(49 days)
The UltraFlow™ HPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary vasculature.
The UltraFlow™ HPC Flow Directed Micro Catheters are single-lumen, endhole catheters designed for the subselective infusion of physician-specified pharmacologic agents or contrast media in tortuous, distal vessels. The catheters have a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheter are coated to increase lubricity. The stylet accompanying the catheter is used to increase the rigidity of the distal section during introduction into the guiding catheter.
This submission (K024118) is a special 510(k) for a name change and minor design enhancements to an already cleared device, the Modified FlowRider™ Flow Directed Micro Catheter (K010004). Therefore, the provided text does not contain detailed acceptance criteria and a study proving those criteria for a novel device. Instead, the focus is on demonstrating substantial equivalence to the predicate device.
However, I can extract the information related to the performance testing that was conducted to verify the minor product changes.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Although specific numerical acceptance criteria are not detailed in this summary, the testing performed was to verify minor product changes and demonstrate substantial equivalence to the predicate device. The general acceptance criterion for these tests would be that the UltraFlow™ HPC Micro Catheter performs comparably to the predicate device (Modified FlowRider™) in these specific aspects.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (comparable to predicate) | Biocompatibility testing performed to verify minor changes. |
| Angiographic Visualization (comparable to predicate) | Angiographic visualization testing performed to verify minor changes. |
| Dimensional Verification (within specified tolerance) | Dimensional verification testing performed to verify minor changes. |
| Functional Performance (comparable to predicate) | Functional performance testing performed to verify minor changes. |
| Changes are minor and do not affect safety or effectiveness | Minor enhancements to the design (verified by the above tests). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each of the performance tests (Biocompatibility, Angiographic Visualization, Dimensional Verification, Functional Performance). It simply states that "Selected in-vitro performance testing...were performed."
The data provenance is in-vitro testing. The country of origin for the data is not explicitly stated, but Micro Therapeutics, Inc. is located in Irvine, CA, USA, so it's reasonable to infer the testing was conducted in the USA or managed by a US-based company. The study is prospective in the sense that the tests were specifically designed and executed for this 510(k) submission to evaluate the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For in-vitro performance testing, "ground truth" is typically established by engineering standards, specifications, and validated test methods, rather than clinical experts.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of in-vitro performance testing, an adjudication method like 2+1 or 3+1 (common in image analysis or clinical trials) is generally not applicable. Test results would be compared against pre-defined engineering specifications.
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
No, an MRMC comparative effectiveness study was not done. This device is a micro catheter, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
For the in-vitro performance tests, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device (Modified FlowRider™ Flow Directed Micro Catheter (K010004)) and established industry standards for similar devices. For biocompatibility, it would be compliance with relevant ISO standards.
8. The Sample Size for the Training Set
This concept is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as there is no training set for this type of device.
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Micro Therapeutics, Inc.
Special 510(k) (modifications to K010004) Special 510(tr) (modifications to No 10001)
UltraFlow™ HPC Flow Directed Micro Catheter
December 13, 2002
FEB 0 3 2003
4. 510(k) Summary
| Prepared December 13, 2002 | |||
|---|---|---|---|
| TRADE NAME | UltraFlow™ HPC Flow Directed Micro Catheter | ||
| GENERIC NAME | Flow Directed Micro Catheter | ||
| CLASSIFICATION | Class II (21 CFR 870.1210) | ||
| SUBMITTED BY | Micro Therapeutics, Inc.2 GoodyearIrvine, CA 92618 | CONTACT | Bill HyattRegulatory Affairs(949) 837-3700 |
| PREDICATEDEVICE(S) | Modified FlowRider™ Flow Directed Micro Catheter (K010004), clearedFebruary 13, 2001. | ||
| DEVICEDESCRIPTION | The UltraFlow™ HPC Flow Directed Micro Catheters are single-lumen, endholecatheters designed for the subselective infusion of physician-specifiedpharmacologic agents or contrast media in tortuous, distal vessels. The cathetershave a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate theadvancement of the catheter in the anatomy. The proximal end of the catheterincorporates a standard luer adapter to facilitate the attachment of accessories.The catheter has a radiopaque marker at the distal end to facilitate fluoroscopicvisualization. The outer surfaces of the catheter are coated to increase lubricity.The stylet accompanying the catheter is used to increase the rigidity of the distalsection during introduction into the guiding catheter. | ||
| INDICATIONS FORUSE | The UltraFlow™ HPC Flow Directed Micro Catheter is intended for thecontrolled selective infusion of physician-specified pharmacologic agents orcontrast media into the distal vasculature of the peripheral and neuro anatomy. Itis not intended for use in the coronary vasculature. | ||
| TESTING | Selected in-vitro performance testing of the MTI UltraFlow™ HPC MicroCatheter were performed to verify the minor product changes. These testsincluded the following:BiocompatibilityAngiographic visualizationDimensional verificationFunctional performance. | ||
| SUMMARY OFSUBSTANTIALEQUIVALENCE | The UltraFlow™ HPC Flow Directed Micro Catheter is the same device as theModified FlowRider™ Flow Directed Micro Catheter (K010004). Thissubmission has been made to change the device name as it appears on the CDRHdatabase for Premarket Notification decisions. | ||
| Minor enhancements to the design would normally have required letters to filebased upon FDA's guidance document "Deciding When To Submit a 510(k) for achange to an Existing device", January 10, 1997 and are being presented here forinformation purposes only. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and the USA. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 3 2003
Mr. Bill Hyatt Manager, Regulatory Affairs Micro Therapeutics, Inc. 2 Goodyear Irvine, CA 92618
Re: K024118
Trade/Device Name: UltraFlow™ HPC Flow Directed Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA Dated: January 14, 2003 Received: January 16, 2003
Dear Mr. Hyatt:
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 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
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Page 2 - Mr. Bill Hyatt
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 (301) 594-4586. 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Kelleher
am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Micro Therapeutics, Inc. Special 510(k) (modifications to K010004) UltraFlow™ HPC Flow Directed Micro Catheter December 13, 2002
Indications for Use Statement 6.
510(k) Number (if known): _________
Device Name:
MTI UltraFlow™ HPC Flow Directed Micro Catheter
Indications for Use:
The UltraFlow™ HPC Flow Directed Micro Catheter is intended for the controlled selective infusion of physicianspecified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy. It is not intended for use in the coronary vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over the Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K084118 |
|---|---|
| --------------- | --------- |
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).