(72 days)
Not Found
No
The summary describes a mechanical delivery system for accessing the coronary venous system and delivering leads. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on mechanical and biological properties, not algorithmic performance.
No
This device is a delivery system intended to access the coronary venous system and serve as a conduit for the delivery of contrast medium and other devices, including implantable coronary venous leads. It does not actively treat a condition.
No
This device is a lead delivery system intended to access the coronary venous system and serve as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads. Its purpose is to facilitate the placement of leads, not to diagnose a condition.
No
The device description clearly outlines physical components like catheters, a torque device, guidewire introducer, and cutter, 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ACUITY Break-Away™ Lead Delivery System is a medical device used in vivo (within the body) to facilitate the delivery of other devices (like leads) into the coronary venous system. It acts as a conduit and provides access.
- Lack of Diagnostic Testing: The description does not mention any analysis of biological samples or the provision of diagnostic information based on such analysis. Its purpose is purely procedural and delivery-oriented.
Therefore, the ACUITY Break-Away™ Lead Delivery System is a therapeutic/interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACUITY Break-Away™ Delivery System is intended to access the coronary venous system and may be used alone (8F) or in dual catheter delivery (8F with 6F).. The catheters serve as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.
Product codes
DQY
Device Description
The ACUITY Break-Away™ Delivery System consists of two guide catheters plus the following accessories: torque device, guidewire introducer and cutter. The system is designed to provide venous access and to aid with the selective placement of implantable venous leads in the left cardiac vasculature. The catheters, provided in a 8F size and 6F size models, are packaged separately. The 8F catheter package also contains the torque device and guidewire introducer accessories, which assist with implanting the lead, and the cutter, which is used to facilitate removal of the catheters after implant. The 6F catheter is packaged alone. The 8F catheter may be used by itself or in conjunction with the 6F catheter in a telescoping manner to improve the access and delivery capabilities of the system.
The ACUITY Break-Away catheter models feature a hub that is manually split apart rather than cut, and also incorporate a hemostasis valve to eliminate the need for an external accessory valve. The catheter is designed with a flexible distal segment and a soft tip to atraumatically enter the main coronary sinus and branch veins. The 6F ACUITY Break-Away catheter must be used with an 8F ACUITY Break-Away guide catheter to gain access to the main coronary sinus
ACUITY Break-Away 8F Guide Catheters are available in the following shapes:
- Extended Hook (CS-EH) 0
- Right (CS-EH ST R) o
- Wide (CS-W) o
- Multipurpose (CS-MP) ర
- Coronary Sinus Hook (CS-H) o
- Amplatz (CS-A6) o
- Straight (CS-ST) o
ACUITY Break-Away 6 Fr. Inner Catheter are available in the following shapes:
- 90 degree (CS-IC 90) O
- 130 degree (CS-IC 130) o
Complete US Model List:
- 7063 6F 68CM 90 DEG (Degree) 0
- 7064 6F 63CM 90 DEG 0
- 7065 6F 68CM 130 DEG 0
- 7066 6F 63CM 130 DEG 0
- 7067 8F 54CM EH (Extended Hook) 0
- 7068 8F 49CM EH 0
- 7069 8F 54CM EH ST R (Extended Hook Straight Right) 0 o
- 7070 8F 49CM EH ST R
- 7071 8F 54CM W (Wide) 0
- 7072 8F 49CM W o
- 7073 8F 54CM MP (Multipurpose) o 0
- 7074 8F 49CM MP
- 7075 8F 54CM H (Hook) 0
- 7076 8F 49CM H 0 O
- 7077 8F 54CM AMP (Amplatz
- 7078 8F 49CM AMP 0
- 7079 8F 54CM ST (Straight) 0
- 7080 8F 49CM ST
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary venous system, left 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 testing, including mechanical bench testing, animal testing and heart modeling, were conducted to verify that the performance of ACUITY Break-Away catheters remains substantially equivalent to the predicate devices. Biocompatibility, packaging and sterility testing were also performed.
Test results confirm that the modified catheters continue to meet all design and performance specifications. Biocompatibility testing confirmed that the modified catheters continue to conform with ISO standard 10993-1 (Biological Evaluation of Medical Devices - Evaluation and ' Testing), and can be effectively sterilized in accordance with sterilization standard ISO 11137.and EtO residual standard ISO 11135
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RAPIDO™ Cut-Away™ Guiding Catheter (K031505)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR ~ 5 2010
LOS3969
4100 Hamline Avenue North St. Paul, MN 55112-5798 651.582.4000 Tel 651.582.5134 Fax
510(k) Summary
December 22, 2009
Boston Scientific CRM
Date Prepared:
Submitted by:
Contact Person:
4211 Hamline Avenue North St. Paul, Minnesota 55112-5798
Kathleen Vittum Requlatory Affairs Specialist 651-582-4820 (Telephone) 651-582-5134 (Fax)
Trade name: Common name: Classification:
ACUITY Break-Away™ Delivery System Percutaneous Catheter Class II, 21 CFR 870.1250 DQY
Predicate devices:
RAPIDO™ Cut-Away™ Guiding Catheter (K031505)
The ACUITY Break-Away™ Delivery System consists of two Device Description: guide catheters plus the following accessories: torque device, guidewire introducer and cutter. The system is designed to provide venous access and to aid with the selective placement of implantable venous leads in the left cardiac vasculature. The catheters, provided in a 8F size and 6F size models, are packaged separately. The 8F catheter package also contains the torque device and guidewire introducer accessories, which assist with implanting the lead, and the cutter, which is used to facilitate removal of the catheters after implant. The 6F catheter is packaged alone. The 8F catheter may be used by itself or in conjunction with the 6F catheter in a telescoping manner to improve the access and delivery capabilities of the system.
