(14 days)
No
The document describes a physical guide wire and its intended use and testing, with no mention of AI or ML technologies.
No
The device is a guide wire intended to aid in the placement of interventional devices and leads, not to provide therapy itself.
No
The device is described as an aid in the selective placement of interventional devices and implantable coronary venous leads, indicating its use in therapeutic procedures rather than for diagnosis. While the "Intended Use" section mentions "diagnostic and/or therapeutic procedures," the primary role of the guidewire itself is to facilitate placement, not to provide diagnostic information.
No
The device description explicitly states it is a "steerable guide wire" with a nominal diameter, indicating it is a physical hardware device used in intravascular procedures.
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 device is for "general intravascular use to aid in the selective placement of interventional devices and implantable coronary venous leads in the coronary and/or peripheral vasculature during diagnostic and/or therapeutic procedures." This describes a device used within the body for procedural guidance, not a device used to test samples outside the body.
- Device Description: The description of a "steerable guide wire" further supports its use as an interventional tool within the body.
- Anatomical Site: The specified anatomical site is the "coronary and/or peripheral vasculature," which are locations within the living organism.
- Performance Studies: The performance studies involve "In Vivo Testing" (animal studies) and "Human Clinical Testing Data," which are typical for devices used within the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The HI-TORQUE Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices and implantable coronary venous leads in the coronary and/or peripheral vasculature during diagnostic and/or therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
DTL, DQO, DQY, DQX
Device Description
The HI-TORQUE Guide Wires are steerable guide wires available in a nominal diameter of 0.14".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or peripheral 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)
In Vivo Testing: Animal studies were conducted to evaluate the performance of the HI-TORQUE Guide Wires when the devices were used within the coronary vein. The results of the in vivo animal evaluation showed that the Hi-Torque Guide Wires are acceptable within the coronary vein when used with a compatible lead system.
Human Clinical Testing Data: HI-TORQUE Guide Wires were evaluated in a clinical investigation. The function of the HI-TOROUE Guide Wire in this clinical investigation was to aid in the placement of a coronary venous pace/sense lead in the coronary venous vasculature. The results demonstrated that the HI-TORQUE Guide Wires are safe and effective for use in placing a compatible coronary venous pace/sense lead in the coronary venous vasculature.
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.
K950156, K963702, K982083, K991152, K002206
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
KQ/a85
MAY 0 2 2002
510(k) Summary
- Device Name: HI-TORQUE Guide Wire -
- HI-TORQUE BALANCED MIDDLEWEIGHT (BMW), Model 6720 .
- HI-TORQUE BALANCED HEAVYWEIGHT (BHW), Model 6722 .
- HI-TORQUE BALANCED TREK, Model 6723 ●
- HI-TOROUE EXTRA S'PORT, Model 6724 .
- HI-TOROUE IRON MAN, Model 6725 .
- HI-TORQUE WHISPER LS, Model 6726
- HI-TOROUE WHISPER MS, Model 6737
- Devices to Which Equivalence is Claimed: HI-TORQUE BALANCED MIDDLEWEIGHT (K983033, cleared 11/10/98) with regard to intended use and all other aspects of the proposed HI-TORQUE Guide Wires are identical to the currently marketed Guide Wires (K950156, cleared 4/5/95; K963702, cleared 1/22/97; K982083, cleared 9/11/98; K983033, cleared 11/10/98; K991152, cleared 4/29/99; and K002206, cleared 8/24/00).
-
- Intended Use: The HI-TORQUE Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices and implantable coronary venous leads in the coronary and/or peripheral vasculature during diagnostic .
منزلوبر سرور سر
منزل المنتدى and/or therapeutic procedures.
- 4. Device Description: The HI-TORQUE Guide Wires are steerable guide wires available in a nominal diameter of 0.14".
-
- Summary of Technological Characteristics: This notification concerns a labeling modification to expand the indications for currently marketed devices. There are no changes to the design, materials, manufacturing process, packaging process, sterilization process, or shelf life of the subject devices.
-
- Summary of Substantial Equivalence: This notification concerns a labeling modification to expand the indications for the currently marketed device. The indications are equivalent to the currently marketed HI-TORQUE BALANCED MIDDLEWEIGHT (K983033, cleared 11/10/98). All other aspects of the proposed Guide Wires are identical to the currently marketed Guide Wires (K950156, cleared 4/5/95; K963702, cleared 1/22/97; K982083. cleared 9/11/98; K983033. cleared 1 11/10/98; K991152, cleared 4/29/99; and K002206, cleared 8/24/00).
7. Testing Data:
In Vivo Testing
Animal studies were conducted to evaluate the performance of the HI-TORQUE Guide Wires when the devices were used within the coronary vein. The results of the
510(k) Submission for Guidant HI-TORQUE Guide Wires Guidant/CRM - March, 2001
Page 10 of 11
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1
in vivo animal evaluation showed that the Hi-Torque Guide Wires are acceptable within the coronary vein when used with a compatible lead system.
Human Clinical Testing Data:
HI-TORQUE Guide Wires were evaluated in a clinical investigation. The function of the HI-TOROUE Guide Wire in this clinical investigation was to aid in the placement of a coronary venous pace/sense lead in the coronary venous vasculature. The results demonstrated that the HI-TORQUE Guide Wires are safe and effective for use in placing a compatible coronary venous pace/sense lead in the coronary venous vasculature.
Conclusion: The HI-TORQUE Guide Wires with the expanded indication are substantially equivalent to the currently marketed HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wire (K983033, cleared 11/10/98) with regard to intended use. All other aspects of the proposed HI-TORQUE Guide Wires are identical to the currently marketed Guide Wires (K950156, cleared 4/5/95; K963702; cleared 1/22/97; K982083, cleared 9/11/98; K983033, cleared 11/10/98; K991152, cleared 4/29/99; and K002206, cleared 8/24/00).
510(k) Submission for Guidant HI-TORQUE Guide Wires Guidant/CRM - March, 2001
Page 11 of 11
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
MAY - 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Ms. Karen S. Alsop Pr. Regulatory Affairs Associate Guidant Corporation 4100 Hamline Avenue N St. Paul. MN 55112
Re: K021282
Trade Name: LV-1 Hemostasis Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold fitting Regulatory Class: Class II (two) Product Code: DTL
Re: K021283
Trade Name: Guidant Balloon Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO
Re: K021284
Trade Name: EASYTRAK® Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: DQY
Re: K021285
Trade Name: HI-TORQUE® Guide Wires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: April 17, 2002 Received: April 18, 2002
Dear Ms. Alsop:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave leviewed your bootion 910(t) probstantially equivalent (for the indications for use stated in the enclosures) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, onolood 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 approvial of a provisions of the Act. The general controls provisions of the Act include
3
Page 2 - Ms. Karen S. Alsop
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 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 vours.
DaStiller
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular' and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Kod 1285
Device Name: HI-TORQUE®BALANCE MIDDLEWEIGHT™ Guide Wire HI-TORQUE EXTRA S'PORT™ Guide Wire HI-TORQUE IRON MANTM Guide Wire HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire HI-TORQUE BALANCE TREK™ Guide Wire HI-TORQUE WHISPER™ LS and MS Guide Wires
Indications for Use:
The HI-TORQUE Guide Wire is intended for general intravascular use to aid in the selective placement of interventional devices and implantable coronary venous leads in the coronary and/or peripheral vasculature during diagnostic and/or therapeutic procedures.
(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 _ (Optional Format 1-1-96)
MegacMginsh
for Donna-Bea Tillman
of Cardiovascular & Respiratory Devic