(116 days)
The CROSSER System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.
The CROSSER System consists of a re-usable electronic Generator, Foot Switch, high frequency Transducer, and single-use CROSSER 14 Catheter. The CROSSER 14 Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high frequency mechanical vibrations which are propagated through a Nitinol core wire to the stainless steel tip of the CROSSER 14 Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal 90cm of the catheter.
The provided text describes the FlowCardia CROSSER System and its 510(k) submission (K062868). It primarily focuses on demonstrating substantial equivalence to a predicate device, the Intraluminal Therapeutics (ILT) Safe-Cross System, through technological characteristics, physical test data, and clinical study data.
However, the document does not contain specific acceptance criteria, detailed device performance metrics, or the full study design typically expected for a comprehensive report on device performance against acceptance criteria. It mentions that "the FlowCardia CROSSER System met the acceptance criteria and performed similarly to the predicate device" in physical tests and that a "clinical study... demonstrated substantially equivalent safety and effectiveness," but it does not elaborate on what those criteria were or the specific results.
Therefore, much of the requested information cannot be extracted directly from the provided text. I will provide what can be inferred or explicitly stated.
Acceptance Criteria and Device Performance Study Data - FlowCardia CROSSER System (K062868)
The provided 510(k) summary indicates that various tests were conducted to demonstrate the substantial equivalence of the FlowCardia CROSSER System to its predicate device. While it states that the system "met the acceptance criteria," it does not specify what those acceptance criteria were in quantitative terms for most of the tests. Similarly, detailed device performance metrics are not reported.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document states that the device "met the acceptance criteria" but does not explicitly define these criteria or report specific performance values against them. The information below is inferred from the types of tests mentioned.
| Test Category | Acceptance Criteria (Inferred from text) | Reported Device Performance (as stated in text) |
|---|---|---|
| Physical Tests | Adherence to design specifications, material properties, and functional requirements, and performance similar to the predicate device. | Met the acceptance criteria; performed similarly to the predicate device. |
| Dimensional Verification | Specific dimensions (e.g., working length around 146cm vs. 175cm for predicate). | Not explicitly stated, but implies verification occurred. |
| Tensile Strength | Sufficient strength to withstand typical forces during use. | Met the acceptance criteria. |
| Torque Strength | Sufficient strength to withstand torquing actions. | Met the acceptance criteria. |
| Torqueability | Ability to transmit torque effectively. | Met the acceptance criteria. |
| Tip Flexibility | Appropriate flexibility for navigation within coronary arteries. | Met the acceptance criteria. |
| Coating Adherence/Integrity | Hydrophilic coating remains intact and functional. | Met the acceptance criteria. |
| Biocompatibility | Biologically safe for intended use. | Met the acceptance criteria. |
| Bench top Simulated Efficiency | Efficient operation in a simulated environment. | Met the acceptance criteria. |
| Catheter Fatigue Testing | Durability over repeated use or simulated life. | Met the acceptance criteria. |
| Shelf Life | Maintains integrity and functionality over its specified shelf life. | Met the acceptance criteria. |
| Package Integrity Testing | Packaging protects the device until use. | Met the acceptance criteria. |
| Clinical Study | Demonstration of substantially equivalent safety and effectiveness to the predicate device in facilitating guidewire placement beyond CTOs. | Demonstrated substantially equivalent safety and effectiveness to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The document only mentions "clinical study of the FlowCardia CROSSER System" without detailing the number of patients or cases.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective nature). The text simply refers to a "clinical study."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided in the given text. The study mentioned is a "clinical study" to demonstrate substantial equivalence, but it's not described as an MRMC study comparing human readers with and without AI assistance. The device itself is a percutaneous catheter, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable as the device is a physical medical instrument (percutaneous catheter), not an algorithm or AI system for standalone performance evaluation without human intervention. The "Generator" is an electronic component that powers the catheter, not a diagnostic algorithm.
