(26 days)
No
The device description and performance studies focus on mechanical recanalization and physical markings, with no mention of AI or ML technologies.
Yes
The device is designed to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy, which is a medical procedure to remove plaque from arteries. This direct intervention on the body to treat a medical condition qualifies it as a therapeutic device.
No
The device is designed to facilitate the placement of guidewires through chronic total occlusions via atherectomy. Its description focuses on mechanical recanalization and catheter advancement tools, not on diagnosing conditions.
No
The device description explicitly lists hardware components including a generator, foot switch, transducer, and catheter.
Based on the provided information, the CROSSER CTO Recanalization System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to facilitate the placement of guidewires beyond peripheral artery chronic total occlusions via atherectomy. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device description details a mechanical system that uses high-frequency vibrations to recanalize obstructed arteries. This is a physical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. The CROSSER system is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The CROSSER CTO Recanalization System indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy.
The CROSSER CTO Catheter is only intended for use with the CROSSER Generator. Refer to the CROSSER Generator Manual of Operations for proper use.
Product codes
PDU
Device Description
The CrossER® Catheter is a high frequency mechanical recanalization system designed for recanalization of obstructed peripheral arteries. The system consists of an electronic CROSSER® Generator, Foot Switch, high frequency Transducer, and CROSSER® Catheter. The CrossER® CTO Recanalization catheter, which is intended for one procedure only, is connected to the CROSSER® Generator through the high frequency Transducer. The Foot Switch is used to activate the CROSSER® Recanalization System. The CROSSER® Generator and Transducer convert AC power into high frequency mechanical vibrations, which are propagated to the tip of the CROSSER® Catheter.
The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GEOALIGN® Markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GEOALIGN® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GEOALIGN® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GEOALIGN® Marking System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral artery
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
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using the FDA quidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessment procedures, the following nonclinical tests were performed:
- GEOALIGN® Marking Legibility
- Dimensional Analysis:
- GEOALIGN® Marking Location (Distal Position)
- GEOALIGN® Marking Location (Proximal Position)
- GEOALIGN® Marking Spacing
- Catheter Outer Diameter (OD)
- GEOALIGN® Marking durability with Support Catheters
- GEOALIGN® Marking durability with Introducer Sheaths
- GEOALIGN® Marking compatibility with Support Catheters
- GEOALIGN® Marking compatibility with Introducer Sheaths
The results demonstrate that the technological characteristics and performance criteria of the CROSSER® CTO Recanalization Catheter is comparable to the predicate device and that it performs substantially equivalent to the legally marketed predicate device.
Biocompatibility and chemical characterization demonstrate the subject device is biocompatible and does not elicit any substances at levels of concern as result of this change.
Stability shelf life testing demonstrates the device is has the appropriate shelf life as labeled.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping and merging into a single form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2016
Bard Peripheral Vascular, Inc. Ms. Melanie Hadlock Regulatory Affairs Specialist 1625 West 3rd Street Tempe, Arizona 85281
Re: K161208
Trade/Device Name: Crosser CTO Recanalization Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: April 27, 2016 Received: April 28, 2016
Dear Ms. Hadlock:
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. Please note: CDRH does not evaluate information related to contract liability 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.
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for 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
510(k) Number (if known) K161208
Device Name CROSSER CTO Recanalization Catheter
Indications for Use (Describe)
The CROSSER CTO Recanalization System indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy.
The CROSSER CTO Catheter is only intended for use with the CROSSER Generator. Refer to the CROSSER Generator Manual of Operations for proper use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary 21 CFR 807.92
1. Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc.
1625 West 3rd Street
Tempe, Arizona 85281 |
|------------|--------------------------------------------------------------------------------|
| Phone: | 480.350.6083 |
| Fax: | 480.449.2546 |
| Contact: | Melanie Hadlock, Regulatory Affairs Specialist |
| Date: | April 27, 2016 |
2. Subject Device:
| Device Trade Name: | CROSSER® CTO Recanalization Catheter |
|---|---|
| Common or Usual Name: | Catheter for Crossing Total Occlusions |
| Classification: | Class II |
| Classification Name: | Catheter for Crossing Total Occlusions |
| Review Panel: | Cardiovascular |
| Regulation Number: | 21 CFR 870.1250 |
3. Predicate Device:
CROSSER® CTO Recanalization Catheter (K112308)
Reference device: ULTRAVERSE® 035 PTA Dilatation Catheter (K142261)
4. Summary of Change:
The GEOALIGN® Marking System has been added to the device. The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip.
