(265 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description focuses on mechanical infusion capabilities.
Yes
The device is intended for the infusion of "therapeutic agents" into the vein wall or perivascular area, or intraluminally, which indicates a therapeutic purpose.
No
The device is an infusion catheter intended for delivering diagnostic and therapeutic agents, not for performing a diagnostic function itself.
No
The device description clearly describes a physical catheter, which is a hardware component, intended for insertion into veins. The performance studies also include bench testing, animal testing, and other tests typical for a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the infusion of diagnostic and therapeutic agents into the vein wall, perivascular area, or intraluminally. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) test.
- Device Description: The description clearly states it's a peripheral infusion catheter designed to access and infuse fluid into a vein.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, etc.) or performing tests on those samples outside of the body, which are hallmarks of IVD devices.
Therefore, the Stratus Infusion Catheter is a medical device used for direct administration of substances into the body, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
In selective areas of peripheral veins between 7 and 16 mm in diameter, the Stratus Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the vein wall or perivascular area, or intraluminally.
Product codes
NPG
Device Description
The Stratus Infusion Catheter is a peripheral infusion catheter designed to access an intraluminal, intramural, or perivascular vein wall layer and infuse fluid diagnostic and/or therapeutic agents. The Stratus Infusion Catheter is a non-implantable device that is provided sterile and is intended for single patient use.
The Stratus Infusion Catheter is designed to accommodate individual vein anatomies or disease progression (e.g., thrombosis), by the catheter platform allowing multiple infusions and infusion locations per device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral veins
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)
The following design verification and validation testing was performed and successfully completed on the Stratus Infusion Catheter:
- Bench testing
- Packaging testing
- Biocompatibility testing - testing included cytotoxicity, sensitization, intracutaneous reactivity, acute system toxicity, pyrogenicity, complement activation, hemolysis (direct contact and extract method), partial thromboplastin time, platelet and leukocyte count and thromboresistance
- Sterilization validation testing
- Corrosion testing
- Luer testing
- Simulated use testing
- Human factors testing
- Animal testing, including a chronic GLP animal study
Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. In addition, all user requirements were validated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains 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.
April 13, 2023
InterVene, Inc. % Mark Smutka Regulatory Consultant 10984 Northseal Square Cupertino, California 95014
Re: K222185
Trade/Device Name: Stratus Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: NPG Dated: July 21, 2022 Received: July 22, 2022
Dear Mark Smutka:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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 W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.04.13
10:04:56 -04'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222185
Device Name Stratus Infusion Catheter
Indications for Use (Describe)
In selective areas of peripheral veins between 7 and 16 mm in diameter, the Stratus Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the vein wall or perivascular area, or intraluminally.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Premarket Notification 510(k) Summary for the Stratus Infusion Catheter
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K222185
Applicant Information:
| Date Prepared: | July 21, 2022 |
|---|---|
| Name: | InterVene, Inc. |
| Address: | 415 Grand Avenue, Suite 302 |
| South San Francisco, CA 94080 |
| Contact Person: | Mark Smutka, Consultant |
|---|---|
| msmutka@comcast.net | |
| Mobile Number: | (408) 981-7531 |
Device Information:
| Device Trade Name: | Stratus Infusion Catheter |
|---|---|
| Common Name: | Continuous Flush Catheter |
| Classification Name(s): | Continuous Flush Catheter |
| Product Code/ Regulation: | NPG / 21 CFR 870.1210 |
| Classification: | Class II |
Predicate Device:
Bullfrog Micro-Infusion Device - K161402
Subject Device Description
The Stratus™ Infusion Catheter is a peripheral infusion catheter designed to access an intraluminal, intramural, or perivascular vein wall layer and infuse fluid diagnostic and/or therapeutic agents. The Stratus Infusion Catheter is a non-implantable device that is provided sterile and is intended for single patient use.
The Stratus Infusion Catheter is designed to accommodate individual vein anatomies or disease progression (e.g., thrombosis), by the catheter platform allowing multiple infusions and infusion locations per device.
Subject Device Indications for Use
In selective areas of peripheral veins between 7 and 16 mm in diameter, the Stratus Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the vein wall or perivascular area, or intraluminally.
Predicate and Subject Device Comparison
The table below provides a comparison of the Stratus Infusion Catheter to the predicate device, the Bullfrog Micro-Infusion Device.
