The Guidant Guiding Catheter is intended to access the coronary venous system, and may be used as a dual-catheter assembly. The catheter serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.

Device Description

The RAPIDO Guiding Catheters are available in two French sizes (6F and 8F). The 6F RAPIDO Guiding Catheter has a standard working length of 69 cm. The 8F RAPIDO Guiding Catheter has as standard working length of 47 cm.

AI/ML Overview

The provided text is a 510(k) summary for the RAPIDO™ Guiding Catheter. This type of regulatory document focuses on establishing substantial equivalence to a predicate device based on technological characteristics and performance data. It does not contain the kind of detailed information requested about clinical study design, specific acceptance criteria for performance metrics, ground truth establishment, or human-AI interaction studies.

Therefore, for many of your questions, the answer will be that the information is not provided in the given text.

Here's a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria: Not explicitly stated in the provided text. The summary only says "Testing demonstrated that the 6F/8F RAPIDO Guiding Catheters met the acceptance criteria." The specific criteria (e.g., burst pressure, tensile strength, flow rate thresholds) are not listed.
Reported Device Performance: Not explicitly stated in quantitative terms. The summary says "performed similarly to the predicate device (EASYTRAK Guiding Catheter)." No numerical performance metrics are given.

Acceptance Criteria	Reported Device Performance
Not specified	Performed similarly to predicate device

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.
Data Provenance: Not specified, but likely refers to bench testing data rather than patient data given the device type and 510(k) context.

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 guiding catheter, not an AI diagnostic tool that relies on expert interpretation for ground truth in a clinical study. The performance data would generally come from engineering bench tests (e.g., mechanical, material, fluid dynamics).

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

Not applicable. As above, this concept applies to studies where human interpreters (or AI outputs) are being adjudicated, not to physical device performance testing.

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

No. This is not an AI diagnostic device. No MRMC study or human-in-the-loop AI performance evaluation would have been conducted or reported for this type of medical device.

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

No. This is not an AI algorithm. Its performance is evaluated through physical and mechanical testing, not as an algorithm.

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

Not applicable/Not specified in this context. For a medical device like a catheter, "ground truth" refers to established engineering standards, material specifications, and validated test methods (e.g., for burst pressure, flexibility, lubricity). The 510(k) summary does not detail these specific "ground truths."

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 above, this is not an AI device.

Summary

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Koa14ss

510(K) Summary

1. Device Trade Name

6F RAPIDO™ Guiding Catheter 8F RAPIDO™ Guiding Catheter

2. Device Common Name

Percutaneous Catheter

3. Device Description

4. Intended Use

5. Technological Characteristics

Comparisons of the 6F/8F RAPIDO Guiding Catheters and predicate devices show that the technological characteristics such as product performance, design, and intended use are substantially equivalent to the currently marketed predicate devices.

6. Performance Data

Testing demonstrated that the 6F/8F RAPIDO Guiding Catheters met the acceptance criteria and performed similarly to the predicate device (EASYTRAK Guiding Catheter). No new safety or effectiveness issues were raised during the testing program. The 6F/8F RAPIDO Guiding Catheter may be considered substantially equivalent to the predicate device.

7. Conclusion

The Guidant 6F/8F RAPIDO Guiding Catheters are substantially equivalent to the currently marketed EASYTRAK Guiding Catheter (K021284, May 2, 2002) with regards to intended use and design.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 2 2002

Guidant Corporation c/o Ms. Karen S. Alsop Principal Regulatory Affairs Associate Cardiac Rhythm Management 4100 Hamline Avenue North St. Paul, MN 55112-5798

Re: K021455

Trade Name: RAPIDO™ Guiding Catheters, 6F and 8F Regulation Number: 21 CFR.870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 3, 2002 Received: May 6, 2002

Dear Ms. Alsop:

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 - Ms. Karen S. Alsop

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 you 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 your 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,

N. Dale Till

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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INDICATIONS FOR USE STATEMENT

Applicant: Guidant Corporation 4100 Hamline Avenue North St. Paul, MN 55112

510(k) Number (if known): To be assigned by FDA

Device Names: RAPIDO™ Guiding Catheter, 6F and 8F

Intended Use/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
X
(Per 21 CFR 801.109)

Over-The-Counter _ (Optional Format 1-1-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021455

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).