(44 days)
No
The document describes a physical medical device (catheter) and its intended use for infusion and navigation. There is no mention of software, algorithms, or any form of AI/ML technology. The performance studies focus on physical properties like kink resistance and burst strength.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature."
No
Explanation: The device is an infusion catheter used for delivering agents and facilitating other devices within the vasculature. While it can be used with "diagnostic agents," the catheter itself does not perform diagnostic functions (like imaging or analysis) but rather delivers substances used for diagnosis. Its primary function is mechanical access and delivery, not diagnosis.
No
The device description clearly describes a physical catheter with various material properties and features, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a mechanism for infusing various agents (diagnostic, embolic, therapeutic) and for supporting procedures within the body's vasculature. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a catheter designed for navigating and accessing blood vessels. This aligns with an in vivo device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples in vitro (outside the body). This device is designed for use in vivo (inside the body).
N/A
Intended Use / Indications for Use
The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support, and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with manufacturer's instructions for use.
Product codes
KRA
Device Description
The Cordis Neurovascular, Inc. HYPERTRANSIT™ Infusion Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices. The catheter body is radiopaque to aid visualization under fluoroscopy, and the distal tip is distinguished by a radiopaque marker. Select configurations are available with pre-shaped tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary, neuro and peripheral vasculatures
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 following in-vitro testing was conducted to support substantial equivalence to the predicate device, addressing the design changes made to improve kink resistance at the distal end of the strain relief.
PERFORMANCE & DESIGN VALIDATION TESTING
Microcatheter Visual Standards for Kinks
Microcatheter Inspection
Dynamic Burst
Static Burst
Joint Pull Test
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the word "Cordis" in a bold, sans-serif font. A registered trademark symbol is to the right of the word. Below the word "Cordis" is the phrase "a johnson johnson company" in a smaller, less bold font.
K070279 pg | of 2
a Joh
Page 1 of 2 CFF 10463867 Revision 02
Only the Native File to be Used
1.11
510(k) Summary of Safety and Effectiveness
| Submitter's Name/Contact Person | Roberto F. Refeca
Senior Regulatory Affairs Associate
Cordis Neurovascular, Inc.
14000 NW 57th Ct.
Miami Lakes, Fl 33014
Ph. 786 313 2850
Fax. 786 313 6480
rrefeca@crdus.jnj.com |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MAR 1 4 2007 |
| Trade Name / Common Name | The trade name/common name is :
HYPERTRANSIT™ Infusion Catheter/Catheter, Continuous Flush |
| Classification | This is a Class II Device, per 870.1210 (KRA). |
| Performance Standard | The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this device. |
| Intended use | The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support, and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with manufacturer's instructions for use. |
| Device Description | The Cordis Neurovascular, Inc. HYPERTRANSIT™ Infusion Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices. The catheter body is radiopaque to aid visualization under fluoroscopy, and the distal tip is distinguished by a radiopaque marker. Select configurations are available with pre-shaped tips. |
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Image /page/1/Picture/0 description: The image shows the Cordis logo, which is a Johnson & Johnson company. The logo is in black and white. The image also contains the text 'K070279 pg 2 of 2'.
Page 2 of 2 CFF 10463867 Revision 02 Only the Native File to be Used Predicate The predicate devices are listed in the table below: Devices
1111
| Device | Company | Product
Code | 510(k) Number | Predicate for:
(if multiple
predicates) |
|------------------------------------|----------------------------------|-----------------|---------------|------------------------------------------------------------------------------------------|
| HYPERTRANSIT™
Infusion Catheter | Cordis
Neurovascular,
Inc. | KRA | K043538 | Intended Use
Sterilization
Dimensions
Performance
Packaging
Manufacturing |
Summary of The following in-vitro testing was conducted to support substantial equivalence to the predicate device, addressing the design changes made to improve kink resistance Studies at the distal end of the strain relief.
| PERFORMANCE & DESIGN VALIDATION TESTING |
|---|
| Microcatheter Visual Standards for Kinks |
| Microcatheter Inspection |
| Dynamic Burst |
| Static Burst |
| Joint Pull Test |
The proposed HYPERTRANSIT™ Infusion Catheter is similar in its basic design, Summary of construction, indication for use, and performance characteristics to the predicate Substantial HYPERTRANSIT™ Infusion Catheter. Equivalence
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Image /page/2/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-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is smaller than the central symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR. 1. 4 2007
Mr. Roberto F. Refeca Sr. Regulatory Affairs Associate Cordis Neurovascular, INC. 14000 N.W. 57th Court Miami Lakes, FL 33014
Re: K070279/S001 Trade/Device Name: HYPERTRANSIT™ Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II Product Code: KRA Dated: February 14, 2007 Received: February 16, 2007
Dear Mr. Refeca:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can
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Page 2 - Mr. Roberto F. Refeca
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 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, stylized font, with a registered trademark symbol next to it. Below the company name, the text "a Johnson & Johnson company" is written in a smaller, less bold font.
Page 1 of 1 CFF 20014 Only the Native File to be Used Intended Use Statement
Page 1 of
Indications for Use
510(k) Number (if known):
HYPERTRANSIT™ Infusion Catheter Device Name:
Indications For Use: The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support, and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature.
All agents must be used in accordance with manufacturer's instructions for use.
Prescription Use x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
C. Moray Mayr
Vision Digitally
ion of Cardiovascular Devices
10(k) Number K070279