(14 days)
Not Found
No
The summary describes a physical medical device (a balloon catheter) used for occlusion and contrast administration. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on the physical function of the catheter.
No
The device is described as assisting in obtaining venograms by occluding the coronary sinus, which is a diagnostic procedure, not a therapeutic one. Its function is to facilitate imaging, not treat a condition.
Yes
The device is intended for use in obtaining venograms, which are diagnostic images of veins. The clinical investigation explicitly states the function of the device was "to aid in obtaining a venogram by occluding the coronary sinus," indicating a diagnostic purpose.
No
The device description clearly describes a physical catheter with a balloon, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is a catheter intended for use within the body to occlude the coronary sinus and aid in obtaining venograms. This is an in vivo procedure.
- Lack of Specimen Testing: There is no mention of the device being used to test or analyze any biological specimens. Its function is purely mechanical and procedural within the body.
Therefore, based on the provided information, this Balloon Catheter is a medical device used for an in vivo procedure, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The catheter is intended for use in obtaining venograms by occluding the coronary sinus.
Product codes
DQO
Device Description
The Balloon Catheter is a 6 F occluding catheter with a latex balloon. It is available in three lengths: 60 cm (Model 6746), 90 cm (Model 6714), and 110 cm (Model 6747). All models provide a balloon with an inflation capacity of 1 cc and accept a maximum guide wire diameter of .035 inches. The inflated balloon diameter is 10 mm.
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
In Vivo Testing: An animal study was conducted to evaluate the performance of the Balloon Catheter when used as a conduit for contrast dye administration in the coronary vein. The results of the in vivo animal evaluation showed that the performance of the Balloon Catheter is acceptable within the coronary vein. These results support use for the proposed indications.
Human Clinical Testing Data: The Balloon Catheter was evaluated in a clinical investigation. The function of the Balloon Catheter in this clinical investigation was to aid in obtaining a venogram by occluding the coronary sinus. The results demonstrated that the Balloon Catheter is safe and effective for use in occluding the coronary sinus to obtain a venogram.
Key Metrics
Not Found
Predicate Device(s)
Cardima VUEPORT Guiding Catheter (K973298)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
510(k) Summary
-
- Device Name: Guidant Balloon Catheter, Models 6714, 6746, 6747
-
- Devices to Which Equivalence is Claimed: Arrow Balloon Wedge Pressure . Catheter with regard to indications for use and design, materials, manufacturing process, packaging process, sterilization process, quality control procedures, and shelf life of the device (pre-enactment device); Cardima VUEPORT Guiding Catheter (K973298) with regard to indications for use.
-
- Indication for Use: The catheter is intended for use in obtaining venograms by occluding the coronary sinus.
-
- Device Description: The Balloon Catheter is a 6 F occluding catheter with a latex balloon. It is available in three lengths: 60 cm (Model 6746), 90 cm (Model 6714), and 110 cm (Model 6747). All models provide a balloon with an inflation capacity of 1 cc and accept a maximum guide wire diameter of .035 inches. The inflated balloon diameter is 10 mm.
- Summary of Technological Characteristics: This notification concerns a labeling 5. modification to the indications for a currently marketed device. There are no changes to the design, materials, manufacturing process, packaging process, sterilization process, or shelf life of the subject device.
-
- Summary of Substantial Equivalence: This notification concerns a labeling modification to the indications for the currently marketed device. Substantial equivalence of the proposed indications to the current indications for use are supported by animal GLP and human clinical data. All other aspects of the proposed Guidant Balloon Catheter are identical to the currently marketed Arrow Balloon Wedge Pressure Catheter (pre-enactment device). The indications for use are also substantially equivalent to those of the Cardima VUEPORT Guiding Catheter (K973298).
7. Testing Data:
In Vivo Testing
An animal study was conducted to evaluate the performance of the Balloon Catheter when used as a conduit for contrast dye administration in the coronary vein. The results of the in vivo animal evaluation showed that the performance of the Balloon Catheter is acceptable within the coronary vein. These results support use for the proposed indications.
510(k) Submission for the Guidant Balloon Catheter Guidant/CRM - March, 2001
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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is black. The background is white. The text is centered in the image.
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure.
Public Health Service
MAY - 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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
Human Clinical Testing Data:
The Balloon Catheter was evaluated in a clinical investigation. The function of the Balloon Catheter in this clinical investigation was to aid in obtaining a venogram by occluding the coronary sinus. The results demonstrated that the Balloon Catheter is safe and effective for use in occluding the coronary sinus to obtain a venogram.
-
- Conclusion: The Balloon Catheter with the modified indication is substantially equivalent to the currently marketed Arrow Balloon Wedge Pressure Catheter (preenactment device) with regard to indications for use, design, materials, manufacturing process, packaging process, sterilization process, or shelf life of the subject device. Animal GLP and human clinical data support the modified indication for use. The modified indication for use is also substantially equivalent to the currently marketed Cardima VUEPORT Guiding Catheter (K973298).
510(k) Submission for the Guidant Balloon Catheter Guidant/CRM - March, 2001
- Conclusion: The Balloon Catheter with the modified indication is substantially equivalent to the currently marketed Arrow Balloon Wedge Pressure Catheter (preenactment device) with regard to indications for use, design, materials, manufacturing process, packaging process, sterilization process, or shelf life of the subject device. Animal GLP and human clinical data support the modified indication for use. The modified indication for use is also substantially equivalent to the currently marketed Cardima VUEPORT Guiding Catheter (K973298).
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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 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.
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 and additionally 21 CFR Part 809.10 for 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 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,
Reseller
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular' and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): (To be assigned by FDA)
KO 21282
Device Name: Guidant Balloon Catheter
Indications for Use:
The catheter is intended for use in obtaining venograms by occluding the coronary sinus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter (Optional Format 1-1-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021283
510(k) Submission for the Guidant Balloon Catheter Guidant/CRM - March, 2001
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