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.

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.

AI/ML Overview

The provided document, K112308, describes the CROSSER™ Recanalization System. However, it explicitly states that no new clinical studies or in-vivo tests were conducted for this 510(k) submission. Instead, it refers to prior bench testing and relies on the substantial equivalence to predicate devices. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria (especially clinical performance) is largely absent from this specific document.

Here's a breakdown based on the provided text, highlighting the absence of certain requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific acceptance criteria (e.g., success rates, safety endpoints) and corresponding device performance from a new study. It mentions an evaluation of "technological characteristics and performance criterion... through bench testing" and that the "Crosser System previously met all requirements."

Acceptance Criteria	Reported Device Performance
(Not explicitly defined in this document for the specific 510(k) filing)	(Not explicitly reported from new studies in this document for the specific 510(k) filing)
Implied: Substantial Equivalence to predicate devices in terms of:	The device satisfied design requirements related to the modified indications for use statement, based on applicable standards, guidance, test protocols, and/or customer inputs.
- Similar intended use	Confirmed to have similar intended use as all predicates.
- Similar indications for use	Confirmed to have similar indications for use as all predicates, with a clarification of the atherectomy mechanism of action.
- Same target population	Confirmed to have the same target population as all predicates.
- Same fundamental scientific technology	Confirmed to have the same fundamental scientific technology as all predicates.
- Same/similar operating principle	Confirmed to have the same operating principle as Crosser predicates and similar to Diamondback and Jetstream predicates.
- Same mechanism of action	Confirmed to have the same mechanism of action as all predicates.
- Same materials (Crosser predicates)	Confirmed.
- Same packaging materials and configuration (Crosser predicates)	Confirmed.
- Same sterility assurance level and method of sterilization (Crosser predicates)	Confirmed.
- Facilitate intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy	This is the updated indication for use, which the device is claimed to meet based on substantial equivalence and prior testing.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable/not provided for any new test set in this document. The submission relies on prior bench testing and established equivalence.
Data Provenance: Not applicable/not provided for any new test set in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided because there was no new clinical test set with human-established ground truth. The submission refers to "internal Risk Assessment procedures" and "applicable standards, guidance, test protocols and/or customer inputs" from prior evaluations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/not provided, as there was no new clinical test set requiring adjudication in this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical medical device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an algorithm. Its performance is inherent to its mechanical and functional design.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" for substantial equivalence was based on bench testing for technological characteristics and performance criterion, and the previously established "requirements" from the original Crosser System clearances, as well as the indications for use and technological principles of the listed predicate devices (Diamondback 360 Orbital Atherectomy System and Jetstream System). No new pathology or outcomes data were presented.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this mechanical device submission.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" for this mechanical device.

Summary

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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, Inc745 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 CFR870.4875, Product Code MCW)
Classification:	Class II
Classification Panel:	Cardiovascular

Predicate Devices:

CROSSER™ System .
- Models: GEN200, CRU14S, CRU14P, CRU18 (K072776; cleared o December 7, 2007)
- Models: GEN200, CRUO14S, CRUO14P (K091119; cleared May o 15, 2009)
- Models: GEN200, CRUS6 (K092175; cleared February 17, 2010) O
Diamondback 360 Orbital Atherectomy System (K090521; cleared March ● 20, 2009)
. Jetstream System (K110626; cleared April 20, 2011)

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Device Description:

	CROSSER Catheters14P and 14S	CROSSER Catheter18	CROSSER CatheterS6
Working Length	146cm	125cm	154cm
Tip Outer Diameter	1.1mm (0.044")	1.5mm (0.061")	0.6mm (0.025")
Catheter Shaft OuterDiameter	RapidExchange1.3mm(0.052")	1.5mm (0.058")	1.3mm (0.051")
	Over TheWire1.6mm(0.063")
Guidewire LumenLength	RapidExchange20cm	Rapid Exchange20cm	n/a*
	Over TheWire152 cm
Guidewire Compatibility	0.014" (0.36mm)	0.018" (0.46mm)	n/a*
Guide CatheterCompatibility	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

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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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Regulation Number and Section

§ 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).