(22 days)
Not Found
No
The description focuses on the physical construction and materials of a guidewire, with no mention of AI or ML capabilities. Performance studies are based on bench tests and biocompatibility, not algorithmic performance.
No.
The guidewire facilitates the introduction and placement of therapeutic devices but does not provide direct therapeutic action itself.
No
The device is a guidewire intended to facilitate the introduction and placement of other interventional devices, not to diagnose a condition.
No
The device description clearly states it is a physical guidewire constructed of bi-metal core wire, PTFE coated Stainless Steel, and has a coiled wire feature. This indicates it is a hardware device, not software-only.
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 guidewire is used to facilitate the introduction and placement of catheters and interventional devices during medical procedures (PTA and PTCA). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details the physical construction and materials of a guidewire, which is a tool used in interventional procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing samples taken from the body. This guidewire is a surgical/interventional tool used directly within the body.
N/A
Intended Use / Indications for Use
The Heraeus TMW Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices during Percutaneous Transluminal Angioplasty (PTA) and/or Percutaneous Transluminal Coronary Angioplasty (PTCA).
Product codes
DQX
Device Description
Heraeus TMW Guidewire is a steerable guidewire constructed of a bi-metal core wire. The distal core is made of Triton™ Nitinol alloy and has a coiled wire feature at the distal end. The proximal core is comprised of PTFE coated Stainless Steel material. The wire is available in .014" diameter and lengths ranging from 180 to 300 cm. The distal segment is coated with hydrophilic coating and is shapeable with a 3 cm radiopaque distal tip.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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
Performance Testing: In vitro bench tests were utilized to demonstrate equivalence with reference to the FDAs guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995". The performance testing assessment supports that the biocompatibility, shelf life, and functional specifications of the proposed Guidewire device were met. The Heraeus TMW Guidewire device test data supports the claims of substantial equivalence to the predicate devices. Biological Safety of the predicate device has been established through biocompatibility testing carried out in compliance with ISO10993-1:2009 and G95-1, FDA General Program Memorandum: Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The following bench tests were conducted or evaluated to support the proposed device: biocompatibility testing (including: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Testing, Hemolysis, Complement Activation, In-Vivo Thrombogenicity), particulate testing, corrosion resistance, dimensional inspection, sterilization, sterile package integrity testing, tensile strength, tip stiffness, torque response, corrosion resistance, radiopacity, tip stiffness. The Heraeus TMW Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2017
Heraeus Medical Components, LLC Margaret Batchelder Principal Regulatory Specialist 2605 Fernbrook Lane North, Suite J Plymouth, Minnesota 55447
Re: K173052
Trade/Device Name: Heraeus TMW Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: September 27, 2017 Received: September 28, 2017
Dear Margaret Batchelder:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173052
Device Name Heraeus TMW Guidewire
Indications for Use (Describe)
The Heraeus TMW Guidewire is intended to facilitate the introduction and placement of catheters and interventional devices during Percutaneous Transluminal Angioplasty (PTA) and/or Percutaneous Transluminal Coronary Angioplasty (PTCA).
Type of Use (Select one or both, as applicable)
| Research Use (Part 21 CFR 601 Subpart D) | Compassionate Use (21 CFR 601 Subpart E) |
|---|---|
| ------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary -- K173052 6
| Submitter: | Heraeus Medical Components, LLC
1805 Fernbrook Lane North, Suite J
Plymouth, MN 55447 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Margaret Batchelder, Principal Regulatory Specialist
1805 Fernbrook Lane North, Suite J
Plymouth, MN 55447
763-225-6675 (voice)
763-559-7676 (fax) |
| Summary Preparation
Date | September 27, 2017 |
| Device Name | Heraeus TMW Guidewire |
| Device
Classification: | Common Name: Guidewire
Classification Name: Catheter, Guidewire Device Classification: Class II, 21 CFR §870.1330
Product Code: DQX |
| Intended Use: | The Heraeus TMW Guidewire is intended to facilitate the introduction
and placement of catheters and interventional devices during
Percutaneous Transluminal Angioplasty (PTA) and/or Percutaneous
Transluminal Coronary Angioplasty (PTCA). |
| Contraindications: | The guidewire is not intended for use in the cerebral vasculature. |
| Device Description | Heraeus TMW Guidewire is a steerable guidewire constructed of a bi-
metal core wire.
The distal core is made of Triton™ Nitinol alloy and has a coiled wire
feature at the distal end. The proximal core is comprised of PTFE
coated Stainless Steel material.
