The 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 or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

Device Description

The HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coaling to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "HD Guide Catheter." This document describes the device and claims substantial equivalence to a predicate device, rather than providing detailed performance studies with acceptance criteria in the manner of an AI/ML device validation.

Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission for this specific device. The device is a physical, mechanical catheter, not a software or AI-based diagnostic tool that would typically have acceptance criteria presented in terms of sensitivity, specificity, or human performance metrics.

Here's a breakdown based on the provided text:

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

Acceptance Criteria (Anticipated - Not Explicitly Stated in Document)	Reported Device Performance (Implied from "Testing Summary")
Device performs as designed (e.g., proper dimensions, material integrity, steerability, lubricity)	"The results of verification and validation conducted on the HD Guide Catheter demonstrate that it performs as designed..."
Suitable for intended use (facilitating insertion/guidance of other catheters, diagnostic angiography)	"...is suitable for its intended use..."
Substantially equivalent to predicate device (K080583) without new safety/effectiveness issues	"...and is substantially equivalent to the predicate device."

Explanation: The document does not list specific numerical acceptance criteria (e.g., bend radius, tensile strength values) or corresponding performance metrics. Instead, it makes a general statement that "The results of verification and validation conducted on the HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device." This is typical for a 510(k) summary for a Class II medical device, where detailed test reports are submitted to the FDA but not necessarily included in the public-facing summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document states "Testing Summary" and "results of verification and validation," implying laboratory or bench testing, but no human subject or clinical study details are provided.
Data Provenance: Not applicable, as this refers to a physical device's characteristics, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical catheter, not a diagnostic or AI-driven interpretative tool that requires expert-established ground truth. Validation would involve engineering and materials testing by qualified personnel, not medical experts establishing a "ground truth" for diagnostic accuracy.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, which are not described for this device's validation.

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 is not an AI-assisted diagnostic device.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable. The "ground truth" for a physical device like this would be its engineering specifications, material properties, and performance under simulated use conditions.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/ML model.

Summary

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6 2009

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

General Information

Trade Name	HD Guide Catheter
Common Name	Percutaneous Catheter
Classification	Percutaneous Catheter, 21CFR 870.1250 – Class II
Submitter	Concentric® Medical, Inc.
	301 E. Evelyn Avenue
	Mountain View, CA 94041
	Tel 650-938-2100
	Fax 650-938-2700
Contact	Laraine Pangelina
	Director, Regulatory Affairs

Intended Use

Predicate Device

HD Guide Catheter, K080583

Device Description

Materials

All materials used in the manufacture of the HD Guide Catheter are suitable for the intended use of the device and have been used in numerous previously cleared products,

Testing Summary

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

Summary of Substantial Equivalence

The HD Guide Catheter is substantially equivalent to the predicate device with regard to device design, intended use, patient population and anatomical site. Any differences in technological characteristics between the HD Guide Catheter and the predicate device do not raise any new issues of safety or effectiveness.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular and contains an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are written around the eagle in a circular fashion.

Public Health Service

MAY - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Concentric Medical c/o Ms. Laraine Pangalina Director, Regulatory Affairs 301 East Evelyn Avenue Mountain View, CA 94041

Re: K090335

Trade/Device Name: Concentric HD Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 16, 2009 Received: April 20, 2009

Dear Ms. Pangalina:

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.

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

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Page 2 - Ms. Laraine Pangalina

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

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

510(k) Number (if known):	This application
Device Name:	HD Guide Catheter
Indications for Use:	The 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 or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of GDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)	5/5/09
Division of Cardiovascular Devices
510(k) Number	K090335

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).