(229 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical device (balloon system) and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is indicated for use to facilitate the localized infusion of therapeutic fluids.
Yes
The "Intended Use / Indications for Use" states the device is used to facilitate the localized infusion of "therapeutic or diagnostic fluids." While its primary role isn't diagnostic, it facilitates the use of diagnostic fluids.
No
The device description explicitly states "PercuSurge Temporary Occlusion Balloon (TOB) System," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used in the peripheral vasculature to facilitate the localized infusion of fluids. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism, typically in a lab) diagnostic test.
- Device Description: The device is described as a "Temporary Occlusion Balloon System," which is a medical device used within the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), performing laboratory tests, or providing diagnostic information based on the analysis of these samples.
Therefore, the PercuSurge Temporary Occlusion Balloon (TOB) System is a medical device used for therapeutic or diagnostic fluid infusion within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PercuSurge Temporary Occlusion Balloon (TOB) System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids with or without vessel occlusion.
The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature (see WARNINGS).
Product codes
MJN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's seal. The seal features an abstract image of an eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
SEP 22 199
. .
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debora D. Hinman Ms. Be Director, Regulatory Affairs PercuSurge Incorporated 777 N. Pastoria Avenue Sunnyvale, CA 94086
K972777 NSE Appeal Re : Appeal
PercuSurge Temporary Occlusion Balloon (TOB) System Trade Name: Regulatory Class: II MJN Product Code: Dated: May 20, 1998 Received: May 21, 1998 Received. May 21, June 29, and August 5, 1998
Dear Ms. Hinman:
We have reviewed your Section 510(k) notification of intent to market we nave reviewed your becaused and we have determined the device is the device reletenced above and will ations for use stated in the substantial enclosure) to legally marketed predicate devices marketed in enclobure) Co regally marketed provent date bays boon reclargified Medical Device Amendments, or to devices that have been reclassified Medical Device Imendance, with Federal Food, Drug, and In accordance with the provisione of therefore, market the device, subject to the general controls provisions of the Act and the limitations the general controls provisions of the Act include described befor - The generation, listing of devices, good requirements for annual regenting, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could Therefore, in accordance with Section 513(i)(1)(E) of the cause harm. Act, the following limitation must appear in the Indications and Warnings section of the device's labeling:
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INDICATIONS AND INTENDED USE: 1.
The PercuSurge Temporary Occlusion Balloon (TOB) System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids with or without vessel occlusion.
The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature (see WARNINGS).
In bold and first to appear in the WARNINGS section, 2.
WARNINGS :
.
The safety and effectiveness of the PercuSurge Temporary Occlusion Balloon (TOB) System, used as an adjunct in interventional procedures, have NOT been established. Complications from the use of the device in this manner could lead to death, permanent impairment, and/or the need for emergency surgical intervention.
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 A substantially equivalent determination assumes compliance to 895. 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 requlatory 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.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k)
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Page 3 - Debora D. Hinman
premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Please note that the above fame act. Therefore, a new 510 (k) is required Section 513(1) (1) (1) or the xec. " increases, and on removed from the device's labeling.
If you desire specific information about the application of other If you desire specific information and in the part 801 and additionally
labeling requirements to your device (21 CFF Part on the Office of labeling requirements to your actives), please contact the Office of
809.10 for in vitro diagnostic devices), for questions on the 809.10 for in Victo dragable additionally, for questions on the Compliance at (301) 594-4040. Thateban, please contact the office of promotion and advertising or four as please note the regulation Compilance at (301) 594 1059.
entitled, "Misbranding by reference to premarket notification" (21 CFR) "Misbranding by rereaches on your responsibilities under the 807.97). 807.97). Ocher general Inhostivision of Small Manufacturers Assistance at its toll the bring (800) 638-2041 or (301) 443-6597 of Assistance at Ics Corr-Liec namber (600) (600) cdrh/dsma/dsmamain.html".
at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Phing & Chitizer
Susan Alpert, Ph.D., M.D.
Director
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
.
510(k) Number (if known): K972777
Device Name: PercuSurge Temporary Occlusion Balloon (TOB) System__
FDA's Statement of the Indications For Use for device:
OR
The PercuSurge Temporary Occlusion Balloon (TOB) System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids with or without vessel occlusion.
The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature (see WARNINGS).
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________