(245 days)
Not Found
No
The description focuses on the physical construction and manual operation of a guiding catheter, with no mention of AI or ML capabilities.
No
The device is described as a guiding catheter to deliver other agents or devices, not as a therapeutic agent or device itself.
No
The device description indicates it is a "Guiding Catheter" used to "deliver radiopaque media, guide wires, catheters, and therapeutic agents" or for "support and exchange of guide wires, catheters, and/or therapeutic agents" during procedures. While it can be used during a "diagnostic procedure," its primary function described is to facilitate the delivery or exchange of other tools or substances, not to directly diagnose a condition itself. The visibility under fluoroscopy is for guidance, not diagnosis.
No
The device description clearly details a physical catheter made of various materials with a specific construction and intended for manual operation within the vascular system. It undergoes bench and biocompatibility testing, which are characteristic of hardware medical devices, not software-only devices.
Based on the provided information, the Heartrail™ III Guiding Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "cardiac and vascular procedures" and is designed to "deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system." This describes a device used within the body for diagnostic and therapeutic purposes, not for testing samples outside the body.
- Device Description: The description details a physical catheter inserted into the vascular system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Heartrail™ III Guiding Catheter is an interventional/diagnostic medical device used directly on the patient.
N/A
Intended Use / Indications for Use
The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery.
Product codes (comma separated list FDA assigned to the subject device)
DOO
Device Description
The Heartrail™ III Guiding Catheter (5Fr.) is a three-layer construction comprised of a stainless steel mesh sandwiched between a layer of polytetrafluorofluoroethylene and a layer of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tin is a flexible, supple polyester elastomer containing tungsten. This tip is permanently welded to the catheter shaft. Depending on the product code, the tip is either straight or curved into a specific shape.
The Heartrail™ III Guiding Catheter (5Fr.) is operated manually or by a manual process. During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing a guide wire and introducer within a vessel. Then the Heartrail™ III Guiding Catheter would be advanced over the guide wire. Next, the guide wire and Guiding Catheter would be advanced to the target vessel. The Heartrail™ III Guiding Catheter can then be used for injection of radiopaque media or for support and exchange of guide wires, catheters, and/or therapeutic agents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Vascular system, arteries (e.g., radial artery)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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 performance of the Heartrail™ III Guiding Catheter (5Fr.) is substantially equivalent to the performance of the predicate device. The equivalence was shown through bench testing. The following testing was performed on non-aged and aged devices:
- Surface
- Tip configuration
- Product dimensions(O.D. ,effective length)
- Force at break(1.shaft 2.hub)
- Freedom from leakage
- Radio detectability
- Catheter burst /Leakage pressure
- Flexibility / Catheter stiffness (1.shaft 2.distal)
- Tip durability
- Flow rate
- Tip strength
- Catheter inner surface friction
- Torque control
- Simulated use testing
- Torque Strength
- Flexibility and Kink Test
- Catheter Bond Strength (1.soft tip 2.shaft)
Biocompatibility Testing on the Heartrail III Guiding Catheter (non-aged, sterile)
- Cytotoxicity (ISO 10993-5): Non-cytotoxic
- Sensitization - NaCl and CSO Extract (ISO 10993-10): No evidence of causing delayed dermal contact sensitization.
- Acute Intracutaneous Reactivity - NaCl and CSO Extract (ISO 10993- 10): No evidence of significant irritation or toxicity.
- Acute Systemic Toxicity - NaCl and CSO Extract (ISO 10993-11): No mortality or evidence of systemic toxicity.
- Hemolysis (ASTM F756): Non-hemolytic.
- Pyrogen Study (ISO 10993-11): Non-pyrogenic.
- InVivo Thromboresistance (ISO10993-4): Thromboresistant
- Complement Activation Testing C3a (ISO10993-4): Not a complement system activator
- Complement Activation Testing Sc5b-9 (ISO10993-4): Not a complement system activator
Limited screening tests were conducted on the accelerated-aged, sterile device to demonstrate that aging does not affect the device's biocompatibility.
- Physicochemical Profile (USP): Meets requirements
- Cytotoxicity (ISO 10993-5): Non-cytotoxic
- Hemolysis (ASTM F756): Non-hemolytic.
Sterilization conditions have been validated in accordance with ANSI/AAMI/ISO 11135-1, Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices. The device is sterilized to a SAL of 10-6.
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.
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
K113335
Page 1 of 7
Image /page/0/Picture/1 description: The image shows the logo for Terumo. The logo consists of a circle with a T inside of it, followed by the word "TERUMO" in all capital letters. There is a small circle in the upper right corner of the word "TERUMO".
TERUMO CORPORA Head Office 44-1. 2-chome. Hatagava. Telephone: 81-3-3374-8111 Facs
JUL 16 2012
Terumo Medical Corporation 950 Elkton Blvd, Elkton, MD 21921 Telephone: 410-392-7213 Facsimile: 410-398-6079
510(K) SUMMARY - HEARTRAIL™ III GUIDING CATHETER (5FR.)
1) Submitter Information
Owner/Operator
Terumo Corporation, Tokyo, Japan 44-1, 2-chome Hatagaya Shibuya-ku Tokyo 151-0072 Japan Registration No: 801 002 6
Manufacturing Facility and Sterilization Facility Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya Shizuoka 418-0015 Japan Registration No: 968 183 4
Distributor
Terumo Medical Corporation, Somerset, NJ 2101 Cottontail Lane Somerset, NJ 08873 Registration No: 224 344 1
Submitter's Name: Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist
Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921 Phone: (410) 392-7213 Fax: (410) 398-6079 Email: mark.unterreiner@terumomedical.com
Date Prepared:
January 30, 2012
1
2) Device Name
| Proprietary Name: | Heartrail™ III Guiding Catheter |
|---|---|
| Common Name: | Guiding Catheter |
| Classification Name: | Catheter, Intravascular, Diagnostic |
3) Predicate Device
The predicate device is the Terumo Heartrail™ III Guiding Catheter cleared under K092372. The differences between the devices do not raise any new issues of safety or effectiveness.