The wire is available in .014" diameter and lengths ranging from 180
to 300 cm. The distal segment is coated with hydrophilic coating and
is shapeable with a 3 cm radiopaque distal tip. |
| Predicate Device: | The subject device is substantially equivalent to the Hi-Torque
Balance Middleweight Guidewire (K152709, 10/21/2015)
manufactured by Abbott Vascular. |
| Principle of
Operation: | The Heraeus TMW Guidewire is operated by a manual process. |
| Comparison of
Technological
Characteristics | The key technological and performance similarities examined between
the approved devices and the proposed Heraeus TMW Guidewire
device are as follows: |
| | Indications for use - The Indications for use for the proposed device is
a subset of indications for use of the predicate device as proposed
device, |
| | Fundamental scientific technology, including design are equivalent to
the predicate devices |
| | Operating principle - equivalent to the predicate devices |
| | Packaging materials - equivalent to the predicate device |
| | Sterility assurance level and method of sterilization - equivalent to
the predicate devices |
| | The length and diameter of the device are equivalent to the
dimensions of the predicate devices. |
| | The proposed device and that of the predicate device are identical in
that they are constructed with equivalent materials to provide
equivalent tip stiffness, torque responses, and coating properties. |
| | The proposed device has equivalent tip stiffness characteristics to that
the predicate device |
| Substantial
Equivalence | The Heraeus TMW Guidewire System is substantially equivalent to
the substantially equivalent to the Hi-Torque Balance Middleweight
Guidewire (K152709). Substantial equivalence, which is summarized
in the following table, is based on indications for use, physical and
technological characteristics, and comparative device testing. |
4
5
| | TMW Guidewire
(current submission) | Abbott Vascular
Hi-Torque Balance
Middleweight Universal II
Guidewire (K152709) | Abbott Vascular
Hi-Torque Balance
Middleweight Elite
Guidewire (K152709) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Common/Usual
Name | Catheter Guide Wire | Catheter Guide Wire | Catheter Guide Wire |
| Device Class | Class II | Class II | Class II |
| Product Code /
Regulation | DQX / 21 CFR 870.1330 | DQX / 21 CFR 870.1330 | DQX / 21 CFR 870.1330 |
| Regulation
Name | Catheter Guide Wire | Catheter Guide Wire | Catheter Guide Wire |
| Prescription Use | Rx Only | Rx Only | Rx Only |
| Indications for
Use | The Heraeus TMW
Guidewire is intended to
facilitate the introduction and
placement of catheters and
interventional devices during
Percutaneous Transluminal
Angioplasty (PTA) and/or
Percutaneous Transluminal
Coronary Angioplasty
(PTCA). | To facilitate the placement of
balloon dilatation catheters
during percutaneous
transluminal coronary
angioplasty (PTCA) and
percutaneous transluminal
angioplasty (PTA). This guide
wire may also be used with
compatible stent devices
during therapeutic procedures. | To facilitate the placement of
balloon dilatation catheters
during percutaneous
transluminal coronary
angioplasty (PTCA) and
percutaneous transluminal
angioplasty (PTA). This
guide wire may also be used
with compatible stent devices
during therapeutic
procedures. |
| Guidewire OD | 0.014" | 0.014" | 0.014" |
| Guidewire
Length | 180 & 300 cm | 190 & 300 cm | 190 & 300 cm |
| Guidewire
Materials | Nitinol Cobalt, Stainless
Steel, Pebax, Platinum
Tungsten, Solder, and
Adhesive | Nitinol, Stainless Steel,
Radiopaque Coil, Solder,
Polymer Jacket, Adhesive | Nitinol, Stainless Steel,
Radiopaque Coil, Solder,
Adhesive |
| Guidewire
Coating | PTFE, Hydrophilic coating | PTFE, Hydrophilic coating | PTFE, Hydrophilic coating |
| Tip Shape | Straight Tip | Straight, J-Tip | Straight, J-Tip |
| Sterile Device? | Yes | Yes | Yes |
| Sterilization
Type | Ethylene Oxide | Irradiation | Irradiation |
| EO Sterilization
Residuals | Per ISO 10993-7 | N/A | N/A |
| Disposable /
Reusable | Disposable | Disposable | Disposable |
6
- Performance Testing: In vitro bench tests were utilized to demonstrate equivalence with reference to the FDAs guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995".
The performance testing assessment supports that the biocompatibility, shelf life, and functional specifications of the proposed Guidewire device were met.
The Heraeus TMW Guidewire device test data supports the claims of substantial equivalence to the predicate devices. Biological Safety of the predicate device has been established through biocompatibility testing carried out in compliance with ISO10993-1:2009 and G95-1, FDA General Program Memorandum: Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.
The following bench tests were conducted or evaluated to support the proposed device:
- . biocompatibility testing (including: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Testing, Hemolysis, Complement Activation, In-Vivo Thrombogenicity)
- particulate testing ●
- corrosion resistance
- dimensional inspection ●
- sterilization ●
- sterile package integrity testing
- tensile strength ●
- tip stiffness ●
- torque response ●
- corrosion resistance ●
- . radiopacity
- . tip stiffness
The Heraeus TMW Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device.