(391 days)
The RadialSource Catheter Sheath Introducer is indicated for use in arterial or venous procedures requiring percutaneous introduction of intravascular devices.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the RadialSource™ Transradial Access Kit:
Given the provided text is for a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a standalone de novo approval with novel performance criteria, the information will be structured based on what's available.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria with specific thresholds for each test. Instead, it states that the device "passed all verification specification criteria" and "performs as intended without raising new questions of safety and efficacy." The table below will list the tests performed, and the "Reported Device Performance" will reflect the general statement of compliance.
| Acceptance Criteria (Test Type) | Reported Device Performance |
|---|---|
| Biocompatibility Testing (per ISO 10993-1) | "Passed all verification specification criteria." (Implies compliance with specific criteria defined for each subclass of biocompatibility test: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Rabbit Pyrogen, Bacterial Mutagenicity, In Vitro Chromosome Aberration, In Vitro Mouse Lymphoma, Hemolysis, Partial Thromboplastin Time, Platelet and Leukocyte counts, Complement Activation, Thrombosis (In-vivo)). |
| USP Physicochemical Testing | "Passed all verification specification criteria." |
| Sterilization Testing | "Passed all verification specification criteria." |
| Shelf Life Testing | "Passed all verification specification criteria." |
| Performance Bench Testing: | "Passed all verification specification criteria." (Implies compliance with specific criteria defined for each subclass of performance test: 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). |
| Functionality (General) | "Performs as intended." |
| Safety and Efficacy (General) | "Does not raise new questions of safety or efficacy compared to the predicate devices." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document explicitly states: "no pre-clinical (animal) or clinical study was necessary." Therefore, there is:
- No specific test set or sample size dedicated to a clinical study.
- The data provenance for the non-clinical tests (biocompatibility, performance bench testing, etc.) would be from internal Greatbatch Medical testing laboratories or contracted labs. Specific country of origin is not mentioned but typically these are conducted in the country of manufacture or a recognized testing facility. The nature of these tests is by definition retrospective relative to the design and manufacturing of the device for the purpose of regulatory submission.
- For the "Thrombosis (In-vivo)" test, 2 dogs were used for a 4-hour contact. This is the only direct mention of an in-vivo sample size.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Since no clinical study was performed, there was no test set requiring expert ground truth establishment in the conventional sense of a clinical trial (e.g., radiologists interpreting images).
- For the non-clinical tests, the "ground truth" is established by the scientific and technical standards recognized in the industry (e.g., ISO standards for biocompatibility) and the expertise of the test engineers and scientists performing and evaluating the results of these bench and in-vitro tests at Greatbatch Medical or contracted labs. No specific number or qualifications of these individuals are stated.
4. Adjudication Method for the Test Set
- None applicable in the context of a clinical test set with human readers, as no such study was conducted.
- For the non-clinical tests, compliance to specifications would be determined by standard laboratory protocols and quality control measures, but not an "adjudication method" in the sense of expert consensus on ambiguous findings.
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 MRMC study was done. This device is a physical medical device (introducer sheath kit), not an AI/software-as-a-medical-device (SaMD) that would assist human readers with interpretations. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" for evaluating performance criteria is based on pre-defined engineering specifications, international standards (e.g., ISO, USP), and established scientific principles for device function, material properties, and biological interaction. For example, for biocompatibility, the ground truth is whether the material elicits a toxic response as per ISO 10993. For dimensional checks, the ground truth is adherence to design drawings.
8. The Sample Size for the Training Set
- Not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this device.
Summary of Study Type:
The submission relies on non-clinical (bench and in-vitro) testing and biocompatibility testing to demonstrate substantial equivalence to legally marketed predicate devices. The core argument for acceptance is that the RadialSource™ Transradial Access Kit performs as intended, has similar technological characteristics, and does not raise new questions of safety or efficacy compared to its predicates, thus negating the need for pre-clinical animal or clinical studies.
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510(k) Summary
1.0 Applicant Information
| Applicant: | Greatbatch Medical |
|---|---|
| Submitter: | Greatbatch Medical2300 Berkshire Lane NorthMinneapolis, 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
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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 .
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- 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).
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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
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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
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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
§ 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).