The ACUITY Break-Away catheter models feature a hub that is manually split apart rather than cut, and also incorporate a hemostasis valve to eliminate the need for an external accessory valve. The catheter is designed with a flexible distal segment and a soft tip to atraumatically enter the main coronary sinus and branch veins. The 6F ACUITY Break-Away catheter must be used with an 8F ACUITY Break-Away guide catheter to gain access to the main coronary sinus
ACUITY Break-Away 8F Guide Catheters are available in the following shapes:
- Extended Hook (CS-EH) 0
- Right (CS-EH ST R) o
- Wide (CS-W) o
- Multipurpose (CS-MP) ర
- Coronary Sinus Hook (CS-H) o
- Amplatz (CS-A6) o
- Straight (CS-ST) o
ACUITY Break-Away 6 Fr. Inner Catheter are available in the following shapes:
- 90 degree (CS-IC 90) O
- 130 degree (CS-IC 130) o
Complete US Model List:
- 7063 6F 68CM 90 DEG (Degree) 0
Page 1 of 3 BSC 510(k) Summary - ACUITY™ Break-Away Delivery System
1
7064 6F 63CM 90 DEG 0 7065 6F 68CM 130 DEG 0 7066 6F 63CM 130 DEG 0 7067 8F 54CM EH (Extended Hook) 0 7068 8F 49CM EH 0 7069 8F 54CM EH ST R (Extended Hook Straight Right) 0 o 7070 8F 49CM EH ST R 7071 8F 54CM W (Wide) 0 7072 8F 49CM W o 7073 8F 54CM MP (Multipurpose) o 0 7074 8F 49CM MP 7075 8F 54CM H (Hook) 0 7076 8F 49CM H 0 O 7077 8F 54CM AMP (Amplatz 7078 8F 49CM AMP 0 7079 8F 54CM ST (Straight) 0
- o 7080 8F 49CM ST
Intended Use: The ACUITY Break-Away™ Delivery System is intended to access the coronary venous system and may be used alone (8F) or in dual catheter delivery (8F with 6F).. The catheters serve as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.
Technological Characteristics:
- Similarities: The ACUITY Break-Away Catheters and predicate RAPIDO Cut-Away Catheters o share these characteristics:
- Same fundamental design serving as a single or dual-catheter delivery conduit for o leads or contrast medium.
- Catheter bodies are constructed from the same basic materials. o
- Require use of a cutting accessory to separate the outer catheter for removal. 0
- Differences: The Acuity Break-Away Catheters differ from the predicate RAPIDO Cuto Away catheters in the following respects:
- Design and material change in the hub from plastic to a breakable resin material, which C allows hub to be split manually rather than cut. (The catheter body must still be cut.)
- The predicate catheter requires use of a separate hemostasis accessory (a rotating o hemostasis valve or bleedback control valve) during lead implant. The new catheters have a built-in hemostasis valve and do not require a separate accessory.
- Tungsten has been added to the Break-Away catheter tip to increase radiopacity o
Summary of Non-Clinical Testing: Design verification testing, including mechanical bench testing, animal testing and heart modeling, were conducted to verify that the performance of ACUITY Break-Away catheters remains substantially equivalent to the predicate devices. Biocompatibility, packaging and sterility testing were also performed.
Test results confirm that the modified catheters continue to meet all design and performance specifications. Biocompatibility testing confirmed that the modified catheters continue to conform with ISO standard 10993-1 (Biological Evaluation of Medical Devices - Evaluation and ' Testing), and can be effectively sterilized in accordance with sterilization standard ISO 11137.and EtO residual standard ISO 11135
Summary of Clinical Testing: Clinical evaluation was not required.
2
Statement of Substantial Equivalence: Results of testing and evaluation demonstrate that the ACUITY Break-Away Catheters are similar to the RAPIDO Cut-Away Catheters in the following aspects:.
-
- Same intended use,
-
- Same operating principle
-
- Same basic design,
-
- Catheter body contains the same primary materials
Therefore, Boston Scientific considers ACUITY Break-Away Delivery System to be substantially equivalent to the legally marketed predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR - 5 2010
Boston Scientific Corporation c/o Ms. Kathleen Vittum 4100 Hamline Avenue North St. Paul ,MN 55112
Re: K093969
Trade/Device Name: ACUITY Break-Away™ Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: February 3, 2010 Received: February 4, 2010
Dear Ms. Vittum:
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.
4
Page 2 - Ms. Kathleen Vittum
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-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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Special 510(k) - ACUITY Break-Away™ Lead Delivery System Attachment B
INDICATION FOR USE STATEMENT
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| 510(k) Number (if known): | K093969 |
|---|---|
| Device Name: | ACUITY Break-Away™ Lead Delivery System |
| Indications For Use: | The ACUITY Break-Away™ Lead Delivery System is intended to access the coronary venous system and may be used alone (8F) or in dual catheter delivery (8F with 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 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device-Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K093969
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