It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results of a novel AI/software medical device. As such, information regarding AI-specific studies (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies) will not be present. The studies mentioned are primarily bench testing, biocompatibility, and packaging/shelf-life.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a format typical for software or AI medical devices. Instead, it refers to compliance with general standards and expectations for a cardiac introducer sheath.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	In compliance with ISO 10993.
Bench Testing	In compliance with ISO 10555-1. Meets expectations of the medical community and product labeling.
Packaging & Shelf Life	Packaging is robust and maintains a sterile barrier for the stated expiration time.
Intended Use	Facilitates intracardiac placement of interventional devices such as guidewires.

Study Details (Based on available information)

1. A table of acceptance criteria and the reported device performance:
See table above.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified. The studies mentioned are "Bench testing," "Biocompatibility data," and "Packaging and shelf life testing." These are not typically described with a "test set" in the context of diagnostic performance or AI validation, but rather as tests performed on a defined number of device units or materials.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). These are laboratory/bench studies, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. For bench testing and biocompatibility, ground truth is established by standardized testing methods and regulatory standards (e.g., ISO), not by expert consensus on clinical cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not specified. Adjudication methods are relevant for subjective interpretations, typically in clinical imaging or diagnostic studies. The reported studies are objective laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a physical medical device (cardiac introducer sheath), not an AI/software device whose performance would be measured in an MRMC study comparing human readers with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a physical medical device and does not involve an algorithm with standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Biocompatibility: Ground truth is defined by the requirements of ISO 10993 (e.g., cytotoxicity, sensitization, irritation).
Bench Testing: Ground truth is defined by the requirements of ISO 10555-1 (e.g., tensile strength, burst pressure, flow rate, torqueability) and general engineering/medical device performance expectations.
Packaging and Shelf Life: Ground truth is defined by sterility maintenance, package integrity, and material degradation over time.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable. As noted above, there is no training set for this type of device.

Summary of Device Type and Study Context:

The GDS-DC6 is a physical medical device (a cardiac introducer sheath), not a software or AI-driven diagnostic device. Therefore, the types of studies and associated metrics (such as test set sample sizes, expert adjudication, MRMC studies, training data, ground truth for AI models) typically requested for AI-enabled devices are not applicable to the information provided in this 510(k) summary. The studies conducted are standard engineering, materials, and biological safety tests to demonstrate the safety and effectiveness of a physical product by showing substantial equivalence to existing predicate devices.

Summary

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KO91367

Section 5: 510(k) Summary

NOV – 5 7000

Device Information:

Category	Comments
Sponsor:	Guided Delivery Systems, Inc2355 Calle de LunaSanta Clara, CA 95054
Correspondent ContactInformation:	Bonnie McInerney, Quality ManagerGuided 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-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 870.1200Diagnostic intravascular catheter
	Predicate Device Classification &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 (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

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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

Regulation Number and Section

§ 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).