(88 days)
No
The description focuses on the physical properties and mechanical performance of a guide wire, with no mention of AI or ML capabilities.
No
The device is a guide wire intended to facilitate the placement of a catheter, not to directly treat a medical condition.
No
Explanation: The device is a guide wire intended to facilitate the placement of a catheter during diagnostic or interventional procedures, but it does not perform the diagnostic function itself. It is an accessory to a diagnostic procedure.
No
The device description clearly outlines physical components (nickel titanium core, polyurethane jacket, hydrophilic coating) and physical characteristics (diameter, length, tip flexibility), indicating it is a hardware 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description and Intended Use: The Kayak™ Hydrophilic Guide Wire is a physical tool used inside the body during medical procedures. Its purpose is to facilitate the placement of a catheter, not to analyze biological samples.
- Lack of IVD Characteristics: The description doesn't mention any components or functions related to sample collection, analysis, reagents, or diagnostic testing.
Therefore, the Kayak™ Hydrophilic Guide Wire is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Boston Scientific Corporation (BSC) Kayak™ Hydrophilic Guide Wires are intended to facilitate the placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. This device is not intended for use in the coronary arteries or the neurovasculature.
Product codes
DOX
Device Description
The Kayak™ Hydrophilic Guide Wires are steerable guide wires available in a nominal diameter of 0.035 and 0.038 inches and nominal lengths of 80, 150 and 180 centimeters. The available tip flexibilities will be: Standard, Stiff, Long Taper. The distal three centimeters of all models are available in straight and pre-formed angled tip design. The Kayak™ Hydrophilic Guide Wire consists of the following three components: nickel titanium core, polyurethane jacket, hydrophilic coating. The full length of the guide wire has a polyurethane jacket containing tungsten encasing the core wire. The full length of the guide wire has a hydrophilic coating for lubricity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical Test Summary: Testing and evaluation of the guide wires included: tensile strength, torque strength, cantilever stiffness, tip prolapse, peel test, lubricity and durability, biocompatibility, product shelf life.
Results: Test results demonstrate that the Kayak™ Hydrophilic Guide Wires met all evaluation acceptance criteria and are adequate for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 862.3550 Lead test system.
(a)
Identification. A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.(b)
Classification. Class II.
0
MAR 1 9 2002
Summary of Safety and Effectiveness
Section 6
Submitter's Information
Name and Address Boston Scientific Scimed, Inc. One Scimed Place Maple Grove, Minnesota 55311
Contact Person Mark Murphy 763-494-2377
Date December 20, 2001
Device Name
Proprietary Name Boston Scientific Corporation Kayak™ Hydrophilic Guide Wires
Common or Usual Name Kayak™ Guide Wires
Classification Name Catheter Guide Wire
Predicate Devices:
The following predicate devices are currently marketed.
| Product | 510(k) | Clearance Date |
|---|---|---|
| Terumo Radifocus Glidewire | K961445 | 07/09/1996 |
| Cordis Hydronol Steerable | ||
| Guidewire | K973845 | 01/05/1998 |
6-1
1
Summary of Safety and Effectiveness, Continued
| Models
Available | The Kayak™ Hydrophilic Guide Wires are steerable guide wires
available in a nominal diameter of 0.035 and 0.038 inches and nominal
lengths of 80, 150 and 180 centimeters. The available tip flexibilities
will be
• Standard,
• Stiff
• Long Taper.
The distal three centimeters of all models are available in straight and
pre-formed angled tip design. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Components | The Kayak™ Hydrophilic Guide Wire consists of the following three
components:
• nickel titanium core
• polyurethane jacket
• hydrophilic coating |
| Polyurethane
Jacket | The full length of the guide wire has a polyurethane jacket containing
tungsten encasing the core wire. |
| Hydrophilic
Coating | The full length of the guide wire has a hydrophilic coating for lubricity. |
2
Summary of Safety and Effectiveness, Continued
The Boston Scientific Corporation (BSC) Kayak™ Hydrophilic Guide Intended Use Fires are intended to facilitate the placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to diaghoods or ination through tortuous arteries and/or avoid unwanted side branches. This device is not intended for use in the coronary arteries or the neurovasculature.
Summary of Technological Characteristics The Kayak™ Hydrophilic Guide Wires are manufactured in a similar manner to legally marketed BSC hydrophilic guide wires and manner to 10gaily including the Renegade Braided Microcather (K973645) and the predicate device -- Terumo Radifocus Glidewire (K961445).
Non-Clinical Test Summary Testing and evaluation of the guide wires included:
- · tensile strength
- · torque strength
- · cantilever stiffness
- · tip prolapse
- peel test
- · lubricity and durability
- · biocompatibility
- · product shelf life
Results
Test results demonstrate that the Kayak™ Hydrophilic Guide Wires met all evaluation acceptance criteria and are adequate for their intended use.
Summary
The Kayak™ Hydrophilic Guide Wires are considered to be substantially equivalent to guide wires currently marketed by BSC and for Terumo Corporation based on a comparison of intended use, design and the results of in vitro testing and evaluation.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three distinct profiles visible within its form. The bird is oriented to the right, and the profiles suggest a sense of forward movement or progress. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2002
Mr. Mark Murphy Regulatory Affairs Specialist Boston Scientific Scimed, Inc. One Scimed Place Maple Grove MN 55311
Re: K014195
Trade/Device Name: Kayak™ Hydrophilic Guide Wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire. Regulatory Class: Class II Product Code: DOX Dated: December 20, 2001 Received: December 21, 2001
Dear Mr. Murphy:
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
4
Page 2 - Mr. Mark Murphy
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty by systems (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) This letter wification. The FDA finding of substantial equivalence of your device to a legally premarket notification. The PDF micing of casion 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 If you desire specific acrise for for invitro diagnostic devices), please contact the Office of additionally 21 CH Far 8071 or additionally, for questions on the promotion and advertising of Compliance at (301) 291 1016. Timber of Compliance at (301) 594-4639. Also, please note the your do roo, product of market notification" (21CFR Part 807.97). If guilation chittived, "Nisoftananing of responsibilities under the Act may be obtained from the Other general mionmation on your neernational 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,
Dork Teen
Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Notification BSC Kayak Guide Wires
.
Indications for Use
Section 2
| 510(k) Number | K014195 |
|---|---|
| Device Name: | Kayak™ Hydrophilic Guide Wires |
| Indications for | |
| Use: | The Boston Scientific Corporation (BSC) Kayak™ Hydrophilic Guide Wires are intended to facilitate the placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches. This device is not intended for use in the coronary arteries or the neurovasculature. |
(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)
Division of Cardiovascular & Respiratory Devices
510(k) Number K014195