(161 days)
Preamendment, Preamendment, Preamendment, K030788
Not Found
No
The device description and performance studies indicate a manual, mechanical device with no mention of AI or ML capabilities.
No
The device is used for flushing, irrigation, and solution injection during surgical procedures to confirm patency and prevent leakage, which are supportive functions rather than direct therapeutic actions.
No
The devices are used for flushing, irrigation, and solution injection, as well as to confirm no leakage and ensure patency of veins, which are functional tasks rather than diagnostic assessments.
No
The device description clearly states that the device is a manual, stainless steel catheter cannula, which is a physical hardware component. The performance studies also focus on the physical properties and sterilization of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for flushing, irrigation, and solution injection into a vessel or cavity during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device is described as a manual, stainless steel catheter cannula used in conjunction with a syringe. Its purpose is to confirm patency and prevent leakage in vessels. This is a surgical tool, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and procedural.
IVD devices are used to examine specimens obtained from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Integra® Jarit® Heparin Cannulas, Injectors, and Needles are used in conjunction with various syringe sizes (not supplied by Integra®) for flushing, irrigation and solution injection into a vessel or cavity during vascular, bypass or other cardiovascular surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQR
Device Description
Integra® Jarit® Heparin Cannulas, Injectors, and Needles are manual, stainless steel catheter cannulas provided in various sizes, shapes, and lengths for use during cardiovascular surgical procedures such as coronary artery bypass surgery. The cannulas are intended to be connected to a syringe filled with heparinized saline to confirm there is no leakage as well as ensure patency of harvested and/or grafted veins. The syringes are not being supplied with the cannulas nor are the syringes offered by Integra; therefore they are not part of this submission. These reusable devices are packaged non-sterile and are steam sterilizable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel or cavity
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)
Non-Clinical Tests Submitted:
- Manual Cleaning Validation (Protein Analyses) per AAMI TIR30:2003. - Pass
- Mechanical Cleaning Validation (Protein Analyses) per AAMI TIR30:2003. - Pass
- Pre-Vacuum (wrapped) Steam Sterilization Validation per ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an Exposure Time of 4 minutes and Drying Time of 30 minutes - Pass
- Repeated Autoclave Testing, Boiling Water Testing, Copper Sulfate Corrosion Testing and Thermal Testing per ISO 13402:1995 and ASTM F 1089-02. - Pass
- Mechanical Strength Testing - Laser Weld Joint - Pass
- Mechanical Strength Testing - Brazed Joint - Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Preamendment, Preamendment, Preamendment, K030788
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1300 Catheter cannula.
(a)
Identification. A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.(b)
Classification. Class II (performance standards).
0
510(k) Summary
| Submitted by: | Integra York PA, Inc.
589 Davies Drive
York, PA 17402 USA |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | OCT 2 8 2013 |
| Contact Person: | Stephanie Sheesley
Sr. Regulatory Affairs Manager
Integra York PA, Inc.
589 Davies Drive, York, PA 17402 USA
Phone: (717) 717-840-3522
Facsimile: (717) 840-9347 |
| Date Prepared: | August 15, 2013 |
| Device Trade Name: | Integra® Jarit® DeBakey Heparin Cannula, Integra® Jarit® Stoney
Heparin Injector, and Integra® Jarit® Heparin Flushing Needle |
| Device Common Name: | Cardiovascular cannulas, injectors, and needles |
| Part Numbers: | 310-379, 310-382, 310-383, 310-384 |
| Classification Name: | Cannula, Catheter |
| Device Class: | Class II |
| Product Code: | DQR |
| CFR Classification: | 21 CFR 870.1300 |
Device Description:
Integra® Jarit® Heparin Cannulas, Injectors, and Needles are manual, stainless steel catheter cannulas provided in various sizes, shapes, and lengths for use during cardiovascular surgical procedures such as coronary artery bypass surgery. The cannulas are intended to be connected to a syringe filled with heparinized saline to confirm there is no leakage as well as ensure patency of harvested and/or grafted veins. The syringes are not being supplied with the cannulas nor are the syringes offered by Integra; therefore they are not part of this submission. These reusable devices are packaged non-sterile and are steam sterilizable.
