(146 days)
The Upstream Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.
The Upstream Support Catheter is not intended for use in the coronary, cerebral or carotid vasculature.
The Upstream Support Catheter is a sterile, single lumen polymer coated stainless steel hypotube, with a tapered tip at the distal end and a proximal hub.
The Upstream Support Catheter is intended for use with 0.014" guidewires. The Upstream Support Catheter is provided in 95 cm length and its outer diameter is 0.8mm (0.0315"). A hub at the proximal end of the Upstream Support Catheter allows guidewire access.
The provided 510(k) summary for the Upstream Support Catheter does not describe an AI/ML powered device, therefore, many of the requested fields are not applicable. The device is a physical medical device (catheter) and the acceptance criteria and supporting studies are based on traditional engineering and biocompatibility testing, not AI/ML performance metrics.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission outlines benchmark and performance data based on in vitro bench testing for the physical properties and biocompatibility of the catheter. Specific numerical acceptance criteria and reported performance values are not explicitly listed in a comparative table format in the provided text. However, it states that "All of these tests demonstrated that the Upstream Support Catheter meets its intended performance specifications."
| Acceptance Criteria Category | Reported Performance (Qualitative/Outcome) |
|---|---|
| Biocompatibility (ISO 10993) | Device materials are biocompatible. (Tests included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic injection, hemolysis, thromboresistance, complement activation) |
| Tensile Force Testing | Meets intended performance specifications. |
| Air Leakage Testing | Meets intended performance specifications. |
| Corrosion Resistance Testing | Meets intended performance specifications. |
| Liquid Leakage Pressure Testing | Meets intended performance specifications. |
| Catheter Torque Testing | Meets intended performance specifications. |
| Hub Compatibility Testing | Meets intended performance specifications. |
| Surface and Dimensional Analysis | Meets intended performance specifications. |
| Radiopacity Testing | Meets intended performance specifications. |
| Component Biocompatibility Testing | Meets intended performance specifications. |
| Package Testing | Meets intended performance specifications. |
| Sterilization Validation Testing | Meets intended performance specifications. |
| Substantial Equivalence to Predicates | Device performs as intended, meets all design specifications, materials are biocompatible, and raises no new safety/effectiveness questions compared to Asahi Tornus Support Catheter (K051772) and Spectranetics Quick-Cross Extreme Support Catheter (K082561, K092396). |
2. Sample Size for Test Set and Data Provenance
This information is not applicable to this device submission. The testing performed was primarily in vitro bench testing on the physical device itself. There isn't a "test set" in the context of diagnostic data, and thus no country of origin or retrospective/prospective data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. Ground truth for a physical catheter's performance is established through engineering specifications and standardized testing protocols, not through expert consensus on diagnostic data.
4. Adjudication Method for the Test Set
This information is not applicable. There is no "test set" requiring adjudication in the context of diagnostic performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The device is a physical catheter, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance
This information is not applicable. The device is a physical catheter, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications, industry standards (e.g., ISO 10555-1, ISO 10993), and internal performance requirements established by the manufacturer.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" for a physical medical device. The device design is based on engineering principles and material science.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" in the AI/ML sense. The "ground truth" for the device's design and manufacturing is established through the adherence to design specifications, material properties, and manufacturing processes aimed at achieving the intended performance and safety profile, informed by industry standards and preclinical testing.
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FEB 2 3 2012
510(k) SUMMARY
Upstream Peripheral Technologies Support 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: | February 16, 2012 |
Device Information:
| Trade Name: | Upstream Support Catheter |
|---|---|
| Common or Usual Name: | Percutaneous Catheter |
| Classification: | Class II per 21 CFR 870.1250 |
| Product Code: | DQY |
| Predicate Device: | Asahi Tornus Support Catheter (K051772)Spectranetics Quick-Cross Extreme Support Catheter(K082561, K092396) |
Intended Use / Indications for Use:
The Upstream Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.
The Upstream Support Catheter is not intended for use in the coronary, cerebral or carotid vasculature.
Technological Characteristics:
The Upstream Support Catheter is a sterile, single lumen polymer coated stainless steel hypotube, with a tapered tip at the distal end and a proximal hub.
The Upstream Support Catheter is intended for use with 0.014" guidewires. The Upstream Support Catheter is provided in 95 cm length and its outer diameter is 0.8mm (0.0315"). A hub at the proximal end of the Upstream Support Catheter allows guidewire access.
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Safety and Performance Data:
The Upstream Support 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. Biocompatibility tests included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic injection, hemolysis, thromboresistance and complement activation. Additionally, in vitro bench testing has been performed, based on Upstream in-house requirements and requirements listed in ISO-10555-1, Sterile, single-use intravascular catheters-part-1; including: tensile force testing; air leakage testing; corrosion resistance testing; liquid leakage pressure testing; catheter torque testing; hub compatibility testing; surface and dimensional analysis; radiopacity testing; component bio-compatibility testing; package testing; and sterilization validation testing. All of these tests demonstrated that the Upstream Support Catheter meets its intended performance specifications.
Substantial Equivalence:
The Upstream Support Catheter and the predicate devices have the same intended use and very similar indications, technological characteristics and principles of operation. The minor technological differences between the Upstream Support Catheter and its predicate devices raise no new types of safety or effectiveness questions. In vitro verification testing demonstrates that the Upstream Support Catheter performs as intended and meets all design specifications with respect to its mechanical and handling characteristics, and that its materials are biocompatible. Thus, the Upstream Support Catheter is substantially equivalent to the Tornus Support Catheter and the Ouick-Cross Extreme Support Catheter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
FEB 2 3 2012
Upstream Peripheral Technologies c/o Janice Hogan Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103
Re: K112886
Trade/Device Name: Upstream Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 17, 2012 · Received: February 17, 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
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Page 2 – Ms. Janice Hogan
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of I cacial reegalations) Tour device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fill I DA s issuance of a baceannal equites with other requirements of the Act that FDA hade a decembination that your de roo ver correst on other Federal agencies. You must comply
or any Federal statutes and regulations administered by other Federal ag of any Federal Statutes and regulations and limited to: registration and listing (21 CFR with an the Act s requirements, mercumes, mercesses in the can
Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-Part 807), labeling (21 CFR 803); good manufacturing practice requirements as set forth in related adverse events) (21 CFR 802), good manasti, and if applicable, the electronic product
the quality systems (QS) regulation (21 CFR Part 820), and 1980, 1960, 1960, the quality systems (QS) regulation (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 If you desire specific advice for your devices of the softices/ucm II 5809.htm for a go to http://www.rua.gov/Abouti Drive.com/street/Compliance. Also, please, please, please, please, please, please, part the Center for Devices and Radionogical Heath of (22 cm market notification" (21 CFR Patt )
note the regulation entitled, "Misbranding by reference to premarket notifical (1) note the regulation entitled, "Misoranants of receives to pears under the MDR regulation (21 CFR Part 803), please go to
CFK Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office nttp://www.radigometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may of all other general information on your responser Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (800) 030-2041 01 (301) //2017) 121 (2017) 12 01 // 12 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11
Sincerely yours,
M.A. Hillemann
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known): K11 صاکه & G
Device Name: Upstream Support Catheter
Indications for Use:
The Upstream Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.
The Upstream Support Catheter is not intended for use in the coronary, cerebral or carotid vasculature.
X 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)
M.A. Killebrew
(Division Sign-Off) Division of Čardiovascular Devices
11/12886 510(k) Number_
§ 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).