5. Device Description:
The CrossER® Catheter is a high frequency mechanical recanalization system designed for recanalization of obstructed peripheral arteries. The system consists of an electronic CROSSER® Generator, Foot Switch, high frequency Transducer, and CROSSER® Catheter. The CrossER® CTO Recanalization catheter, which is intended for one procedure only, is connected to the CROSSER® Generator through the high frequency Transducer. The Foot Switch is used to activate the CROSSER® Recanalization System. The CROSSER®
4
Generator and Transducer convert AC power into high frequency mechanical vibrations, which are propagated to the tip of the CROSSER® Catheter.
The GEOALIGN® Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The GEOALIGN® Markings are designated on the catheter shaft by 1cm increment bands with an accuracy within ±1mm. The distance from the distal catheter tip is labeled in 10cm increments. Thicker bands denote the midway point (5cm) between the labeled distances. The GEOALIGN® Marking System is designed to be used as a tool to externally measure the intravascular advancement and/or retraction of the catheter. This can provide an intravascular reference regarding the location of the distal tip of the catheter or an approximate intravascular length measurement between two points. The GEOALIGN® Marking System may also facilitate geographic alignment of an adjunctive therapy that includes the same GEOALIGN® Marking System.
6. Indications for Use of Device:
The CROSSER® CTO Recanalization System indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy.
The CROSSER® Catheter is only intended for use with the CROSSER® Generator. Refer to the CROSSER® Generator Manual of Operations for proper use.
7. Technological Comparison to Predicate Devices:
The technological characteristics of the subject device are substantially equivalent to those of the predicate device because the two have the following similarities:
- Same intended use
- Same indications for use ●
- Same target population ●
- Same fundamental scientific technoloqy
- o Same operating principal and method of action
- Same packaging configuration .
- Same sterility assurance level and method of sterilization ●
The subject device is a modification to the predicate device and is different as follows:
- The GEOALIGN® Marking System has been added to the device. The GEOALIGN® ● Marking System is a non-radiopaque ruler on the catheter shaft measured from the distal tip. The markings have the same intended purpose, use the same ink formulation, and ink application process as the previously cleared reference device of the same regulation number, the ULTRAVERSE® 035 PTA Dilatation Catheter (K142261, cleared September 24, 2014, Regulation Number 870.1250).
5
8. Performance Testing Summary:
To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using the FDA quidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessment procedures, the following nonclinical tests were performed:
- GEOALIGN® Marking Legibility ●
- Dimensional Analysis: .
- GEOALIGN® Marking Location (Distal Position) o
- o GEOALIGN® Marking Location (Proximal Position)
- o GEOALIGN® Marking Spacing
- o Catheter Outer Diameter (OD)
- GEOALIGN® Marking durability with Support Catheters ●
- GEOALIGN® Marking durability with Introducer Sheaths ●
- GEOALIGN® Marking compatibility with Support Catheters ●
- GEOALIGN® Marking compatibility with Introducer Sheaths ●
The results demonstrate that the technological characteristics and performance criteria of the CROSSER® CTO Recanalization Catheter is comparable to the predicate device and that it performs substantially equivalent to the legally marketed predicate device.
Biocompatibility and chemical characterization demonstrate the subject device is biocompatible and does not elicit any substances at levels of concern as result of this change.
Stability shelf life testing demonstrates the device is has the appropriate shelf life as labeled.
9. Conclusion:
The CROSSER® CTO Recanalization Catheter is substantially equivalent to the legally marketed predicate device, the CROSSER® CTO Recanalization Catheter (K112308, cleared Auqust 17, 2011)