The Guidant RAPIDO™ Cut- Away™ Guiding Catheter is intended to access the coronary venous system, and may be used as a dualcatheter 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 Cut-Away Guiding Catheter is similar to the approved RAPIDO Guiding Catheter. The Cut-Away Catheter is comprised of a flexible shaft, lucr (hub) and a soft tip. The catheter shaft is comprised of an inner liner of polytetrafluoroethylene (PTFE), an outer layer of radiopaque polyether block amide (PEBAX), with a reinforcing layer of 304V stainless steel braid sandwiched between the two. A blue PEBAX luer (sometimes referred to as a "hub") is attached to the proximal end of the shaft using a cyanoacrylate adhesive. A silicone coating is applied to the exterior of the shaft to improve device lubricity. The distal end of the catheter is formed into a variety of shapes as needed to access differing areas of the anatomy.

AI/ML Overview

The provided document describes a 510(k) summary for the RAPIDO™ Cut-Away™ Guiding Catheter. This type of regulatory submission establishes substantial equivalence to a predicate device, rather than providing detailed clinical study data with specific acceptance criteria as might be found for a novel device or one requiring a PMA.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment are not explicitly present in the provided text. The document focuses on demonstrating substantial equivalence through technological characteristics and performance testing in comparison to a predicate.

However, I can extract and infer some information based on the typical content of a 510(k) and the statements made.

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

Acceptance Criteria (Inferred)	Reported Device Performance
Substantial equivalence to predicate device (RAPIDO Guiding Catheter K021455) in design and intended use	"Testing demonstrated that the RAPIDO Cut-Away Guiding Catheters met the acceptance criteria and performed similarly to the predicate device."
No new safety or effectiveness issues	"No new safety or effectiveness issues were raised during the testing program."
Functional equivalence in serving as a conduit for delivery of contrast medium and devices to the coronary venous system	Performed similarly to the predicate device, which is indicated for this use.
Similar technological characteristics to predicate device	"Comparisons of the RAPIDO Cut-Away Guiding Catheters and predicate devices show that the technological characteristics such as design and intended use are substantially equivalent to the currently marketed predicate device."

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

Sample Size for Test Set: Not specified. The document mentions "testing" but does not provide details on the number of catheters or tests performed.
Data Provenance: Not explicitly stated, but typically, performance testing for 510(k) submissions is conducted by the manufacturer (Guidant Corporation) in a controlled laboratory environment. It is retrospective in the sense that the data is generated to demonstrate equivalence of a new design to an existing one. No information on country of origin of data (e.g., patient data) is relevant or provided, as this is a device performance test, not a clinical trial with human subjects.

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

This is not applicable/not provided. The "ground truth" for this type of device (a guiding catheter) is typically established through engineering specifications, material testing, and functional performance benchmarks rather than expert consensus on medical images or clinical outcomes. The performance is compared to the predicate device, not against an "expert ground truth" in a diagnostic sense.

4. Adjudication method for the test set

This is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where there might be disagreement in expert interpretation. For a medical device like a catheter, performance is assessed against engineering and functional specifications, not subjective interpretations 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

This is not applicable. The RAPIDO™ Cut-Away™ Guiding Catheter is not an AI-powered diagnostic device, nor is it a device that enhances human reader performance in interpreting medical cases. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.

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

This is not applicable. This is a physical medical device (catheter), not an algorithm or software.

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

The "ground truth" for this submission would be engineering specifications, material properties, and functional performance benchmarks that the predicate device (RAPIDO Guiding Catheter, K021455) was designed and cleared to meet. The new device is then tested to confirm it meets these same implicit standards.

8. The sample size for the training set

Not applicable/not provided. This is a physical medical device, not a machine learning algorithm, so there is no concept of a "training set" in this context.

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

Not applicable. As stated above, there is no training set for this device.

Summary

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K031505
page 1 of 1

510(K) Summary

1. Device Trade Name RAPIDOTM Cut-Away™ Guiding Catheter
1. Device Common Name Percutaneous Catheter

3. Device Description

4. Intended Use

The Guidant RAPIDO™ 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.

5. Technological Characteristics

Comparisons of the RAPIDO Cut-Away Guiding Catheters and predicate devices show that the technological characteristics such as design and intended use are substantially equivalent to the currently marketed predicate device.

6. Performance Data

Testing demonstrated that the RAPIDO Cut-Away Guiding Catheters met the acceptance criteria and performed similarly to the predicate device . No new safety or effectiveness issues were raised during the testing program. The RAPIDO Cut-Away Guiding Catheter may be considered substantially equivalent to the predicate device.

7. Conclusion

The Guidant RAPIDO Cut-Away Guiding Catheters are substantially equivalent to the currently marketed Guidant RAPIDO Guiding Catheter (K021455, cleared August 02, 2002) with regards to intended use and design.

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Image /page/1/Picture/11 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2003

Guidant Coporation Cardiac Rhythm Management c/o Mr. Shah M. Hilali Senior Regulatory Affairs Associate 4100 Hamline Avenue North St. Paul, MN 55112

Re: K031505

Trade Name:RAPIDO™ Cut-Away™ Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY Dated: May 14, 2003 Received: May 14, 2003

Dear Mr. Hilali:

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. Shah M. Hilali

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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

V
Bram D. Zuckerman, M.D.

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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K031505

Special 510(k) K031505

Manufacturer: GUIDANT Corporation

Device Name: RAPIDO™ Cut-Away™ Guiding Catheter

Indications for Use: The Guidant RAPIDO™ Cut- Away™ Guiding Catheter is intended to access the coronary venous system, and may be used as a dualcatheter 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.

Valentin

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K103505

Prescription Use Only

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).