(131 days)
Unknown Classification name: A. Laser needle positioner, Common/usual name: stereotactic needle guide, needle guide, etc. Blunt Needle Hawkins Access System (Medical Device Technologies), SiteRite II Vascular Access Guidance System ColorMark (EchoCath, (Dymax Corporation), Interventional AccuPlace (Medtronic Inc.). Radiology).
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on laser-based aiming.
No
The device is described as an "aiming device" to assist with interventional procedures and does not directly treat or diagnose a disease or condition.
No.
The device is described as an "aiming device" used to "verify and control correct angulation" of interventional devices like needles in guided procedures, rather than to diagnose a medical condition.
No
The device description explicitly states that the device "utilizes lasers," which are hardware components. Therefore, it is not a software-only medical device.
Based on the provided information, the TarqoBeam 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.
- TarqoBeam's Intended Use: The intended use of TarqoBeam is to "verify and control correct angulation of interventional devices such as needles used in CT- or MRI-quided punctures, biopsies, and related procedures." This describes a device used during a medical procedure on a patient, not a test performed on a sample outside the body.
- Device Description: The description reinforces this by stating it's an "aiming device which utilizes lasers to precisely place the correct angulation and position on interventional device such as a biopsy an needle." This is a tool for guiding procedures, not for analyzing biological samples.
The information provided clearly indicates that TarqoBeam is a medical device used for guiding interventional procedures, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The TargoBeam is intended to be used to verify and control correct angulation of interventional devices such as needles used in CT- or MRI-guided punctures, biopsies, and related procedures.
Product codes
90 JAK
Device Description
The TargoBeam is an aiming device which utilizes lasers to precisely place the correct angulation and position on interventional device such as a biopsy an needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT- or MRI-guided
Anatomical Site
Not Found
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)
Unknown Classification name: A. Laser needle positioner, Common/usual name: stereotactic needle guide, needle guide, etc. Blunt Needle Hawkins Access System (Medical Device Technologies), SiteRite II Vascular Access Guidance System ColorMark (EchoCath, (Dymax Corporation), Interventional AccuPlace (Medtronic Inc.). Radiology).
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "M" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The logo is in black and white.
916-342-4133 FAX: 916-343-4541
JUL 1 4 1997
05 February 1997
510(k) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- Unknown Classification name: A .
Laser needle positioner, Common/usual name: stereotactic needle guide, needle guide, etc.
Proprietary name: TargoBeam
- Blunt Needle Hawkins Substantial equivalence: B. Access System (Medical Device Technologies), SiteRite II Vascular Access Guidance System ColorMark (EchoCath, (Dymax Corporation), Interventional AccuPlace (Medtronic Inc. ) . . Radiology).
- The TargoBeam is an aiming C. Device description: device which utilizes lasers to precisely place the correct angulation and position on interventional device such as a biopsy an needle.
- The TargoBeam is intended to be D. Intended use: used to verify and control correct angulation of interventional devices such as needles used in CT- or MRI-guided punctures, biopsies, and
1
related procedures.
- Technological characteristics: The TargoBeam E. device is similar to predicate devices, and existent methodologies in its intended use.
The proposed device is different than many needles in that the TargoBeam is entirely noninvasive, and suitable for use under MRI.
Submitted, FERGUSON MEDICAL Establishment Registration Number 2937794
Frank Lau
Frank Ferguson Official Correspondent
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name 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 wings and a body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Frank Ferguson Official Correspondent Ferguson Medical 3407 Bay Avenue Chico, California 95926
Re: K970819
TargoBeam (Laser Needle Positioner) Dated: June 20, 1.997 ... .......................................... JUL 1 4 1997 Received: June 27, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Ferguson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begine as described in your 5100k) 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fdu.gov/odrh/dsmamain.html".
Sincerely yours
W. Hiau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (If known): K 970819
Device Name: TarqoBeam
Indications`For Use:
TarqoBeam is an aiming device intended to be used to verify and control correct angulation of interventional -----devices such as needles used in CT- or MRI-quided punctures, biopsies, and related procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ra. Philly
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
OR