(25 days)
Not Found
No
The device description focuses on the physical construction and materials of a guide wire, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is intended to aid in the placement of another medical device (a lead) and does not directly treat a disease or condition itself.
No
The device is a guide wire intended to aid in the placement of a lead, which is a procedural/interventional function, not a diagnostic one.
No
The device description clearly details a physical guide wire made of stainless steel, polyurethane, and PTFE, with specific dimensions and coatings. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature." This describes a device used in vivo (within the body) for a procedural purpose (guiding a lead).
- Device Description: The description details the physical construction of a guide wire, a tool used during medical procedures.
- 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 screening.
IVD devices are specifically designed to perform tests on samples taken from the body. This guide wire is a surgical/interventional tool used directly within the body.
N/A
Intended Use / Indications for Use
The HI-TORQUE WHISPER Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The general guide wire design consists of a stainless steel tapered core with a flexible tip, jacketed by polyurethane on the distal portion of the wire and polytetrafluoroethylene (PTFE) on the proximal portion of the wire. The polyurethane is subsequently covered with a hydrophilic coating to increase lubricity. The guide wires are available with either a straight distal tip that is shapeable, or as a pre-formed 'J' distal tip shaped specifically for accessing the coronary sinus (designated 'CS-J'). The straight tip can be manually shaped to accommodate specific patient anatomy or physician preference; the CS-J shape provides the convenience of an existing 'J' shape without manual shaping.
The HI-TORQUE WHISPER LS, MS/MS CS-J and ES/ES CS-J guide wires with Hydrocoat hydrophilic coating are guide wires with a 0.014" maximum diameter and a length of 190 cm. These wires are constructed with a high tensile (Hyten) stainless steel core wire having a nominal diameter of 0.0128" (LS/MS versions) or 0.0132" (ES versions). The distal segment of each guide wire consists of a series of unique tapers and grinds which reduce the diameter and support at the distal core, thus yielding the desired flexibility and performance characteristics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary venous 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)
The results of the verification testing demonstrate that the HI-TORQUE WHISPER LS, MS, ES, MS CS-J, and ES CS-J Guide Wires meet the established acceptance criteria and perform in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during the testing program.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
§ 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.
0
GUIDANT
and the state of the research and
and the may
..
..............................................................................................................................................................................
OCT 2 8 2002
| 7. 510(K) SUMMARY | |
|---|---|
| Submitter's Name: | Guidant Corporation |
| CRM Division | |
| Submitter's Address: | 4100 Hamline Avenue |
| Mail Stop F330 | |
| St. Paul, Minnesota 55112 | |
| Telephone: | (651) 582-6691 |
| Fax: | (651) 582-5134 |
| Contact Person: | Janell A. Colley |
| Date Prepared: | October 1, 2002 |
| Device Trade Name: | HI-TORQUE® WHISPER™ LS (Light Support) Guide |
| Wire with Hydrocoat Hydrophilic Coating, | |
| Model 6726 | |
| HI-TORQUE® WHISPER™ MS (Medium Support) Guide | |
| Wire with Hydrocoat Hydrophilic Coating, | |
| Model 6737 | |
| HI-TORQUE® WHISPER™ MS CS-J (Medium Support | |
| Coronary Sinus J) Guide Wire with Hydrocoat Hydrophilic | |
| Coating, | |
| Model 6738 | |
| HI-TORQUE® WHISPER™ ES (Extra Support) Guide Wire | |
| with Hydrocoat Hydrophilic Coating, | |
| Model 4482 | |
| HI-TORQUE® WHISPER™ ES CS-J (Extra Support | |
| Coronary Sinus J) Guide Wire with Hydrocoat Hydrophilic | |
| Coating, | |
| Model 4483 | |
| Device Common Name: | Guide Wire |
| Device Classification Name: | Catheter Guide Wire |
| Device Classification: | Class II |
1
Summary of Substantial Equivalence:
The design, materials, method of delivery and intended use features of the HI-TORQUE WHISPER LS, MS, ES, MS CS-J, and ES CS-J Guide Wires are substantially equivalent with regard to these features in their predicate device, the HI-TORQUE WHISPER Guide Wires (K020340/March 1, 2002, and K021285/May 2, 2002).
Device Description:
The general guide wire design consists of a stainless steel tapered core with a flexible tip, jacketed by polyurethane on the distal portion of the wire and polytetrafluoroethylene (PTFE) on the proximal portion of the wire. The polyurethane is subsequently covered with a hydrophilic coating to increase lubricity. The guide wires are available with either a straight distal tip that is shapeable, or as a pre-formed 'J' distal tip shaped specifically for accessing the coronary sinus (designated 'CS-J'). The straight tip can be manually shaped to accommodate specific patient anatomy or physician preference; the CS-J shape provides the convenience of an existing 'J' shape without manual shaping.
The HI-TORQUE WHISPER LS, MS/MS CS-J and ES/ES CS-J guide wires with Hydrocoat hydrophilic coating are guide wires with a 0.014" maximum diameter and a length of 190 cm. These wires are constructed with a high tensile (Hyten) stainless steel core wire having a nominal diameter of 0.0128" (LS/MS versions) or 0.0132" (ES versions). The distal segment of each guide wire consists of a series of unique tapers and grinds which reduce the diameter and support at the distal core, thus yielding the desired flexibility and performance characteristics.
Intended Use:
The HI-TORQUE WHISPER Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.
Technological Characteristics:
Comparisons of the proposed and predicate device show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed device.
Performance Data:
The results of the verification testing demonstrate that the HI-TORQUE WHISPER LS, MS, ES, MS CS-J, and ES CS-J Guide Wires meet the established acceptance criteria and perform in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during the testing program.
Conclusions:
The Guidant CRM HI-TORQUE WHISPER LS, MS, ES, MS CS-J, and ES CS-J Guide Wires have the same intended use, materials, technological characteristics, performance properties, and use identical sterilization processes as the Guidant VI Whisper LS and MS (Enhanced Radiopacity) guidewires and the Guidant CRM HI-TORQUE guidewires; therefore, there are no new safety or effectiveness issues. The modified HI-TORQUE WHISPER Guide Wires are substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -
OCT 28 2002
Guidant Corporation c/o Ms. Janell A. Colley Regulatory Affairs Associate Cardiac Rhythm Management 4100 Hamline North St. Paul. MN 55112-5798
Re: K023300
Trade Name: Hi-Torque Whisper LS, MS, MS CS-J, ES, and ES CS-J Guide Wires with Hydrocoat Hydrophilic Coating Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX
Dated: October 1, 2002 Received: October 3, 2002
Dear Ms. Colley:
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 mav publish further announcements concerning your device in the Federal Register.
3
Page 2 -- Ms. Janell A. Colley
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 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. 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 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 Division of Small 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,
Odell Tun
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name | HI-TORQUE WHISPER LS, MS, MS CS-J, ES, and ES CS-J Guide Wires with Hydrocoat Hydrophilic Coating |
| Indications for Use | The HI-TORQUE WHISPER Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
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:
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K023300
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use OR (Per 21 CFR 801.109) Guidant CRM HI-TORQUE WHISPER Guide Wire