The ACUITY™ Pro Lead Delivery System is intended to access the coronary venous system, and may be used alone (9F) or in a dual catheter delivery (9F with 7F). 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 ACUITY™ Pro Lead Delivery System is 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 a PTFE inner liner, a reinforcing layer of stainless steel braid, and an outer polymer jacket. The distal end has a radiopaque polymer tip, while the proximal end has a hub with flush luer fitting to allow flush, contrast injection and aspiration polymer.

The approximate working lengths of the catheters are 45-54cm for the 9F design and 60-69 cm for the 7F design.

The ACUITY Pro 9F is provided with the following accessories: 0.014 inch guidewire torquer, 0.014 inch guidewire introducer, ACUITY™ Universal Cutter, two transvalve introducer tools, and a venous access dilator

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the ACUITY™ Pro Lead Delivery System. This type of document is for a medical device, not an AI model or software. Therefore, the questions related to AI/algorithm performance (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance) are not applicable.

The document discusses the substantial equivalence of the ACUITY™ Pro Lead Delivery System to a previously cleared predicate device (K132914). The key change in the new device is a modified hub seal design and material. The "acceptance criteria" here refers to demonstrating that this modified device performs as safely and effectively as the predicate device for its intended use.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct "table of acceptance criteria" with specific numerical thresholds, but rather lists the types of performance tests conducted and concludes that the device continues to meet specifications and user requirements. The reported performance is that the device "continues to meet the specification requirements impacted by the design change as well as meet the new product specification requirement for air aspiration" and that "no new safety or performance issues were raised."

Acceptance Criteria Category	Tests Performed	Reported Device Performance
Functional/Performance	- Ancillary Device Passage through Valve - 7F Catheter Passage through 9F Valve - Hub Valve Hemostasis/Static Leak - Air Aspiration	Met specification requirements for design changes and new air aspiration requirement. No new safety/performance issues raised.
Usability	- Catheter provides a conduit/back-up support for other devices to pass - Catheter is able to be removed by cutting	Continues to meet all user requirements.
Biocompatibility/Chemical Safety	- Volatile/Semi-volatile organic compounds observed by GC-MS - Non-volatile organic compounds observed by LC-MS	Extractable species in modified hub seal material and process do not pose an increased chemical safety risk when compared to predicate seal material.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the summary. The testing described is bench testing, which typically involves a certain number of devices or components. The document doesn't specify the sample sizes for these tests, nor the "provenance" in the sense of patient data, as this is a physical device evaluation.

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)

This is not applicable as the document describes bench testing of a physical medical device, not a diagnostic AI or algorithm requiring expert-established ground truth on clinical data.

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

This is not applicable as the document describes bench testing of a physical medical device, not a diagnostic AI or algorithm requiring adjudication of clinical interpretations.

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. This document describes the regulatory clearance of a physical medical device, not an AI-assisted diagnostic tool.

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

This is not applicable. This document describes a physical medical device.

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

The "ground truth" for this device's performance is based on engineering specifications and established performance requirements for similar percutaneous catheters, as demonstrated through various bench tests (e.g., measuring leak, force, materials properties). The comparison is largely against the performance of the predicate device (K132914).

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this physical medical device. The device's design and manufacturing processes are validated through engineering and design controls, not machine learning training.

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

This is not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it is irrelevant in this context.

Summary

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

June 30, 2017

Public Health Service

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

Boston Scientific Corporation Lori Berends Sr. Regulatory Affairs Specialist Three Scimed Place

Maple Grove, MN 55311-1566

Re: K171612

Trade/Device Name: ACUITYTM Pro Lead Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 31, 2017 Received: June 1, 2017

Dear Lori Berends:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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 (reporting of medical device

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

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hilleman

for

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

Enclosure

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

Indications for Use

510(k) Number (if known) K171612

Device Name ACUITY™ Pro Lead Delivery System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary for K171612

