(72 days)
Not Found
No
The device description focuses on the mechanical and material properties of a catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as a catheter used to facilitate the placement of guidewires and other interventional devices for accessing regions of the vasculature, not for treating a disease or condition itself.
No
The device description indicates it is a catheter used to access the vasculature and facilitate placement of guidewires and other interventional devices. It is explicitly for interventional use, not for diagnosing conditions.
No
The device description clearly details a physical catheter with a stainless steel shaft, distal tip, and other hardware components. It is not solely software.
Based on the provided information, the BridgePoint Medical CrossBoss™ Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used in conjunction with a guidewire to access discrete regions of the coronary or peripheral vasculature and facilitate placement of guidewires and other interventional devices. This describes a device used within the body for a medical procedure, not a device used to test samples outside the body.
- Device Description: The description details a physical catheter designed for insertion into blood vessels, with features like a guidewire lumen, a distal tip for navigation, and a torque device for manipulation. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CrossBoss Catheter is an interventional device used directly in the patient's body during a procedure.
N/A
Intended Use / Indications for Use
The BridgePoint Medical CrossBoss™ Catheter is intended to be used in conjunction with a guidewire in order to access discrete regions of the coronary or peripheral vasculature. It may be used to facilitate placement of guidewires and other interventional devices.
Product codes
DOY
Device Description
The CrossBoss Catheter is a single use over the wire disposable percutaneous catheter consisting of a full length coiled stainless steel shaft with polyester and polyurethane exterior. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. The distal shaft transitions to an enlarged (1mm diamcter) rounded distal tip. This stainless steel tip provides an atraumatic element that is intended to enhance the catheter's ability to move within the vasculature with reduced risk of arterial tissue engagement while providing radiopaque visibility. The distal portion of the CrossBoss Catheter is hydrophilic coated to enhance lubricity. The proximal portion includes an internal stainless steel hypotube stiffener that provides the additional tolerance to push. A torque device, coaxially positioned over the proximal portion of the CrossDoos Catalors, frinilar to a guidewire torque device) is positionable along the proximal portion of the on insures the torque input generated by the user remains within the torsional operating strength of the catheter shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K081130 - CrossBoss™ Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
BridgePoint Medical Special 510k - CrossBoss Catheter
AUG 2 8 2009
9. 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| 510(k) Number: | K091841 |
|---|---|
| ---------------- | --------- |
Applicant Information:
Name: Address: BridgePoint Medical 2800 Campus Drive, #50 Plymouth, MN 55441 Phone: 763-225-8500 Fax: 763-225-8718
| Contact Person: | Jill Munsinger |
|---|---|
| Phone Number: | office: 763-225-8510 / cell: 651-270-0572 |
| E-mail: | jmunsinger@bridgepointmedical.com |
Device Information:
| Classification: | Class II Percutaneous Catheter |
|---|---|
| Trade Name: | CrossBoss™ Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter |
Predicate Devices:
The BridgePoint Medical CrossBoss Catheter is substantially equivalent in intended use, method of operation and technical aspects to the following predicate device:
K081130 - CrossBoss™ Catheter
Device Description:
The CrossBoss Catheter is a single use over the wire disposable percutaneous catheter consisting of a full length coiled stainless steel shaft with polyester and polyurethane exterior. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. The distal shaft transitions to an enlarged (1mm diamcter) rounded distal tip. This stainless steel tip provides an atraumatic element that is intended to enhance the catheter's ability to move within the vasculature with reduced risk of arterial tissue engagement while providing radiopaque visibility. The distal portion of the CrossBoss Catheter is hydrophilic coated to enhance lubricity. The proximal portion includes an internal stainless steel hypotube stiffener that provides the
1
additional tolerance to push. A torque device, coaxially positioned over the proximal additional toferance to pass: "I reserveded a comfortable user interface for device portion of the CrossDoos Catalors, frinilar to a guidewire torque device) is positionable manipulation: "The torque as the catheter and includes a torsion release safety along the proximal portion of the on insures the torque input generated by the user remains within the torsional operating strength of the catheter shaft.
Intended Use:
The BridgePoint Medical CrossBoss™ Catheter is intended to be used in conjunction with The Dridger out in order to access discrete regions of the coronary or peripheral vasculature. It a guidewire in order went of guidewires and other interventional devices.
Comparison to Predicate Device(s):
The design of the BridgePoint Medical CrossBoss™ Catheter with revised instructions for use is identical to the original cleared CrossBoss™ Catheter (K081130) with the exception of an additional contraindication.
Summary:
Based upon the intended use and descriptive information provided in this pre-market Dusod upon the BridgePoint CrossBoss™ Catheter has been shown to be substantially equivalent to the currently marketed predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, with its wings and body represented by thick, curved lines. The bird is oriented towards the upper right of the image. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Bridgepoint Medical, Inc. c/o Ms. Jill Munsinger Regulatory Affairs 2800 Campus Drive, #50 Plymouth, MN 55441
AUG 2 8 2009
Re: K091841
Trade/Device Name: BridgePoint Medical CrossBoss™ Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: August 6, 2009 Received: August 7, 2009
Dear Ms. Munsinger:
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 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. Jill Munsinger
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 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.gov/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/ReportaProblem/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
BridgePoint Medical Special 510k - CrossBoss Catheter
8. INDICATIONS FOR USE STATEMENT
510(k) Number: (TBA) KO9 l 84 l
BridgePoint Medical CrossBoss™ Catheter Device Name:
Indications For Use:
The BridgePoint Medical CrossBoss™ Catheter is intended to be used in conjunction with a guidewire in order to access discrete regions of the coronary or peripheral vasculature. It may be used to facilitate placement of guidewires and other interventional devices.
Prescription Use x AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K091841 |
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