The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

Device Description

The Modified HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance of an occlusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. A luer hub on the proximal end allows attachments for flushing, insertion of catheters and aspiration. A rotating hemostatic valve with side-arm adapter is provided with each catheter for flushing, catheter insertion and aspiration. Modified HD Guide Catheter dimensions are indicated on product label. The Modified HD Guide catheter family is being extended to include a 6.3 F size.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Modified HD Guide Catheter." It describes the device, its intended use, a summary of testing, and the FDA's substantial equivalence determination.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test Performed)	Reported Device Performance
Kink resistance	Performs as designed
Flow rate	Performs as designed
Coating lubricity	Performs as designed
Leak resistance	Performs as designed
Tensile strength	Performs as designed
Flexibility	Performs as designed

Explanation: The document states that "The same performance standards, test methods and specifications were applied as those previously submitted in the predicate HD Guide Catheter 510(k) submissions." It then lists the specific tests. The general finding for all these tests is that the device "demonstrate[s] that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device." While specific numerical performance values for acceptance criteria are not provided in this summary, the statement implies that the Modified HD Guide Catheter met the established performance standards of its predicate device for each of these tests.

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

Sample Size: Not explicitly stated. The document mentions "verification and validation conducted on the Modified HD Guide Catheter" and that "The same performance standards, test methods and specifications were applied as those previously submitted in the predicate HD Guide Catheter 510(k) submissions." Without more detail on those predicate submissions, the exact sample sizes for each test listed (kink resistance, flow rate, etc.) are unknown.
Data Provenance: Not explicitly stated. This is a medical device submission, so it's likely internal company testing data. There is no mention of country of origin of data, nor whether it was retrospective or prospective in this 510(k) summary.

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

This is a physical medical device (catheter), not an AI or diagnostic imaging device. Therefore, the concept of "ground truth" established by human experts in the context of diagnostic interpretation or classification does not apply. The "ground truth" for this device would be established by engineering specifications and physical test methods.

4. Adjudication method for the test set:

Not applicable, as this is a physical medical device and not related to interpretive diagnostic tasks requiring adjudication.

5. 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. This document is for a physical medical catheter, not an AI or diagnostic imaging device that involves human readers.

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

Not applicable. This is not an AI algorithm. The performance described relates to the physical characteristics of the catheter itself.

7. The type of ground truth used:

The "ground truth" for this device is based on engineering specifications and established test methods for medical catheters. For example, "kink resistance" would have a defined standard or threshold that the catheter must meet, which is determined by physical testing rather than human expert opinion on an image or medical case.

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set.

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

Not applicable, as there is no training set for a physical medical device like this catheter.

Summary

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<110483

510(k) Summary

Name of Device:	Trade Name:Modified HD Guide CatheterCommon Name:Percutaneous CatheterClassification Name:Percutaneous Catheter, 21CFR 870.1250 – Class II	Trade Name:	Modified HD Guide Catheter	Common Name:	Percutaneous Catheter	Classification Name:	Percutaneous Catheter, 21CFR 870.1250 – Class II
Trade Name:	Modified HD Guide Catheter
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter, 21CFR 870.1250 – Class II
Submitter	Concentric ® Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 650-938-2100Fax 650-237-5230Facility Registration #2954917
	Contact: Kirsten Valley
Predicate Device	HD Guide Catheter (K090335)
Date	March 23, 2011

Device Description

Intended Use

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Technological Characteristics

The Modified HD Guide Catheter has the same technological characteristics as the K080583 and K090335 predicate devices. The device design, materials used, function, physical properties and composition have not been changed.

Testing Summary

The results of verification and validation conducted on the Modified HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. The same performance standards, test methods and specifications were applied as those previously submitted in the predicate HD Guide Catheter 510(k) submissions. Specifically, kink resistance, flow rate, coating lubricity, leak resistance, tensile strength and flexibility testing were performed.

Summary of Substantial Equivalence

The Modified HD Guide Catheter is substantially equivalent to the predicate device with regard to device design, intended use, and patient population. The results of verification and validation conducted on the Modified HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The caduceus is rendered in black, and the text is also in black.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Concentric Medical c/o Ms. Kirsten Valley Senior Vice President, Technology and Regulatory Affairs 301 East Evelyn Avenue Mountain View, CA 94041

APR - 4 2011

Re: K110483

Trade/Device Name: Modified HD Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 23, 2011 Received: March 24, 2011

Dear Ms. Valley:

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. Kirsten Valley

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 (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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Dummer D. Viener

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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Statement of Indications for Use

	INDICATIONS FOR USE
510(k) Number (if known):	This application K110483
Device Name:	Modified HD Guide Catheter
Indications for Use:	The Modified HD Guide Catheter is indicated foruse in facilitating the insertion and guidance ofan occlusion catheter, infusion catheter orother appropriate microcatheter into a selectedblood vessel in the peripheral, coronary andneuro vascular systems. It may also be used as adiagnostic angiographic catheter.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. W. Wiem

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_KILO:483

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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).