(94 days)
The CROSSER LP 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, highfrequency Transducer, and single-use CROSSER LP Catheter. Each 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 LP Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.
The provided document is a 510(k) summary for the FlowCardia CROSSER LP System, a medical device used to facilitate the placement of guidewires beyond chronic total occlusions in coronary arteries. It primarily focuses on demonstrating substantial equivalence to a predicate device through physical and functional testing, rather than an AI-powered diagnostic system.
Therefore, many of your requested categories are not applicable to the information contained within this document. The document describes a traditional medical device (catheter system), not an AI algorithm.
Here's a breakdown of the applicable and non-applicable information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines functional tests performed, which serve as the acceptance criteria for the device's performance. However, it does not provide a table format with specific numerical acceptance criteria and a corresponding numerical reported performance for each test. Instead, it states that "the FlowCardia CROSSER LP System met the acceptance criteria and performed similarly to the predicate device."
| Acceptance Criteria (Functional Tests Performed) | Reported Device Performance |
|---|---|
| Tensile Strength | Met acceptance criteria |
| Torque Strength | Met acceptance criteria |
| Torqueability | Met acceptance criteria |
| Tip Flexibility | Met acceptance criteria |
| Coating Adherence/Integrity | Met acceptance criteria |
| Biocompatibility | Met acceptance criteria |
| Bench top Simulated Efficiency | Met acceptance criteria |
| Catheter Fatigue Testing | Met acceptance criteria |
| Shelf Life | Met acceptance criteria |
| Package Integrity Testing | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for each functional test. The document mentions "Design analysis, bench, and biocompatibility testing were conducted."
- Data Provenance: Not applicable in the context of an AI study. These are bench and lab tests, not clinical data sets from specific countries.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is proven through physical and functional testing, not through expert-labeled data sets for an AI algorithm.
4. Adjudication Method for the Test Set:
- Not Applicable. Again, this refers to expert consensus for AI ground truth, which is not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is for evaluating human readers with and without AI assistance. The FlowCardia CROSSER LP System is a physical medical device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not Applicable. This is not an AI algorithm.
7. Type of Ground Truth Used:
- For the functional and bench tests, the "ground truth" is defined by the engineering specifications and performance requirements for a catheter system.
- Animal studies were also conducted "to establish initial safety and performance," which serves as an in-vivo form of ground truth for safety and general performance.
8. Sample Size for the Training Set:
- Not Applicable. This is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. This is not an AI algorithm.
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Image /page/0/Picture/0 description: The image shows the logo for Flowcardia, Inc. along with the date JUN 20 2008. The logo includes a stylized heart with a sine wave running through it. The company name is written in a bold, serif font.
5) 510(k) Summary
This summary of 510(k) information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21CFR807.92.
| 510(k) Number | K080765 |
|---|---|
| --------------- | --------- |
Applicant Information
| Date Prepared: | March 17, 2008 | FDA CDRH DMC MAR 18 2008 |
|---|---|---|
| Name and Address: | FlowCardia, Inc.745 N. Pastoria AvenueSunnyvale, CA 94085Ph: (408) 617-0352 | Received |
| Contact Person: | Dustin Michaels, Vice President of CR/QA/RAPh: (408) 617-0352 x302Fax: (408) 617-9198 |
Device Information
| Classification: | DQY |
|---|---|
| Trade Name: | The CROSSER LP System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 74 DQY / 21 CFR 870.1250 |
Predicate Device
The CROSSER System manufactured by FlowCardia, Inc. (K062868)
Device Description
The CROSSER System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER LP Catheter.
Each 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 LP Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.
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Technological Characteristics
The FlowCardia CROSSER LP System is substantially equivalent to the predicate device. The predicate and CROSSER LP System catheters are substantially equivalent with respect to materials, design construction and performance. Both devices are indicated for use in coronary chronic occlusions. Both utilize the same CROSSER Electronics for operation. The main difference between the two devices is the diameter of the distal tip. The CROSSER LP has a 0.6mm distal tip while the predicate device has a 1.1mm tip.
Physical Test Data
Design analysis, bench, and biocompatibility testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia CROSSER LP 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. Animal studies were conducted with the CROSSER LP to establish initial safety and performance.
Conclusion
Based upon device physical comparisons the CROSSER System is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine. The caduceus in the logo is depicted with a modern, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2008
FlowCardia Inc. c/o Mr. Dustin Michaels Vice President of CR/QA/RA 745 N. Pastoria Avenue Sunnyvalc, CA 94085
Re: K080765
Trade Name: Percutaneous Catheter Regulation Number: 21 CFR 870.1330 Regulation Name: Cather Guide Wire Regulatory Class: Class II (two) Product Codc: DQX Dated: March 17, 2008 Received: March 18, 2008
Dear Mr. Michaels:
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 such 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
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Page 2 - Mr. Dustin Michaels
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 LP System
Indications for Use:
The CROSSER LP 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 D)
AND/OR
Over-The-Counter Use (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)
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§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.