(23 days)
Not Found
No
The summary describes a physical medical device (a guide catheter) and its material composition and mechanical properties. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No
The device, a guide catheter, creates a pathway for other medical instruments, including therapeutic devices, but does not itself provide therapy.
Yes
The device description explicitly states: "The Boston Scientific RunWay Guide Catheters are designed to provide a pathway through which medical instruments such as balloon dilatation catheters, guide wires or other diagnostic or therapeutic devices may be introduced."
No
The device description clearly details the physical components and materials of a guide catheter, which is a hardware medical device. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guide catheters are for providing a pathway for introducing medical instruments into the body (intravascular and coronary applications). This is an in vivo use, meaning it's used within a living organism.
- Device Description: The description details the physical construction of a catheter designed to be inserted into blood vessels.
- 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.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is used to facilitate procedures within the body.
N/A
Intended Use / Indications for Use
Boston Scientific Guide Catheters are intended for use in general intravascular, coronary and peripheral applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Boston Scientific 6F RunWay Guide Catheters are similar to the currently marketed 6F Mach1 Guide Catheter, with the addition of Vestodur to the shaft for added strength, a different blend of Hytrel in the tip, a different colorant used in the shaft, and a different braid pattern using thirty-two 0.001" stainless steel wires, eight 0.002" Stainless Steel wires, and eight 0.002" Tungsten wires to strengthen the catheter for better backup support.
The Boston Scientific RunWay Guide Catheters are designed to provide a pathway through which medical instruments such as balloon dilatation catheters, guide wires or other diagnostic or therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature. The RunWay catheters will be offered in a 6F outer diameter, available in lengths ranging from 40-125 cm, with optional side holes. The devices are provided sterile and intended for one procedure use only.
The RunWav catheters are manufactured using similar construction techniques as other currently marketed Boston Scientific guide catheters. The catheter shaft consists of three layers: inner, middle, and outer. The outer laver is composed of three segments.
The outer laver segments one and two consist of various durometers of Amitel. Segment three is a blend of Vestodur 3000 and Arnitel. Vestodur is added to the shaft to strengthen the catheter. The use of varying durometers of Amitel provides specific flexibility zones at the distal end of the catheter. The tip consists of a reinforced portion and a non-reinforced portion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravascular, coronary and peripheral applications. Not intended for use in the cerebral 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)
Testing and evaluation of the 6F RunWay Guide Catheter consisted of shaft and distal segment tensile and elongation, tip tensile, tip deflection, hub to shaft tensile, pressure shaft burst and leak, torque response, lumen integrity and radiopacity. Biocompatibility, package pouch burst, and product shelf life testing have also been conducted. Test results verified that the 6F RunWay Guide Catheters are adequate for the intended use. The 6F RunWay guide catheters are considered substantially equivalent to the currently marketed 6F Mach1 Guide Catheters based on a comparison of the intended use, the device design, and the results of in-vitro testing and evaluation.
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
Section 6
Summary of Safety and Effectiveness
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
6.1 General Provisions
| Submitter's Name
and Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 |
|---------------------------------|-------------------------------------------------------------------------------------------|
| Contact Person | Heidi M. Erickson
Phone: 763-494-2564
Fax: 763-494-2981
email: ericksoh@bsci.com |
| Classification of Device | Class II, 21CFR Part 870.1200 Similar to
Diagnostic IntravascularCatheters |
| Common or Usual Name | Coronary or Peripheral Guide Catheter |
| Proprietary Name | Boston Scientific 6F RunWay Guide
Catheter |
| Product Code | DQY |
| Date Prepared | October 28, 2003 |
| Name of Predicate Device | 6F Mach1 Guide Catheter
K010874, June 21, 2001 |
6.3 Device Description
6.2
The Boston Scientific 6F RunWay Guide Catheters are similar to the currently marketed 6F Mach1 Guide Catheter, with the addition of Vestodur to the shaft for added strength, a different blend of Hytrel in the tip, a different colorant used in the shaft, and a different braid pattern using thirty-two 0.001" stainless steel wires, eight 0.002" Stainless Steel wires, and eight 0.002" Tungsten wires to strengthen the catheter for better backup support.
1
Section 6
The Boston Scientific RunWay Guide Catheters are designed to provide a pathway through which medical instruments such as balloon dilatation catheters, guide wires or other diagnostic or therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature. The RunWay catheters will be offered in a 6F outer diameter, available in lengths ranging from 40-125 cm, with optional side holes. The devices are provided sterile and intended for one procedure use only.
The RunWav catheters are manufactured using similar construction techniques as other currently marketed Boston Scientific guide catheters. The catheter shaft consists of three layers: inner, middle, and outer. The outer laver is composed of three segments.
The outer laver segments one and two consist of various durometers of Amitel. Segment three is a blend of Vestodur 3000 and Arnitel. Vestodur is added to the shaft to strengthen the catheter. The use of varying durometers of Amitel provides specific flexibility zones at the distal end of the catheter. The tip consists of a reinforced portion and a non-reinforced portion.
6.4 Intended Use
Boston Scientific Guide Catheters are intended for use in general intravascular, coronary and peripheral applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.
ર્ભ રહ્યું હતું. સ Summary of Technological Characteristics
The 6F RunWay Guide Catheter utilizes similar materials and methods of construction as the currently marketed 6F Mach1 guide catheter, cleared for market under K010874, June 21, 2001. The differences in construction are in the braid pattern of the shaft, shaft colorant, shaft material, and the distal tip blend.
6.6 Non-clinical Test Summary
Testing and evaluation of the 6F RunWay Guide Catheter consisted of shaft and distal segment tensile and elongation, tip tensile, tip deflection, hub to shaft tensile, pressure shaft burst and leak, torque response, lumen integrity and radiopacity. Biocompatibility, package pouch burst, and product shelf life testing have also been conducted. Test results verified that the 6F RunWay Guide Catheters are adequate for the intended use. The 6F RunWay guide catheters are considered substantially equivalent to the currently marketed 6F Mach1 Guide Catheters based on a comparison of the intended use, the device design, and the results of in-vitro testing and evaluation.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2003
Boston Scientific Corporation c/o Ms. Heidi M. Erickson Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
K033441 Re:
6F Run Way Guide Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQY Dated: October 28, 2003 Received: October 29, 2003
Dear Ms. Erickson:
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 such 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. Heidi M. Erickson
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Elisa Dttay for
Bram D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k) Notification Boston Scientific Corporation 6F RunWay Guide Catheter
Section 4
Indications for Use
510(k) Number (if known) K03244
Device Name: 6F RunWay Guide Catheter
Indications for Use:
Boston Scientific Guide Catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over The Counter Use_
(Optional Format 1-2-96)
Shra D.A. for
Bram Zochm
er 21 CFR 801.109)
vision of Cardio r & Respiratory Devices 010/k) Nur
) Number
Elias Diaz for Brian Johnson
11/21/09
Section 4 Page 1