(391 days)
No
The device description and performance studies focus on the physical components and their mechanical/biocompatibility performance, with no mention of AI or ML capabilities.
No
The device is an introducer for other intravascular devices, meaning it facilitates the use of therapeutic or diagnostic devices but is not therapeutic itself.
No
Explanation: The device is described as a sheath introducer and associated components used for percutaneous introduction of other intravascular devices, not for diagnosing a condition or disease. While it aids in procedures that might be diagnostic, it is not a diagnostic tool itself.
No
The device description clearly outlines multiple physical components (catheter sheath introducer, vessel dilator, mini-guidewire, IV catheter) and describes their physical properties and functions. This is a hardware-based medical 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 "percutaneous introduction of intravascular devices" in arterial or venous procedures. This describes a surgical or interventional procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The components (catheter sheath introducer, dilator, guidewire, IV catheter) are all tools used to access and work within the patient's vasculature. They are not designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD.
Therefore, the RadialSource Catheter Sheath Introducer is a medical device used in interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RadialSource Catheter Sheath Introducer is indicated for use in arterial or venous procedures requiring percutaneous introduction of intravascular devices.
Product codes
DYB
Device Description
The RadialSource™ Transradial Access (TRA) Kit consists of a catheter sheath introducer (CSI), a vessel dilator, a mini-guidewire, and an IV catheter (consisting of an IV cannula and a needle). The CSI is intended to facilitate percutaneous introduction of intravascular devices in arterial or venous procedures through, but not limited to, a radial approach. The vessel dilator and mini-guidewire are used in conjunction with the CSI to gain access to the vasculature. The CSI and vessel dilator contain a lubricious coating intended to reduce friction during insertion into the vessel. The CSI contains a hemostasis valve at the proximal end which minimizes blood loss and air intake to the vasculature. A sideport infusion line extends from the CSI proximal hub and terminates at a 3-way stopcock with a standard luer fitting for flushing/infusion. The CSI and dilator contain radiopaque material for visualization under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Not Found
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)
The RadialSource Transradial Access Kit passed all verification specification criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility and shelf life tests. Test results confirm that the device performs as intended without raising new questions of safety and efficacy when compared to the predicate devices. Given the similar technological characteristics and principles of operation of the RadialSource™ Transradial Access Kit as compared to the predicate devices, it was determined that no pre-clinical (animal) or clinical study was necessary. The following non-clinical tests were performed for the RadialSource Transradial Access Kit:
- Biocompatibility testing per ISO 10993-1.
- Cytotoxicity.
- Sensitization.
- ISO Irritation/Intracutaneous Reactivity.
- Acute Systemic Toxicity.
- Materials Mediated Rabbit Pyrogen.
- Bacterial Mutagenicity Test.
- In Vitro Chromosome Aberration Assay.
- In Vitro Mouse Lymphoma Assay.
- Hemolysis Test.
- Partial Thromboplastin Time.
- Platelet and Leukocyte counts.
- Complement Activation -- C3a and SC5b-9.
- Thrombosis (In-vivo) 2 dog (4-hour contact).
- USP Physicochemical testing.
- Sterilization testing.
- Shelf Life.
- Performance Bench:
- Visual.
- Dimensional.
- Functional:
- Valve Hemostasis.
- Sheath Hemostasis.
- Sheath/Dilator Compatibility.
- Insertion/Retraction Force.
- Sheath/Dilator Retention.
- Kink.
- Tensile Strength.
- Dilator Luer Taper.
- Guidewire Fracture.
- Guidewire Flex.
- Guidewire Strength of Core Wire to Coil.
- Packaging Seal Strength/Integrity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
1/11/05/
FEB - 2 2012
Image /page/0/Picture/2 description: The image contains the logo for Greatbatch Medical. The logo consists of a hexagon shape made up of six smaller hexagons, with one of the hexagons filled in black. To the right of the hexagon shape is the text "Greatbatch" in a bold, sans-serif font, with the word "Medical" underneath it in a smaller font size.
510(k) Summary
1.0 Applicant Information
| Applicant: | Greatbatch Medical |
|---|---|
| Submitter: | Greatbatch Medical |
| 2300 Berkshire Lane North | |
| Minneapolis, MN 55441 | |
| (763) 951-8181 (Phone) | |
| (763) 559-0148 (Fax) | |
| Contact Person: | Sara Bakker |
| Date Prepared: | January 5, 2011 (modified August 28, 2011) |
2.0 Device Information
| Trade Name: | RadialSource™ Transradial Access Kit |
|---|---|
| Common Name: | Sheath Introducer |
| Classification Name: | Introducer, Catheter |
| Product Code: | DYB |
| Regulation: | Class II 21 CFR 870.1340 |
| Classification Panel: | Cardiovascular |
| Predicates: | Terumo Glidesheath (K082644) |
| Cordis Avanti Trans-Radial Kit (K962746) |
3.0 Device Description
The RadialSource™ Transradial Access (TRA) Kit consists of a catheter sheath introducer (CSI), a vessel dilator, a mini-guidewire, and an IV catheter (consisting of an IV cannula and a needle). The CSI is intended to facilitate percutaneous introduction of intravascular devices in arterial or venous procedures through, but not limited to, a radial approach. The vessel dilator and mini-guidewire are used in conjunction with the CSI to gain access to the vasculature. The CSI and vessel dilator contain a lubricious coating intended to reduce friction during insertion
1
into the vessel. The CSI contains a hemostasis valve at the proximal end which minimizes blood loss and air intake to the vasculature. A sideport infusion line extends from the CSI proximal hub and terminates at a 3-way stopcock with a standard luer fitting for flushing/infusion. The CSI and dilator contain radiopaque material for visualization under fluoroscopy.
