(173 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a simple medical device (needle holder) and do not mention any computational or data-driven components indicative of AI/ML.
No
The device is intended to facilitate the placement of guidewires, not to treat a condition or disease.
No
The "Intended Use" states that the device is "intended to facilitate the placement of guidewires into the vascular system," which describes a procedural aid, not a device used to diagnose a medical condition.
No
The device description clearly outlines a physical, rigid polymer tube with luer connectors and a shut-off mechanism, indicating it is a hardware device. The performance studies also focus on biocompatibility and bench testing of physical properties.
Based on the provided information, the Upstream Needle Holder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "facilitate the placement of guidewires into the vascular system." This is a direct intervention within the body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The description details a physical device used for accessing the vascular system with a guidewire. It does not describe a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on biocompatibility and physical performance characteristics of the device itself (tensile strength, leakage, etc.), not on the accuracy or reliability of a diagnostic test.
- Anatomical Site: The device is used within the "vascular system," which is inside the body.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., outside of the body to provide information about a person's health. The Upstream Needle Holder is a medical device used for a procedural purpose within the body.
N/A
Intended Use / Indications for Use
The Upstream Needle Holder is intended to facilitate the placement of guidewires into the vascular system.
Product codes
DYB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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-off
connector |
|-----------------------|---------------------------------------------------------------------------|
| 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:
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.
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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
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