GDS-DCS

K091367 · Guided Delivery Systems · DYB · Nov 5, 2009 · Cardiovascular

Device Facts

• Record ID: K091367
• Device Name: GDS-DCS
• Applicant: Guided Delivery Systems
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

GDS-DC6 is intended to facilitate the intracardiac placement of interventional devices such as guidewires.

Device Story

GDS-DC6 is a polymeric, single-use, sterile, non-pyrogenic, disposable intracardiac catheter available in various sizes and curvatures. It functions as a cardiac introducer sheath to facilitate the placement of interventional devices, such as guidewires, within the heart. The device is intended for use by clinicians in a clinical setting. It provides a pathway for interventional tools, aiding in cardiac procedures. No complex electronics or software are involved.

Clinical Evidence

No clinical data. Evidence consists of biocompatibility testing per ISO 10993, bench testing per ISO 10555-1, and packaging/shelf-life validation.

Technological Characteristics

Polymeric intracardiac catheter; single-use; sterile; non-pyrogenic. Complies with ISO 10993 (biocompatibility) and ISO 10555-1 (sterile intravascular catheters).

Indications for Use

Indicated for facilitating intracardiac placement of interventional devices, such as guidewires, in patients requiring cardiac catheterization procedures.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Convoy Advanced Delivery Sheath Kit (K072719)
• Softouch Diagnostic Intravascular Catheter (K000659)

Submission Summary (Full Text)

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KO91367

# Section 5: 510(k) Summary

NOV – 5 7000

## Device Information:

| Category | Comments |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Guided Delivery Systems, Inc<br>2355 Calle de Luna<br>Santa Clara, CA 95054 |
| Correspondent Contact<br>Information: | Bonnie McInerney, Quality Manager<br>Guided Delivery Systems, Inc<br>2355 Calle de Luna<br>Santa Clara, CA 95054<br>Tel: [phone] x227<br>Fax: [phone]<br>Email: [e-mail] |
| Device Common Name: | Cardiac Introducer Sheath |
| Device Classification Number: | 21 CFR §870.1340 |
| Device Classification &<br>Product Code: | Class II (two)<br>DYB |
| Device Proprietary Name: | GDS-DC6 |

# Predicate Device Information:

| Predicate Device: | Convoy Advanced Delivery Sheath Kit |
|-------------------------------------------|-------------------------------------|
| Predicate Device Manufacturer: | Boston Scientific Corporation |
| Predicate Device Premarket Notification # | K072719 |
| Predicate Device Common Name: | Cardiac Introducer Sheath |
| Predicate Device Classification & Name: | 21 CFR §870.1340; |
| | Catheter introducer |
| Predicate Device Classification & | Class II (two) |
| Product Code: | DYB |

# Predicate Device Information:

| Predicate Device: | Softouch Diagnostic Intravascular Catheter |
|-------------------------------------------|------------------------------------------------------|
| Predicate Device Manufacturer: | Merit Medical Systems, Inc. |
| Predicate Device Premarket Notification # | K000659 |
| Predicate Device Common Name: | Angiographic Catheter |
| Predicate Device Classification & Name: | 21 CFR 870.1200<br>Diagnostic intravascular catheter |
| | Predicate Device Classification &<br>Product Code: |

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#### b. Date Summary Prepared

May 6, 2009 (revised September 17, 2009)

#### c. Description of Device

GDS-DC6 is a polymeric, single use, sterile, non-pyrogenic, disposable intracardiac catheter of various sizes and curvatures.

#### d. Intended Use

GDS-DC6 is intended to facilitate the intracardiac placement of interventional devices such as guidewires.

#### e. Comparison to Predicate Device

The GDS-DC6 is substantially equivalent in intended use, technology, design and materials to the predicate devices. The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy. Therefore, Guided Delivery Systems, Inc. concludes that the devices are substantially equivalent.

## f. Summary of Supporting Data

Biocompatibility data demonstrates that the device is in compliance with ISO 10993.

Bench testing data has demonstrated that the device is in compliance with ISO 10555-1, the expectations of the medical community and the product labeling.

Packaging and shelf life testing demonstrates that the device packaging is robust and maintains a sterile barrier for the stated expiration time.

Revised Section 5 510(k) Summary Sept 17, 2009

Guided Delivery Systems, Inc

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a human profile.

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

NOV - 5 2009

Guided Delivery Systems, Inc. c/o Ms. Bonnie McInerney Manager, Regulatory Affairs and Quality 2355 Calle de Luna Santa Clara, CA 95054

Re: K091367

Trade/Device Name: GDS-DC6 Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: October 30, 2009 Received: November 2, 2009

Dear Ms. McInerney:

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 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.

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Page 2 - Ms. Bonnie McInerney

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,

. Dana R. Widener

Sram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4: Indications for Use Statement

510(k) Number K091367

Device Name: GDS-DC6

Indications for Use:

GDS-DC6 is intended to facilitate the intracardiac placement of interventional devices such as guidewires.

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)

Page 1 of 1

Mma R. h. hmer
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number K0-91367