(56 days)
Not Found
No
The summary describes a mechanical catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is described as a catheter intended for accessing different regions of the peripheral vasculature and for guidewire exchange, which are diagnostic and interventional access functions rather than directly therapeutic.
No
The device description and intended use indicate it is an access and exchange catheter for guidewires, which is an interventional/therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical catheter with an anchoring balloon and funnel, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to access discrete regions of the peripheral vasculature and for guidewire exchange. This is a procedural device used within the body, not for testing samples taken from the body.
- Device Description: The description details a catheter with a balloon and funnel, designed for physical manipulation within blood vessels. This is consistent with a medical device used for intervention, not for diagnostic testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
In summary, the Upstream GR Catheter is a medical device used for interventional procedures within the peripheral vasculature, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The Unstream GR Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
Product codes
DQY
Device Description
The Upstream GR Catheter is a sterile, single-use, dual-lumen catheter, having anchoring balloon and funnel at its distal tip, and Y-connector at its proximal end.
The Upstream GR Catheter is intended for use with up to 0.035" guidewires. The Upstream GR Catheter is provided in 100 cm effective length and its shaft's outer diameter is 1.7mm (5F). A hub at the Y-connector center port, at the proximal end of the Upstream GR Catheter, allows guidewire access. The Y-connector side port is used for balloon inflation and deflation. The distal balloon is used for catheter anchoring and centering. The distal funnel is used as soft tip and soft stopper when an occlusion is reached.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Upstream GR Catheter has been evaluated for biocompatibility in accordance with ISO 10993 to ensure that the materials used in the manufacturing of the device are biocompatible. These tests included:
- cytotoxicity, .
- sensitization,
- . irritation/intracutaneous reactivity,
- systemic toxicity (acute), .
- complement activation,
- hemocompatibility (hemolysis and thromboresistance), and .
- . pyrogenicity.
Additionally, in vitro bench testing has been performed, based on Upstream's internal requirements and requirement listed in ISO-10555-1. Sterile, single-use intravascular catheters-part-1, and ISO-10555-4, Balloon dilatation catheters, including:
- . tensile force testing;
- air leakage testing; .
- corrosion resistance testing: ●
- liquid leakage pressure testing; .
- . catheter torque testing;
- . kink testing;
- . tip test;
- freedom from leakage;
- . balloon burst testing;
- . surface and dimensional analysis;
- . radiopacity testing;
- package testing; and .
- sterilization validation testing. ●
All of these tests demonstrated that the Upstream GR Catheter meets its intended performance specifications.
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
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
K120964
MAY 25 2012
510(k) SUMMARY
Upstream Peripheral Technologies GR Catheter
Applicant Information;
Upstream Peripheral Technologies Ltd. ARAN Building P.O. Box 3067 43 Haeshel Street Caesarea 38900 Israel
| Phone: | (972) 4-6239014 |
|---|---|
| Facsimile: | (972) 4-6273260 |
| Contact Person: | Dan Rottenberg |
| Date Prepared: | March 30, 2012 |
Device Information:
| Trade Name: | Upstream GR Catheter |
|---|---|
| Common or Usual Name: | Percutaneous Catheter |
| Classification: | Class II per 21 CFR 870.1250 |
| Product Code: | DQY |
| Predicate Device: | Endocross Ltd Enabler-P Support Catheter (K082339) |
Intended Use / Indications for Use:
The Unstream GR Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
Technological Characteristics:
The Upstream GR Catheter is a sterile, single-use, dual-lumen catheter, having anchoring balloon and funnel at its distal tip, and Y-connector at its proximal end.
The Upstream GR Catheter is intended for use with up to 0.035" guidewires. The Upstream GR Catheter is provided in 100 cm effective length and its shaft's outer diameter is 1.7mm (5F). A hub at the Y-connector center port, at the proximal end of the Upstream GR Catheter, allows guidewire access. The Y-connector side port is used for balloon inflation and deflation. The
1
distal balloon is used for catheter anchoring and centering. The distal funnel is used as soft tip and soft stopper when an occlusion is reached.
Safety and Performance Data:
The Upstream GR Catheter has been evaluated for biocompatibility in accordance with ISO 10993 to ensure that the materials used in the manufacturing of the device are biocompatible. These tests included:
- cytotoxicity, .
- sensitization,
- . irritation/intracutaneous reactivity,
- systemic toxicity (acute), .
- complement activation,
- hemocompatibility (hemolysis and thromboresistance), and .
- . pyrogenicity.
Additionally, in vitro bench testing has been performed, based on Upstream's internal requirements and requirement listed in ISO-10555-1. Sterile, single-use intravascular catheterspart-1, and ISO-10555-4, Balloon dilatation catheters, including:
- . tensile force testing;
- air leakage testing; .
- corrosion resistance testing: ●
- liquid leakage pressure testing; .
- . catheter torque testing;
- . kink testing;
- . tip test;
- freedom from leakage;
- . balloon burst testing;
- . surface and dimensional analysis;
- . radiopacity testing;
- package testing; and .
- sterilization validation testing. ●
All of these tests demonstrated that the Upstream GR Catheter meets its intended performance specifications.
Substantial Equivalence:
The Upstream GR Catheter and the predicate device have intended use and indications for use and very similar technological characteristics and principles of operation. The minor technological differences between the Upstream GR Catheter and its predicate device raise no new types of safety or effectiveness questions. In vitro verification testing demonstrates that the Upstream GR Catheter performs as intended and meets all design specifications with respect to
2
its mechanical and handling characteristics, and that its materials are biocompatible. Thus, the Upstream GR Catheter is substantially equivalent to the Enabler-P Support Catheter.
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Upstream Peripheral Technologies c/o Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market St., 29th Floor Philadelphia, PA 19103
MAY 2 5 2012
Re: K120964
Trade Name: Upstream GR Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 30, 2012 Received: March 30, 2012
Dear Ms. Hogan:
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. However, we remind you 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 fridy of our of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Janice M. Hogan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lotto be devices and i Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I vithe 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 device-related develop (21 OFF 2007) 8 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 n you atti.it bpvc.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 note and regarding the reporting 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 I valual 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,
M. Y. Hillebert
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use Statement
510(k) Number (if known): K 120964
Device Name: Upstream GR Catheter
Indications for Use:
The Upstream GR Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
Prescription Use X (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)
Sm A. Killebrew
(Division Sign-Off) Division of Cardiovascular Devices
11/20964 510(k) Number_
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