(81 days)
The TomCat™ Guide Wire is intended to facilitate the placement of interventional catheters during therapeutic intravascular procedures.
The TomCat Extender™ Wire is used to facilitate exchange of one therapeutic device for another, while still maintaining the guide wire position in the coronary vasculature.
The guide wire extension tool is a device used to facilitate the joining of a guide wire with an extension wire.
There are three guide wire designs: Coil, Tube and Fighter. Accessories include an extension wire and extension tool.
Coil Design: Consists of a coated core wire gradually tapered by grinding in a multi-step process at the distal end over a 30 cm length. The distal tip is flattened. A radiopaque helically wound coil 30 cm in length is soldered in three places to the core wire. The distal 30 cm is coated to reduce friction. Manufactured in two tip configurations: pre-shaped J-Tip or unmodified straight tip. For 175 cm wires, the proximal end is tapered to accommodate attachment to the Merit TomCat™ Extender™ Wire.
Tube Design: The coated core wire is tapered and shaped in the same manner as the coil design. A 3 cm radiopaque helically wound coil is soldered in two places to the core wire instead of the 30 cm coil. A tube is then bonded in two places over the remainder of the exposed area of the core wire. The distal 30 cm is coated to reduce friction. Manufactured in two tip configurations: pre shaped J-tip or unmodified straight tip. For 175 cm wires, the proximal end is tapered to accommodate attachment to the Merit TomCat™ Extender™ Wire.
Fighter Design: A modification of the coil design. The coated core wire is tapered and shaped in the same manner as the coil design. A 3 cm long radiopaque helically wound coil is soldered to the ground core wire in 2 places, instead of a 30 cm coil. The remainder of the tapered portion of the core wire is left bare. The distal 30 cm is coated to reduce friction. Manufactured in two tip configurations: pre shaped J-tip or unmodified straight tip. For 175 cm wires, the proximal end is ground to accommodate attachment to the Merit TomCat™ Extender™ Wire.
Extender Wire: A coated core wire, 150 cm long and has a 0.014 inch diameter. It is tapered at the distal end, where a nickel/titanium hypotube is bonded to the core wire. This hypotube mates with the proximal tapered section of the Merit TomCat™ Guide Wire.
Extension Tool: Provides for axial alignment between the TomCat Extender Wire and a TomCat guide wire. The tool is a flat molded piece with two tabs. One tab holds the guide wire in place in the alignment channel. An embossed arrow shows where the end of the wire needs to be placed. The extension wire is placed in the alignment channel on the other side and the other tab holds it in place. The guide wire is then slid along the alignment channel until it is inserted into the extension wire's hypotube.
This submission, K973708, is a 510(k) premarket notification for the TomCat™ PTCA Guide Wire, Extender™ Wire, and Extension Tool. These are medical devices used for facilitating the placement of interventional catheters and the exchange of therapeutic devices during intravascular procedures.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" or present a table of device performance against such criteria. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria for a novel device. The implicit acceptance criteria are that the device performs similarly to or better than predicate devices in relevant functional aspects, addressing safety and effectiveness concerns for an intravascular guide wire system.
However, based on the device description and the nature of guide wires, essential performance characteristics (and therefore implicit acceptance criteria) would include:
| Characteristic/Implicit Acceptance Criteria | Reported Device Performance/Design Attributes (from document) |
|---|---|
| Biocompatibility (non-pyrogenic) | "Non-Pyrogenic: Yes" (Page 3) |
| Sterility | "Sterile: Yes" (Page 3) |
| Tip Flexibility & Shapeability (for navigation and placement) | Coil Design: Gradual taper over 30 cm, flattened tip, flexibility determined by tip dimension and taper pattern (Floppy, Intermediate, Standard, X-Support). Pre-shaped J-Tip or unmodified straight tip for custom shaping. (Page 1) Tube Design: Tapered and shaped same as coil design; 3cm radiopaque coil, bonding of tube over core wire. Pre-shaped J-tip or unmodified straight tip. (Page 1) Fighter Design: Tapered and shaped same as coil design; 3 cm radiopaque coil, remainder of tapered portion bare. Pre-shaped J-tip or unmodified straight tip. (Page 2) |
| Radiopacity (for visualization during procedure) | Coil Design: Radiopaque helically wound coil 30 cm in length. (Page 1) Tube Design: 3 cm radiopaque helically wound coil. (Page 1) Fighter Design: 3 cm long radiopaque helically wound coil. (Page 2) (Also implied in catalog descriptions like "3 cm Opaque," "30 cm Opaque" on page 3) |
| Friction Reduction (for smooth device advancement) | Distal 30 cm of wire is coated to reduce friction. (Pages 1 & 2) |
| Guide Wire Diameter (standardization) | "0.014 inches (0.36 mm)" (Page 3) |
| Guide Wire Lengths | "175 cm; 300 cm" (Page 3) |
| Compatibility with Extender Wire System | Proximal end of 175 cm wires tapered to accommodate attachment to TomCat™ Extender™ Wire. (Page 1 & 2) Extender Wire: 150 cm long, 0.014 inch diameter, tapered distal end with nickel/titanium hypotube to mate with guide wire. (Page 2) Extension Tool: provides axial alignment for joining guide wire and extension wire. (Page 2) |
| Shelf Life | "2 Years" (Page 3) |
| Single Use | "Single Use: Yes" (Page 3) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This 510(k) summary does not contain information about a specific "test set" and its sample size for evaluating the device's performance through a clinical study or specific performance testing data (e.g., in vitro or bench testing results like tensile strength, tortional integrity, etc.).
