NMI FC

K091634 · Navilyst Medical, Inc. · DTL · Mar 1, 2010 · Cardiovascular

Device Facts

• Record ID: K091634
• Device Name: NMI FC
• Applicant: Navilyst Medical, Inc.
• Product Code: DTL · Cardiovascular
• Decision Date: Mar 1, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

Intended Use

The Flush Connector is indicated for providing hemostasis around catheters, guidewires, and other devices during general intravascular procedures.

Device Story

Flush Connector is a medical fitting used during intravascular procedures; features main lumen body with hemostasis valve and rotating male luer; includes side arm with extension tube and female luer for fluid administration/flushing. Device seals around guidewires or catheters to maintain hemostasis. Used by clinicians in clinical settings; provided as standalone or in kits. Benefits patient by preventing blood loss and facilitating fluid delivery during catheterization.

Clinical Evidence

Bench testing only. Evaluated per ISO 594-2, EN ISO 11070, EN ISO 8536-9, and ISO 10993 standards. Testing included air and hydrodynamic leak, luer bond flex/pull strength, valve detachment, collar rotation, and interface compatibility. Biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, and complement activation.

Technological Characteristics

Main lumen body with hemostasis valve and rotating male luer; side arm with extension tube and female luer. Materials tested per ISO 10993. Standards: ISO 594-2, EN ISO 11070, EN ISO 8536-9, ASTM F750, USP <88>, USP <661>, AAMI/ANSI/ISO 11135-1, 11138-1, 11737-1, 11607, ASTM F1980, F88, F1929, F1886. Sterilization via validated methods.

Indications for Use

Indicated for patients undergoing general intravascular procedures requiring hemostasis around catheters, guidewires, or other devices.

Regulatory Classification

Identification

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• GateWay™ Plus Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting (K951089)

Submission Summary (Full Text)

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K09/634

MAR - 1 2010

Marhorough MA 017

v.navilystmedical.com

## 510(k) Summary

### A. Sponsor

Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752

### B. Contact

Lori Fitton Regulatory Affairs Specialist 508-658-7938

### Lorraine M. Hanley Director, Global Regulatory Affairs 508-658-7945

### C. Device Name

Trade name: Common/usual name: Classification Name:

Flush Connector Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting DTL - Cardiovascular 21 CFR 870.4290, Class II

### D. Predicate Device(s)

Trade Name: Common/usual name: Classification Name: Premarket Notification:

GateWay™ Plus Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting DTL - Cardiovascular21 CFR 870.4290, Class II Boston Scientific Corporation previously Scimed Life Systems, Inc. Scimed Gateway Plus, K951089

### E. Device Description

The Flush Connector consists of a main lumen body with a hemostasis valve at one end and a rotating male luer at the other end. In addition, the body has a side arm lumen with attached extension tube and female luer fitting. The haemostatic valve is designed to seal around a guide wire, stiffening wire, or other devices: and the side arm tubing is provided for fluid administration and flushing. The rotating male luer is designed to a female luer such as on a catheter. The proposed Flush Connector may be provided as a stand alone device or may be provided in a kit configuration with other legally marketed devices as a convenience to the user.

### F. Intended Use

The Flush Connector is indicated for providing hemostasis around catheters, guidewires, and other devices during general intravascular procedures.

### G. Performance Evaluation

The proposed flush connector was assessed in accordance with various FDA recognized Standards and voluntary industry standards including: ISO 594-2, EN ISO 11070, EN ISO 8536-9. Testing included evaluation for air and hydrodynamic leak, luer bond flex and pull strength, valve detachment, collar rotation, securement and interface with ancillary devices. ANSI/AAMI/ISO 10993 Cytotoxicity, Sensitization, Intracutaneous Irritation. Acute Systemic Injection, Pyrogenicity, Hemolysis, Complement Activation, and Thromboplastin. ASTM F750, USP 29<88>, USP 31 NF26 <88> and USP (31) <661>; A AMI/ANSI/ISO 10993-7, A AMI/ANSI/ISO 11135-1, AAMI/ANSI/ISO 11138-1, AAMI/ANSI/ISO 11737-1, AAMI ST72, EN 556-1; ANIS/AAMI/ISO 11607 Part 1&2, ASTM F1980, F88, F1929, and F1886.

### H. Substantial Equivalence

Based on responses to questions posed in FDA's 510(k) Decision Making Tree, the proposed device is determined to be substantially equivalent to the predicate.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus, a symbol often associated with healthcare and medicine.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Navilyst Medical Incorporated c/o Ms. Lorraine Hanley Director Global Regulatory Affairs 26 Forest Street Marlborough, MA 01752

# MAR - 1 2010

Re: K091634

Trade/Device Name: Flush Connector Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II (two) Product Code: DTL Dated: January 8, 2010 Received: January 11, 2010

Dear Ms. Hanley:

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.

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## Page 2 - Ms. Lorraine Hanley

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 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 (OS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nume R.V. din

Image /page/2/Picture/8 description: The image shows a handwritten symbol that appears to be a combination of letters or a stylized signature. The symbol consists of a curved line resembling a 'C' or a crescent shape at the top, connected to a line that crosses diagonally downwards, similar to the letter 'X'. The overall impression is that of a unique, possibly personal, mark or initial.

Bram Zuckerman, MD Division Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

| 510(k) Number (if Known): | K091634 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Flush Connector |
| Indications for Use: | The Flush Connector is indicated for providing hemostasis around catheters, guidewires and other devices during general intravascular procedures. |

| Prescription Use | X | AND/OR | Over-The-Counter Use ______ |
|------------------------|------------------------|--------|-----------------------------|
| (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)

Dina D. Vicker

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_2016 24

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