern of small dots, giving them a textured appearance. The word is presented in a horizontal arrangement, with each letter clearly distinguishable.
20 som Rose, bun Artunio, x xx xx M 대 11월 8일06일28일20일20일25일25일23일2 The Free Redure US - 866-479 8500 www.vi.iki084w.ci I
SUMMARY
Submitter's name: Address:
Vidacare Corporation 722 Isom Road San Antonio, TX 78216 210-375-8500 210-375-8537
NOV 21 2008
Phone: Fax number:
Name of contact person:
Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821
Date the summary was prepared: November 4, 2008
| Name of the device:
Trade or proprietary name:
Common or usual name: | Vertebral Access System by Vidacare®
Vertebroplasty System
Cement Dispenser Conduit for
Vertebroplasty |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification name: | Injector, vertebroplasty (does not contain
cement) |
| Classification | Class I
21 CFR sec. 888.4200 Injector,
vertebroplasty (does not contain cement).
And
21CFR sec. 878.4820 Surgical instrument
motors and accessories/attachments. |
| Product Code | OAR and MOQ |
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The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer | |
|---|---|---|---|
| 1 | K072045 | EZ-IO® Bone Marrow Biopsy | |
| System | Vidacare Corp. | ||
| 2 | K051820 | Parallax EZFlow Cement Delivery | |
| System | Parallax | ||
| Medical |
Description of the device:
The Vertebral Access System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve, 1 beveled needle set and 2 sharps protectors. The Vertebral Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The 11 gauge, 152mm needle set is identical in gauge and length to the predicate devices: OnControl™ Bone Marrow Biopsy System (cleared via K072045) and the Parallax EZFlow Cement Delivery System (cleared via K051820). The powered driver is identical to the predicate driver cleared via K072045.
Indications:
The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain cement.
Summary of the technological characteristics of our device compared to the predicate device:
The predicates and the Vidacare Vertebral Access System were compared in the following areas and found to have similar technological characteristics and to be equivalent.
- Indications for Use Target Population Driver Design Features Needle Design Technique Sterility Biocompatibilitv Anatomical Sites Where Used
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vidacare Corporation % Regulatory Specialists, Inc. Ms. Grace Holland Regulatory Specialist 3722 Avenue Sausalito Irvine, California 92606
NOV 21 2008
Re: K081713
Tradc/Device Name: Vertebral Access System by Vidacare® Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: I Product Code: MOQ, OAR Dated: November 7, 2008 Received: November 10, 2008
Dear Ms. Holland:
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
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Page 2 - Ms. Grace Holland
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.
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 Compliary, at (240) 276-0120. 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 Postmanect 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
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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4. Indications for Use Statement
Indications for Use
510(k) Number (if known): K081713
Device Name: Vertebral Access System by Vidacare®
Indications for Use:
The Vertebral Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty. This system does not contain 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 OF NEEDED) ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millerm
(Division Sign-Of Division of Gene and Neurolog
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