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.

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.

AI/ML Overview

The provided text describes the Upstream Peripheral Technologies GR Catheter and its 510(k) summary. It details the device's intended use, technological characteristics, and the safety and performance data used to demonstrate substantial equivalence to a predicate device.

However, the information provided does not pertain to an AI/ML device or a study involving human readers or ground truth established by experts. Instead, it describes a medical device (a catheter) and the engineering bench testing and biocompatibility assessments performed to support its marketing clearance.

Therefore, many of the requested elements for describing acceptance criteria and a study for an AI/ML device, such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment methods relevant to AI/ML, are not applicable or present in this document.

Here's an attempt to answer the questions based only on the provided text, while highlighting where the requested information is not available due to the nature of the device and study described:

Acceptance Criteria and Device Performance Study (for a non-AI medical device: Upstream GR Catheter)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Requirement	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Cytotoxicity	Biocompatible	Meets requirements
	Sensitization	Biocompatible	Meets requirements
	Irritation/Intracutaneous Reactivity	Biocompatible	Meets requirements
	Systemic Toxicity (Acute)	Biocompatible	Meets requirements
	Complement Activation	Biocompatible	Meets requirements
	Hemocompatibility (Hemolysis and Thromboresistance)	Biocompatible	Meets requirements
	Pyrogenicity	Biocompatible	Meets requirements
Bench Testing (ISO-10555-1 & 4, and Internal)	Tensile Force Testing	Meets specifications	Meets intended performance
	Air Leakage Testing	Meets specifications	Meets intended performance
	Corrosion Resistance Testing	Meets specifications	Meets intended performance
	Liquid Leakage Pressure Testing	Meets specifications	Meets intended performance
	Catheter Torque Testing	Meets specifications	Meets intended performance
	Kink Testing	Meets specifications	Meets intended performance
	Tip Test	Meets specifications	Meets intended performance
	Freedom from Leakage	Meets specifications	Meets intended performance
	Balloon Burst Testing	Meets specifications	Meets intended performance
	Surface and Dimensional Analysis	Meets specifications	Meets intended performance
	Radiopacity Testing	Meets specifications	Meets intended performance
	Package Testing	Meets specifications	Meets intended performance
	Sterilization Validation Testing	Meets specifications	Meets intended performance

Note: The document states "All of these tests demonstrated that the Upstream GR Catheter meets its intended performance specifications." The specific quantitative acceptance criteria or results for each test are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/not provided for this type of medical device clearance. The "test set" in this context refers to physical units of the device subjected to various engineering and biocompatibility tests, not a dataset for an AI/ML algorithm. The provenance of the data would be the results from these lab tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The "ground truth" for this device is established by engineering specifications and recognized biocompatibility standards (e.g., ISO 10993, ISO 10555-1, ISO 10555-4), not by expert medical review of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple expert readers, which is not relevant for the type of testing described (bench testing and biocompatibility).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument (a catheter), not an AI algorithm intended to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone performance evaluation in the context of an "algorithm" was not done. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on:

Compliance with international standards (e.g., ISO 10993 for biocompatibility, ISO 10555-1 and ISO 10555-4 for catheters).
Internal engineering and design specifications for mechanical and handling characteristics.
The performance of the predicate device (Endocross Ltd Enabler-P Support Catheter (K082339)) as a benchmark for substantial equivalence.

8. The sample size for the training set

This information is not applicable/not provided. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/not provided. As above, this is not an AI/ML device.

Summary

{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_

Page of of

Regulation Number and Section

§ 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).