(198 days)
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.
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 iner, 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:
Guidewire Introducer Guidewire Torquer
Venous Access Dilator ACUITY™ Universal Cutter
Transvalve Introducer Tool (2)
The provided document describes the ACUITY™ Pro Lead Delivery System, a percutaneous guide catheter. However, it does not contain acceptance criteria for device performance or a study that specifically proves the device meets such criteria in the context of an AI/ML device.
The document details a Traditional 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices through a summary of non-clinical testing. This regulatory pathway does not typically involve the type of clinical performance studies and acceptance criteria that would be relevant for an AI/ML device.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with vs. without AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
What the document does provide is a summary of non-clinical (bench) testing performed to demonstrate substantial equivalence of a medical device (a guide catheter) to its predicates, which is a different type of evaluation than what is asked for regarding an AI/ML device.
The summary of non-clinical testing includes:
- Dimensional Verification
- Tensile
- Pushability and Shaft Stiffness
- Shaft Cutting
- Kink Resistance
- Curve Shape
- Radiopacity
- Tip Deflection
- Torque Strength
- Hub Leak
- Hub Separation
- Hub Cutting / Catheter Removal
- Compatibility With Accessories And Adjunctive Devices
- Lead Passage
- Product Marking And Identification
- Product Integrity
- Ease Of Removal Of Device And Accessories From Packaging
- Particulates
- Microbiology Endotoxin
- EO Residuals
- Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation Or Intracutaneous Reactivity, Systemic Toxicity (Acute), Hemocompatibility, Latex, USP Physicochemical)
The document explicitly states: "Clinical Evaluation was not required for these devices." This reinforces that the evaluation was based on bench testing for substantial equivalence, not clinical performance for an AI/ML algorithm.
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510(k) Summary per 21 CFR §807.92
| Sponsor: | Boston Scientific CorporationOne Boston Scientific PlaceNatick MA 01760 |
|---|---|
| Contact Person: | Holly Ramirez |
| Phone Number: | 763-494-2113 |
| Fax Number: | 763-494-2222 |
| Prepared: | September 16, 2013 |
| Trade Name: | ACUITY™ Pro Lead Delivery System |
| Common Name: | Percutaneous Guide Catheter |
| Classification: | II |
| Product Code: | DQY21 CFR 870.1250 |
Predicate Device:
ACUITY Break-Away™ Guide Catheters (K093969; March 05, 2010) and ACUITY Cut-Away™ Guide Catheters (K111252, June 02, 2011).
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 iner, 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:
Guidewire Introducer Guidewire Torquer
Venous Access Dilator ACUITY™ Universal Cutter
Transvalve Introducer Tool (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.
Substantial Equivalence:
The ACUITY™ Pro Lead Delivery System design, materials, manufacturing process and intended use are substantially equivalent to the ACUITY Break-Away™ Guide Catheter (K093969) and the ACUITY Cut-Away™ Guide Catheter (K111252).
Summary of Non-Clinical Testing:
Design verification and validation testing, including mechanical bench testing, was performed to verify that the performance and usability of the ACUITY™ Pro Lead Delivery System remains substantially equivalent to both predicate devices. Biocompatibility, and packaging testing were also performed to verify the overall safety and efficacy of the device.
Boston Scientific Corporation Premarket Notification - Traditional 510(k) ACUITY™ Pro Lead Delivery System
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Specifically the following design verification and validation testing was performed:
- � Dimensional Verification
- Tensile �
- � Pushability and Shaft Stiffness
- � Shaft Cutting
- � Kink Resistance
- � Curve Shape
- � Radiopacity
- � Curve Shape
- � Tip Deflection
- Torque Strength �
- � Hub Leak
- � Hub Separation
- � Hub Cutting /Catheter Removal
- � Compatibility With Accessories And Adjunctive Devices
- Lead Passage �
- � Product Marking And Identification
- � Product Integrity
- � Ease Of Removal Of Device And Accessories From Packaging
- � Particulates
- Microbiology Endotoxin �
- EO Residuals �
- Biocompatibility Testing �
- Cytotoxicity o
- Sensitization O
- Irritation Or Intracutaneous O Reactivity
- Systemic Toxicity (Acute) ಂ
- Hemocompatibility 0
- Latex ೧
- USP Physicochemical O
Summary of Clinical Testing:
Clinical Evaluation was not required for these devices.
Boston Scientific Corporation Premarket Notification - Traditional 510(k) ACUITY™ Pro Lead Delivery System
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with three overlapping wings. The seal appears to be a government or official emblem.
April 3, 2014
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation % Holly Ramirez Sr. Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K132914
Trade/Device Name: ACUITY™ Pro Lead Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: March 27, 2014 Received: March 28, 2014
Dear Holly 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. 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 that I Driver Inatutes 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
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Page 2 - Holly Ramirez
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Bram D. Zuckerman -S
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 Statement
510(k) Number (if known): K132914 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Name:
ACUITY Pro Lead Delivery System
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Bram D. Zuckerm 2014.04.03 13
§ 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).