(6 days)
Not Found
No
The device description focuses on mechanical vibration and atherectomy, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a "Recanalization System" that uses mechanical vibration to remove or reduce occlusive material in peripheral arteries, facilitating the placement of guidewires. This actions aligns with the definition of a therapeutic intervention.
No
The device description clearly states it is a "high frequency mechanical vibration device designed for placement of guidewires through obstructed peripheral arteries by the removal or reduction of occlusive material." This describes a therapeutic, not a diagnostic, function.
No
The device description clearly outlines multiple hardware components including a generator, foot switch, transducer, and catheter, which are integral to the device's function.
Based on the provided text, the CROSSER™ 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 in peripheral arteries by removing or reducing occlusive material within the body. This is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- Device Description: The device description details a system that uses mechanical vibrations to ablate plaque within the blood vessels. This is a therapeutic intervention performed directly on the patient.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition. Its purpose is to treat a physical obstruction.
Therefore, the CROSSER™ Recanalization System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CROSSER™ Recanalization System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. The device is contraindicated for use in the carotid arteries. The CROSSER™ Catheter is only intended for use with the CROSSER™ Generator. Refer to the CROSSER™ Generator Manual of Operations for proper use.
Product codes (comma separated list FDA assigned to the subject device)
MCW, PDU
Device Description
The CROSSER™ Recanalization System is a high frequency mechanical vibration device designed for placement of guidewires through obstructed peripheral arteries by the removal or reduction of occlusive material. The system consists of an electronic CROSSER™ Generator, Foot Switch, high frequency Transducer, single-use CROSSER™ Catheter and sterile drape. The catheters are offered in a variety of configurations as shown in the table below. The system is required to be used with a power injector system for the delivery of saline. The CROSSER™ Catheter, which is intended for one procedure only, is connected to the CROSSER™ Generator through the high frequency The Foot Switch is used to activate the CROSSER™ System. The Transducer. CROSSER™ Generator and Transducer convert AC power into high frequency mechanical vibrations, which are propagated through a Nitinol core wire to the titanium or stainless steel tip of the CROSSER™ Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter. The vibrational energy ablates intravascular plaque by mechanical impact and cavitational effects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries
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)
To demonstrate substantial equivalence of the subject device, the CROSSER™ Recanalization System to the predicate devices, the technological characteristics and performance criterion were evaluated through bench testing. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, no additional in vitro tests or in vivo studies were required as the Crosser System previously met all requirements. As this 510(k) is clarifying the system mechanism of action, prior bench testing is presented.
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.
K072776, K091119, K092175, K090521, K110626
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
§ 870.1250 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
K112308 page 1 of 4
AUG 17 2011
CROSSER™ Recanalization System
510(k) Summary 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
Submitter Information:
| Applicant: | FlowCardia, Inc
745 N. Pastoria Ave.
Sunnyvale, CA 94085 |
|------------|----------------------------------------------------------------|
| Phone: | 480-638-2939 |
| Fax: | 480-449-2546 |
| Contact: | Timothy Wade, Regulatory Affairs Associate |
| Date | July 28, 2011 |
| Device Trade Name: | CROSSER TM Recanalization System |
|---|---|
| Common or Usual Name: | Peripheral Atherectomy Catheter (21 CFR |
| 870.4875, Product Code MCW) | |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
Predicate Devices:
- CROSSER™ System .
- Diamondback 360 Orbital Atherectomy System (K090521; cleared March ● 20, 2009)
- . Jetstream System (K110626; cleared April 20, 2011)
Image /page/0/Picture/17 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The letters are evenly spaced and appear to be of uniform size. The overall impression is clean and professional.
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Device Description:
The CROSSER™ Recanalization System is a high frequency mechanical vibration device designed for placement of guidewires through obstructed peripheral arteries by the removal or reduction of occlusive material. The system consists of an electronic CROSSER™ Generator, Foot Switch, high frequency Transducer, single-use CROSSER™ Catheter and sterile drape. The catheters are offered in a variety of configurations as shown in the table below. The system is required to be used with a power injector system for the delivery of saline. The CROSSER™ Catheter, which is intended for one procedure only, is connected to the CROSSER™ Generator through the high frequency The Foot Switch is used to activate the CROSSER™ System. The Transducer. CROSSER™ Generator and Transducer convert AC power into high frequency mechanical vibrations, which are propagated through a Nitinol core wire to the titanium or stainless steel tip of the CROSSER™ Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter. The vibrational energy ablates intravascular plaque by mechanical impact and cavitational effects.
