(89 days)
No
The device description focuses on mechanical assistance for bone marrow procedures and does not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
The device is intended for bone marrow aspiration and biopsy, which are diagnostic procedures, not therapeutic.
No
Explanation: The device is intended for bone marrow aspiration and biopsy, which are procedures for collecting samples. It does not analyze or interpret the samples to diagnose a condition.
No
The device description clearly outlines hardware components including a reusable battery-powered driver, a disposable bone marrow biopsy needle set, and a cannula. It describes the physical interaction of these components during the bone marrow aspiration and biopsy procedure.
Based on the provided information, the OnControl™ Bone Marrow Biopsy System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "for bone marrow aspiration and biopsy." This describes a procedure performed on the patient to collect a sample.
- Device Description: The description details a system for physically obtaining a bone marrow sample from the patient. It involves inserting a needle into the bone, aspirating fluid, and taking a tissue biopsy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. The OnControl™ system's primary function is the collection of the sample, not the analysis of it.
While the collected bone marrow sample will likely be used for in vitro diagnostic testing later, the device itself is a tool for sample collection, not an IVD.
N/A
Intended Use / Indications for Use
The OnControl™ Bone Marrow Biopsy System is intended for bone marrow aspiration and biopsy.
Product codes
KNW, FCG
Device Description
The OnControl™ Bone Marrow Biopsy System consists of a reusable battery powered driver (similar to the one cleared for bone marrow aspiration in adults via K062833) connected to a disposable bone marrow biopsy needle set. The 11 gauge, 152mm cannula is identical in gauge and length to the predicate InterV® TrapLok, cleared via K043523. The BioAccess Bone Marrow Harvest System is an FDAcleared powered biopsy device (K953064), which has a battery power source similar to Vidacare's product.
Upon activation, the driver assists the clinician to insert a biopsy needle set through the cortex of the bone. The driver is then separated from the hub of the biopsy needle set by retracting the collar on the driver - coupler. The trocar/stylet is then removed from the needle set leaving an 11-gauge biopsy cannula firmly seated in the bone. A standard Luer lock (part of the 11 gauge cannula) then permits attachment of a standard syringe for aspiration of bone marrow. The driver/coupler is then reattached to the biopsy cannula and the power driver is activated. The biopsy cannula is advanced to the desired depth in the medullary cavity for capturing adequate bone marrow biopsy samples. The entire needle assembly is then withdrawn from the patient using power to facilitate removal. At this point the driver is separated from the biopsy needle assembly; the specimen is removed from the biopsy cannula by attaching an alignment guide to the cutting end of the biopsy cannula and pushing out the bone specimen with an ejector rod. The cannula length is 152mm (6"), which is identical to the predicate InterV® TrapLok, K043523.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone marrow
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Premarket Notification [510(k)], Vidacare, Bone Marrow Biopsy/Aspiration System
- 510(k) Summary
Image /page/0/Picture/3 description: The image shows the word "vidacare" in a stylized, sans-serif font. The letters are bold and black, with rounded edges. A small circle, likely a trademark symbol, is present to the right of the letter 'e'.
007 2 2007
722 Isom Road San Antonio, TX 78216 210-375-8500
SUMMARY
Submitter's name: Address:
Phone: Fax number: Vidacare Corporation 722 Isom Road San Antonio, TX 78216 210-375-8500 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 prepared: July 23, 2007
Name of the device: Trade or proprietary name: Common or usual name: Classification name:
OnControl™ Bone Marrow Biopsy System Bone Biopsy/Aspiration System Bone Biopsy Needle Biopsy instrument
The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:
| 510(k)
Number | Trade or Proprietary or Model
Name | Manufacturer |
|------------------|-----------------------------------------------|---------------------------------|
| K062833 | EZ-IO® Bone Marrow Aspiration
System | Vidacare Corp. |
| K043523 | InterV TrapLok ™ Bone Marrow
Biopsy Needle | Medical Devices
Technologies |
| K953064 | Bone Marrow Harvest System | BioAccess |
1
Description of the device:
The OnControl™ Bone Marrow Biopsy System consists of a reusable battery powered driver (similar to the one cleared for bone marrow aspiration in adults via K062833) connected to a disposable bone marrow biopsy needle set. The 11 gauge, 152mm cannula is identical in gauge and length to the predicate InterV® TrapLok, cleared via K043523. The BioAccess Bone Marrow Harvest System is an FDAcleared powered biopsy device (K953064), which has a battery power source similar to Vidacare's product.
Upon activation, the driver assists the clinician to insert a biopsy needle set through the cortex of the bone. The driver is then separated from the hub of the biopsy needle set by retracting the collar on the driver
- coupler. The trocar/stylet is then removed from the needle set leaving な an 11-gauge biopsy cannula firmly seated in the bone. A standard Luer lock (part of the 11 gauge cannula) then permits attachment of a standard syringe for aspiration of bone marrow. The driver/coupler is then reattached to the biopsy cannula and the power driver is activated. The biopsy cannula is advanced to the desired depth in the medullary cavity for capturing adequate bone marrow biopsy samples. The entire needle assembly is then withdrawn from the patient using power to facilitate removal. At this point the driver is separated from the biopsy needle assembly; the specimen is removed from the biopsy cannula by attaching an alignment guide to the cutting end of the biopsy cannula and pushing out the bone specimen with an ejector rod. The cannula length is 152mm (6"), which is identical to the predicate InterV® TrapLok, K043523.
Indications:
The OnControl™ Bone Marrow Biopsy System is intended for bone marrow aspiration and biopsy.
Summary of the technological characteristics of our device compared to the predicate device:
The predicates and the OnControl™ Bone Marrow 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
2
Image /page/2/Picture/0 description: The image contains two instances of the number 3, with a small symbol between them. The symbol appears to be a combination of a circle and a line, possibly representing a mathematical or symbolic notation. The numbers are written in a simple, handwritten style, with thick strokes and slightly irregular shapes.
Needle Design Technique Sterility Biocompatibility Anatomical Sites Where Used
1 .
-2-20
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vidacare Corporation % Regulatory Specialist, Inc. Ms. Grace Holland Regulatory Specialist 3722 Sausalito Irvine, California 92606
OCT 2 2 2007
Re: K072045
Trade/Device Name: OnControl™ Bone Marrow Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW, FCG Dated: September 13, 2007 Received: September 17, 2007
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
4
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 Office of Compliance at (240) 276-0115. 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 yours,
for
Mark N. Melkerson 1/09/08
Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
P l c t l
4. Indications for Use Statement Indications for Use
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The OnControl™ Bone Marrow Biopsy System is intended for bone marrow aspiration and biopsy.
Prescription Use (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number 4072645
REGULATORY SPECIALISTS, INC.