4) Description
The Heartrail™ III Guiding Catheter (5Fr.) is a three-layer construction comprised of a stainless steel mesh sandwiched between a layer of polytetrafluoroethylene and a layer of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tin is a flexible, supple polyester elastomer containing tungsten. This tip is permanently welded to the catheter shaft. Depending on the product code, the tip is either straight or curved into a specific shape.
The Heartrail™ III Guiding Catheter (5Fr.) is operated manually or by a manual process. During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing a guide wire and introducer within a vessel. Then the Heartrail™ III Guiding Catheter would be advanced over the guide wire. Next, the guide wire and Guiding Catheter would be advanced to the target vessel. The Heartrail™ III Guiding Catheter can then be used for injection of radiopaque media or for support and exchange of guide wires, catheters, and/or therapeutic agents.
2
Terumo Corporation Special 510(k) - Heartrail™ III Guiding Catheter (5Fr.) Section II. 510(k) Summary
5) Intended Use
The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and the prooutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery.
This is the same intended use as the unmodified device the Heartrail™ III Guiding Catheter cleared under K092372.
6) Design / Materials/ Specifications
The Heartrail TM III Guiding Catheter (5Fr.) in this submission uses similar materials as the Heartrail™ III Guiding Catheter cleared under K092372. Differences in materials between the devices do not raise any new issues of safety and effectiveness.
| Part | Raw material |
|---|---|
| Soft tip* | Polyester elastomer containing tungsten |
| Inner layer* | Polytetrafluoroethylene |
| Braid | Stainless steel |
| Outer layer* | Polyester elastomer containing |
| tungsten** | |
| Strain relief | Polyester elastomer |
| Hub* | Nylon 12 |
- Blood contacting material
** Some parts of outer layer may not contain tungsten.
3
Terumo Corporation Special 510(k) – Heartrail™ III Guiding Catheter (5Fr.)
Section II. 510(k) Summary
| Summary of Comparative Information Between the Modified | ||
|---|---|---|
| Device and the Predicate Device | ||
| Before Device Modification | After Device Modification | |
| Cleared Under K092372 | ||
| Trade name | Heartrail™ III Guiding Catheter | |
| (6Fr.) | Heartrail™ III Guiding Catheter | |
| (5Fr.) | ||
| Tip Shape/Material | AMPLATZ LEFT/ | |
| SHORT AMPLATZ/ | ||
| AMPLATZ RIGHT/ | ||
| BYPASS/ |
IKARI LEFT/
IKARI RIGHT/
TIGER-MODIFIED/
INTERNAL MAMMARY/
JUDKINS LEFT/
JUDKINS RIGHT/
MULTIPURPOSE | AMPLATZ LEFT/
SHORT AMPLATZ/
AMPLATZ RIGHT/
BYPASS/
BACKUP LEFT/
BACKUP LEFT-MODIFIED/
IKARI LEFT/
IKARI RIGHT/
TIGER-MODIFIED/
IKARI FEMORAL LEFT/
IKARI FEMORAL RIGHT/
INTERNAL MAMMARY/
JUDKINS LEFT/
JUDKINS RIGHT/
MULTIPURPOSE |
| | Polyester elastomer
containing tungsten | Polyester elastomer
containing tungsten |
| Catheter O.D. | 6Fr. | 5Fr. |
| Usable length | 100 cm | 100 cm, 110cm |
| Maximum Injection Pressure | 700 psi | 700 psi |
4
Terumo Corporation Special 510(k) - Heartrail™ III Guiding Catheter (5Fr.) Section II. 510(k) Summary
7) Nonclinical Performance Testing
The performance of the Heartrail™ III Guiding Catheter (5Fr.) is substantially equivalent to the performance of the predicate device. The equivalence was shown through bench testing. The following testing was performed on non-aged and aged devices:
-
Surface
-
Tip configuration
-
Product dimensions(O.D. ,effective length)
-
Force at break(1.shaft 2.hub)
-
Freedom from leakage
-
Radio detectability
-
Catheter burst /Leakage pressure
-
Flexibility / Catheter stiffness (1.shaft 2.distal)
-
Tip durability
-
Flow rate
-
Tip strength
-
Catheter inner surface friction
-
Torque control
-
Simulated use testing
-
Torque Strength
-
Flexibility and Kink Test
-
Catheter Bond Strength (1.soft tip 2.shaft)
5
8) Additional Safety Information
Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-I, "Biological Evaluation of Medical Devices Part-1:15maluation and Testing within a risk management process.".
The catheter is classified as Externally Communicating Devices, Circulating Blood, limited Contact ( Trade Name: Heartrail III Guiding Catheter (5Fr) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (two) Product Code: DOO Dated: June 28, 2012 Received: June 29, 2012
Dear Mr. Unterreiner:
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. Ilsting 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.
8
Page 2 - Mr. Mark Unterreiner
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 CFR Part 807); labeling (21 CFR Part 801); medical device 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" (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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
. A. Hillen
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
9
Indications for Use
KII3335 510(k) Number (if known): _
Heartrail™ III Guiding Catheter (5Fr) Device Name:
Indications For Use:
The Heartrail™ III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
CmA Stillwell
on Sign-Off) Division of Cardiovascular Devices
118335 510(k) Number