The entire submission is focused on demonstrating "substantial equivalence" to legally marketed predicate devices based on design and intended use similarities. No specific study data is presented. Therefore, no information on data provenance (country, retrospective/prospective) is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no specific test set or study data is presented, there is no mention of experts or ground truth establishment in this document for the device itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or related adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical medical instrument (guide wire, extender wire, and extension tool), not an AI-based system. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe the use of ground truth data for performance evaluation of the device in the context of a study. The basis of this submission is substantial equivalence to predicate devices, meaning the established safety and effectiveness of the existing devices serve as the benchmark.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is a physical medical device and not an AI/machine learning system.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment for it is mentioned.
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Image /page/0/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the word "MERIT" in bold, black letters. To the right of "MERIT" is the word "MEDICAL" in outlined letters.
MERIT MEDICAL
DEC 19 1997
510(k) SUMMARY SAFETY AND EFFECTIVENESS SUMMARY
This information of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitted by Name/Address: | SYSTEMS, INC. |
|---|---|
| Dennis Reigle | |
| Regulatory Affairs Manager | |
| Merit Medical Systems, Inc. | |
| 1600 West Merit Parkway | |
| South Jordan, UT 84095 | |
| (801) 253-1600 | |
| (801) 253-1684 fax | |
| 1600 WEST | |
| MERIT PARKWAY | |
| SOUTH JORDAN, | |
| Contact Person: | |
| Same as above | |
| UTAH 84095 | |
| Date Summary Prepared: | |
| September 26, 1997 | |
| 801-253-1600 | |
| Device Name: | |
| FAX 801-253-1651 | |
| Common Name: | PTCA Guide Wire and Accessories |
| Trade Name: | TomCat™ PTCA Guide Wire, Extender™ Wire and Extension Tool |
| Classification Name: | Catheter Guide Wire |
| Classification: | 74DQX |
| Predicate Devices: | |
| Device | Manufacturer |
| ACS Hi Torque™ 3 cm Extra S'Port Guide Wire | Advanced Cardiovascular Systems, Inc. |
| ACS Hi Torque™ 30 cm Standard Guide Wire | Advanced Cardiovascular Systems, Inc. |
ACS Hi Torque™ 30 cm Floppy Guide Wire SciMed Sceptor™ 3 cm Floppy Guide Wire SciMed Sceptor™ 2 cm Standard Guide Wire ACS DOCTM Guide Wire Extension 145 cm
diovascular Advanced Cardiovascular Systems, Inc. SciMed Life Systems, Inc. SciMed Life Systems, Inc. Advanced Cardiovascular Systems, Inc.
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Systems, Inc.
1600 West
MERIT PARKWAY
Image /page/1/Picture/1 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the word "MERIT" in bold, black letters. To the right of "MERIT" is the word "MEDICAL" in outlined letters. The logo has a professional and corporate look.
Intended Use:
The TomCat™ Guide Wire is intended to facilitate the placement of interventional catheters during therapeutic intravascular procedures.
The TomCat Extender™ Wire is used to facilitate exchange of one therapeutic device for another, while still maintaining the guide wire position in the coronary MERIT MEDICAL vasculature.
The guide wire extension tool is a device used to facilitate the joining of a guide wire with an extension wire.
DEVICE DESCRIPTION
There are three guide wire designs: Coil, Tube and Fighter. Accessories include an extension wire and extension tool.
