(14 days)
Not Found
No
The description focuses on mechanical components and their function in maintaining a seal and facilitating guide wire movement. There is no mention of AI or ML technologies.
No
Explanation: The device is a delivery system accessory for maintaining a seal during lead placement and introduction/withdrawal of interventional devices, which are procedural functions, not therapeutic ones.
No
The device is described as a hemostasis valve used to maintain a seal around a lead terminal pin and facilitate the introduction/withdrawal of interventional devices, rather than to diagnose a condition.
No
The device description clearly describes a physical medical device (valve, delivery system accessory, seals, side arm port, wire guide) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to maintain a seal around a lead terminal pin during a medical procedure (implanting a left ventricular lead). This is a surgical/interventional accessory, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a mechanical valve and its function in a delivery system for a lead implant. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or any other biological specimen. The device's function is purely mechanical and related to maintaining a seal during a procedure.
Therefore, the LV-1 Hemostasis Valve with the Wire Guide is a medical device used in an interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LV-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal around the LV-1 lead terminal pin while flushing the lead lumen and/or during introduction/withdrawal of interventional devices.
Product codes (comma separated list FDA assigned to the subject device)
DTL
Device Description
The LV-1 HEMOSTASIS VALVE, Model 6789 is a delivery system accessory for use in the implant of a GUIDANT left ventricular (LV-1) lead through the coronary sinus. The tip of the valve attaches to the LV-1 lead terminal pin and maintains a seal. A side arm port allows the lumen seal to be flushed and a bleedback control seal allows the introduction of an appropriately sized guide wire through an inside diameter of 0.070" (1.8 mm) while providing a seal.
The bleedback control seal is a diaphragm seal that forms around a guide wire as it moves into and out of the lead lumen, catheter, and vasculature. This seal restricts fluid loss without significantly inhibiting wire movement. The bleedback control seal is easily penetrated by the wire guide, a small plastic funnel accessory that facilitates the introduction of a guide wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary sinus
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)
Not Found
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
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
MAY 0 2 2002
Appendix A - 510(k) Summary
Submitter
GUIDANT CORPORATION Cardiac Rhythm Management 4100 Hamline Avenue St. Paul, MN 55112
Contact: Michael Husby, Sr. Regulatory Affairs Associate Tel: 651/ 582-5774, Fax: (651) 582-5134
Date
November 30, 2001
Device name
Device Trade Name: Device Common Name: Device Classification Name: LV-1 HEMOSTATIC VALVE Hemostatic Valve Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Class II
Device Classification:
Summary of substantial equivalence
The design, materials, method of operation, and intended use features of the GUIDANT LV-1™ Bleedback Control Valve are substantially equivalent to those of the predicate device, the GUIDANT COPILOT™ Bleedback Control Valve (K991102).
Device description
The LV-1 HEMOSTASIS VALVE, Model 6789 is a delivery system accessory for use in the implant of a GUIDANT left ventricular (LV-1) lead through the coronary sinus. The tip of the valve attaches to the LV-1 lead terminal pin and maintains a seal. A side arm port allows the lumen seal to be flushed and a bleedback control seal allows the introduction of an appropriately sized guide wire through an inside diameter of 0.070" (1.8 mm) while providing a seal.
The bleedback control seal is a diaphragm seal that forms around a guide wire as it moves into and out of the lead lumen, catheter, and vasculature. This seal restricts fluid loss without significantly inhibiting wire movement. The bleedback control seal is easily penetrated by the wire guide, a small plastic funnel accessory that facilitates the introduction of a guide wire.
47
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of three abstract shapes that resemble a human figure with outstretched arms, symbolizing care and protection. The overall design is simple, clean, and conveys a sense of government authority and public service.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2002
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 above and have determined the device is substantially equivalent (for the indications for use stated in the enclosures) 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
2
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 11 Jour do not additional controls. Existing major regulations affecting your device can be found in the . burger to been a 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 I 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 r 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 11 Jul desire spotial or 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 roop classimer 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.
Desh Tuller
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular' and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Appendix C - Indications for Use Statement
Applicant: GUIDANT CORPORATION
510(k) Number (if known): KO Q L 2
Device Name: LV-1 HEMOSTASIS VALVE
Indications for Use:
The LV-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal around the LV-1 lead terminal pin while flushing the lead lumen and/or during introduction/withdrawal of interventional devices.
(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
Division of Cardiovascular & Respiratory Devices
510(k) Number K021282
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