7. Type of Ground Truth Used
For the "clinical study," the ground truth would likely be based on clinical outcomes (e.g., successful crossing of chronic total occlusions, patient safety, absence of major adverse cardiac events) as assessed by interventional cardiologists or relevant medical professionals during the procedure and follow-up. However, the specific method for establishing this ground truth (e.g., expert consensus, pathology, long-term outcomes data) is not detailed in the provided text.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical medical instrument and not an AI/machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (not an AI/ML model).
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FLOWCARDIA, INC.
5) 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21CFR807.92.
| 510(k) Number | K062868 |
|---|---|
| --------------- | --------- |
Applicant Information Date Prepared: September 22, 2006 Name and Address: FlowCardia, Inc. 745 N. Pastoria Avenue Sunnyvale, CA 94085 Ph: (408) 617-0352 Contact Person: Dustin Michaels, Director of RA/CR Ph: (408) 617-0352 x302 Fax: (408) 617-9198
Device Information
| Classification: | DQY |
|---|---|
| Trade Name: | The CROSSER System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |
Predicate Device
Safe Cross Radio Frequency Total Occlusion Crossing System manufactured by Intraluminal Therapeutics, Inc. (K032031)
Device Description
The CROSSER System consists of a re-usable electronic Generator, Foot Switch, high frequency Transducer, and single-use CROSSER 14 Catheter. The CROSSER 14 Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high frequency mechanical vibrations which are propagated through a Nitinol core wire to the stainless steel tip of the CROSSER 14 Catheter. The main
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body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal 90cm of the catheter.
Technological Characteristics
The FlowCardia CROSSER System is substantially equivalent to the Intraluminal Therapeutics (ILT) Safe-Cross System in intended use. The design (or mode of operation) of the Safe-Cross Wire is similar to the CROSSER 14 Catheter in that it is intended to be delivered through standard coronary guide catheters to a vascular occlusion and then used to facilitate recanalization of the obstruction. Both have roughly the same working length (146cm vs. 175cm) and are designed to be compatible with standard percutaneous techniques and equipment. The devices are constructed from commonly used catheter materials and coated with a hydrophilic material for increased lubricity. Their radiopaque tips are used to visualize their location within the body.
The Safe-Cross and the CROSSER System both use an energy source to facilitate placement of devices beyond total occlusions. The Safe-Cross System uses RF energy for this purpose versus the CROSSER System which utilizes high frequency vibration. Despite the differences in both energy source and construction materials the intended and method of use are substantially equivalent.
Physical Test Data
Design analysis, bench, and biocompatibility testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia CROSSER System met the acceptance criteria and performed similarly to the predicate device. In addition to dimensional verification, the following functional tests were performed: Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence/Integrity, Biocompatibility, Bench top Simulated Efficiency, Catheter Fatigue Testing. Shelf Life and Package Integrity Testing.
Clinical Test Data
In addition to the physical test data above, clinical study of the FlowCardia CROSSER System demonstrated substantially equivalent safety and effectiveness.
Conclusion
Based upon device physical and clinical comparisons the CROSSER System is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2007
FlowCardia, Inc. c/o Mr. Dustin Michaels Director of Regulatory Affairs and Clinical Research 745 N. Pastoria Avenue Sunnyvale, CA 94085
Re: K062868 The CROSSER System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutancous Catheter Regulatory Class: II (two) Product Code: DQY Dated: January 11, 2007 Received: January 12, 2007
Dear Mr. Michaels:
We have reviewed your Scction 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 adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA move publish further announcements concerning your device in the Federal Register.
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Page 2 -- Mr. Dustin Michaels
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.
Sincerely yours,
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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Statement of Indications for Use
510(k) Number (if known):
Device Name: .
The CROSSER System
Indications for Use:
The CROSSER System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.
Prescription Use X (Part 21 CFR 801 Subpart
AND/OR
Over-The-Counter Use
D)
(21 CFR 801 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 | |
| 510(k) Number | K062868 |
§ 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).