4.0 Indications for Use
The RadialSource Catheter Sheath Introducer is indicated for use in arterial or venous procedures requiring percutaneous introduction of intravascular devices.
Predicate Device Comparison / Technological Characteristics 5.0
The RadialSource™ Transradial Access Kit has similar indications for use as the market cleared Cordis Avanti™ Trans-Radial Sheath Introducer Kit and Terumo GlideSheath™. Like the predicates, the RadialSource Transradial Access Kit includes a guidewire, IV catheter/needle vessel dilator and valved introducer intended to gain access and provide percutaneous introduction of catheters and intravascular devices. Terumo GlideSheath and RadialSource are indicated for both arterial and venous procedures; Avanti is indicated for arterial only. The RadialSource Transradial Access Kit shares similar principles of operation and technological characteristics as the predicates. RadialSource is available in similar French sizes but provides a smaller sheath length on the lower end of its sheath length offering. RadialSource also provides a smaller diameter guidewire offering. Performance (bench) testing and biocompatibility testing were performed to demonstrate that the proposed device performs as intended and does not raise new questions of safety or efficacy compared to the predicate devices.
Summary of Testing 6.0
The RadialSource Transradial Access Kit passed all verification specification criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility and shelf life tests. Test results confirm that the device performs as intended without raising new questions of safety and efficacy when compared to the predicate devices. Given the similar technological characteristics and principles of operation of the RadialSource™ Transradial Access Kit as compared to the predicate devices, it was determined that no pre-clinical (animal) or clinical study was necessary. The following non-clinical tests were performed for the RadialSource Transradial Access Kit:
- Biocompatibility testing per ISO 10993-1 .
- Cytotoxicity .
- Sensitization .
- ISO Irritation/Intracutaneous Reactivity .
- Acute Systemic Toxicity .
- Materials Mediated Rabbit Pyrogen .
- Bacterial Mutagenicity Test .
- In Vitro Chromosome Aberration Assay .
- In Vitro Mouse Lymphoma Assay �
- Hemolysis Test .
2
- Partial Thromboplastin Time .
- Platelet and Leukocyte counts .
- Complement Activation -- C3a and SC5b-9 .
- Thrombosis (In-vivo) 2 dog (4-hour contact) .
- USP Physicochemical testing
- Sterilization testing .
- Shelf Life .
- Performance Bench: .
- Visual .
- Dimensional .
- Functional: .
- Valve Hemostasis 1
- . Sheath Hemostasis
- D Sheath/Dilator Compatibility
- 트 Insertion/Retraction Force
- 트 Sheath/Dilator Retention
- 트 Kink
- 미 Tensile Strength
- 트 Dilator Luer Taper
- 트 Guidewire Fracture
- Guidewire Flex 트
- Guidewire Strength of Core Wire to Coil l
- Packaging Seal Strength/Integrity
Statement of Equivalence 7.0
The RadialSource™ Transradial Access Kit has similar indications for use, principles of operation, and technological characteristics as the identified predicates. Based on these operation, and technological characteristics as the identifica preciences. "DRadiollance TM
similarities, in addition to the results from safety and performance testing, Radi Shimarities, in addition to the results from sately and personaling, radias seat.
Transradial Access Kit is considered substantially equivalent to the Terumo Glidesheath™ (K082644) and Cordis Avanti™ Trans-Radial Sheath Introducer Kit (K962746).
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 eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
FEB - 2 2012
Greatbatch Medical c/o Ms. Sara Bakker Senior Regulatory Affairs Specialist 2300 Berkshire Lane N Minneapolis, MN 55441
Re: K110051
Trade Name: RadialSource Transradial Access Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: January 26, 2012 Received: January 27, 2012
Dear Ms. Bakker:
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. Sara Bakker
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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
M.g. Willemann
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Greatbatch Medical Traditional Premarket Notification 510(k)
RadialSource Transradial Access Kit
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: RadialSource Transradial Access Kit
Indications for Use:
The RadialSource Catheter Sheath Introducer is indicated for use in arterial or venous procedures requiring percutaneous introduction of intravascular devices.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(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. Killmann
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_JL 1100(k) اک