(137 days)
Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.
The Impress® Angiographic Catheters with hydrophilic coating are single lumen catheters offered in 4F and 5F sizes and 40cm to 125cm. The outer surface of the distal segment of the catheter shaft is coated with a hydrophilic coating.
The provided text pertains to a 510(k) premarket notification for a medical device, specifically the Impress® Angiographic Catheter with Hydrophilic Coating. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with a statistical analysis plan typically associated with novel AI devices.
Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, ground truth types) are not applicable to this document. The submission relies on comparative testing to existing, legally marketed devices.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list a table of "acceptance criteria" against numerical performance metrics for the device, as would be expected for an AI/diagnostic device. Instead, it states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Efficacy | Met acceptance criteria |
| Substantial Equivalence to Predicate Devices | Demonstrated based on indications for use, design, safety, and performance testing. |
The "performance tests" mentioned are likely a series of engineering and biocompatibility tests (e.g., burst pressure, tensile strength, lubricity for the hydrophilic coating) to ensure the device meets its design specifications and operates safely, as opposed to a diagnostic accuracy study. The document emphasizes substantial equivalence to existing predicate devices (Impress® Angiographic Catheter K053171 and Radifocus® Glidecath™ K915414).
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device registration (510(k)) for an angiographic catheter, not a diagnostic AI device requiring a clinical test set with patient data. The "tests" refer to device-specific engineering and biological compatibility evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. Ground truth establishment by experts is relevant for diagnostic performance studies, which are not detailed here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies when establishing ground truth from multiple expert interpretations, which is not described in this 510(k) 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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as relevant to diagnostic accuracy is not discussed. The "truth" here would refer to the device meeting its engineering specifications and being biologically safe and compatible.
8. The sample size for the training set
Not applicable. Training sets are relevant for AI algorithms.
9. How the ground truth for the training set was established
Not applicable. Training sets and their ground truth are relevant for AI algorithms.
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| Section 5 | |||
|---|---|---|---|
| 510(k) Summary | FEB 12 2010 | ||
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4196(801) 253-6932Michaela RivkowichSeptember 25, 20091721504 | |
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name: | Impress® Angiographic Catheter withHydrophilic CoatingAngiographic CatheterDiagnostic Intravascular Catheter | |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | Impress® Angiographic CatheterDiagnostic Intravascular CatheterK053171Merit Medical Systems, Inc. | |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | Radifocus® Glidecath™Diagnostic Intravascular CatheterK915414Terumo Corporation | |
| Classification | Class II21 CFR § 870.1200, 74 DQODivision of Cardiovascular Devices | ||
| Intended Use | Angiography catheters are designed to be used for deliveringradiopaque media to selected sites in the vascular system inconjunction with routine diagnostic procedures. Angiographiccatheters with marker bands may also be used for anatomicalmeasurements. |
and the control of the county of
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| DeviceDescription | The Impress® Angiographic Catheters with hydrophilic coating aresingle lumen catheters offered in 4F and 5F sizes and 40cm to125cm. The outer surface of the distal segment of the catheter shaftis coated with a hydrophilic coating. |
|---|---|
| TechnologicalCharacteristics | Technological characteristics of the subject Impress catheter withhydrophilic coating are substantially equivalent to those of thepredicate devices, the Impress Angiographic Catheter (K053171)and the Radifocus Glidecath Angiographic Catheter (K915414). |
| Safety &PerformanceTests | No performance standards have been established under Section 514of the Food, Drug and Cosmetic Act for these devices. However,testing was performed demonstrating that the subject device met theacceptance criteria determined to demonstrate the safety andefficacy of the device. |
| Summary ofSubstantialEquivalence | Based on the indications for use, design, safety and performancetesting, the subject Impress® Angiographic Catheter with hydrophiliccoating is substantially equivalent to the predicate devices, theImpress® Angiographic Catheter, manufactured by Merit MedicalSystems, Inc., and the Radifocus Glidecath Angiographic Catheter,manufactured by Terumo Corporation. |
. . .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a logo for the Department of Health & Human Services - CSA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - CSA" arranged around the top half of the circle. In the center of the circle is an abstract image of three human profiles facing to the right, which is a common symbol used by the Department of Health and Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Merit Medical Systems, Inc. c/o Ms. Michaela Rivkowich Regulatory Affairs Specialist III 1600 West Merit Parkway South Jordan, UT 84095
FEB 1 2 2010
Re: K093004
Trade/Device Name: Impress® Angiographic Catheter with Hydrophilic Coating Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO Dated: January 28, 2010 Received: January 29, 2010
Dear Ms. Rivkowich:
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 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.
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Page 2 – Ms. Michaela Rivkowich
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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
una R. Viilunen
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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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Section 4
Indications for Use
510(k) Number (if known):
Device Name: Impress® Angiographic Catheter with Hydrophilic Coating
KO93004
Indications for Use:
Angiography catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures. Angiographic catheters with marker bands may also be used for anatomical measurements.
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)
Duna R. Vi
Division Sign-Off) Division Sign-Off)
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Tivision of Cardiovascular 0.0 % 0.0 % % % 0(k) Number Kong 300 R
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).