(30 days)
Not Found
No
The description focuses on the mechanical and material properties of a catheter system for delivering leads, with no mention of AI or ML capabilities.
No
The device is a delivery system and guide catheter for cardiovascular procedures, intended to assist in the delivery of other devices and contrast medium, not to provide therapy itself.
No.
The device is described as a "Lead Delivery System" and "Guide Catheters" intended to serve as a conduit for delivering contrast medium and devices, specifically implantable coronary venous leads, within the coronary venous system for cardiac resynchronization therapy. Its purpose is to aid in placement, not to diagnose a condition.
No
The device description clearly details physical components made of materials like PTFE, stainless steel, and PEBAX, indicating it is a hardware device, not software-only.
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 system is for accessing the coronary venous system and serving as a conduit for delivering contrast medium and devices (like leads) into the body. This is an in vivo (within a living organism) procedure, not an in vitro (in glass, or outside the body) diagnostic test.
- Device Description: The description details a catheter designed for insertion into the body to facilitate the placement of leads. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body, which are hallmarks of IVD devices.
Therefore, the ACUITY™ Cut-Away™ Lead Delivery System is a medical device used for an in vivo procedure, not an IVD.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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.
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)
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
-
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
Clinical Evaluation was not required for these devices.
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
KIII 252
JUN - 2 2011
510(k) Summary per 21 CFR §807.92
لر.
| Sponsor: | Boston Scientific Corporation
One Boston Scientific Place
Natick 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: | DQY
21 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:
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.
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:
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.
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
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