The RAPIDO™ Cut-Away™ Cutter is intended to facilitate RAPIDO™ Cut- Away™ Guiding Catheter removal after the Guidant coronary venous lead is positioned.

Device Description

The Cutter is an accessory manufactured for use with the RAPIDO Cut-Away Guiding Catheter, for the treatment of Congestive Heart Failure. The Cutter attaches to the lead and cuts one wall of the guiding catheter as it is removed from the patient, allowing the guiding catheter to be removed from the lead. This new removal process is necessitated by the larger IS-1 terminal pin that future leads will incorporate. The Cutter currently has only one manufacturing configuration.

The Cutter consists of three sections; A handle, a stainless steel blade and a lead management section. The lead management section stabilizes the lead, prior to, and during the cutting procedure. After the lead has been fixed in the patient, the cutter is connected to the lead body as close to the catheter hub as possible. Holding the cutter stationary and fixed to a surface, the doctor pulls the catheter against the cutter blade. The hub is cut first and then the catheter section.

AI/ML Overview

The provided text describes a medical device, the RAPIDO™ Cut-Away™ Cutter, and its clearance through the 510(k) pathway. This means it was found substantially equivalent to a predicate device, not necessarily that a full clinical study demonstrating its effectiveness against specific acceptance criteria was conducted or described in detail in this summary.

Based on the provided information, I can extract what is explicitly stated or can be reasonably inferred. Many of your requested details (e.g., sample size for the test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not typically part of a 510(k) summary for a device like this (a mechanical cutter) and are not included in the provided text. The performance data section is brief and refers to "acceptance criteria" but does not detail them.

Here's a breakdown of what can be provided from the text, with an acknowledgment of the missing information for other sections:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Ability to cut the guiding catheter after lead implantation	"Testing demonstrated that the RAPIDO Cut-Away Cutters met the acceptance criteria and performed similarly to the predicate device."
No new safety issues	"No new safety or effectiveness issues were raised during the testing program."
No new effectiveness issues	"No new safety or effectiveness issues were raised during the testing program."
Substantial equivalence to predicate device (Medtronic Attain Cutter) in design and intended use	"The Guidant RAPIDO Cut-Away Cutters are substantially equivalent to the currently marketed Medtronic Attain Cutters (K024035, cleared 12/30/02) with regards to intended use and design."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified. It's highly likely to be internal engineering/bench testing rather than human clinical data, given the device type and 510(k) summary context.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable/not specified. This type of device's performance evaluation typically relies on objective physical testing rather than expert-established ground truth in a diagnostic sense.
Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC study was almost certainly not done. This type of study is relevant for diagnostic imaging or interpretation tasks, not for a mechanical cutter.

6. If a Standalone (Algorithm Only) Performance Study was done

Standalone Study: Not applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For this mechanical device, "ground truth" would likely be defined by engineering specifications and objective measurements (e.g., successful cutting, intact lead after cutting, material integrity, force required). The summary states "Testing demonstrated that the RAPIDO Cut-Away Cutters met the acceptance criteria," implying these objective measures were successfully achieved.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not specified. This is a mechanical device, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

How Ground Truth was Established: Not applicable.

Summary

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K 03)459

JUL 2 3 2003

510(K) Summary

1. Device Trade Name RAPIDOTM Cut-Away™ Cutter

2. Device Common Name Cutter

3. Device Description

4. Intended Use

The RAPIDO Cut-Away Cutter is intended to assist with the removal of the RAPIDO Cut-Away Guiding Catheter that is used to access the coronary venous system. The cutter cuts the guiding catheter after lead implantation.

5. Technological Characteristics

Comparisons of the RAPIDO Cut-Away Cutters and predicate devices show that the technological characteristics such as design and intended use are substantially equivalent to the currently marketed predicate device (Medtronic Attain Cutter).

6. Performance Data

Testing demonstrated that the RAPIDO Cut-Away Cutters 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 Cutter may be considered substantially equivalent to the predicate device.

7. Conclusion

The Guidant RAPIDO Cut-Away Cutters are substantially equivalent to the currently marketed Medtronic Attain Cutters (K024035, cleared 12/30/02) with regards to intended use and design.

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or ribbons, which are arranged in a way that suggests movement or flow. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2003

Guidant Corporation Cardiac Rhythm Management c/o Mr. Shah Hilali Senior Regulatory Affairs Associate 4100 Hamline Avenue North St. Paul, MN 55112-5798

Re: K031459

Trade Name: RAPIDOTM Cut-Away™ Cutter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 7, 2003 Received: May 8, 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 - 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 yours,

N. Quattlebaum, MD

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 STATEMENT

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

510(k) Number (if known): To be assigned by FDA (そのるハイラリ

Device Names: RAPIDO™ Cut-Away™ Cutter

Intended Use/Indications for Use:

The RAPIDO™ Cut-Away™ Cutter is intended to facilitate RAPIDO™ Cut- Away™ Guiding Catheter removal after the Guidant coronary venous lead is positioned.

(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)

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

DeaTTM

510(k) Number K031459

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).