(560 days)
Not Found
No
The document describes a physical medical device (balloon catheter) and its materials, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is intended to facilitate the placement of interventional devices, not to directly treat or diagnose a disease.
No
The device is described as facilitating the placement of interventional devices during procedures, not for generating diagnostic information itself.
No
The device description explicitly states it is a catheter with a shaft, hub, and balloon made from physical materials (Pebax and latex), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "facilitat[ing] the placement of interventional devices during diagnostic and interventional cardiovascular procedures." This describes a device used within the body for a medical procedure, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a catheter with a balloon, designed for insertion into the cardiovascular system. This is consistent with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Percu-Pro™ Messenger Balloon Catheter is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Percu-Pro™ Messenger Balloon Catheter is intended to facilitate the placement of interventional devices during diagnostic and interventional cardiovascular procedures. The device is not intended for coronary or neurovascular use.
Product codes
DYG
Device Description
The Cardiosolutions Percu-Pro™ Messenger Balloon Catheter is a 5Fr catheter with a bifurcated proximal hub. The catheter shaft and connection ends are made from Pebax and the distal tip balloon is made from latex.
Mentions image processing
radiopaque and are useful for viewing the position of the catheter during insertion and manipulation.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular
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
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices, However, testing was conducted in accordance with protocols based on the requirements of industry standards and FDA Guidance documents. Non-clinical testing included: biocompatibility, catheter tensile strength; balloon bond tensile strength; multiple inflation to burst; marker band adherence; and Insertion and withdrawal force testing.
Key Metrics
Not Found
Predicate Device(s)
K051137, K961999, K010853, K083384
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).
0
510(k) Summary
JUL 1 4 2011
As required by section 807.92(c)
| Company Name | Cardiosolutions Inc. |
|---|---|
| Address | 75 Mill St. |
| Stoughton, MA 02072 | |
| Phone: 781-344-0801 | |
| Fax: 781-344-0803 | |
| Contact Person | Michele Lucey |
| Date Prepared | May 10, 2011 |
| Trade Name | Percu-Pro™ Messenger Balloon Catheter |
| Common Name | Intravascular Guiding Catheter |
| Classification Name | Flow-Directed Catheter |
| Product Code | DYG |
| Regulation # | 21 CFR 870.1240 |
| Class | 2 |
| Panel | Circulatory System Devices Panel |
| Predicate Devices | TechDevice Percutaneous Occlusion Balloon Catheter K051137 |
| Boston Scientific Schneider Guider™ Softip™ Guiding Catheter K961999, K010853 | |
| Biosensors International Flow Directed Thermodilution Catheter K083384 | |
| Device Description | The Cardiosolutions Percu-Pro™ Messenger Balloon Catheter is a 5Fr catheter with a |
| bifurcated proximal hub. The catheter shaft and connection ends are made from Pebax | |
| and the distal tip balloon is made from latex. | |
| Intended Use | The Percu-Pro™ Messenger Balloon Catheter is intended to facilitate the placement of |
| interventional devices during diagnostic and interventional cardiovascular procedures. | |
| The device is not intended for coronary or neurovascular use. | |
| Safety and | |
| Performance | |
| Testing | No performance standards have been established under Section 514 of the Food, Drug |
| and Cosmetic Act for these devices, However, testing was conducted in accordance | |
| with protocols based on the requirements of industry standards and FDA Guidance | |
| documents. Non-clinical testing included: biocompatibility, catheter tensile strength; | |
| balloon bond tensile strength; multiple inflation to burst; marker band adherence; and | |
| Insertion and withdrawal force testing. | |
| Substantial | |
| Equivalence | The Percu-Pro™ Messenger Balloon Catheter is identical in design to the TechDevice |
| Occlusion Balloon Catheter K051137 with the exception of the platinum-iridium | |
| marker bands that are contained in the Percu-Pro Device but not in the TechDevice. By | |
| identical we mean that the Percu-Pro device is made from the same materials, is | |
| specified by the same design, and is manufactured by the same processes used for the | |
| TechDevice Occlusion Balloon Catheter. These marker bands have been added | |
| because they are radiopaque and are useful for viewing the position of the catheter | |
| during insertion and manipulation. | |
| The Percu-Pro™ Messenger Balloon Catheter has the same intended use as the Boston | |
| Scientific Schneider™ Softip™ Guiding Catheter( K961999), is made from similar | |
| materials, and is similar in length and diameter. Both devices have multi-lumen to | |
| allow for insertion of a guide wire to permit access for other devices. The Boston | |
| Scientific device is provided with multiple distal tip designs with varying stiffnesses to | |
| accommodate different uses, the Percu-Pro™ device is offered in only one | |
| configuration. Based upon a significant history of use for the same purpose in the | |
| same area of the body new questions regarding safety are not raised. | |
| The Percu-Pro™ Messenger Balloon Catheter incorporates an inflatable balloon tip to | |
| allow for flow direction for catheter tip positioning. This intended use and design | |
| feature are substantially equivalent to the Biosensors Thermodilution Catheter | |
| (K083384) which defines a balloon tip to allow for flow direction for catheter tip | |
| positioning in their intended use statement by means of an inflatable balloon tip. | |
| The Percu-Pro™ Messenger Balloon Catheter is substantially equivalent to the | |
| predicate devices in terms of intended use, design, materials, technology, and | |
| performance. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cardiosolutions. Inc. c/o Michele Lucey 75 Mill Street Stoughton, MA 02072
JUL 1 4 2011
Re: K094048
Trade/Device Name: Percu-Pro™ Messenger Balloon Catheter Regulation Number: 21 CFR 870.1240 Regulation Name: Flow-directed catheter Regulatory Class: Class II Product Code: DYG Dated: May 10, 2011 Received: May 12, 2011
Dear Ms. Lucey:
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, l'isting of devices, good manufacturing practice, labeling, and prohibitions against misbanding and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Michele Lucey
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
jll
Bram D. Zuckerm
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
12/23/2009
INDICATIONS FOR USE
510(k) Number (if known):
:
Device Name: Percu-Pro™ Messenger Balloon Catheter
Indications for Use:
The Percu-Pro™ Messenger Balloon Catheter is intended to facilitate the placement of interventional devices during diagnostic and interventional cardiovascular procedures. The device is not intended for coronary or neurovascular use.
Prescription Use
AND/OR Over-The_Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOTR WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Cardiovascular Devices | |
| 510(k) Number | K094048 |