ACUITY Pro Lead Delivery System

K171612 · Boston Scientific Corporation · DQY · Jun 30, 2017 · Cardiovascular

Device Facts

• Record ID: K171612
• Device Name: ACUITY Pro Lead Delivery System
• Applicant: Boston Scientific Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 30, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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 Story

Percutaneous catheter system designed for selective placement of cardiac resynchronization therapy (CRT) leads in cardiac vasculature; used in clinical settings by physicians. Device acts as conduit for contrast medium and lead delivery; provides back-up support. Features 9F and 7F catheter designs with PTFE inner liner, stainless steel braid reinforcement, and outer polymer jacket. Distal end includes radiopaque polymer tip; proximal end features hub with flush luer fitting. Accessories include guidewire torquer, introducer, cutter, transvalve tools, and venous access dilator. Modified hub seal design improves hemostasis and air aspiration performance. Physician navigates catheter to target site; output is physical access and conduit for therapy delivery; facilitates successful lead implantation.

Clinical Evidence

Bench testing only. Performance testing verified modified hub seal functionality, including ancillary device passage, 7F catheter passage through 9F valve, hemostasis, static leak, and air aspiration. Usability testing confirmed device maintains conduit/back-up support and cut-ability. Chemical characterization (GC-MS/LC-MS) demonstrated that extractable species in the new hub seal material do not pose increased safety risks compared to the predicate.

Technological Characteristics

Percutaneous guide catheter; 9F and 7F diameters; 45-69cm working lengths. Materials: PTFE inner liner, stainless steel braid reinforcement, outer polymer jacket, radiopaque polymer tip. Hub includes flush luer fitting. Sterilization: Not specified (facilities listed). No software or electronic components.

Indications for Use

Indicated for accessing the coronary venous system to deliver contrast medium and implantable coronary venous leads in patients requiring cardiac resynchronization therapy.

Regulatory Classification

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.

Predicate Devices

• ACUITY™ Pro Lead Delivery System (K132914)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known) K171612

Device Name ACUITY™ Pro Lead Delivery System

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 510(k) Summary for K171612

## Per 21 CFR §807.92

| Common or Usual<br>Name | Percutaneous Guide Catheter | | |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Trade Name(s) | ACUITY™ Pro Lead Delivery System | | |
| Product Code | DQY - Percutaneous Catheter | | |
| Classification of<br>Device | Class II (special controls) - 21 CFR 870.1250 | | |
| Submitter's Name<br>and Address | Boston Scientific Corporation<br>Three Scimed Place<br>Maple Grove, MN 55311-1566 | | |
| Contact Name and<br>Information | Lori Berends<br>Sr. Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| Date Prepared | 26 May 2017 | | |
| Section 514 of the<br>Act Performance<br>Standards | No performance standards have been established under Section 514 of<br>the Food, Drug and Cosmetic Act for percutaneous catheters. | | |
| Establishment<br>Registration<br>Numbers | Owner /Operator: Boston Scientific Corporation<br>300 Boston Scientific Way<br>Marlborough, MA 01752<br>USA<br>ERN: 9912058<br><br>Manufacturing<br>Facility: Boston Scientific Corporation<br>Two Scimed Place<br>Maple Grove, MN 55311<br>USA<br>ERN: 2134265 | | |
| | | | |
| Sterilization Facilities: | | BSC Coventry<br>8 Industrial Drive<br>Coventry, RI 02816<br>USA<br>ERN: 1000121056<br>Steris Isomedix<br>3459 South Clinton Ave<br>South Plainsfield, NJ 07080<br>USA<br>ERN: 2246552<br>Synergy Health Ireland, LTD<br>IDA Business and Technology Park<br>Sragh, Tullamore<br>Co. Offaly<br>Ireland<br>ERN: 3002807314<br>Synergy Health AST, Venlo<br>Faunalaan 38<br>Venlo Limburg, 5928 RZ<br>Netherlands<br>ERN: 3009337401<br>Synergy Health AST, SRL<br>B13.1 Street 4, Avenue 1<br>El Coyol Free Zone<br>El Coyol Alajeula 20102<br>Costa Rica<br>ERN: 3010273872 | |
| Predicate Device | K132914 - ACUITY™ Pro Lead Delivery System<br>Cleared on 03 April 2014 | | |
| Device Description | The ACUITY™ Pro Lead Delivery System is designed for venous use to<br>aid in the selective placement of cardiac resynchronization therapy (CRT)<br>implantable venous leads in the cardiac vasculature. The catheter shafts<br>are comprised of a PTFE inner liner, a reinforcing layer of stainless steel<br>braid, and an outer polymer jacket. The distal end has a radiopaque<br>polymer tip, while the proximal end has a hub with flush luer fitting to allow<br>flush, contrast injection and aspiration polymer .<br><br>The approximate working lengths of the catheters are 45-54cm for the 9F<br>design and 60-69 cm for the 7F design.<br><br>The ACUITY Pro 9F is provided with the following accessories: 0.014 inch<br>guidewire torquer, 0.014 inch guidewire introducer, ACUITY™ Universal<br>Cutter, two transvalve introducer tools, and a venous access dilator | | |
| Intended Use/<br>Indications for Use | The ACUITY™ Pro Lead Delivery System is intended to access the<br>coronary venous system, and may be used alone (9F) or in a dual catheter<br>delivery (9F with 7F). The catheter serves as a conduit for the delivery of<br>contrast medium and devices, including implantable coronary venous<br>leads. introduced into the coronary venous system. | | |
| Comparison of<br>Technological<br>Characteristics | The proposed ACUITY™ Pro Lead Delivery System is substantially<br>equivalent to the existing ACUITY™ Pro Lead Delivery System cleared<br>under premarket notification K132914 on 03 April 2014. The ACUITY™<br>Pro Lead Delivery System has the same intended use, scientific<br>technology, design (with the exception of the hub seal design), materials<br>(with the exception of the hub seal material), sterilization method, and<br>packaging materials as the applicable predicate device. | | |
| Summary of Non-<br>Clinical Test<br>Summary | Bench testing was performed to support a determination of substantial<br>equivalence. The results of these tests provide reasonable assurance that<br>the proposed device with the modified hub seal has been designed and<br>tested to assure conformance to the requirements for its intended use. No<br>new safety or performance issues were raised during the device testing.<br><br>The following performance tests were completed on the ACUITY™ Pro<br>Lead Delivery System to verify that the modified device continues to meet<br>the specification requirements impacted by the design change as well as<br>meet the new product specification requirement for air aspiration:<br>Ancillary Device Passage through Valve 7F Catheter Passage through 9F Valve Hub Valve Hemostasis/Static Leak Air Aspiration<br>The 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 cutting<br>The 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). | | |

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