(214 days)
EndoSonics Automatic Pull Back Device, CVIS Catheter Pull-Back Device, Intertherapy Interpret Catheter Linear Translator
Not Found
No
The description focuses on mechanical pullback functionality with selectable speeds, and there is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is described as an accessory that withdraws an imaging catheter at a uniform rate, making it a tool for imaging rather than a device intended to treat or cure a disease or condition.
No
This device is described as an accessory that withdraws an imaging catheter. While it's used during "intravascular ultrasound assessment," the device itself is performing a mechanical function (pulling back the catheter) rather than directly producing or analyzing diagnostic information. The diagnostic function is performed by the Intravascular Ultrasound Imaging Catheters, not the Trak Back.
No
The device description explicitly states it is a "battery powered device" and describes its physical construction and function as a mechanical pull-back accessory, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device function: The EndoSonics Trak Back is a mechanical device used to physically withdraw an intravascular ultrasound imaging catheter from a vessel. It facilitates the imaging process but does not perform any diagnostic tests on biological samples.
- Intended Use: The intended use clearly states it's a "pull back accessory" for an imaging catheter.
- Device Description: The description focuses on its mechanical function (linear travel, pull back rate) and power source.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on sample analysis.
The device is an accessory for an imaging system used in vivo (within the body) for visualization, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The EndoSonics Trak Back is intended for use as a pull back accessory to the EndoSonics Intravascular Ultrasound Imaging Catheters. The Trak Back Device withdraws the imaging catheter from the vessel through the guide catheter.
The Trak Back can be used with the Visions Five-64 series ultrasound imaging catheter. The Trak Back withdraws the imaging catheter from the vessel through the guide catheter.
Product codes
DQX
Device Description
The Trak Back is a battery powered device that is used in the catheterization laboratory during intravascular ultrasound assessment. The Trak Back has a nominal linear travel distance which is only limited by the catheter length, and provides a uniform, slow pull back rate of the catheter's imaging element. The speed is selectable between 1 mm/sec or 0.5mm/sec. The Trak Back has no direct patient contact. The device is constructed of materials common to the medical industry for both patient and non-patient contact devices and equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
catheterization laboratory
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)
EndoSonics Automatic Pull Back Device, CVIS Catheter Pull-Back Device, Intertherapy Interpret Catheter Linear Translator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Image /page/0/Picture/2 description: The image shows the text "K990271" at the top, followed by "510(k) Premarket Notification" and "January 26, 1999" below. The text is black and the background is white. The text appears to be handwritten.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
ENDOSONICS Trak Back Device
As an accessory, the Trak Back Device does not affect the safe and effective use of the EndoSonics Intravascular Ultrasonic Imaging System or the Endosonics Imaging catheters.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The Trak Back device is substantially equivalent in intended use and technologic characteristics to cardiovascular accessory devices: the EndoSonics Automatic Pull Back Device, the CVIS Catheter Pull-Back Device and the Intertherapy Interpret Catheter Linear Translator. These predicate devices are legally commercially available.
COMPANY AND CONTACT PERSON
EndoSonics Corporation 2870 Kilgore Road Rancho Cordova, CA 95670
Adam Savakus Vice President, Clinical and Regulatory Affairs 916-638-8008
DEVICE NAME
Trak Back
PREDICATE DEVICE(S)
-
- EndoSonics Automatic Pull Back Device
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- CVIS Catheter Pull-Back Device
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- Intertherapy Interpret Catheter Linear Translator
1
DESCRIPTION OF DEVICE
The Trak Back is a battery powered device that is used in the catheterization laboratory during intravascular ultrasound assessment. The Trak Back has a nominal linear travel distance which is only limited by the catheter length, and provides a uniform, slow pull back rate of the catheter's imaging element. The speed is selectable between 1 mm/sec or 0.5mm/sec. The Trak Back has no direct patient contact. The device is constructed of materials common to the medical industry for both patient and non-patient contact devices and equipment.
STATEMENT OF INTENDED USE OF THE DEVICE
The EndoSonics Trak Back is intended for use as a pull back accessory to the EndoSonics Intravascular Ultrasound Imaging Catheters. The Trak Back Device withdraws the imaging catheter from the vessel through the guide catheter.
INTENDED USE OF PREDICATE DEVICE
- The EndoSonics Automatic PBD is intended for use as a pull back accessory to the 1. EndoSonics Intravascular Ultrasound Imaging Catheters. The Automatic PBD withdraws the imaging catheter from the vessel through the guide catheter.
- The Auto PBD is intended to be used as a pull-back accessory to CVIS intravascular 2. ultrasound catheters. The Auto PBD pulls back the imaging element inside the catheter while the outer catheter body is stationary in the vessel.
- The CVIS Catheter Pull-Back Device is intended to be used for uniform, slow velocity 3. pull-back of intravascular ultrasound catheters.
- The Intertherapy Interpret Catheter Linear Translator is intended to be used for uniform, 4. slow velocity pull-back of intravascular ultrasound catheters.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE
The Trak Back and the predicate devices have substantially equivalent technological characteristics (materials, design, specifications, and mode of operation). These accessory devices have no patient contact. The devices are designed so catheters will attach to a movable carriage. The Trak Back incorporates pull-back rates comparable to predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three wavy lines that resemble human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 30 1999
Mr. Richard Hebert Vice President, Quality Assurance, Clinical and Regulatory Affairs Endosonics 2870 Kilgore Road Rancho Cordova, CA 95670
Re : K990271 Endosonics Trak Back Device II (Two) Regulatory Class: Product Code: DQX Dated: June 4, 1999 Received: June 8, 1999
Dear Mr. Hebert:
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 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, Druq, 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Richard Hebert
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion 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" (21CFR 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.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K990271
Device Name:__Endosonics Trak Back Disposable Pullback Device
Indications For Use: The Trak Back can be used with the Visions Five-64 series ultrasound imaging catheter. The Trak Back withdraws the imaging catheter from the vessel through the guide catheter.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
of Device Evaluation (ODE) Concurrence of
Katha Silk
Division of Cardiovascular. Respiratory.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)