(87 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML.
No
The device is intended to facilitate the placement of other interventional devices and does not directly provide therapy.
No
The device is intended to facilitate the placement of interventional devices like guidewires, not to diagnose a condition or disease.
No
The device description explicitly states it is a "polymeric, single use, sterile, non-pyrogenic, disposable intracardiac catheter of various sizes and curvatures with a deflectable tip and hemostasis valve," which are physical hardware components. The performance studies also focus on physical characteristics like dimensions, tensile strength, flexibility, and biocompatibility.
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 within the body for a procedural purpose, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description details a physical catheter with a deflectable tip and hemostasis valve, designed for insertion into the heart. This is consistent with an interventional medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the GDS-DC12 is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
GDS-DC12 is intended to facilitate the intracardiac placement of interventional devices such as guidewires.
Product codes (comma separated list FDA assigned to the subject device)
DYB, DOY
Device Description
GDS-DC12 is a polymeric, single use, sterile, non-pyrogenic, disposable intracardiac catheter of various sizes and curvatures with a deflectable tip and hemostasis valve.
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
physicians trained in interventional cardiology procedures
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The clearance of this device was based in part on the evaluation of the following performance characteristics:
- Dimensional measurements (OD, ID, Lengths)
- Torsional Response
- Pull Wire Movement
- Corrosion Resistance
- Shaft to Hub Tensile
- Shaft Tensile
- Pull Wire Tension
- Tip Tensile
- Torque Test
- Shaft Leak Under Pressure
- Shaft Leak Under Vacuum
- Catheter Flexibility/ Kink Resistance
- Catheter Turns To Failure
- Radiopacity (leveraged from GDS-DC6 K091367)
- Biocompatibility
Bench testing data (appendix B) has demonstrated that the device is in compliance with design input requirements, the expectations of the medical community and the product labeling.
Sterilization, packaging and shelf life testing (appendix C) demonstrates that the device is sterile, the packaging is robust and that it maintains a sterile barrier for the stated expiration time.
Biocompatibility data (appendix D) demonstrates that the device is biocompatible and in compliance with ISO 10993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
APR 1 6 2010
| a. | Device Information: | |
|---|---|---|
| Category | Comments | |
| Sponsor: | Guided Delivery Systems, Inc | |
| 2355 Calle de Luna | ||
| Santa Clara, CA 95054 | ||
| Correspondent Contact Information: | Bonnie McInerney, Manager, Regulatory & Quality | |
| 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-DC12 |
Predicate Device Information:
| Predicate Device: | GDS-DC6 Catheter |
|---|---|
| Predicate Device Manufacturer: | Guided Delivery Systems |
| Predicate Device Premarket Notification # | K091367 |
| Predicate Device Common Name: | Cardiac Introducer |
| Predicate Device Classification & Name: | 21 CFR §870.1340; Catheter introducer |
| Predicate Device Classification & Product Code: | Class II (two); DYB |
Predicate Device Information:
| Predicate Device: | Enpath Deflectable Catheter |
|---|---|
| Predicate Device Manufacturer: | Bard, Enpath Medical |
| Predicate Device Premarket Notification # | K043489 |
| Predicate Device Common Name: | Cardiac Introducer |
| Predicate Device Classification & Name: | 21 CFR §870.1340; Catheter introducer |
| Predicate Device Classification & Product Code: | Class II (two); DYB |
b. Date Summary Prepared
April 5, 2010
c. Description of Device
GDS-DC12 is a polymeric, single use, sterile, non-pyrogenic, disposable intracardiac catheter of various sizes and curvatures with a deflectable tip and hemostasis valve.
d. Intended Use
GDS-DC12 is intended to facilitate the intracardiac placement of interventional devices such as guidewires.
e. Comparison to Predicate Device
The GDS-DC12 catheter is substantially equivalent in intended use, fundamental technology, and design to the GDS-DC6 and the Enpath Deflectable Catheter. Each of the catheters is a polymeric, single lumen shaft that is advanced through the vasculature to reach a chamber within heart. Other interventional devices can be introduced through each of the catheters.
The GDS-DC12 catheter is substantially equivalent in physician use to the GDS-DC6 and the Enpath Deflectable Catheter. All the catheters are intended for use under fluoroscopic quidance by physicians trained in interventional cardiology procedures. The GDS-DC12 and the GDS-DC6 contain barium sulfate filled tubing for radiopacity.
1
ﻟﺴﺎ
f. Summary of Supporting Data
The clearance of this device was based in part on the evaluation of the following performance characteristics:
- . Dimensional measurements (OD, ID, Lengths)
- Torsional Response �
- Pull Wire Movement ♥
- Corrosion Resistance ●
- Shaft to Hub Tensile .
- . Shaft Tensile
- . Pull Wire Tension
- . Tip Tensile
- Torque Test .
- Shaft Leak Under Pressure .
- Shaft Leak Under Vacuum �
- . Catheter Flexibility/ Kink Resistance
- Catheter Turns To Failure .
- . Radiopacity (leveraged from GDS-DC6 K091367)
- Biocompatibility .
Predicate information is provided in appendix A.
Bench testing data (appendix B) has demonstrated that the device is in compliance with design input requirements, the expectations of the medical community and the product labeling.
Sterilization, packaging and shelf life testing (appendix C) demonstrates that the device is sterile, the packaging is robust and that it maintains a sterile barrier for the stated expiration time.
Biocompatibility data (appendix D) demonstrates that the device is biocompatible and in compliance with ISO 10993.
g. Conclusion
The GDS-DC12 is substantially equivalent in intended use, technology, design and materials to the predicate devices. The testing described above 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling a stylized human figure or a bird in flight, composed of flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Guided Delivery Systems, Inc c/o Ms. Bonnie McInerney Manager, Regulatory & Quality 2355 Calle de Luna Santa Clara, CA 95054
APR 1 6 2010
Re: K100135
Trade/Device Name: GDS-DC 12 Catheter Common Name: Catheter, Introducer Regulation Number: 21 CFR §870.1340 Regulatory Class: II Product Code: DOY Dated: January 14, 2010 Received: January 19, 2010
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. 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.
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
3
Page 2 - Ms. Bonnie McInerney
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 (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.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
una D. lohner
Image /page/3/Picture/7 description: The image shows a signature. The signature is illegible, but it appears to be written in cursive. The signature is on a white background. The signature is likely from a document or form.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number K0100135 Device Name: GDS-DC12
Indications for Use:
GDS-DC12 is intended to facilitate the intracardiac placement of interventional devices such as guidewires.
Prescription Use X (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 __ ______________________________________________________________________________________________________________________________________________________________
R. Palmer
ivision of Cardiovascular Devices
510(k) Number_K100135