(14 days)
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.
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.
Here's an analysis of the provided documents regarding the acceptance criteria and study for the GUIDANT LV-1 HEMOSTASIS VALVE:
Acceptance Criteria and Device Performance:
The provided documents do not contain a table of acceptance criteria or reported device performance metrics. The 510(k) summary only states that the device is "substantially equivalent" to a predicate device based on its design, materials, method of operation, and intended use. This implies that the device is expected to perform similarly to the predicate, but specific quantifiable acceptance criteria and performance data are not disclosed in these public summaries.
Detailed Study Information (Based on available documents):
Given the provided text, a comprehensive response to many of the detailed study questions cannot be fully constructed because the 510(k) summary format does not typically include the granular detail of a full study report. However, I can extract and infer information where possible and explicitly state what is not available.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
| (No specific quantitative or qualitative criteria are detailed in the 510(k) summary for this device.) | (No specific performance data is reported in the 510(k) summary.) |
Explanation: The 510(k) summary states "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)." This is the primary "finding" of the review, but it does not present specific acceptance criteria or performance numbers for the LV-1 valve itself.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not provided. The 510(k) summary does not mention any specific test set or clinical study with a defined sample size for the LV-1 Hemostasis Valve. The substantial equivalence claim is based on comparing the device's features to a predicate.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not provided. No clinical data is presented, so data provenance is not applicable here.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable. No expert ground truth establishment for a test set is discussed in these documents. The substantial equivalence hinges on design and intended use comparison.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No test set or related adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No. The documents do not indicate that a MRMC comparative effectiveness study was performed. These types of studies are typically for image analysis or diagnostic devices where human reader performance is a key metric. This device is a mechanical accessory.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study Done: No. This device is a mechanical accessory (hemostasis valve), not an algorithm or software. Therefore, an "algorithm only" standalone performance study is not relevant or described.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. Since no clinical studies or evaluations generating performance data are detailed, there is no discussion of ground truth in this context. The "ground truth" for substantial equivalence is the functional characteristics and safety profile of the predicate device.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is a mechanical accessory undergoing a 510(k) submission based on substantial equivalence to a predicate. Machine learning or AI models requiring a training set are not mentioned as part of its development or evaluation.
9. How Ground Truth for the Training Set Was Established:
- How Ground Truth Was Established: Not applicable. As no training set or AI model is described, this question is not relevant.
Summary of What Can Be Inferred from 510(k) Submissions:
It is crucial to understand that 510(k) summaries, by their nature, are relatively brief overviews provided by the applicant to demonstrate substantial equivalence to a legally marketed predicate device. They often do not contain the detailed study protocols, raw data, or comprehensive performance metrics that would be found in a full clinical trial report or a more extensive PMA (Premarket Approval) application.
For devices like the LV-1 Hemostasis Valve, which are considered accessories and rely on physical function, the "proof" often comes from:
- Bench testing: Demonstrating sealing capabilities, fluid flow, wire compatibility, and material integrity under various conditions (though not detailed here).
- Biocompatibility testing: Ensuring the materials are safe for human contact.
- Sterility validation: Ensuring the device can be sterilized and maintained sterile.
- Comparison to predicate: Highlighting identical or similar design features, materials, and intended use as a device already on the market.
The provided documents confirm that the FDA found the device "substantially equivalent" to the predicate, meaning it is considered as safe and effective as the predicate device for its stated indications for use.
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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
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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
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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
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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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§ 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.