The InfusaSleeve IIa is intended to infuse fluids such as heparinized saline, diagnostic agents such as contrast media, and thrombolytic agents such as urokinase into the coronary vasculature. The catheter is designed for use with a commercially available dilatation catheter to facilitate selective and subselective access and regional infusion.

Device Description

The Kaplan-Simpson InfusaSleeve™ IIa is a multi-lumen catheter consisting of a proximal infusion port, a proximal shaft, and a main catheter shaft with a distal infusion region. An entry port for balloon and guide wire access is located at the proximal end of the main shaft which is proximal to the infusion region. The infusion region consists of four separate infusion lumens each with multiple sideholes. Radiopaque markers are located within the infusion region. Infusion solution is delivered through the proximal infusion port, through the four infusion lumens and exits through the sideholes into the coronary vasculature. A standard luer adapter allows for attachment of a syringe with a manometer or equival infusion port. A flushing tool is included to facilitate flushing the main catheter shaft through the distal tip. The InfusaSleeve IIa is designed to track over standard dilatation catheters.

AI/ML Overview

The provided text outlines a 510(k) summary for the InfusaSleeve IIa (IS-2a) catheter, mainly focusing on its substantial equivalence to a predicate device, the InfusaSleeve II.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., a specific percentage for sensitivity or specificity). Instead, it relies on demonstrating equivalence to a predicate device through various non-clinical tests. The "reported device performance" is framed as being "equivalent to, or exceeds" the predicate device.

Acceptance Criteria (Implicit from Equivalence)	Reported Device Performance (InfusaSleeve IIa)
Biocompatibility: Meet established standards for materials in contact with the body.	Verified (presumably met accepted biocompatibility standards).
Bond Joint Tensile Strengths: Withstand force without failure at critical junctures.	Verified, equivalent to or exceeding InfusaSleeve II.
Infusion Pathway Fatigue: Maintain integrity and function after repeated stress cycles.	Verified, equivalent to or exceeding InfusaSleeve II.
Burst Pressure: Withstand maximum operating pressures without bursting.	Verified, equivalent to or exceeding InfusaSleeve II. (Maximum proximal infusion pressure: 50 psig)
Infusate Flow: Deliver fluids effectively and consistently.	Verified, equivalent to or exceeding InfusaSleeve II.
Torque Strength: Withstand twisting forces during manipulation.	Verified, equivalent to or exceeding InfusaSleeve II.
Histology: Induce no adverse tissue reactions.	Verified, equivalent to or exceeding InfusaSleeve II.
In-vivo animal evaluations: Demonstrate safe and effective performance in a living system.	Verified, equivalent to or exceeding InfusaSleeve II.
Design & Construction Equivalence: Match or improve upon key design features of the predicate device.**	Infusion region with nine delivery sideholes per peripheral lumen, 0.028 mm sidehole diameters (vs. 0.04 mm in predicate). Maximum balloon diameter 4.0 mm (vs. 3.5 mm in predicate). Maximum balloon catheter shaft size 3.8 Fr (vs. 3.5 Fr in predicate). Other features are equivalent.
Material Equivalence: Utilize similar or identical materials for components.**	Polycarbonate (infusion port), Stainless Steel/Nylon (proximal shaft), Nylon (main shaft & tip), Silicone (lubricious coating), Gold/Stainless steel (radiopaque marker), Stainless steel (support elements) - all equivalent to predicate.

2. Sample sizes used for the test set and the data provenance

The document does not explicitly state specific sample sizes for each non-clinical test. It mentions "Material biocompatibility, bond joint tensile strengths, infusion pathway fatigue, burst pressure, infusate flow, torque strength, histology, and in-vivo animal evaluations."
The data provenance is from non-clinical tests, including in-vivo animal evaluations. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective, though in-vivo animal evaluations are typically prospective for such device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For non-clinical tests, "ground truth" often refers to predefined engineering specifications or biological endpoints, rather than expert consensus on interpretations of images or clinical outcomes.

4. Adjudication method for the test set

This information is not provided in the document. With non-clinical tests, adjudication methods like 2+1 or 3+1 are typically not applicable. Test results are objectively measured against predefined criteria.

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 document describes the clearance of a physical medical device (catheter) for infusing fluids, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without 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 evaluation was not done. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical tests would have been based on predefined engineering specifications, material standards, and biological endpoints from animal studies. For example:

Engineering specifications: For burst pressure, torque strength, tensile strength, and flow rates.
Material standards: For biocompatibility.
Biological endpoints: For histology (e.g., absence of inflammation, tissue damage) and in-vivo animal evaluations (e.g., functional performance, safety, absence of adverse events).

8. The sample size for the training set

This information is not applicable as this is a physical medical device and not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set with established ground truth.

Summary

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February 3, 2022

LocalMed, Inc. Ed Lee Director, Regulatory Affairs/quality Assurance 1820 Embarcadero Rd. Palo Alto, California 94303

Re: K972175

Trade/Device Name: InfusaSleeve IIa (IS-2a) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA

Dear Ed Lee:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 28, 1997. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Image /page/0/Picture/9 description: The image shows a digital signature. The signature is from Gregory W. O'connell. The date of the signature is 2022.02.03, and the time is 14:35:39 -05'00'.

