The Upstream Needle Holder is a sterile, single lumen rigid polymer tube having male luer connector at the distal end to provide connection to standard needle, and female luer connectors at the proximal end for guidewire access. The Upstream Needle Holder with shut-off connector includes a standard shut-off connector. The shut-off connector includes a sliding element that opens and closes the connector lumen.
The Upstream Needle Holder is intended for use with guidewires of up to 0.0315" diameter. The Upstream Needle Holder is provided in a 23 cm length. The hub at distal end of the Upstream Needle Holder interfaces with a standard needle connection. The hub at the proximal end of the Upstream Needle Holder allows guidewire access, or connection of shut-off connector through which a guidewire is inserted and may be locked in position using the connector lock position.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Upstream Peripheral Technologies Needle Holder, structured according to your requested information.

It's important to note that this document is a 510(k) summary for a medical device and not a study report for an AI algorithm. Therefore, many of the requested points, particularly those related to AI algorithm performance, ground truth establishment for AI, and MRMC studies, will not be applicable. This device is a physical medical instrument, not a software algorithm.

Acceptance Criteria and Device Performance (Upstream Needle Holder)

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary lists the types of tests performed but generally does not provide specific numerical acceptance criteria or detailed quantitative results for each test. It states a general conclusion for each category of testing.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (ISO 10993 Series):
- Cytotoxicity: Acceptance (no significant cytotoxic effect)	Meets biocompatibility standards
- Sensitization: Acceptance (no significant sensitization)	Meets biocompatibility standards
- Irritation: Acceptance (no significant irritation)	Meets biocompatibility standards
- Acute Systemic Toxicity: Acceptance (no significant toxicity)	Meets biocompatibility standards
- Hemolysis: Acceptance (acceptable hemolytic index)	Meets biocompatibility standards
- Partial Thromboplastin Time: Acceptance (no significant effect)	Meets biocompatibility standards
- Platelet and Leukocyte Counts: Acceptance (within normal range)	Meets biocompatibility standards
- Complement Activation Testing: Acceptance (no significant effect)	Meets biocompatibility standards
In Vitro Bench Testing:
- Tensile Strength: Acceptance (e.g., specific force threshold)	Meets intended performance specifications
- Air Leakage: Acceptance (e.g., no detectable air leakage)	Meets intended performance specifications
- Liquid Leakage Under Pressure: Acceptance (e.g., no leakage at specified pressure)	Meets intended performance specifications
- Surface Test: Acceptance (e.g., smooth, free of defects)	Meets intended performance specifications
- Needle Holder Dimensions: Acceptance (within specified tolerances)	Meets intended performance specifications
- Guidewire Capture and Passage Test: Acceptance (e.g., guidewire passes smoothly, properly captured)	Meets intended performance specifications
- Hub Testing: Acceptance (e.g., secure fit, no detachment, proper function)	Meets intended performance specifications
- Environmental Packaging Testing: Acceptance (e.g., maintains sterility, structural integrity)	Meets intended performance specifications
- Endotoxin Testing: Acceptance (e.g., below specified endotoxin limit)	Meets intended performance specifications
- Sterilization and Shelf-Life Validation Testing: Acceptance (e.g., maintains sterility and function for shelf-life)	Meets intended performance specifications

General Conclusion from Document: "All of these tests demonstrated that the Upstream Needle Holder meets its intended performance specifications." And "In vitro verification testing demonstrates that the Upstream Needle Holder performs as intended and meets all design specifications with respect to their mechanical and handling characteristics, and that its materials are biocompatible."

2. Sample Size Used for the Test Set and Data Provenance

This document describes the testing of a physical medical device, not an AI algorithm. Therefore, the concept of "test set" and "data provenance" (in the context of country of origin of data or retrospective/prospective studies) as typically applied to AI performance evaluation does not apply.

Sample Size: The document does not specify the exact number of units tested for each in-vitro bench test or biocompatibility assessment. Standard practice for such device testing would involve a statistically relevant number of samples to ensure reproducibility and reliability, but specific numbers are not provided in this summary.
Data Provenance: Not applicable in the context of an AI test set. The tests were performed in vitro (bench testing) and in vivo (biocompatibility animal testing, though specific to material interaction, not clinical data) as part of the device's development and regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not an AI algorithm requiring expert-established ground truth from diagnostic images or clinical data. The "ground truth" for the device's performance is established by direct physical measurements according to engineering specifications and biological assessments against established safety standards.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI algorithm requiring adjudication of diagnostic outputs. The "adjudication" of device performance is through direct measurement, observation, and adherence to predefined test methods and acceptance criteria.

