(69 days)
Not Found
No
The description focuses on mechanical components (power driver, needles) and their function in bone access and biopsy, with no mention of AI or ML for image analysis, decision support, or any other function.
No.
The device is intended for fixation of vertebral body fractures and bone biopsy, which are diagnostic and procedural interventions, not strictly therapeutic in the sense of treating a disease or condition with direct medical or physical therapy. While vertebroplasty can alleviate pain (a symptom), its primary listed purpose here is anatomical fixation rather than direct therapeutic healing.
Yes
Explanation: The device is described as a "Bone Biopsy System," and one of its intended uses is "for bone biopsy of the vertebral body and bone lesions." A biopsy is a procedure that involves removing tissue for examination, which is a diagnostic purpose.
No
The device description explicitly details physical components like a reusable Power Driver, disposable sterile needle set, cannula, stylet, and Luer lock, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bone access and bone biopsy of the vertebral body and bone lesions, and for vertebroplasty (a surgical procedure for fracture fixation). These are surgical procedures performed directly on the patient's body.
- Device Description: The device is a system of needles and a powered driver used to physically access bone and obtain tissue samples. It is a surgical instrument.
- No mention of in vitro analysis: The description focuses on the physical act of accessing bone and obtaining a sample. There is no mention of analyzing the sample outside of the body (in vitro) using this device. While the biopsy sample will likely be analyzed in vitro later, the device itself is not performing that analysis.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or treatment. This device is used to obtain the specimen, not to analyze it.
N/A
Intended Use / Indications for Use
The OnControl Bone Access and Bone Biopsy System is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and/or for bone biopsy of the vertebral body and bone lesions.
Product codes (comma separated list FDA assigned to the subject device)
OAR, MOQ, KNW
Device Description
The OnControl Bone Access and Bone Biopsy 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 OnControl Bone Access System Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices: the OnControl Bone Access System (cleared via K112468, The OnControl Bone Access System by Vidacare®) and 11g, the same as Clearview Plus Bone and Vertebral Body Biopsy Needles (cleared via K022169). The powered driver is identical to the predicate driver cleared via K112468, The OnControl Bone Access System by Vidacare®.
Under fluoroscopic imaging quidance, activation of the driver assists the clinician to insert the needle set through the cortex of the bone, into the vertebral body or area of lesion. The driver is then separated from the hub of the needle set by retracting the OnControl Connector release mechanism ring on the OnControl Connector. The needle set consists of two parts, an 11g outer cannula (3.05mm x 197mm) with an inner stylet (diameter of 2.54mm). The inner stylet is used only to penetrate the cortex and is then removed. A standard Luer lock (part of the 11 gauge cannula) permits attachment of the syringe for aspiration. The driver is activated and advanced to obtain the biopsy specimen and then withdrawn.
The driver is then separated from the needle assembly for specimen removal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic imaging
Anatomical Site
vertebral body, bone lesions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
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): 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
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
K 113872, Addendum 2, Additional Indications for K112468
- 510(k) Summary
:
vidacare
MAR - 8 2012 Page 1 of 3
4350 Lockhill Selma Road Shavano Park, TX 78249+2095 210-375-8500
SUMMARY
Submitter's name: Address:
Phone: Fax number: Vidacare Corporation 4350 Lockhill Selma Road Shavano Park, TX 78249 210-375-8500 210-375-8537
Name of contact person: Grace Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine CA 92606 Telephone: 949-262-0411 Fax: 949-552-2821
Date the summary was revised: February 24, 2012
The OnControl™ Bone Access and Bone Biopsy System Name of the device: bv Vidacare® Trade or proprietary name: The OnControl™ Bone Access and Bone Biopsy System by Vidacare® Common or usual name: Cement Dispenser Conduit for Vertebroplasty and Bone Biopsy Needle Classification panel: Orthopedic Spine Devices Branch
| Product Code | Classification Regulation | Classification Name |
|---|---|---|
| OAR | 888.4200 | Injector, vertebroplasty |
| MOQ | 878.4820 | Battery, replacement, rechargeable |
| KNW | 876.1075 | Instrument, biopsy |
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 | K112468 | The OnControl™ Bone Access System by Vidacare® | Vidacare Corp. |
| 2 | K022169 | Clearview Plus Bone and Vertebral Body Biopsy Needles | Parallax Medical |
| 3 | K962425 | The Bonopty® Coaxial Bone Biopsy System with Eccentric Drill | AprioMed |
5 Page
1
Description of the device:
The OnControl Bone Access and Bone Biopsy 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 OnControl Bone Access System Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices: the OnControl Bone Access System (cleared via K112468, The OnControl Bone Access System by Vidacare®) and 11g, the same as Clearview Plus Bone and Vertebral Body Biopsy Needles (cleared via K022169). The powered driver is identical to the predicate driver cleared via K112468, The OnControl Bone Access System by Vidacare®.
Under fluoroscopic imaging quidance, activation of the driver assists the clinician to insert the needle set through the cortex of the bone, into the vertebral body or area of lesion. The driver is then separated from the hub of the needle set by retracting the OnControl Connector release mechanism ring on the OnControl Connector. The needle set consists of two parts, an 11g outer cannula (3.05mm x 197mm) with an inner stylet (diameter of 2.54mm). The inner stylet is used only to penetrate the cortex and is then removed. A standard Luer lock (part of the 11 gauge cannula) permits attachment of the syringe for aspiration. The driver is activated and advanced to obtain the biopsy specimen and then withdrawn.
The driver is then separated from the needle assembly for specimen removal.
Indications:
The OnControl Bone Access and Bone Biopsy System is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and/or for bone biopsy of the vertebral body and bone lesions.
Summary of the technological characteristics of our device compared to the predicate device:
The predicates and The OnControl™ Bone Access and Bone Biopsy System were compared in the following areas and found to have similar characteristics with one or more of the predicates and to be equivalent.
Anatomical sites
2
Biocompatibility Dimensional specifications Driver design features Energy type Environmental specifications Ergonomics of the patient-user interface Firmware Indication for Use
ﺔ ﻣ
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a bird or a stylized human figure. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
- 8 2012
Vidacare Corporation % Regulatory Specialists, Inc. Ms. Grace Holland · 3722 Avenue Sausalito Irvine, California 92606
Re: K113872
Trade/Device Name: The OnControl™ Bone Access and Bone Biopsy System by Vidacare®
Regulation Number: 21 CFR 876.1075
Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: December 30, 2011
Received: December 30, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
4
Page 2 - Ms. Grace Holland
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions 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 Division 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,
Jon
Mark N. Melkerson
Director
Division of Surgical, Orthopedic
and Restorative Devices
Office of Device Evaluation
Center for Devices and
Com
Dir
Radiological Health
Enclosure
5
4. Indications for Use Statement
Device Name: The OnControl™ Bone Access and Bone Biopsy System by Vidacare®
Device 510(k) number: K113872
Indications for Use:
The OnControl Bone Access and Bone Biopsy System is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and/or for bone biopsy of the vertebral body and bone lesions.
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Siem-Off)
(Division of Surgical, Division Siern-Off), Orthopedical
Division of Surgical Devices
Bread Restorative Devices
Breat Restorative Devices (1) 3 (Division Sien-Off)
Sturision of Sturgica Division of Surgical, Or
Division of Surgical, Division of Surgices
and Restorative Devices 510(k) Number -