Coil Design
The coil design includes the following tip flexibilities: Floppy, Intermediate, South Jordan, Standard and X-Support. This design consists of a coated core wire gradually tapered by grinding in a multi-step process at the distal end over a 30 cm length. The distal tip of the wire is then flattened. The flattened tip dimension and the UTAH 84095 taper pattern determine the flexibility of the distal 30 cm section of the guide wire. A radiopaque helically wound coil 30 cm in length is soldered in three places to the core wire. The distal 30 cm of the wire is coated to reduce friction 801-253-1600 between the guide wire and the interventional device. The wire is manufactured in two tip configurations: a pre-shaped J-Tip for immediate use or an unmodified straight tip to allow the clinician to custom shape the tip. For the 175 cm length FAX 801-253-1651 wires, the proximal end of the wire is tapered to accommodate attachment to the Merit TomCat™ Extender™ Wire.
Tube Design
The tube design includes the following tip flexibilities: Floppy, Intermediate, Standard and X Support. The coated core wire is tapered and shaped in the same manner as the coil design. However, a 3 cm radiopaque helically wound coil is soldered in two places to the core wire instead of the 30 cm coil. A tube is then bonded in two places over the remainder of the exposed area of the core wire. The distal 30 cm of the wire is coated to reduce friction between the guide wire and the interventional device. The wire is manufactured in two tip configurations: a pre shaped J-tip for immediate use or an unmodified straight tip to allow the clinician to custom shape the tip. For the 175 cm length wires, the proximal end of the wire is tapered to accommodate attachment to the Merit TomCat™ Extender™ Wire.
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Image /page/2/Picture/1 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the word "MERIT" in bold, black letters. To the right of "MERIT" is the word "MEDICAL" in an outlined font.
Fighter Design
The Merit Fighter guide wire is a modification of the coil design. The coated core wire is tapered and shaped in the same manner as the coil design. However, a 3 cm long radiopaque helically wound coil is soldered to the ground core wire in 2 places, instead of a 30 cm coil. The remainder of the tapered portion of the core wire is left bare. The distal 30 cm of the wire is coated to reduce friction MERIT MEDICAL between the guide wire and the interventional device. The wire is manufactured in two tip configurations: a pre shaped J-tip for immediate use or an unmodified straight tip to allow the clinician to custom shape the tip. For the 175 cm length Systems, Inc. wires, the proximal end of the wire is ground to accommodate attachment to the Merit TomCat™ Extender™ Wire. 1600 WEST
Extender Wire
The Merit TomCat Extender Wire is a coated core wire, 150 cm long and has a 0.014 inch diameter. It is tapered at the distal end, where a nickel/titanium hypotube is bonded to the core wire. This hypotube mates with the proximal tapered section of the Merit TomCat™ Guide Wire.
Extension Tool
The Merit guide wire extension tool provides for axial alignment between the TomCat Extender Wire and a TomCat guide wire. The tool is a flat molded piece with two tabs. One of the tabs is folded over to hold the guide wire in place in the tool's alignment channel (located in the middle of the tool). An embossed arrow on the tool shows where the end of the wire needs to be placed. The extension wire is placed in the alignment channel on the other side of the tool and the other tab is folded over holding the extension wire in place. The guide wire is then slid along the alignment channel until it is inserted into the extension wire's hypotube.
| Merit TomCat™ Specifications | |
|---|---|
| Guide Wire Diameter | 0.014 inches (0.36 mm) |
| Guide Wire Lengths | 175 cm; 300 cm |
| Sterile | Yes |
| Non-Pyrogenic | Yes |
| Single Use | Yes |
| Tip | J-Shaped or Straight |
| Shelf Life | 2 Years |
MERIT PARKWAY
SOUTH JORDAN,
UTAH 84095
801-253-1600
FAX 801-253-1651
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Image /page/3/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a stylized "M" symbol on the left, followed by the words "MERIT MEDICAL" in a bold, sans-serif font. The "MERIT" portion of the name is solid black, while the "MEDICAL" portion is outlined in black.
