(29 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and performance of a standard angiographic catheter, with no mention of AI/ML capabilities or data processing beyond standard imaging.
No
The device is described as an "intravascular diagnostic catheter" for delivering radiopaque media for "routine diagnostic procedures" and "fluoroscopic studies." Its intended use is for diagnosis (imaging), not for treating a condition.
Yes
The device is described as an "intravascular diagnostic catheter" for use "in conjunction with routine diagnostic procedures."
No
The device description clearly describes a physical catheter with various hardware components (braided configurations, lengths, marker bands, hydrophilic coating, tip shapes) and performance studies focused on physical properties and biocompatibility. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an angiographic catheter used for delivering radiopaque media to selected sites in the vascular system for diagnostic procedures (fluoroscopic studies). It is an intravascular diagnostic catheter.
- Method of Use: The device is used within the patient's vascular system, not on a sample taken from the patient.
Therefore, while it is a diagnostic device used in conjunction with diagnostic procedures, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Angiographic 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.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Impress Angiographic Catheter with Hydrophilic Coating is an intravascular diagnostic catheter intended for the administration of contrast for conducting fluoroscopic studies. The catheter is available in a variety of 5F braided configurations including lengths from 40 cm to 125 cm, with or without marker bands and with hydrophilic coating. The device is available in variety of tip shapes to cater to variation in physician preference and patient anatomy. The device is intended for single use only and is supplied in a sterile configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the subject Impress Angiographic Catheter with Hydrophilic Coating was conducted based on the risk analysis and based on the requirements of several international consensus standards (listed in the document).
Biocompatibility testing was conducted:
- Cytotoxicity
- Hemolysis
Bench Testing was conducted:
- Marker band radiopacity
- Marker band position
- Marker band width
- Marker band integrity
- Tensile – shaft at marker band and tip to shaft bond
- Shaft ID/OD
- Catheter length
- Catheter stiffness
- Kink resistance
- Hydrophilic coating lubricity and coating integrity friction testing
- Tip length
- Burst pressure rating
- Flow rate
Design Validation was conducted:
- Marker band size, shape, location, surface profile, and radiopacity
- Distal Tip Inspection
- Guidewire compatibility
- Catheter push-ability
- Catheter track-ability
- Kink resistance
- Catheter stiffness
- Catheter torque-ability
- Curve retention
- Catheter withdrawal
The results of the testing do not bring up new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 16, 2019
Merit Medical Systems, Inc. Luke Meidell Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095
Re: K191608
Trade/Device Name: Impress Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: June 14, 2019 Received: June 17, 2019
Dear Mr. Meidell:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gregory O'Connell Assistant Director Plaque Modification Devices Team DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191608
Device Name Impress Angiographic Catheter
Indications for Use (Describe)
Angiographic 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary – K191608
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 208-4623
(801) 826-4174
Luke Meidell
June 13, 2019
1721504 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Impress Angiographic Catheter
Angiographic Catheter
Diagnostic intravascular catheter
2
DQO
870.1200
Cardiovascular |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Regulatory Class:
Product Code:
21 CFR §:
Manufacturer: | Impress Angiographic Catheter
Diagnostic intravascular catheter
K093004
2
DQO
870.1200
Merit Medical Systems, Inc. |
| Device
Description | The Impress Angiographic Catheter with Hydrophilic Coating is an
intravascular diagnostic catheter intended for the administration of
contrast for conducting fluoroscopic studies. The catheter is available in
a variety of 5F braided configurations including lengths from 40 cm to
125 cm, with or without marker bands and with hydrophilic coating. The
device is available in variety of tip shapes to cater to variation in
physician preference and patient anatomy. The device is intended for
single use only and is supplied in a sterile configuration. | |
| Indications for
Use | | Angiographic 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. |
| Comparison to
Predicate
Device | The subject device is substantially equivalent to the predicate device
based on identical indications for use statement, and same basic
performance and safety profile, principle of operation, fundamental
design principles, materials and manufacturing technology. The primary
reason for submitting this special 510(k) is the addition of a marker
band on the current Impress Angiographic Catheter with Hydrophilic
Coating cleared under K093004. | |
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Note: There is no change in the Indications for Use Statement from the predicate to the subject device.
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Impress Angiographic Catheter with Hydrophilic Coating was conducted based on the risk analysis and based on the requirements of the following international consensus standards:
- . ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
- ISO 594-1:1986, Conical Fittings with 6% (Luer) Taper for . Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements.
- ISO 594-2:1998, Conical Fittings with 6% (Luer) Taper for ● Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock fittings.
- ASTM F640-12, Standard Test Methods for Determining . Radiopacity for Medical Use
- Safetv & Performance Tests
- ANSI/AAMI/ISO 11135:2014, Sterilization of health care products. ● Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (2016).
- ISO 10993-4:2017, Biological Evaluation of Medical Devices – Part 4: Selection of Tests for Interactions with Blood
- ISO 10993-5:2009, Biological evaluation of medical devices Part ● 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2017, Biological evaluation of medical devices -● Part 11: Tests for systemic toxicity
- United States Pharmacopeia 41-NF36:2018, Pyrogen Test ●
- ASTM F756-13, Standard Practice for Assessment of Hemolytic ● Properties of Materials
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The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Impress Angiographic Catheter with Hydrophilic Coating was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following testing was conducted for the catheter:
- Cytotoxicity ●
- Hemolysis .
The Impress Angiographic Catheter with Hydrophilic Coating is considered to be an externally communicating device with circulating blood contact for a limited (≤ 24 hours) duration.
Bench Testing
- Marker band radiopacity
- Marker band position ●
- Marker band width ●
Safety & Performance
Tests
- Marker band integrity ● Tensile – shaft at marker band and tip to shaft bond ●
- Shaft ID/OD
- Catheter length .
- Catheter stiffness
- Kink resistance ●
- Hydrophilic coating lubricity and coating integrity friction testing ●
- Tip length ●
- Burst pressure rating ●
- Flow rate ●
Design Validation
- Marker band size, shape, location, surface profile, and ● radiopacity
- Distal Tip Inspection ●
- Guidewire compatibility ●
- Catheter push-ability ●
- Catheter track-ability
- Kink resistance ●
- Catheter stiffness
- Catheter torque-ability ●
- Curve retention ●
6
Catheter withdrawal ●
The results of the testing do not bring up new questions of safety or effectiveness.
Based on the indications for use, design, safety and performance testing, the subject Impress Angiographic Catheter with Hydrophilic Summary of Substantial Coating meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Equivalence Impress Angiographic Catheter, K093004 manufactured by Merit Medical Systems, Inc.