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.

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.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Stratus Infusion Catheter," which focuses on establishing substantial equivalence to a predicate device.

While it mentions "design verification and validation testing" including bench testing, biocompatibility, sterilization validation, and animal testing, it does not provide:

A table of acceptance criteria and reported device performance.
Sample sizes used for a test set or data provenance.
Details about experts used for ground truth or their qualifications.
Adjudication methods.
Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
Details of a standalone (algorithm only) performance study.
The specific type of ground truth used (beyond implying general animal study outcomes).
Sample size for a training set or how its ground truth was established.

The document primarily focuses on a comparison of the characteristics of the Stratus Infusion Catheter to its predicate device (Bullfrog Micro-Infusion Device) to demonstrate substantial equivalence, rather than detailing a study that measures its performance against specific acceptance criteria.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K222185

Device Name Stratus Infusion Catheter

Indications for Use (Describe)

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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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 302South 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 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

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.

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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 StratusInfusion Catheterindications do not includecoronary vessels orarteries. No impact onsafety or effectiveness ofthe product.
Needle Size	25.5 Ga	34 Ga	Stratus needle is slightlylarger than the Bullfrogneedle. Both devicesutilize needles that areamong the smallest ofintravenous injection andinfusion needles. There isno impact on the safety oreffectiveness of the Stratusproduct.
NeedlePenetrationDepth	0.5mm to 1.5mm	1.5 mm	Maximum needlepenetration depth is thesame as the predicate. Theneedle height/penetrationdepth for the StratusInfusion Catheter can beadjusted by the user acrossthe entire range based onlocation and application aswell as from one infusionto the next. No impact onsafety or effectiveness ofthe product.
NeedleDeploymentOrientation	Parallel to catheter	Perpendicular to catheter	The Mercator Bullfrog hasa needle that protrudesperpendicularly to thetarget location andengages the vessel as soonas the balloon is inflated toa specific diameter relativeto the lumen. The StratusInfusion catheter has aneedle that runs parallel tothe vessel and is advancedin a precise fashion by theuser after the balloon hasbeen fully inflated to thedesired diameter. Noneedle engagement occursuntil the user deliberatelyadvances the needle.Engagement of the targetinfusion site is controlledby the user and does not
Use of GuideWire	.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.
BalloonMaterial	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 FlowRate	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.
CatheterWorkingLength	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.
SterilizationMethod	E-beam Radiation	Radiation	Equivalent

Comparison of Subject Device to Predicate Device:

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Table 1 - Comparison between subject and predicate device

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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.

Regulation Number and Section

§ 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).