(30 days)
The Guidant Hemostasis Valve is used to maintain hemostasis around catheters percutaneously introduced into the vasculature.
The Rotating Hemostasis Valve is intended for maintaining a fluid- tight seal around devices, including implantable coronary venous leads, during the implant procedure.
The RAPIDO™ Cut-Away Rotating Hemostasis 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 Rotating Hemostasis Valve has a single adjustable seal that provides control over fluid loss.
The seal is a Tuohy-Borst type that may be adjusted by rotating the cap clockwise to close, and counterclockwise to open. The seal is adjusted to control leakage and device movement. An open RHV seal allows air and fluid to be purged while allowing the advancement/withdrawal of diagnostic/ interventional devices
I am sorry, but the provided text does not contain the detailed information needed to fill out all aspects of your request. The document is a 510(k) summary for a medical device and primarily focuses on establishing substantial equivalence to a predicate device.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance:
The document states: "The results of the verification testing demonstrate that the modified Rotating Hemostasis Valve meets the established acceptance criteria and perform in a manner equivalent to the predicate device." However, it does not provide a specific table of acceptance criteria or the reported performance data. It only makes a general statement of compliance.
What is available form the text:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Meets established acceptance criteria and performs equivalently to the predicate device. |
What is missing: The specific quantitative or qualitative acceptance criteria used for the device and the detailed results of the performance testing against these criteria.
2. Sample size used for the test set and the data provenance:
The document does not specify the sample size used for any testing. It also does not mention data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present in the provided text. The document describes a medical device, and the "ground truth" concept as typically applied to AI/imaging studies (e.g., expert consensus on image interpretation) is not relevant in this context of a physical device's performance testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present and is not typically relevant for the type of device testing described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This type of study is not mentioned in the document. An MRMC study is relevant for AI-assisted diagnostic tools, not for a physical hemostasis valve.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is a physical hemostasis valve, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" as typically used in AI/diagnostic studies is not applicable here. For a physical device, testing typically involves engineering tests, material compatibility tests, and functional performance tests against predefined specifications. The "ground truth" would be the direct measurement or observation of the device's physical properties and functional performance.
8. The sample size for the training set:
There is no mention of a training set as this is a physical medical device, not an AI model.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
In summary, the provided text is a 510(k) summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through verification testing, but it does not disclose the specific details of that testing (e.g., acceptance criteria, test results, sample sizes) that would be needed to answer most of your detailed questions. The concepts of "ground truth," "training set," "experts," and "AI performance" are not relevant to this type of regulatory submission for this device.
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1. 510(K) SUMMARY
| Submitter's Name: | Guidant CorporationCRM Division |
|---|---|
| Submitter's Address: | 4100 Hamline AvenueMail Stop F330St. Paul, Minnesota 55112 |
| Telephone: | (651) 582-4927 |
| Fax: | (651) 582-5134 |
| Contact Person: | Stephanie Isgrigg Robinson |
| Date Prepared: | May 30, 2003 |
| Device Trade Name: | Rotating Hemostasis Valve |
| Device Common Name: | Hemostasis 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 Rotating Hemostasis Valve is substantially equivalent with regard to these features in their predicate device, Rotating Hemostasis Valve (K854261/12-04-85)
Device Description:
The RAPIDO™ Cut-Away Rotating Hemostasis 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 Rotating Hemostasis Valve has a single adjustable seal that provides control over fluid loss.
The seal is a Tuohy-Borst type that may be adjusted by rotating the cap clockwise to close, and counterclockwise to open. The seal is adjusted to control leakage and device movement. An open RHV seal allows air and fluid to be purged while allowing the advancement/withdrawal of diagnostic/ interventional devices
Intended Use:
The Guidant Hemostasis Valve is used to maintain hemostasis around catheters percutaneously introduced into the vasculature.
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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 Rotating Hemostasis Valve meets 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 Rotating Hemostasis Valve has the same intended use, technological characteristics, and performance properties as the Guidant approved Rotating Hemostasis Valve. Therefore, there are no new safety or effectiveness issues. The modified Rotating Hemostasis Valve is substantially equivalent to the predicate device.
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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 or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2003 JUL -
Guidant Corporation c/o Ms. Stephanie Isgrigg Robinson 4100 Hamline Avenue North St. Paul, MN 55112-5798
Re: K031688
RAPIDOTM Cut-Away™ Rotating Hemostasis Valve Regulation Number: 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (two) Product Code: 74 DTL Dated: May 30, 2003 Received: June 2, 2003
Dear Ms. Robinson:
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 may publish further announcements concerning your device in the Federal Register.
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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 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Jusar H. Azsor
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
| 510(k) Number | K031688 |
|---|---|
| Device Name | RAPIDOTM Cut-Away™ Rotating Hemostasis Valve |
| Indications for Use | The Rotating Hemostasis Valve is intended for maintaining a fluid- tight seal around devices, including implantable coronary venous leads, during the implant procedure. |
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 Use_
JhusdOly for BPZ
(Divi
Divis
510(k) Number K031688
Prescription IIse Only
§ 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.