Indications For Use:
Integra® Jarit® Heparin Cannulas, Injectors, and Needles are used in conjunction with various syringe sizes (not supplied by Integra®) for flushing, irrigation and solution injection into a vessel or cavity during vascular, bypass or other cardiovascular surgical procedures.
1
Predicate Devices:
| 510(k) # | Device | Manufacturer |
|---|---|---|
| Preamendment | DeBakey Heparin Cannula | Pilling Co. |
| Preamendment | Stoney Heparin Injector | Pilling Co. |
| Preamendment | Heparin Flushing Needle | V. Mueller |
| K030788 | DeBakey Vessel Dilator | Geister Medizintechnik GmbH |
There are no differences in technology, materials, intended use, or design between the subject devices and the above predicates.
Performance Standards:
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the Integrato Cannulas, Injectors, and Needles conform to the following standards:
- ANSI/AAMI ST79:2010 & A1:2010 Comprehensive guide to steam sterilization . and sterility assurance in health care facilities
- · ANSI/AAMI/ISO 14937:2009 Sterilization of health care products-General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process
- ASTM TIR 30:2003 A Compendium of processes, materials, test methods, and . acceptance criteria for cleaning reusable medical devices
- ASTM F 1089-02 Standard test method for corrosion of surgical instruments
- 0 ISO 13402:1995 Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure
- . ISO 7153-1:2001 Surgical instruments- Metallic Materials- Part 1: Stainless Steel
- . ASTM F899-11 Standard Specification for Wrought Stainless Steels for Surgical Instruments
Non-Clinical Tests Submitted:
| Testing Performed | Results |
|---|---|
| Manual Cleaning Validation (Protein Analyses) per AAMI TIR30:2003. | Pass |
| Mechanical Cleaning Validation (Protein Analyses) per AAMI TIR30:2003. | Pass |
| Pre-Vacuum (wrapped) Steam Sterilization Validation per ANSI/AAMI ST79:2010 | |
| & A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an Exposure | |
| Time of 4 minutes and Drying Time of 30 minutes | Pass |
| Repeated Autoclave Testing, Boiling Water Testing, Copper Sulfate Corrosion | |
| Testing and Thermal Testing per ISO 13402:1995 and ASTM F 1089-02. | Pass |
| Mechanical Strength Testing - Laser Weld Joint | Pass |
| Mechanical Strength Testing - Brazed Joint | Pass |
2
Integra® Jarit® Heparin Cannulas, Injectors, and Needles
No biocompatibility testing was performed on the proposed devices as the 304 and 303 Stainless Steel Materials are recognized biocompatible materials per ASTM F899-11 and ISO 7153-1 and have a long history of safe and effective use as shown in the predicate devices.
Conclusions drawn from Non-Clinical Data:
All necessary testing has been performed on the Integra® Jarit® Heparin Cannulas, Injectors, and Needles and the results support the conclusion that the subject devices are substantially equivalent to the legally marketed predicate devices based on intended use, materials, technology, and design and as such, do not raise any concerns of safety or effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized emblem with three curved lines, resembling a human figure, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the emblem. The emblem is black, and the text is also black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2013
Integra Lifesciences Corporation c/o Stephanie Sheesley Sr. Regulatory Affairs Manager Integra York PA, Inc. 589 Davies Drive York, PA 17402
Re: K131446
Trade/Device Name: Integra® Jarit® DeBakey Heparin Cannula, Integra® Jarit® Stoney Heparin Injector, and Integra® Jarit® Heparin Flushing Needle
Regulation Number: 21 CFR 870.1300 Regulation Name: Cannula Catheter Regulatory Class: Class II Product Code: DQR Dated: August 28, 2013 Received: August 29, 2013
Dear Ms. Sheesley:
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 - Stephanie Sheesley
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M. A. Ellison
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(k) Number (if known):
Device Name: Integra® Jarit® Heparin Cannulas, Injectors, and Needles
Indications for Use:
Integra® Jarit® Heparin Cannulas, Injectors, and Needles are used in conjunction with various syringe sizes (not supplied by Integra®) for flushing, irrigation and solution injection into a vessel or cavity during vascular, bypass or other cardiovascular surgical procedures.
Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
M.A. Hillerman