The Boston Scientific ACUITY™ Universal Cutter is intended to be used with Guidant or Boston Scientific cuttable families of guiding catheters, and is intended to facilitate guiding catheter removal after the Guidant or Boston Scientific coronary venous lead is positioned.

Device Description

The Cutter is an accessory manufactured for use with cuttable guiding catheters, to facilitate removal of the catheter following lead placement. 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. The Cutter consists of three sections: a molded plastic handle, a stainless steel blade and a lead management section. The lead management section secures and stabilizes the lead prior to and during the cutting procedure. After the lead has been positioned 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 implanter pulls the catheter against the cutter blade. The hub is cut first, followed by the catheter section.

AI/ML Overview

The provided text is a 510(k) submission for the ACUITY™ Universal Cutter, which is a medical device. This document does not describe a study that involves an AI algorithm or performance metrics like accuracy, sensitivity, or specificity commonly associated with AI models. Instead, it focuses on demonstrating substantial equivalence to a predicate device for regulatory approval.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to this type of medical device submission.

Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format, nor does it provide specific quantitative performance metrics. Instead, it states:

Acceptance Criteria (Implied)	Reported Device Performance
The Universal Cutter meets acceptance criteria	Testing demonstrates that the Universal Cutter meets the acceptance criteria.
Performs similarly to the predicate device	The Universal Cutter performs similarly to the predicate device.
No new safety or effectiveness issues raised during testing program	No new safety or effectiveness issues were raised during the testing program.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "testing" without detailing the specific methodology or dataset size.

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

Not applicable. The device is a mechanical cutter, and its performance evaluation would typically involve functional testing (e.g., cutting efficacy, durability) rather than expert-established ground truth on medical images or diagnoses.

4. Adjudication method for the test set

Not applicable. No expert adjudication method is mentioned or implied for the performance testing of this mechanical 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

Not applicable. This is not an AI-assisted device, and therefore, no MRMC study or AI-related effect size data would be present.

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

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

7. The type of ground truth used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) does not directly apply here. For this device, the "ground truth" for its performance would be its ability to effectively and safely cut the guiding catheter as intended. This would be established through engineering and performance testing rather than clinical diagnostic ground truth.

8. The sample size for the training set

Not applicable. As a mechanical device, there is no "training set" in the context of machine learning.

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

Not applicable. There is no training set for this mechanical device.

Summary

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ACUITY™ Universal Cutter 510(k) Submission Attachment D

510(K) SUMMARY

MAR 2 0 2008

Submitter:	Boston Scientific Corporation
	Cardiac Rhythm Management (CRM)
	4100 Hamline Avenue North
	St. Paul, Minnesota 55112-5498
Contact:	Kathleen Vittum
	Regulatory Affairs Specialist
Telephone:	(800) 227-3422 or direct (651) 582-4820
FAX:	(612) 582-5134
Email:	kathleen.vittum@bsci.com
Date of Summary:	January 17, 2008
Trade Name:	ACUITY™ Universal Cutter
Common Name:	Cutter
Classification Name:	Catheter Guide Wire, (21 CFR 870.1250, Product Code DQY)
Predicate	RAPIDOTM Cut-Away™ Cutter (K031459, cleared 07/23/2003)

1. Device Trade Name ACUITY™ Universal Cutter
1. Device Common Name

Cutter

3. Device Description

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ACUITY™ Universal Cutter 510(k) Submission Attachment D

4. Intended Use

The Universal Cutter is intended to be used with Guidant or Boston Scientific cuttable families of guiding catheters, and is intended to facilitate guiding catheter removal after the Guidant or Boston Scientific coronary venous lead is positioned.

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5. Technological Characteristics

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

6. Performance Data

· Testing demonstrates that the Universal Cutter meets the acceptance criteria and performs similarly to the predicate device. No new safety or effectiveness issues were raised during the testing program. The Universal Cutter may be considered substantially equivalent to the predicate device.

7. Conclusion

Boston Scientific's ACUITY™ Universal Cutter is substantially equivalent to the currently marketed Guidant RAPIDO Cut-Away Cutter (K031459, cleared 07/23/2003) with regard to intended use and design.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2008

Boston Scientific Corporation c/o Ms. Kathleen Vittum Cardiac Rhythm Management (CRM) 4100 Hamline Avenue North St. Paul, MN 55112-5798

Re: K080154

Trade/Device Name: Acuity™ Universal Cutter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: March 4, 2008 Received: March 5, 2008

Dear Ms. Vittum:

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. Kathleen Vittum

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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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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Special 510(k) - ACUITY Universal Cutter Attachment B

INDICATION FOR USE STATEMENT

510(k) Number (if known):	K080154
Device Name:	ACUITY™ Universal Cutter
Indications For Use:	The Boston Scientific ACUITY™ Universal Cutter is intended to be used with Guidant or Boston Scientific cuttable families of guiding catheters, and is intended to facilitate guiding catheter removal after the Guidant or Boston Scientific coronary venous lead is positioned..
Prescription Use:	X	AND/OR	Over-The-Counter Use:
(Part 21 CFR 801 Subpart D)			(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Cardiovascular Devices

K080154 510(k) Number

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).