CES MASSTRANSIT INFUSION CATHETER

K974222 · Cordis Neurovascular, Inc. · KRA · Feb 10, 1998 · Cardiovascular

Device Facts

• Record ID: K974222
• Device Name: CES MASSTRANSIT INFUSION CATHETER
• Applicant: Cordis Neurovascular, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Feb 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

Intended Use

The MassTRANSIT is indicated for the infusion of various diagnostic, therapeutic and embolic agents in the peripheral, coronary, and neurovasculature.

Device Story

MassTRANSIT is a single-lumen infusion catheter designed to access small, tortuous vasculature. The device features a tapered shaft (3.0F proximal to 2.8F distal), a hydrophilic coating for navigation, and a PTFE-lined inner lumen to facilitate guidewire movement. It is used by clinicians to deliver diagnostic, therapeutic, or embolic agents to target sites within the peripheral, coronary, or neurovasculature. The device functions as a conduit for fluid delivery; it does not involve electronic processing, software, or automated decision-making.

Clinical Evidence

Bench testing only. Biocompatibility testing performed according to ISO-10993 (Blue Book Memorandum G95-1) demonstrated compatibility with biological tissue.

Technological Characteristics

Single-lumen catheter; 3.0F to 2.8F tapered shaft; hydrophilic coating; PTFE-lined inner lumen. Biocompatibility per ISO-10993. Non-electronic, mechanical device.

Indications for Use

Indicated for selective infusion of diagnostic, therapeutic, and embolic agents into peripheral, coronary, and neurovasculatures. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• CES TRANSIT (K952874, K936260, K936282, K965181, K972518)
• FasTRACKER 325 (K960806)
• JETSTREAM 327 (K953900, K953892)

Submission Summary (Full Text)

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## Appendix A - Summary of Safety and Effectiveness
Appendix A - Summary of Safety and Effectiveness and K974222

FEB 1 0 1998

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## 510(k) Summary of Safety and Effectiveness

The predicate devices are listed in the table below. Predicate Devices

| Device | Company | 510 (k) Number, Concurrence Date | Product Code |
|------------------|-----------------------------------|--------------------------------------------------|--------------|
| CES TRANSIT | Cordis Endovascular Systems, Inc. | K952874, K936260<br>K936282, K965181,<br>K972518 | DQO<br>KRA |
| FasTRACKER ® 325 | Target Therapeutics | K960806* | DQO* |
| JETSTREAM® 327 | Medtronic | K953900, K953892* | DQO<br>KRA |

* This information is assumed based on our best current knowledge.

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| Classification | Class II |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Standard | Performance standards have not been established by the FDA under Section 514 of<br>the Food, Drug and Cosmetic Act. |
| Intended use | The MassTRANSIT is indicated for the infusion of various diagnostic, therapeutic and<br>embolic agents in the peripheral, coronary, and neurovasculature. |
| Device<br>Description | The MassTRANSIT is a single lumen catheter designed to access small, tortuous<br>vasculature for the delivery of diagnostic, embolic and therapeutic agents. The shaft<br>tapers from 3.0F proximal to 2.8F distally. The catheter has a hydrophilic coating to<br>provide lubrication for navigation of vessels. The inner lumen is lined with PTFE to<br>facilitate movement of guidewires and other devices. |

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## 510(k) Summary of Safety and Effectiveness (col

| Biocompatibility | All appropriate biocompatibility tests have been performed according to the FDA<br>modified matrix of ISO-10993 (Blue Book Memorandum G95-1). The catheters<br>demonstrated compatibility with biological tissue by meeting the acceptance<br>criteria stipulated in the test protocols. |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Substantial<br>Equivalence | The CES MassTRANSIT Infusion Catheter is similar in its basic design, construction,<br>indication for use and performance characteristics to the predicate devices.2 |

² A statement of substantial equivalence to another product is required by 21CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seq. (1977).

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1998

Ms. Ariel MacTavish Sr. · Requlatory Affairs Associate Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700

Re : K974222 CES Mass Transit™ Infusion Catheter Regulatory Class: II (two) Product Code: 74 KRA Dated: November 7, 1997 November 12, 1997 Received:

Dear Ms. MacTavish:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration™ (FDA) will verify such` assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act ... for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K974222 510 (k) Number:_______________________________________________________________________________________________________________________________________________________________

## Indications for Use Statement

CES MassTRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic and embolic agents into the peripheral, coronary and neurovasculatures.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Tan A Ra

(Division Sign-O)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K974222