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

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Ed Lee Director, Requlatory Affairs and Quality Assurance LocalMed 1820 Embarcadero Road - -Palo Alto, California 94303

AUG 28 1997

Re: K972175 Kaplan-Simpson InfusaSleeve™ IIa Requlatory Class: II (two) Product Code: KRA Dated: June 6, 1997 Received: June 9, 1997

Dear Mr. Lee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic (21 Crk Farc our and dadreronary %07.10 10-12-200 at 13:00 am
devices), please contact the Office of Cómpliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known): K972175

Device Name: InfusaSleeve IIa (IS-2a)

Indications for Use:…… -------------------------------------------------------------------------------------------------------------------------------------------------------

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	____________________________________
Prescription Use (Per 21 CFR 801.109)
	OR
Over-The-Counter Use	____________________________________
	(Optional Format 1-2-96)

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K972175

510(K) SUMMARY

AUG 2 8

SUBMITTER'S NAME AND ADDRESS:	LocalMed, Inc.1820 Embarcadero RoadPalo Alto, CA 94303
PHONE:	(415) 843-6770(415) 843-6771 fax
CONTACT PERSON:	Edwin Lee
DATE SUMMARY PREPARED:	June 6, 1997
DEVICE TRADE NAME:	Kaplan-Simpson InfusaSleeve TM IIa
DEVICE COMMON NAME:	Catheter, infusion
DEVICE CLASSIFICATION NAME:	Catheter, continuous flush
SUBSTANTIALLY EQUIVALENT DEVICE(S):	InfusaSleeve TM II

DEVICE DESCRIPTION AND FUNCTION:

Image /page/4/Figure/6 description: This image shows a medical device with labels pointing to its different parts. The device includes a proximal infusion port, proximal shaft, main catheter shaft, shaft transition marker, balloon/wire entry port, radiopaque markers, tip, and flushing tool. There is also a detailed view of the infusion region, highlighting expansion slits and sideholes.

Figure 1

The infusion region consists of four separate infusion lumens each with multiple sideholes. Radiopaque markers are located within the infusion region. Infusion solution is delivered through the proximal infusion port, through the four infusion lumens and exits through the sideholes into the coronary vasculature. A standard luer adapter allows for attachment of a syringe with a manometer or equival infusion port. A flushing tool is included to facilitate flushing the main catheter shaft through the distal tip. The InfusaSleeve IIa is designed to track over standard dilatation catheters.

INTENDED USE:

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with a commercially available dilatation catheter to facilitate selective access and regional infusion.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
	InfusaSleeve II	InfusaSleeve IIa (premarket notification)
General indications:	General intravascular use, delivery oftherapeutic solutions. Selective and sub-selective controlled infusion of solutions.	General intravascular use, delivery oftherapeutic solutions. Selective and sub-selective controlled infusion of solutions.
Usage:	Single use, disposable	Single use, disposable
How supplied:	Sterile, non-pyrogenic	Sterile, non-pyrogenic
Sterilization method:	100% EtO sterilized	100% EtO sterilized
Materials:
Infusion port:	Polycarbonate	Polycarbonate
Proximal shaft:	Stainless Steel, Nylon	Stainless Steel, Nylon
Main shaft & Tip:	Nylon	Nylon
Lubriciouscoating:	Silicone	Silicone
Radiopaquemarker:	Gold/Stainless steel	Gold/Stainless steel
Support elements:	Stainless steel	Stainless steel
Design &Construction:
Catheterconfiguration:	Introduced coaxially over a dilatationdevice. Infusion through peripherallumens.	Introduced coaxially over a dilatationdevice. Infusion through peripherallumens.
Shaftconfiguration:	Multi-lumen device. Central lumenaccommodates dilatation device. Fouropposing peripheral infusion lumens.	Multi-lumen device. Central lumenaccommodates dilatation device. Fouropposing peripheral infusion lumens.
Distal infusionregion:	Nine delivery sideholes per peripherallumen. 0.04 mm sidehole diameters.	Nine delivery sideholes per peripherallumen. 0.028 mm sidehole diameters.
Mode of operation:
Solution deliverymode:	Solution delivery via the peripheral lumensideholes into the vasculature.	Solution delivery via the peripheral lumensideholes into the vasculature.
Maximumproximal infusionpressures:	50 psig	50 psig
Vascular access:	Percutaneous	Percutaneous
Trackingmechanism:	Over-the-balloon	Over-the-balloon
Size:
Total length:	1.4 m	1.4 m
Working length:	1.3 m	1.3 m
	InfusaSleeve II	InfusaSleeve IIa (premarket notification)
Infusion regionlength:	2 cm	2 cm
Outer diameter:	1.5 - 2.1 mm	1.5 - 2.1 mm
Inner diameter:	0.9 - 1.5 mm	0.9 - 1.5 mm
Compatibility:
Max balloondiameter	3.5 mm	4.0 mm
Max ballooncatheter shaft size:	3.5 Fr	3.8 Fr
Guiding catheter:	Standard	Standard
Infusion portfitting:	ISO 594 luer conical fitting	ISO 594 luer conical fitting
Radiopacity:	via Radiopaque distal markers	via Radiopaque distal markers

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

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NONCLINICAL TESTS:

Material biocompatibility, bond joint tensile strengths, infusion pathway fatigue, burst pressure, infusate flow, torque strength, histology, and in-vivo animal evaluations.

TEST CONCLUSIONS:

The test results verified that the InfusaSleeve IIa performance is equivalent to, or exceeds the InfusaSleeve II device performance.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).