4
| Characteristic | Stratus | Bullfrog | Comparison |
|---|---|---|---|
| Name | Stratus Infusion Catheter | Bullfrog Micro-infusion Device | N/A |
| Regulation Number | 21 CFR 870.1210 | 21 CFR 870.1210 | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Code | NPG | KRA | Equivalent |
| 510(k) Number | N/A | K161402 | N/A |
| Indications for Use | In selective areas of peripheral veins between 7 and 16 mm in diameter, the Stratus Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the vein wall or perivascular area, or intraluminally. | In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents into the vessel wall and perivascular area, or intraluminally. | Indications for Stratus Infusion Catheter are a subset of the predicate device. The Stratus Infusion Catheter indications do not include coronary vessels or arteries. All other indications are unchanged. No impact on safety or effectiveness of the product. |
| Reusable | Single-Use and Disposable | Single-Use and Disposable | Same |
| Power Source | No power source or console required | No power source or console required | Same |
| Radiopaque | Yes | Yes | Same |
| Packaging Configuration | Single device packaged in Tyvek pouch on card within shelf box | Single device packaged in Tyvek pouch on tray within shelf box | Same |
| Catheter Size | 14 Fr | 5 Fr | Catheter shaft diameters of the Bullfrog and Stratus differ to facilitate the capabilities of each. The Stratus was designed for the specific needs of large deep veins while the Bullfrog will also accommodate smaller vessels including arteries. The Stratus 14Fr size does not impact safety or effectiveness. Many other venous interventional 14F products are utilized in the same anatomy. |
| Vessel Size | 7-16 mm | 2-16mm (includes coronary vessels) | Indicated vein sizes are a subset of the predicate |
| device. The Stratus | |||
| Infusion Catheter | |||
| indications do not include | |||
| coronary vessels or | |||
| arteries. No impact on | |||
| safety or effectiveness of | |||
| the product. | |||
| Needle Size | 25.5 Ga | 34 Ga | Stratus needle is slightly |
| larger than the Bullfrog | |||
| needle. Both devices | |||
| utilize needles that are | |||
| among the smallest of | |||
| intravenous injection and | |||
| infusion needles. There is | |||
| no impact on the safety or | |||
| effectiveness of the Stratus | |||
| product. | |||
| Needle | |||
| Penetration | |||
| Depth | 0.5mm to 1.5mm | 1.5 mm | Maximum needle |
| penetration depth is the | |||
| same as the predicate. The | |||
| needle height/penetration | |||
| depth for the Stratus | |||
| Infusion Catheter can be | |||
| adjusted by the user across | |||
| the entire range based on | |||
| location and application as | |||
| well as from one infusion | |||
| to the next. No impact on | |||
| safety or effectiveness of | |||
| the product. | |||
| Needle | |||
| Deployment | |||
| Orientation | Parallel to catheter | Perpendicular to catheter | The Mercator Bullfrog has |
| a needle that protrudes | |||
| perpendicularly to the | |||
| target location and | |||
| engages the vessel as soon | |||
| as the balloon is inflated to | |||
| a specific diameter relative | |||
| to the lumen. The Stratus | |||
| Infusion catheter has a | |||
| needle that runs parallel to | |||
| the vessel and is advanced | |||
| in a precise fashion by the | |||
| user after the balloon has | |||
| been fully inflated to the | |||
| desired diameter. No | |||
| needle engagement occurs | |||
| until the user deliberately | |||
| advances the needle. | |||
| Engagement of the target | |||
| infusion site is controlled | |||
| by the user and does not | |||
| Use of Guide | |||
| Wire | .035" | .014" | introduce any new or increased risks (relative to the predicate) for engaging nearby vessels, arteries, or structures such as organs, bladder, etc. No impact on safety or effectiveness of the product. |
| An 0.035" Guidewire is the most common wire utilized in conjunction with venous interventions in this anatomy. No impact on safety or effectiveness of the product. | |||
| Balloon | |||
| Material | SEBS 65A compliant balloon | Semi-rigid polymer actuator balloon | SEBS is a medical grade polymer utilized in other venous interventional devices. No impact on safety or effectiveness of the product. |
| Balloon Sizes | 7-16 mm (compliant balloon, size based on inflation volume) | 2-4mm, 3-6mm, 4-8mm and 6-16mm | Indicated balloon sizes are a subset of the predicate device balloons. The Stratus Infusion Catheter indications do not include coronary vessels or arteries. No impact on safety or effectiveness of the product. |
| Infusion Flow | |||
| Rate | No more than 1 cc (mL) in 30 seconds | 0.1-0.2mL per 5 seconds | Similar infusion flow rate. No impact on safety or effectiveness of the product. |
| Catheter | |||
| Working | |||
| Length | 80 cm | 145 cm | Shorter working length of Stratus Infusion Catheter is designed for intended access and treatment of selective areas of peripheral veins between 7 and 16mm in diameter. No impact on safety or effectiveness of the product. |
| Sterilization | |||
| Method | E-beam Radiation | Radiation | Equivalent |
Comparison of Subject Device to Predicate Device:
5
6
Table 1 - Comparison between subject and predicate device
7
Testing Completed
The following design verification and validation testing was performed and successfully completed on the Stratus Infusion Catheter:
- . Bench testing
- Packaging testing
- . Biocompatibility testing - testing included cytotoxicity, sensitization, intracutaneous reactivity, acute system toxicity, pyrogenicity, complement activation, hemolysis (direct contact and extract method), partial thromboplastin time, platelet and leukocyte count and thromboresistance
- Sterilization validation testing ●
- Corrosion testing
- Luer testing
- Simulated use testing
- Human factors testing ●
- Animal testing, including a chronic GLP animal study
Testing described in this 510(k) consisted of verification of all design input requirements and product specifications. In addition, all user requirements were validated.
Summary
Based upon the Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the Stratus Infusion Catheter has been shown to be substantially equivalent to the cited predicate.