(30 days)
K854261/12-04-85
Not Found
No
The description focuses on mechanical function and does not mention any computational or learning capabilities.
No
The device is described as a hemostasis valve used to maintain a fluid-tight seal around catheters and leads during procedures to control fluid loss, rather than to treat a disease or condition itself.
No
Explanation: The device is a hemostasis valve used to maintain a fluid-tight seal around catheters and leads during procedures. Its primary function is to control fluid loss and device movement, not to diagnose medical conditions or provide diagnostic information. While it may be used in conjunction with diagnostic devices, it is not a diagnostic device itself.
No
The device description clearly describes a physical valve with a seal and adjustable cap, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to maintain hemostasis around catheters and devices introduced into the vasculature during procedures. This is a function performed in vivo (within the living body) to manage bleeding and fluid loss during a medical procedure.
- Device Description: The description reinforces this by detailing its use with interventional and diagnostic devices during vascular procedures, focusing on maintaining a fluid-tight seal.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device's function is entirely related to managing the physical process of introducing and manipulating devices within the body during a procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
74 DTL
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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.
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.
K854261/12-04-85
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
1. 510(K) SUMMARY
| Submitter's Name: | Guidant Corporation
CRM Division |
|-----------------------------|-----------------------------------------------------------------------------------|
| Submitter's Address: | 4100 Hamline Avenue
Mail Stop F330
St. 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, Cardiopulmonary
Bypass, 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.
1
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.
2
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.
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 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
4
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