(29 days)
Not Found
No
The 510(k) summary describes a mechanical lead delivery system and its accessories. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical and chemical properties.
No
The device is described as a delivery system that serves as a conduit for other devices and contrast medium, rather than providing therapy itself. Its purpose is to aid in the placement of implantable leads.
No
Explanation: The device is described as a delivery system for implantable coronary venous leads and contrast medium, serving as a conduit. Its purpose is to aid in the placement of leads for cardiac resynchronization therapy, not to diagnose a condition.
No
The device description clearly outlines physical components like catheter shafts, a radiopaque tip, a hub with a luer fitting, and various accessories, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for accessing the coronary venous system and serving as a conduit for delivering contrast medium and devices (specifically implantable coronary venous leads). This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The description details a catheter system designed for venous use to aid in the placement of leads in the cardiac vasculature. This further reinforces its use within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory or point-of-care setting to analyze these specimens.
Therefore, the ACUITY™ Pro Lead Delivery System is a medical device used for a surgical/interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary venous system, cardiac vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device with the modified hub seal has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the device testing.
The following performance tests were completed on the ACUITY™ Pro Lead Delivery System to verify that the modified device continues to meet the specification requirements impacted by the design change as well as meet 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 Aspiration 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 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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
| Name | Percutaneous Guide Catheter | ||
|---|---|---|---|
| Trade Name(s) | ACUITY™ Pro Lead Delivery System | ||
| Product Code | DQY - Percutaneous Catheter | ||
| Classification of | |||
| Device | Class II (special controls) - 21 CFR 870.1250 | ||
| Submitter's Name | |||
| and Address | Boston Scientific Corporation | ||
| Three Scimed Place | |||
| Maple Grove, MN 55311-1566 | |||
| Contact Name and | |||
| Information | Lori Berends | ||
| Sr. Regulatory Affairs Specialist | |||
| Phone: 763-494-1528 | |||
| Fax: 763-494-2222 | |||
| Email: Lori.Berends@bsci.com | |||
| Date Prepared | 26 May 2017 | ||
| Section 514 of the | |||
| Act Performance | |||
| Standards | No performance standards have been established under Section 514 of | ||
| the Food, Drug and Cosmetic Act for percutaneous catheters. | |||
| Establishment | |||
| Registration | |||
| Numbers | Owner /Operator: Boston Scientific Corporation | ||
| 300 Boston Scientific Way | |||
| Marlborough, MA 01752 | |||
| USA | |||
| ERN: 9912058 |
Manufacturing
Facility: Boston Scientific Corporation
Two Scimed Place
Maple Grove, MN 55311
USA
ERN: 2134265 | | |
| | | | |
| Sterilization Facilities: | | BSC Coventry
8 Industrial Drive
Coventry, RI 02816
USA
ERN: 1000121056
Steris Isomedix
3459 South Clinton Ave
South Plainsfield, NJ 07080
USA
ERN: 2246552
Synergy Health Ireland, LTD
IDA Business and Technology Park
Sragh, Tullamore
Co. Offaly
Ireland
ERN: 3002807314
Synergy Health AST, Venlo
Faunalaan 38
Venlo Limburg, 5928 RZ
Netherlands
ERN: 3009337401
Synergy Health AST, SRL
B13.1 Street 4, Avenue 1
El Coyol Free Zone
El Coyol Alajeula 20102
Costa Rica
ERN: 3010273872 | |
| Predicate Device | K132914 - ACUITY™ Pro Lead Delivery System
Cleared on 03 April 2014 | | |
| 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 | | |
| Intended Use/
Indications for 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. | | |
| Comparison of
Technological
Characteristics | The proposed ACUITY™ Pro Lead Delivery System is substantially
equivalent to the existing ACUITY™ Pro Lead Delivery System cleared
under premarket notification K132914 on 03 April 2014. The ACUITY™
Pro Lead Delivery System has the same intended use, scientific
technology, design (with the exception of the hub seal design), materials
(with the exception of the hub seal material), sterilization method, and
packaging materials as the applicable predicate device. | | |
| Summary of Non-
Clinical Test
Summary | Bench testing was performed to support a determination of substantial
equivalence. The results of these tests provide reasonable assurance that
the proposed device with the modified hub seal has been designed and
tested to assure conformance to the requirements for its intended use. No
new safety or performance issues were raised during the device testing.
The following performance tests were completed on the ACUITY™ Pro
Lead Delivery System to verify that the modified device continues to meet
the specification requirements impacted by the design change as well as
meet 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 Aspiration
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
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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