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

Not applicable. This is not an AI algorithm, and therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant.

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

Not applicable. This is not an AI algorithm. Its performance is inherent in its physical and mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on well-established engineering principles, material science standards (e.g., ISO 10993 for biocompatibility), and functional requirements for medical devices of its type.

For Biocompatibility: Ground truth is established by standardized biological tests demonstrating the absence of harmful biological reactions.
For In Vitro Bench Testing: Ground truth refers to the device meeting its predefined design specifications and functional requirements (e.g., tensile strength values, leak tightness, dimensional accuracy, smooth guidewire passage). These specifications are engineering-driven and based on the intended use and safety profile required for an Introducer Catheter.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI algorithm; there is no "training set" or corresponding ground truth to establish in this context.

Summary

{0}------------------------------------------------

p. 1 of 3

510(k) SUMMARY

MAR 2 1 2012

Upstream Peripheral Technologies Needle Holder-K112887

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 21, 2012

Device Information:

Trade Name:	Upstream Needle Holder, Upstream Needle Holder with shut-offconnector
Common or Usual Name:	Introducer Catheter
Classification:	Class II per 21 CFR 870.1340
Product Code:	DYB
Predicate Device:	BD Introsyte Precision Introducer (K013304)

Intended Use / Indications for Use:

The Upstream Needle Holder is intended to facilitate the placement of guidewires into the vascular system.

Technological Characteristics:

{1}------------------------------------------------

K112887
p. 2 of 3

The Upstream Needle Holder is intended for use with guidewires of up to 0.0315" diameter. The Upstream Needle Holder is provided in a 23 cm length. The hub at distal end of the Upstream Needle Holder interfaces with a standard needle connection. The hub at the proximal end of the Upstream Needle Holder allows guidewire access, or connection of shut-off connector through which a guidewire is inserted and may be locked in position using the connector lock position.

Safety and Performance Data:

The Upstream Needle Holder has been evaluated for biocompatibility in accordance with ISO 10993 to ensure that the materials used in the manufacturing of the device are biocompatible. The biocompatibility tests performed included the following:

Cytotoxicity .
Sensitization .
Irritation .
Acute Systemic Toxicity .
. Hemolysis
. Partial Thromboplastin Time
Platelet and Leukocyte Counts ●
Complement Activation Testing .

Additionally, the following in vitro bench testing has been performed:

Tensile Strength .
Air Leakage .
Liquid Leakage Under Pressure .
Surface Test .
. Needle Holder Dimensions
. Guidewire Capture and Passage Test
. Hub Testing
. Environmental Packaging Testing
. Endotoxin Testing
. Sterilization and Shelf-Life Validation Testing

All of these tests demonstrated that the Upstream Needle Holder meets its intended performance specifications.

Substantial Equivalence:

The Upstream Needle Holder and the predicate device have the same intended use and very similar indications, technological characteristics, and principles of operation. The minor technological differences between the Upstream Needle Holder and its predicate device raise no new types of safety or effectiveness questions. In vitro verification testing demonstrates that the Upstream Needle Holder performs as intended and meets all design specifications with respect to

{2}------------------------------------------------

· their mechanical and handling characteristics, and that its materials are biocompatible. Thus, the Upstream Needle Holder is substantially equivalent to the BD Introsyte Precision Introducer.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Contro! Room -WO66-G609 Silver Spring, MD 20993-0002

Upstream Peripheral Technologies, Ltd. c/o Ms. Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103

MAR 2 1 2012

Re: K112887

Trade/Device Name: Upstream Needle Holder, Upstream Needle Holder with shut-off connector Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: Class II Product Code: DYB Dated: February 14, 2012 Received: February 14, 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. We remind you, however, 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 found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

{4}------------------------------------------------

Page 2 - Ms. Janice Hogan

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the 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 forth in the quality systems (QS) regulation (21 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 Division 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wm. A. Wilhelm.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K112887

Device Name: Upstream Needle Holder, Upstream Needle Holder with Shut-Off Connector

Indications for Use:

The Upstream Needle Holders are intended to facilitate the placement of guidewires into the vascular system.

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)

M.I. Killebrew

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_KII 2807

Page 1 of 1

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).