| | CROSSER Catheters
14P and 14S | CROSSER Catheter
18 | CROSSER Catheter
S6 |
|----------------------------------|----------------------------------------|--------------------------------|--------------------------------|
| Working Length | 146cm | 125cm | 154cm |
| Tip Outer Diameter | 1.1mm (0.044") | 1.5mm (0.061") | 0.6mm (0.025") |
| Catheter Shaft Outer
Diameter | Rapid
Exchange
1.3mm
(0.052") | 1.5mm (0.058") | 1.3mm (0.051") |
| | Over The
Wire
1.6mm
(0.063") | | |
| Guidewire Lumen
Length | Rapid
Exchange
20cm | Rapid Exchange
20cm | n/a* |
| | Over The
Wire
152 cm | | |
| Guidewire Compatibility | 0.014" (0.36mm) | 0.018" (0.46mm) | n/a* |
| Guide Catheter
Compatibility | 6Fr
(min ID 0.067" [1.7mm]) | 7Fr
(min ID 0.080" [2.0mm]) | 5Fr
(min ID 0.053") [1.3mm] |
| Sheath Compatibility | 5Fr
(min ID 0.067" [1.7mm]) | 6Fr
(min ID 0.080" [2.0mm]) | 5Fr
(min ID 0.053") [1.3mm] |
- CROSSER™ Catheter S6 does not contain a guidewire lumen but creates a channel large enough to accommodate a guidewire up to 0.018".
Indications for Use of Device:
The CROSSER™ Recanalization System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions
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via atherectomy. The device is contraindicated for use in the carotid arteries. The CROSSER™ Catheter is only intended for use with the CROSSER™ Generator. Refer to the CROSSER™ Generator Manual of Operations for proper use.
Review of the Modified Indications for Use:
The modified indication for use statement for the CROSSER™ Recanalization System does not raise any new issues of safety and effectiveness as demonstrated through the risk analysis process based on the proposed indications for use statement as compared to the predicate devices, the CROSSER™ System, the Diamondback System, and the Jetstream System. The modified indication clarifies the mechanism of action by which the CROSSER™ Recanalization System recanalizes a Chronic Total Occlusion (CTO) as the removal or reduction of occlusive material from the artery (atherectomy). The Diamondback System and Jetstream Systems are also indicated for the atherectory of occlusive material in the peripheral arteries. Therefore, the subject device, the CROSSER™ Recanalization System, is substantially equivalent to the predicate devices.
Technological Comparison to Predicate Devices:
The CROSSER™ Recanalization System has the following similarities to the predicate devices:
- Similar intended use (all predicates) .
- Similar indications for use (all predicates) .
- Same target population (all predicates) .
- Same fundamental scientific technology (all predicates) .
- Same operating principle (Crosser predicates) .
- Similar operating principle (Diamondback and Jetstream predicates) .
- Same mechanism of action (all predicates) .
- Same materials (Crosser predicates) .
- Same packaging materials and configuration (Crosser predicates) .
- Same sterility assurance level and method of sterilization (Crosser ● predicates)
Performance Data:
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Image /page/3/Picture/0 description: The image shows a handwritten note that reads "K112308 page 41 of 4". The note appears to be a page number or document identifier. The handwriting is cursive and legible.
ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
To demonstrate substantial equivalence of the subject device, the CROSSER™ Recanalization System to the predicate devices, the technological characteristics and performance criterion were evaluated through bench testing. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, no additional in vitro tests or in vivo studies were required as the Crosser System previously met all requirements. As this 510(k) is clarifying the system mechanism of action, prior bench testing is presented.
Conclusions:
The subject device, the Crosser™ Recanalization System, satisfied the design requirements associated with the modified indications for use statement, as specified by applicable standards, guidance, test protocols and/or customer inputs. Therefore, the Crosser™ Recanalization System is substantially equivalent to the legally marketed predicate devices, the Crosser™ System, the Diamondback System, and the Jetstream System.
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Image /page/4/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 with its wings spread, with three human profiles incorporated into the design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
C.R. Bard, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th St. NW Buffalo, MN 55313
SEP 1 8 2013
Re: K112308
Trade/Device Name: Crosser Recanalization System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: August 10, 2011 Received: August 11, 2011
Dear Mr. Job:
This letter corrects our substantially equivalent letter of August 17, 2011.
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. Isting 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
5
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
ZZn.Z
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): K112308
..
Device Name: CROSSER™ Recanalization System
Indications for Use: The CROSSER™ Recanalization System is indicated · to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. The device is contraindicated for use in carotid arteries.
The CROSSER™ Catheter is only intended for use with the CROSSER™ Generator. Refer to the CROSSER™ Generator Manual of Operations for proper use.
Prescription Use_X (Part21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image does not contain any text.
(Division Sign-Oit) Division of Cardiovascular Devices
510(k) Number K112309
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