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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Boston Scientific's 5F, 7F, and 8F Mach1 Guide Catheters. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (the 6F Mach1 Guide Catheter), rather than establishing performance against specific acceptance criteria for a novel device through clinical trials involving AI or diagnostic performance.

Therefore, many of the requested categories are not applicable or not present in the provided text, as this type of submission relies on non-clinical (in-vitro) testing and comparison to an existing device rather than a comprehensive clinical study with human readers, AI assistance, or complex ground truth establishment for diagnostic accuracy.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly quantifiable metrics like sensitivity or specificity. Instead, they are related to the functional performance and physical characteristics of the guide catheters, ensuring they are safe and perform as intended and are similar to the predicate device. The performance is reported as meeting these criteria.

Acceptance Criteria Category	Reported Device Performance
Material & Design Equivalence	Similar construction techniques and materials (Arnitel, Hytrel) as currently marketed 6F Mach1, with variations in durometers and tip materials for different sizes (5F, 7F, 8F). Design for providing a pathway for medical instruments.
Functional Testing	Test results verified that the 5F, 7F and 8F Mach1 catheters are adequate for the intended use in all areas listed below.
- Shaft and Distal Segment Tensile and Elongation	Adequate
- Tip Tensile	Adequate
- Tip Deflection	Adequate
- Hub to Shaft Tensile	Adequate
- Pressure Shaft Burst and Leak	Adequate
- Torque Response	Adequate
- Lumen Integrity	Adequate
- Radiopacity	Adequate
Biocompatibility	Conducted and adequate
Package Pouch Burst	Conducted and adequate
Product Shelf Life	Conducted and adequate

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as "sample size" in the context of diagnostic or AI performance evaluation. The "test set" consisted of the manufactured 5F, 7F, and 8F Mach1 catheters on which the functional, biocompatibility, packaging, and shelf-life tests were performed. The exact number of units tested for each specific test is not detailed, but it would have been a representative sample from production batches.
Data Provenance: The tests were non-clinical (in-vitro) conducted by Boston Scientific Scimed, Inc. within their facilities. This is not human-patient data from a specific country, but rather laboratory and engineering test data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. For this type of submission, "ground truth" refers to established engineering standards, material specifications, and functional requirements for medical devices, not diagnostic interpretations by human experts. The assessment of whether the functional tests met the requirements would be done by product engineers and quality assurance personnel.
Qualifications of Experts: Not applicable in the context of diagnostic interpretation. The experts involved would be engineers, material scientists, and quality control professionals.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no "adjudication" in the sense of reconciling differing expert opinions on diagnostic findings, as this was a non-clinical evaluation. Test results would be compared against predefined internal specifications and industry standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission does not involve human readers or AI assistance.
Effect Size of AI Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this submission consists of:
- Engineering Specifications: Predefined performance metrics, material properties, and design tolerances.
- Industry Standards: Relevant ISO or ASTM standards for catheter performance and safety.
- Predicate Device Performance: The established, safe, and effective performance of the 6F Mach1 Guide Catheter (K010874) against which the new sizes were compared for substantial equivalence.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no "training set" in the context of AI or machine learning for this device submission. The design and manufacturing processes are based on established engineering principles and prior experience with similar devices.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned for this type of device submission.

Summary

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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 Nameand Address	Boston Scientific Scimed, Inc.One Scimed PlaceMaple Grove, Minnesota 55311
Contact Person	Todd Kornmann(763) 494-2467
Classification Name	Similar to Diagnostic IntravascularCatheters (21CFR Part 970.1200)
Common or Usual Name	Coronary or Peripheral Guide Catheter
Proprietary Name	Boston Scientific 5F, 7F, and 8F Mach1Guide 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.

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(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.

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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

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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

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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)

Regulation Number and Section

§ 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).