(44 days)
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.
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.
The information provided describes the HYPERTRANSIT™ Infusion Catheter and its testing for substantial equivalence to a predicate device. This submission focuses on in-vitro testing to address design changes for improved kink resistance. It does not describe a study involving human readers, AI, or expert ground truth in the way a diagnostic AI device would.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the provided document, as it pertains to a physical medical device and its mechanical performance testing.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document lists the types of in-vitro tests conducted but does not provide specific acceptance criteria or quantitative performance results for each test. Instead, it states that these tests were 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." The conclusion is that the proposed device is "similar in its basic design, construction, indication for use, and performance characteristics to the predicate HYPERTRANSIT™ Infusion Catheter."
| Performance & Design Validation Testing | Reported Device Performance / Purpose of Test |
|---|---|
| Microcatheter Visual Standards for Kinks | Conducted to support substantial equivalence to the predicate device, addressing design changes for improved kink resistance. |
| Microcatheter Inspection | Conducted to support substantial equivalence. |
| Dynamic Burst | Conducted to support substantial equivalence. |
| Static Burst | Conducted to support substantial equivalence. |
| Joint Pull Test | Conducted to support substantial equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The study involved in-vitro testing of a physical medical device, not a diagnostic algorithm with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically understood for diagnostic AI devices (e.g., expert consensus on medical images) is not relevant to this in-vitro mechanical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication process is described for this in-vitro mechanical device testing.
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
Not applicable. This is not a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the in-vitro tests, the "ground truth" would be established by objective physical measurements and adherence to engineering specifications and performance characteristics demonstrating equivalency to the predicate device. The document implies compliance with these standards through the conducted tests.
8. The sample size for the training set
Not applicable. This is not a machine learning model; therefore, there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned.
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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. RefecaSenior Regulatory Affairs AssociateCordis Neurovascular, Inc.14000 NW 57th Ct.Miami Lakes, Fl 33014Ph. 786 313 2850Fax. 786 313 6480rrefeca@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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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 | ProductCode | 510(k) Number | Predicate for:(if multiplepredicates) |
|---|---|---|---|---|
| HYPERTRANSIT™Infusion Catheter | CordisNeurovascular,Inc. | KRA | K043538 | Intended UseSterilizationDimensionsPerformancePackagingManufacturing |
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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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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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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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
0000054
§ 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).