(181 days)
Not Found
No
The 510(k) summary describes a physical catheter used for device placement and does not mention any software, image processing, or AI/ML terms.
No
The device is intended to facilitate the placement of other interventional devices (guidewires) and is described as a catheter, which is typically a diagnostic or delivery tool, not one that directly provides therapy.
No
The device is intended to facilitate the placement of interventional devices like guidewires, not to diagnose a condition. The performance studies focus on biocompatibility, bench testing compliance, and packaging integrity, not diagnostic accuracy.
No
The device description explicitly states it is a "polymeric, single use, sterile, non-pyrogenic, disposable intracardiac catheter," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the intracardiac placement of interventional devices such as guidewires." This describes a device used in vivo (within the body) to assist in a medical procedure.
- Device Description: The description confirms it's an "intracardiac catheter," which is a device inserted into the heart.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. IVDs typically involve analyzing biological samples.
Therefore, the GDS-DC6 is a medical device used for an interventional procedure within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
GDS-DC6 is intended to facilitate the intracardiac placement of interventional devices such as guidewires.
Product codes
DYB
Device Description
GDS-DC6 is a polymeric, single use, sterile, non-pyrogenic, disposable intracardiac catheter of various sizes and curvatures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
KO91367
Section 5: 510(k) Summary
NOV – 5 7000
Device Information:
| Category | Comments |
|---|---|
| Sponsor: | Guided Delivery Systems, Inc |
| 2355 Calle de Luna | |
| Santa Clara, CA 95054 | |
| Correspondent Contact | |
| Information: | Bonnie McInerney, Quality Manager |
| Guided Delivery Systems, Inc | |
| 2355 Calle de Luna | |
| Santa Clara, CA 95054 | |
| Tel: 408 727 1105 x227 | |
| Fax: 408 727 6615 | |
| Email: bmcinerney@gdsmed.com | |
| Device Common Name: | Cardiac Introducer Sheath |
| Device Classification Number: | 21 CFR §870.1340 |
| Device Classification & | |
| Product Code: | Class II (two) |
| 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 |
| Diagnostic intravascular catheter | |
| Predicate Device Classification & | |
| Product Code: |
1
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
2
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.
3
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 (800) 638-2041 or (240) 276-3150 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
4
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