The Concentric Balloon Guide Catheter is indicated for use in facilitating and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

Device Description

The Concentric Balloon Guide Catheter device, cleared under K010954, is a 9F coaxial lumen braided shaft, variable stiffness catheter with a radiopaque marker on the distal end. The balloon is flush mounted on the distal end of the catheter. The inner diameter of the balloon guide catheter is 0.085". The maximum inflation diameter is 10 mm, and the maximum inflation length is 10 mm.

The design of the modified Concentric Balloon Guide Catheter differs in dimension and includes a new material, Cristamid. All other characteristics remain the same as compared to the original device. The outer and inner diameters have been downsized to 7F and 0.059" respectively. Biocompatibility of Cristamid has been established and results provided in the Concentric HD Guide Catheter Premarket Notification (K003880).

AI/ML Overview

The Concentric Balloon Guide Catheter (7F) is being submitted for a Special 510(k) Premarket Notification. The device is a modified version of the previously cleared Concentric Balloon Guide Catheter (9F, K010954). The primary modifications include a reduction in outer and inner diameters (7F and 0.059" respectively) and the introduction of a new material, Cristamid.

The submission focuses on establishing substantial equivalence to the predicate device (Concentric 9F Balloon Guide Catheter, K010954) rather than demonstrating performance against specific qualitative acceptance criteria. Therefore, the information provided does not contain a typical table of acceptance criteria and reported device performance in the manner usually associated with a new device's performance claims (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" can be interpreted as the requirement to demonstrate substantial equivalence through performance testing, and the "study" is this performance testing itself.

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

Since this is a Special 510(k) based on substantial equivalence to a predicate device, specific quantitative acceptance criteria for clinical performance (like sensitivity or specificity) are not provided in the document. The "acceptance criteria" here is that the modified device performs "as designed" and is "suitable for its intended use" when compared to the predicate through performance testing.

Acceptance Criteria (Implied)	Reported Device Performance
Device performs as designed	Performance testing verified the device performs as designed.
Suitable for intended use	Performance testing verified the device is suitable for its intended use.
Substantially Equivalent to Predicate	The Concentric 7F Balloon Guide Catheter is substantially equivalent to the Concentric 9F Balloon Guide Catheter (K010954) with regards to device design, intended use, patient population, and anatomical site.

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

The document states "Performance testing has been conducted," but it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). This typically refers to bench testing rather than clinical data for this type of submission.

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)

This information is not applicable and not provided in the document. For a medical device like a catheter, "ground truth" as it relates to expert review of diagnostic output is not relevant. The "ground truth" for this device would be its mechanical and material properties meeting engineering specifications and its functional performance in a simulated environment replicating its intended use.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or image review settings to establish a consensus ground truth, which is not relevant for the type of performance testing indicated for this device.

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

This information is not applicable and not provided. The device is a physical medical instrument (a catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with or without AI assistance is irrelevant.

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

This information is not applicable and not provided. The device is a physical medical instrument and does not involve an algorithm operating in a standalone mode.

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

The "ground truth" for this type of device modification would be based on:

Engineering specifications and test standards: The device's physical dimensions, material properties (e.g., biocompatibility of Cristamid as established in K003880), mechanical strength, inflation characteristics, and guidability would be tested against established engineering parameters and predicate device performance.
Functional performance: Testing would likely involve bench models simulating vascular systems to evaluate aspects like ease of guidance, occlusion capabilities, and catheter navigation.

The document states "Performance testing has been conducted and the results of the testing verified that the Concentric Balloon Guide Catheter performs as designed and is suitable for its intended use." This implies the ground truth was based on these types of objective engineering and functional evaluations.

8. The sample size for the training set

This information is not applicable and not provided. The device is a physical medical instrument, not a machine learning or AI model that requires a training set.

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

This information is not applicable and not provided. As the device is not an AI/ML model, there is no training set for which ground truth would be established.

Summary

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Concentric Balloon Guide Catheter

Special 510k Premarket Notification

5 510(k) Summary

This summary of the 510(k) premarket notification for the Concentric Balloon Guide Catheter is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

5.1 Manufacturer

Concentric Medical Inc. 2585 Leghorn Street Mountain View, CA. 94043 Telephone: (650) 938-2100 Registration #: 2954917

Contact Person 5.2 Kevin MacDonald Vice President, Clinical and Regulatory Affairs
5.3 Date Prepared June 7, 2002
Classification 5.4 Percutaneous Catheter, 21CFR 870.1250 - Class II Balloon Type Catheter, 21CFR 878.4200 - Class II
ર્સ્ડ Trade Name Concentric Balloon Guide Catheter

5.6 Generic/Common Name Percutaneous Catheter or Balloon Type Catheter

5.7 Predicate Devices

Concentric Balloon Guide Catheter (K010954)

5.8 Intended Use

5.9 Product Description

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5.10 Substantial Equivalence

The Concentric 7F Balloon Guide Catheter is intended for use in interventional radiological procedures. The Concentric 7F Balloon Guide Catheter is equivalent to the Concentric 9FBalloon Guide Catheter (K010954). The Concentric 7F Balloon Guide Catheter is substantially equivalent to the predicate device with regards to device design, intended use, patient population and anatomical site.

5.11 Testing in Support of Substantial Equivalence

Performance testing has been conducted and the results of the testing verified that the Concentric Balloon Guide Catheter performs as designed and is suitable for its intended use.

5.12 Conclusion

As contained in this 510(k) summary, the Concentric Balloon Guide Catheter is substantially equivalent to the predicate devices identified in regards to device design, intended use, patient population and anatomical site.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, representing the department's focus on health and human well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 2002

Concentric Medical, Inc. c/o Mr. Kevin MacDonald Vice President, Clinical and Regulatory Affairs 2585 Leghorn Street Mountain View, CA 94043

Re: K021899

Trade Name: Concentric Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: June 7, 2002 Received: June 10, 2002

Dear Mr. Mac Donald:

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 such 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 - Mr. Kevin MacDonald

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Donna-Bea Tillman, Ph.D. Acting 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 4

INDICATIONS FOR USE

KOZI899

510(k) Number (if known):

Device Name: Concentric Balloon Guide Catheter

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

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

N.Q. Tel

(Division Sign-Off)

Division of Cardiovascular
and Respiratory Devices
510(k) Number: KD21899

Confidential

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).