The ACUITY™ Cut-Away™ Lead Delivery System is intended to access the coronary venous system and may be used alone (8F or 6F) or in a dual catheter delivery (8F and 6F). The system 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 ACUITY™ Cut-Away™ Guide Catheters are designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT) implantable venous leads in the cardiac vasculature.. The catheter shafts are comprised of an inner liner of polytetrafluoroethylene (PTFE), a reinforcing layer of 304V stainless steel braid, and an outer jacket of radiopaque bismuth subcarbonate-loaded polvether block amide (PEBAX). This construction creates a thin catheter wall that is pushable, steerable, and kink-resistant. The stiffness of the PEBAX jacket changes along the catheter from more stiffness proximally to less distally.

A radiopaque PEBAX tip is thermally attached to the distal end of the quide catheter shaft. This tip consists of a layer of tungsten loaded PEBAX co-extruded with an outer layer of bismuth subcarbonate-loaded PEBAX.

A PEBAX hub is attached to the proximal end of the shaft. One wing of the hub is used for the orientation of the curve shape relative to the hub.

The approximate working length of the catheter is 69-74 cm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ACUITY™ Cut-Away™ Guide Catheter. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information related to an AI/ML device or its performance.

Therefore, I cannot provide details on the acceptance criteria and study that proves an AI/ML device meets them, as the input document is for a medical device that is not an AI/ML device. The document primarily describes non-clinical testing for a physical medical catheter.

Based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various non-clinical tests performed, but it does not provide specific acceptance criteria values or detailed quantitative results for each test. It only states that testing was performed to "verify the performance and usability" and that the device "remains substantially equivalent" to predicate devices.

Acceptance Criteria (Implied by testing categories)	Reported Device Performance (Summary)
Hub Separation Performance	Verified (implicitly met performance/usability)
Hub Cutting Performance	Verified (implicitly met performance/usability)
Hub Internal Diameter Conformity	Verified (implicitly met performance/usability)
Particulates Presence	Verified (implicitly met performance/usability)
Biocompatibility	Verified (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity (Acute), Hemocompatibility, Latex, USP Physicochemical testing)
Usability of Multiple Catheter Shapes & Lengths	Verified (implicitly met performance/usability)
Compatibility with Accessories & Adjunctive Devices	Verified (implicitly met performance/usability)
Torquability	Verified (implicitly met performance/usability)
Pushability & Shaft Stiffness	Verified (implicitly met performance/usability)
Product Marking & Identification	Verified (implicitly met performance/usability)
Catheter Removal	Verified (implicitly met performance/usability)
Product Integrity	Verified (implicitly met performance/usability)
Radiopacity	Verified (implicitly met performance/usability)
Ease of Removal of Device & Accessories from Packaging	Verified (implicitly met performance/usability)
Animal Testing Performance	Performed to verify performance and usability

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

Test Set Sample Size: Not specified. The document only mentions "mechanical bench testing, and animal testing" but does not give the number of units or animals tested.
Data Provenance: Not applicable in the context of AI/ML data. The data provenance would be from laboratory bench tests and animal studies. No country of origin for such data is specified. The studies were likely prospective in nature (i.e., designed and executed to test the device).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This device is not an AI/ML device, so there is no notion of "ground truth" established by experts in the context of image interpretation or diagnostic accuracy. Performance was assessed through engineering and biological testing.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication method is mentioned as it's not relevant for this type of device and testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This is not an AI/ML device, and no MRMC study was performed. The document explicitly states: "Clinical Evaluation was not required for these devices."

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

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

Not applicable in the AI/ML sense. For this physical catheter, the "ground truth" for performance would be objective measurements against design specifications and established safety/performance standards (e.g., strength, durability, biocompatibility test results).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable.

Summary

{0}------------------------------------------------

KIII 252

JUN - 2 2011

510(k) Summary per 21 CFR §807.92

لر.

Sponsor:	Boston Scientific CorporationOne Boston Scientific PlaceNatick MA 01760
Contact Person:	Holly Ramirez
Phone Number:	763-494-2113
Fax Number:	763-494-2222
Prepared:	May 2, 2011
Trade Name:	ACUITY™ Cut-Away™ Guide Catheter
Common Name:	Percutaneous Guide Catheter
Classification:	II
Product Code:	DQY21 CFR 870.1250

ACUITY™ Break-Away™ Guide Catheters (K093969; March 05, 2010) Predicate Device: and RAPIDO Cut-Away Guiding Catheter (K031459, July 23, 2003).

Device Description:

A PEBAX hub is attached to the proximal end of the shaft. One wing of the hub is used for the orientation of the curve shape relative to the hub.

The approximate working length of the catheter is 69-74 cm.

Intended Use

The ACUITY™ Cut-Away™ catheters are intended to access the coronary venous system, and may be used in dual-catheter delivery. 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.

Substantial Equivalence

The ACUITY™ Cut-Away™ Guide Catheter design, materials, manufacturing process and intended use are substantially equivalent to the ACUITY™ Break-Away™ Guide Catheter (K093969) and the RAPIDO™ Cut-Away Guiding Catheter (K031459).

{1}------------------------------------------------

Summary of Non-Clinical Testing

Design verification and validation testing, including mechanical bench testing, and animal testing, was performed to verify the performance and usability of the ACUITY™ Cut-Away™ Guide Catheter remains substantially equivalent to both predicate devices. Biocompatibility, sterility, and packaging testing were also performed to verify the overall safety and efficacy of the device. Specifically the following design verification and validation testing was performed.

� Hub Separation
� Hub Cutting
� Hub Internal Diameter
� Particulates
� Biocompatibility Testing
- Cytotoxicity O
- Sensitization o
- Irritation Or Intracutaneous o Reactivity
- Systemic Toxicity (Acute) O
- Hemocompatibility o
- Latex 0
- USP Physicochemical O
� Usability Of Multiple Catheter Shapes And Lengths
111 252
� Compatibility With Accessories And Adjunctive Devices
Torquability �
� Pushability & Shaft Stiffness
� Product Marking And Identification
� Catheter Removal
Product Integrity �
Radiopacity �
� Ease Of Removal Of Device And Accessories From Packaging

Summary of Clinical Testing

Clinical Evaluation was not required for these devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Boston Scientific Corporation c/o Ms. Holly Ramirez Regulatory Affairs Specialist One Boston Scientific Place Natick, MA 01760

JUN - 2 2011

Re: K111252

Trade/Device Name: ACUITYTM Cut-Away™ Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 2, 2011 Received: May 3, 2011

Dear Ms. Ramirez:

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 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.

{3}------------------------------------------------

Page 2 - Ms. Holly Ramirez

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M. A. Willian

Sam D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): KI||252

Device Name: ACUITY™ Cut-Away™ Guide Catheter

Indications For Use:

Prescription Use __X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

.g.killem

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ K 11 | 25 Z

Page 1 of 1

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).