(55 days)
Not Found
No
The device description focuses on mechanical components (power driver, needles) and manual operation under fluoroscopic guidance. There is no mention of AI/ML in the intended use, device description, or the specific sections for AI/ML information.
No.
The device is used for bone biopsy and needle insertion for vertebroplasty, which are diagnostic and procedural access functions, not direct therapeutic treatment delivery.
No
The device is described as an "access system" intended for "fixation of fractures of the vertebral body using vertebroplasty" and for "bone biopsy." While bone biopsy involves obtaining a sample for diagnosis, the device itself is a tool for accessing the bone and collecting the sample, not for analyzing or interpreting the sample to diagnose a condition. Its function is procedural (access and sample collection) rather than diagnostic.
No
The device description explicitly details physical components including a reusable Power Driver and a disposable sterile needle set, indicating it is a hardware-based medical device.
Based on the provided information, the OnControl Bone Access System by Vidacare® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for accessing the vertebral body for fracture fixation (vertebroplasty) and bone biopsy. These are procedures performed on the patient's body, not on samples outside the body.
- Device Description: The device is a system for physically accessing bone. It consists of a power driver and needles for insertion into the bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (in a lab setting). It's a tool for accessing the anatomical site.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical access tool.
N/A
Intended Use / Indications for Use
The OnControl Bone 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 and for bone biopsy. This system does not contain cement.
Product codes (comma separated list FDA assigned to the subject device)
OAR, MOQ, KNW
Device Description
The OnControl Bone 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 (Access and) Biopsy 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 Vertebral Access System (cleared via K081713) 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 K081713.
Under fluoroscopic imaging guidance, activation of the driver assists the clinician to insert the vertebral needle set through the cortex of the bone, into the vertebral body. 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 guidance
Anatomical Site
vertebral body, bone
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
Vidacare Addendum I, K112468, OnControl Bone Access System
5. 510(k) Summary
SUMMARY
| Submitter's name: | Vidacare Corporation |
|---|---|
| Address: | 4350 Lockhill Selma Road |
| Shavano Park, TX 78249-2095 | |
| Phone: | 210-375-8500 |
| Fax number: | 210-375-8537 |
| 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 revised: | October 12, 2011 |
| Name of the device: | The OnControl Bone Access System by |
| Vidacare® | |
| Trade or proprietary name | The OnControl Bone Access 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 | K081713 | Vertebral Access System by Vidacare® | Vidacare Corp |
| 2 | K022169 | Clearview Plus Bone and Vertebral Body
Biopsy Needles | Parallax Medical |
Regulatory Specialists, Inc.
17 Page
1
K11 2468 pg 2 of 3
Vidacare Addendum I, K112468, OnControl Bone Access System
Description of the device:
The OnControl Bone 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 (Access and) Biopsy 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 Vertebral Access System (cleared via K081713) 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 K081713.
Under fluoroscopic imaging guidance, activation of the driver assists the clinician to insert the vertebral needle set through the cortex of the bone, into the vertebral body. 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 System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and for bone biopsy. This system does not contain cement.
Summary of the technological characteristics of our device compared to the predicate devices:
The predicates and the Vidacare Vertebral Biopsy 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
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K112468 pg 3 of 3
Vidacare Addendum I, K112468, OnControl Bone Access System
Technique
Sterility
Biocompatibility Anatomical Sites
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Vidacare Corporation % Regulatory Specialists, Inc. Ms. Grace Holland 3722 Ave. Sausalito Irvine, California 92606
Re: K112468
Trade/Device Name: The OnControl Bone Access System by Vidacare® Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW, OAR Dated: October 12, 2011 Received: October 18, 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 af 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eric D. Keith
Fo Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. Indications for Use Statement
Indications for Use
510(k) Number (if known):
Device Name: The OnControl Bone Access System by Vidacare®
Indications for Use:
The OnControl Bone 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 and for bone biopsy. This system does not contain cement.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X | AND/OR |
|---|---|---|
| ------------------------------------------------- | --- | -------- |
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)
Neil RPO Sider for mxn
Division of Surgical, Orthopedic, and Restorative Devices Page 1 of 1
510(k) Number K112468
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