( 、..alog Numbers and Descriptions:
| Catalog Numbers | Description |
|---|---|
| TC14F03 | 3 cm Opaque, straight tip, Floppy, 0.014" O.D., 175 cm long |
| TC14F03J | 3 cm Opaque, shaped tip, Floppy, 0.014" O.D., 175 cm long |
| TC14F30 | 30 cm Opaque, straight tip, Floppy, 0.014" O.D., 175 cm long |
| TC14F30J | 30 cm Opaque, shaped tip, Floppy, 0.014" O.D., 175 cm long |
| TC14F03L | 3 cm Opaque, straight tip, Floppy, 0.014" O.D., 300 cm long |
| TC14F03LJ | 3 cm Opaque, shaped tip, Floppy, 0.014" O.D., 300 cm long |
| TC14F30L | 30 cm Opaque, straight tip, Floppy, 0.014" O.D., 300 cm long |
| TC14F30LJ | 30 cm Opaque, shaped tip, Floppy, 0.014" O.D., 300 cm long |
| TC14X03 | 3 cm Opaque, straight tip, X-Support, 0.014" O.D., 175 cm long |
| TC14X03J | 3 cm Opaque, shaped tip, X-Support, 0.014" O.D., 175 cm long |
| TC14X30 | 30 cm Opaque, straight tip, X-Support, 0.014" O.D., 175 cm long |
| TC14X30J | 30 cm Opaque, shaped tip, X-Support, 0.014" O.D., 175 cm long |
| TC14X03L | 3 cm Opaque, straight tip, X-Support, 0.014" O.D., 300 cm long |
| TC14X30L | 30 cm Opaque, straight tip, X-Support, 0.014" O.D., 300 cm long |
| TC14SF03 | 3 cm Opaque, straight tip, Fighter, 0.014" O.D., 175 cm long |
| TC14SF03J | 3 cm Opaque, shaped tip, Fighter, 0.014" O.D., 175 cm long |
| TC14SF03L | 3 cm Opaque, straight tip, Fighter, 0.014" O.D., 300 cm long |
| TC14SF03LJ | 3 cm Opaque, shaped tip, Fighter, 0.014" O.D., 300 cm long |
| TC14103 | 3 cm Opaque, straight tip, Intermediate, 0.014" O.D., 175 cm long |
| TC14103J | 3 cm Opaque, shaped tip, Intermediate, 0.014" O.D., 175 cm long |
| TC14130 | 30 cm Opaque, straight tip, Intermediate, 0.014" O.D., 175 cm long |
| TC14130J | 30 cm Opaque, shaped tip, Intermediate, 0.014" O.D., 175 cm long |
| TC14S03 | 3 cm Opaque, straight tip, Standard, 0.014" O.D., 175 cm long |
| TC14S03J | 3 cm Opaque, shaped tip, Standard, 0.014" O.D., 175 cm long |
| TC14S30 | 30 cm Opaque, straight tip, Standard, 0.014" O.D., 175 cm long |
| TC14S30J | 30 cm Opaque, shaped tip, Standard, 0.014" O.D., 175 cm long |
| TC14EXT | Extender Wire, 0.014" O.D., 150 cm long |
| TC14X03LJ | 3 cm Opaque, shaped tip, X-Support, 0.014" O.D., 300 cm long |
| TC14X30LJ | 30 cm Opaque, shaped tip, X-Support, 0.014" O.D., 300 cm long |
| TC14103L | 3 cm Opaque, straight tip, Intermediate, 0.014" O.D., 300 cm long |
| TC14103LJ | 3 cm Opaque, shaped tip, Intermediate, 0.014" O.D., 300 cm long |
| TC14130L | 30 cm Opaque, straight tip, Intermediate, 0.014" O.D., 300 cm long |
| TC14130LJ | 30 cm Opaque, shaped tip, Intermediate, 0.014" O.D., 300 cm long |
| TC14S03L | 3 cm Opaque, straight tip, Standard, 0.014" O.D., 300 cm long |
| TC14S03LJ | 3 cm Opaque, shaped tip, Standard, 0.014" O.D., 300 cm long |
| TC14S30L | 30 cm Opaque, straight tip, Standard, 0.014" O.D., 300 cm long |
| TC14S30LJ | 30 cm Opaque, shaped tip, Standard, 0.014" O.D., 300 cm long |
| 100732 | Extension Tool |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, represented by flowing, curved lines.
Public Health Service
DEC 1 9 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dennis Reigle Requlatory Affairs Manager Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, Utah 84095
Re : K973708 TomCat™ Guide Wire TomCat™ Extender Guide Wire Extension tool Regulatory Class: II (two) Product Code: DQX Dated: September 26, 1997 September 29, 1997 Received:
Dear Mr. Reigle:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the
{5}------------------------------------------------
Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Merit Medical Systems, Inc. 510(k) Notification:
Indications For Use:
The TomCat™ Guide Wire is intended to facilitate the placement of interventional catheters during therapeutic intravascular procedures.
The TomCat Extender™ Wire is used to facilitate exchange of one therapeutic device for another, while still maintaining the guide wire position in the coronary vasculature.
The guide wire extension tool is a device used to facilitate the joining of a guide wire with an extension wire.
(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, Respiratory,
and Devices
| 510(k) Number | K973708 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | Over The Counter Use |
|---|---|
| ------------------------------------------ | ---------------------- |
(Optional Format 1-2-96)
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.