(18 days)
Not Found
No
The description focuses on the physical construction and intended use of a guide catheter, with no mention of AI or ML capabilities.
No
The device is a guide catheter designed to provide a pathway for other medical instruments, including therapeutic devices, meaning it is not a therapeutic device itself.
No
The device description explicitly states it "provides a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other diagnostic or therapeutic devices may be introduced." This indicates it is an access device for other instruments, not a diagnostic device itself.
No
The device description clearly details a physical catheter with specific material compositions, sizes, and construction techniques, indicating it is a hardware 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 Mach1 Guide Catheters are for providing a pathway for medical instruments to be introduced into the body (intravascular and coronary applications). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details the physical construction and function of a catheter used for accessing blood vessels. This aligns with an in vivo medical device.
- 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 compatibility testing.
IVD devices are specifically designed to be used outside the body to analyze biological samples. This device is designed to be used inside the body.
N/A
Intended Use / Indications for Use
The Mach Guide Catheters are intended for use in general intravascular and coronary applications designed to 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.
Mach1 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.
Product codes
DQY
Device Description
The Boston Scientific 5F, 7F, and 8F Mach1 catheters are similar to the currently marketed 6F Mach1 Guide Catheter, with the addition of three French sizes to the catheter line.
The Boston Scientific Mach1 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 Mach1 catheters will be offered in 5F, 6F, 7F, and 8F sizes and are 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 Mach1 catheters are manufactured using similar construction techniques as other currently marketed Boston Scientific guide catheters. The catheter shaft consists of three layers: the inner, middle and outer layers. The outer layer is composed of four segments,(5F has three segments) inclusive of the proximal shaft segment, but not including the distal tip. The outer layer segments are composed of the same material, (Arnitel) but use varying durometers of the Arnitel (polyether-ester) shaft materials providing specific flexibility zones over the length of the catheter. The tip consists of a reinforced tip portion and a non-reinforced tip portion. The 6F, 7F and 8F tip is made of Hytrel, while the 5F has an Arnitel tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravascular and coronary 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)
Functional testing 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 5F, 7F and 8F Mach1 catheters are adequate for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
JAN 2 2 2002
K0200228
Section 6
Summary of Safety and Effectiveness
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
General Provisions 6.1
| Submitter's Name
and Address | Boston Scientific Scimed, Inc.
One Scimed Place
Maple Grove, Minnesota 55311 |
|---------------------------------|------------------------------------------------------------------------------------|
| Contact Person | Todd Kornmann
(763) 494-2467 |
| Classification Name | Similar to Diagnostic Intravascular
Catheters (21CFR Part 970.1200) |
| Common or Usual Name | Coronary or Peripheral Guide Catheter |
| Proprietary Name | Boston Scientific 5F, 7F, and 8F Mach1
Guide Catheters |
| Name of Predicate Device | Boston Scientific Scimed |
Boston Scientific Scimed 6F Mach1 Guide Catheter
Device Description 6.3
6.2
The Boston Scientific 5F, 7F, and 8F Mach1 catheters are similar to the currently marketed 6F Mach1 Guide Catheter, with the addition of three French sizes to the catheter line.
The Boston Scientific Mach1 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 Mach1 catheters will be offered in 5F, 6F, 7F, and 8F sizes and are 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 Mach1 catheters are manufactured using similar construction techniques as other currently marketed Boston Scientific guide catheters. The catheter shaft consists of three layers: the inner, middle and outer layers. The outer layer is composed of four segments,(5F has three segments) inclusive of the proximal shaft segment, but not including the distal tip. The outer layer segments are composed of the same material,
1
(Arnitel) but use varying durometers of the Arnitel (polyether-ester) shaft materials providing specific flexibility zones over the length of the catheter. The tip consists of a reinforced tip portion and a non-reinforced tip portion. The 6F, 7F and 8F tip is made of Hytrel, while the 5F has an Arnitel tip.
6.4 Intended Use
The Mach Guide Catheters are intended for use in general intravascular and coronary applications designed to 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.
Summary of Technological Characteristics ર્ણને સિંહ સિંહ સાંદર્ભ સાંત કર્યા હતા. તાલુકામાં આવેલું એક ગામનાં છે. તે છે. તે છે. આ ગામનાં છે. આ ગામનાં છે. તે છે. આ ગામનાં છે. આ ગામનાં છે. આ ગામનાં છે. આ ગામનાં તાલુકામ
Same as currently marketed 6F Mach1 guide catheters, cleared for market under K010874, June 21, 2001.
Non-clinical Test Summary ર્ભ રહ્યું હતું. હ
Functional testing 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 5F, 7F and 8F Mach1 catheters are adequate for the intended use. The 5F, 7F and 8F Mach1 guide catheters are considered substantially equivalent to the currently marketed 6F Mach 1 guide catheter based on a comparison of the intended use, the device design, and the results of in-vitro testing and evaluation.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2002
Mr. Todd Kornmann Sr. Regulatory Affairs Specialist Boston Scientific Scimed, Inc. One Scimed Place Maple Grove MN 55311
Re: K020028
Trade/Device Name: 5F, 7F and 8F Mach1 Guide Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: January 3, 2002 Received: January 4, 2002
Dear Mr. Kornmann:
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.
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
3
Page 2 - Mr. Todd Kornmann
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of R Fart 877) would by 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 presided 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O inter gollet a mall 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,
J. O'Neill
Bram Zuckerman, M.D.
kerman. M. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k) Notification Boston Scientific Scimed, Inc. 5F, 7F and 8F Mach1 Guide Catheter
Section 4
Indications for Use
K020028 510(k) Number (if known) _
Device Name: 5F, 7F, and 8F Mach1 Guide Catheters
Indications for Use:
Mach1 Guide Catheters are intended for use in general intravascular and coronary Machi Gurac Cathersvide a pathway through which medical instruments, such as applications. They provide a painting and 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)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) | |
| OR | Over The Counter Use |
| (Optional Format 1-2-96) | |
| Division of Cardiovascular & Respiratory Devices | |
| 510(k) Number | K00028 |
Concurrence of CDRH, Office of Device Evaluation (ODE)