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.

AI/ML Overview

The provided text describes a GDS-DC12 Cardiac Introducer Sheath and its 510(k) premarket notification for FDA clearance, not an AI device. Therefore, the questions related to AI studies (sample size, experts, adjudication, MRMC, standalone performance, training set details) are not applicable.

However, I can extract the acceptance criteria and the summary of the study showing the device meets these criteria, which are primarily bench testing and biocompatibility assessments for a medical device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Characteristic)	Reported Device Performance (Summary)
Dimensional measurements (OD, ID, Lengths)	In compliance with design input requirements.
Torsional Response	In compliance with design input requirements.
Pull Wire Movement	In compliance with design input requirements.
Corrosion Resistance	In compliance with design input requirements.
Shaft to Hub Tensile	In compliance with design input requirements.
Shaft Tensile	In compliance with design input requirements.
Pull Wire Tension	In compliance with design input requirements.
Tip Tensile	In compliance with design input requirements.
Torque Test	In compliance with design input requirements.
Shaft Leak Under Pressure	In compliance with design input requirements.
Shaft Leak Under Vacuum	In compliance with design input requirements.
Catheter Flexibility/Kink Resistance	In compliance with design input requirements.
Catheter Turns To Failure	In compliance with design input requirements.
Radiopacity	Leveraged from predicate device GDS-DC6 (K091367).
Biocompatibility	Complies with ISO 10993.
Sterilization	Device is sterile.
Packaging	Packaging is robust and maintains a sterile barrier.
Shelf life	Maintains a sterile barrier for the stated expiration time.

Study Details:

Sample size used for the test set and the data provenance: Not explicitly stated for each test, but the studies were bench testing, sterilization/packaging/shelf life testing, and biocompatibility testing. This indicates the data provenance is from laboratory tests, not human data, and thus is prospective from a manufacturing/testing standpoint. The country of origin of the testing is not specified, but the sponsor is a US company (Guided Delivery Systems, Inc., Santa Clara, CA).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For engineering performance tests, ground truth is established by meeting predefined specifications and standards, not by expert consensus on observational data. Biocompatibility follows ISO 10993.
Adjudication method: Not applicable. Performance is measured against objective engineering specifications and international standards (e.g., ISO 10993 for biocompatibility), not through adjudication of expert opinions.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
The type of ground truth used:
- For performance characteristics: Engineering specifications/design input requirements and industry expectations/product labeling.
- For biocompatibility: ISO 10993 standards.
- For radiopacity: Leveraged from predicate device (K091367), indicating its ground truth was established during the predicate's clearance.
The sample size for the training set: Not applicable, as this is not an AI device.
How the ground truth for the training set was established: Not applicable, as this is not an AI device.

Summary

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APR 1 6 2010

a.	Device Information:
Category	Comments
Sponsor:	Guided Delivery Systems, Inc2355 Calle de LunaSanta Clara, CA 95054
Correspondent Contact Information:	Bonnie McInerney, Manager, Regulatory & QualityGuided Delivery Systems, Inc2355 Calle de LunaSanta Clara, CA 95054Tel: 408 727 1105 x227Fax: 408 727 6615Email: 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.

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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.

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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

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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

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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

Regulation Number and Section

§ 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).