Per 21 CFR §807.92

Common or UsualName	Percutaneous Guide Catheter
Trade Name(s)	ACUITY™ Pro Lead Delivery System
Product Code	DQY - Percutaneous Catheter
Classification ofDevice	Class II (special controls) - 21 CFR 870.1250
Submitter's Nameand Address	Boston Scientific CorporationThree Scimed PlaceMaple Grove, MN 55311-1566
Contact Name andInformation	Lori BerendsSr. Regulatory Affairs SpecialistPhone: 763-494-1528Fax: 763-494-2222Email: Lori.Berends@bsci.com
Date Prepared	26 May 2017
Section 514 of theAct PerformanceStandards	No performance standards have been established under Section 514 ofthe Food, Drug and Cosmetic Act for percutaneous catheters.
EstablishmentRegistrationNumbers	Owner /Operator: Boston Scientific Corporation300 Boston Scientific WayMarlborough, MA 01752USAERN: 9912058ManufacturingFacility: Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311USAERN: 2134265

Sterilization Facilities:		BSC Coventry8 Industrial DriveCoventry, RI 02816USAERN: 1000121056Steris Isomedix3459 South Clinton AveSouth Plainsfield, NJ 07080USAERN: 2246552Synergy Health Ireland, LTDIDA Business and Technology ParkSragh, TullamoreCo. OffalyIrelandERN: 3002807314Synergy Health AST, VenloFaunalaan 38Venlo Limburg, 5928 RZNetherlandsERN: 3009337401Synergy Health AST, SRLB13.1 Street 4, Avenue 1El Coyol Free ZoneEl Coyol Alajeula 20102Costa RicaERN: 3010273872
Predicate Device	K132914 - ACUITY™ Pro Lead Delivery SystemCleared on 03 April 2014
Device Description	The ACUITY™ Pro Lead Delivery System is designed for venous use toaid in the selective placement of cardiac resynchronization therapy (CRT)implantable venous leads in the cardiac vasculature. The catheter shaftsare comprised of a PTFE inner liner, a reinforcing layer of stainless steelbraid, and an outer polymer jacket. The distal end has a radiopaquepolymer tip, while the proximal end has a hub with flush luer fitting to allowflush, contrast injection and aspiration polymer .The approximate working lengths of the catheters are 45-54cm for the 9Fdesign and 60-69 cm for the 7F design.The ACUITY Pro 9F is provided with the following accessories: 0.014 inchguidewire torquer, 0.014 inch guidewire introducer, ACUITY™ UniversalCutter, two transvalve introducer tools, and a venous access dilator
Intended Use/Indications for Use	The ACUITY™ Pro Lead Delivery System is intended to access thecoronary venous system, and may be used alone (9F) or in a dual catheterdelivery (9F with 7F). The catheter serves as a conduit for the delivery ofcontrast medium and devices, including implantable coronary venousleads. introduced into the coronary venous system.
Comparison ofTechnologicalCharacteristics	The proposed ACUITY™ Pro Lead Delivery System is substantiallyequivalent to the existing ACUITY™ Pro Lead Delivery System clearedunder premarket notification K132914 on 03 April 2014. The ACUITY™Pro Lead Delivery System has the same intended use, scientifictechnology, design (with the exception of the hub seal design), materials(with the exception of the hub seal material), sterilization method, andpackaging materials as the applicable predicate device.
Summary of Non-Clinical TestSummary	Bench testing was performed to support a determination of substantialequivalence. The results of these tests provide reasonable assurance thatthe proposed device with the modified hub seal has been designed andtested to assure conformance to the requirements for its intended use. Nonew safety or performance issues were raised during the device testing.The following performance tests were completed on the ACUITY™ ProLead Delivery System to verify that the modified device continues to meetthe specification requirements impacted by the design change as well asmeet the new product specification requirement for air aspiration:Ancillary Device Passage through Valve 7F Catheter Passage through 9F Valve Hub Valve Hemostasis/Static Leak Air AspirationThe following usability tests were completed on the ACUITY™ Pro Lead Delivery System to ensure that the modified device continues to meet all user requirements as part of a lead delivery system: Catheter provides a conduit/back-up support for other devices to pass Catheter is able to be removed by cuttingThe following chemical characterization tests were completed on the ACUITY™ Pro Lead Delivery System to provide evidence that the extractable species in the proposed hub seal material and process do not pose an increased chemical safety risk when compared to the predicate seal material: Volatile/Semi-volatile organic compounds observed by GC-MS Non-volatile organic compounds observed by LC-MS
Conclusion	Based on the indications for use, technological characteristics, and safety and performance testing, the proposed ACUITY™ Pro Lead Delivery System with the modified hub seal has been shown to be appropriate for its intended use and is considered to be substantially equivalent to its predicate (K132914).

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

{5}------------------------------------------------

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).