(257 days)
The Guidant Bleedback Control Valve is intended for maintaining a seal around The Outdailt Dioodback Ochices with an outside diameter of less than 0.185" in the venous anatomy only, during interventional procedures.
The RAPIDO™ Cut-Away Bleedback Control Valve is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices such as balloon catheters, wires, and pacemaker and defibrillation leads. The RAPIDO™ Cut-Away Bleedback Control Valve has a single adjustable seal that provides control over fluid loss.
The Bleedback Control (BBC) seal is a diaphragm seal with a thin membrane across the inside diameter that forms around diagnostic/ interventional devices as they move into and out of the vasculature. This seal provides minimal fluid loss while not restricting device movement. The BBC seal is open when the cap is depressed, and closed with the cap is released. An open BBC seal allows air and fluid to be purged and allows the advancement/withdrawal of diagnostic/ interventional devices. The seal can be locked open by rotating the cap an eighth clockwise turn when the cap is depressed. To release the lock the cap is rotated clockwise an eighth of a turn.
The acceptance criteria and study proving device performance are described as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet established acceptance criteria | "The results of the verification testing demonstrate that the modified Bleedback Control I he received the established acceptance criteria..." |
| Perform in a manner equivalent to predicate device | "...and perform in a manner equivalent to the predicate device." |
| No new safety or effectiveness issues | "No new safety or effectiveness issues were raised during the testing program." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It generally refers to "verification testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth for testing. The evaluation appears to be based on engineering performance testing against established criteria and comparison to a predicate device.
4. Adjudication Method for the Test Set
No adjudication method is described, as the evaluation is based on performance testing rather than human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device is a medical component, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a physical bleedback control valve, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device appears to be defined by engineering specifications and direct comparison to the performance of the predicate device (COPILOT™ Bleedback Control Valve). This is inferred from statements like "received the established acceptance criteria" and "perform in a manner equivalent to the predicate device."
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm and does not involve a "training set."
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
MAR - 3 2004
1. 510(K) SUMMARY
| Submitter's Name: | Guidant CorporationCRM Division |
|---|---|
| Submitter's Address: | 4100 Hamline AvenueMail Stop F330St. Paul, Minnesota 55112 |
| Telephone:Fax: | (651) 582-4927(651) 582-5134 |
| Contact Person: | Stephanie Isgrigg Robinson |
| Date Prepared: | February 20, 2004 |
| Device Trade Name: | - RAPIDO™ Cut-Away™ Bleedback Control Valve |
| Device Common Name: | Bleedback Control Valve |
| Device Classification Name: | Adaptor, Stopcock, Manifold, Fitting, CardiopulmonaryBypass, Hemostasis Valve |
Device Classification: Class II
Summary of Substantial Equivalence:
The design, materials, method of delivery and intended use features of the modified RAPIDOT™ Cut-Away™ Bleedback Control Valve is substantially equivalent with regard to these features in their predicate device, COPILOT™ Bleedback Control Valve (K991102/06-09-99)
Device Description:
The RAPIDO™ Cut-Away Bleedback Control Valve is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices such as balloon catheters, wires, and pacemaker and defibrillation leads. The RAPIDO™ Cut-Away Bleedback Control Valve has a single adjustable seal that provides control over fluid loss.
The Bleedback Control (BBC) seal is a diaphragm seal with a thin membrane across the inside diameter that forms around diagnostic/ interventional devices as they move into and out of the vasculature. This seal provides minimal fluid loss while not restricting device movement. The BBC seal is open when the cap is depressed, and closed with the cap is released. An open BBC seal allows air and fluid to be purged and allows the advancement/withdrawal of diagnostic/ interventional devices. The seal can be locked open by rotating the cap an eighth clockwise turn when the cap is depressed. To release the lock the cap is rotated clockwise an eighth of a turn.
{1}------------------------------------------------
Intended Use:
The Guidant Bleedback Control Valve is intended for maintaining a seal around The Stickinterventional devices with an outside diameter of less than 0.185" in the venous anatomy only, during interventional procedures.
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 predicate device.
Performance Data:
The results of the verification testing demonstrate that the modified Bleedback Control I he received 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 modified Bleedback Control Valve has the same intended use, technological che needistics, and performance properties as the Guidant approved COPILOT Bleedback Control Valve. Therefore, there are no new safety or effectiveness issues. The modified Bleedback Control Valve is substantially equivalent to the predicate device.
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2004
Guidant Corporation c/o Ms. Stephanie Isgrigg Robinson Regulatory Affairs Associate 4100 Hamline Avenue North St. Paul, MN 55112-57908
Re: K031903
K031903
RAPIDO™ Cut-Away™ Bleedback Control Valve -- Model 7568 Regulation Number: 21 CFR 870.4290 Regulation Number. 21 CFN 870-1270
Regulation Name: Cardiopulmonary Bypass Adapter, Stopcock, Manifold or Fitting Regulatory Class: Class II (two) Product Code: DTZ Dated: February 24, 2004 Received: February 25, 2004
Dear Ms. Robinson:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premier is substantially equivalent (for the indications referenced and nave decembred the acresed predicate devices marketed in interstate for use stated in the encrosule) to regally manced producal Device Ameridae, or to
commerce prior to May 28, 1976, the enactment date of the fieders' Food. Drug commerce prior to May 28, 1970, the endomic and the provisions of the Federal Food, Drug, devices that have been recials in accerance while a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presidians of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, belyer in the genirements for annual registration, listing of general controls provisions of the fielding, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entralign Parts 800 to 898. In addition, FDA may be found in the Ood of reams concerning your device in the Federal Register.
{3}------------------------------------------------
Page 2 – Ms. Stephanie Isgrigg Robinson
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 that I DA has made a and regulations administered by other Federal agencies. You must of any I cuclar statutes and regarants, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I art 607), laboring (21 CFR Part 820); and if applicable, the electronic forth in the quant) systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction oonly of the new (seting your device as described in your Section 510(k) This icher wifi anow you to ough mains of substantial equivalence of your device to a legally premarket notification: "The Pitchings of and this, or 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), please If you desire specific of Compliance at (301) 594-4646. Additionally, for questions on the contact the Office of Cour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (2017) 594 4057. Albox Part 807.97) you may obtain. Other general information on your premarket nonneation (a Act may be obtained from the Division of Small Manufacturers, Itsponsional 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
Sincercly yours,
cz
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
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Guidant Bleedback Control Valve is intended for maintaining a seal around The Outdailt Dioodback Ochices with an outside diameter of less than 0.185" in the venous anatomy only, during interventional procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write Below This Line-continue on another Page IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign
Division of Cam
510(k) Num+
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”