The EmboCath® Plus Infusion Microcatheter is intended for: infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.

Device Description

The EmboCath® Plus Infusion Microcatheter, same as its predicate device EmboCath Hydrophilic Catheter (K003105) is sterile, biocompatible, single use, peripheral vascular catheter constructed of a tapered reinforced shaft, inner lubricious lined lumen, hydrophilic outer surface, radiopaque marker and a standard luer adapter at the proximal end.

The device will be provided in the following configurations:

Inner Diameter: 0.028 in.
Outer Diameters: 3 F proximally to 2.8 F distally
Lengths: 100 cm and 135 cm as indicated on product label .

The EmboCath® Plus Infusion Microcatheter is a tapered 3.0-2.8F single lumen catheter designed to facilitate the access of distal vasculature over a guidewire. The catheter has a semi-rigid proximal shaft and becomes progressively more flexible toward the distal end. The shaft is reinforced, which provides improved torque transmission. The inner lumen is lined with a lubricious material to facilitate the movement of guidewires or other devices. The outer diameter of the catheter is coated with a hydrophilic surface to enhance the ability to navigate tortuous anatomy. The distal tip of the catheter has a single radiopaque marker to facilitate fluoroscopic visualization. The hub at the proximal end incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter lumen is 0.028 inches and guidewires measuring up to 0.025 inches (0.635 mm) in diameter are recommended.

AI/ML Overview

This 510(k) summary describes a medical device, the EmboCath® Plus Infusion Microcatheter, and its substantial equivalence to a predicate device, the EmboCath Hydrophilic Catheter (K003105). The submission primarily focuses on functional equivalence rather than clinical performance or AI-driven diagnostic accuracy. Therefore, several of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not applicable or not provided in this document as they pertain to clinical or AI performance studies which were not conducted for this type of device submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide explicit quantitative "acceptance criteria" for clinical performance. Instead, it relies on demonstrating that the EmboCath® Plus Infusion Microcatheter performs equivalently to its predicate device through in-vitro design verification and validation testing, ensuring it meets its design and performance specifications. The "reported device performance" is essentially the successful completion of these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Device successfully passes in-vitro design verification and validation tests to demonstrate equivalence to predicate.	"In-vitro design verification and validation testing demonstrates that the EmboCath® Plus Infusion Microcatheter is equivalent to its predicate device and fulfills design and performance specifications." Tests performed include: Visual Inspection, Dimensional Inspection, Trackability Test (in simulated anatomy), Kink Resistance Test, Patency Test (for embolic patency), Coating Lubricity Test, Aspiration Test, Stiffness Test, Tensile Failure Load Test, Column Test, Leak/Burst Test (Static Pressure).
Meets specified physical dimensions (length, inner diameter, outer diameter).	Length: 100 cm and 135 cm (matches predicate). Inner Diameter: 0.028 in. (matches predicate). Outer Diameter: 0.038 in. distal 30 cm, 0.039 in. proximal (65 cm and 70 cm) (matches predicate).
Uses materials functionally equivalent to the predicate device.	Materials: Predominantly Pebax, Nylon12, Stainless Steel, Polyvinylpyrrolidone (PVP), Polyachrylamide. (Similar to predicate, with expanded description of PVP and inclusion of Polyacrylamide, but considered functionally equivalent.)
Intended Use and Indications for Use are substantially equivalent to the predicate, with minor modifications (e.g., specific vascular systems).	Intended Use is for infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures. This is a narrowing of the predicate's use which included neuro, peripheral, and coronary systems. This change does not raise new questions of safety or effectiveness.
Substantially equivalent in terms of size, construction, performance characteristics, biocompatibility, packaging, and sterilization method.	The device is deemed substantially equivalent in all these aspects to EmboCath Hydrophilic Catheter (K003105).

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

Not applicable. This submission describes in-vitro engineering tests (e.g., trackability, kink resistance, patency) rather than a clinical study involving a test set of patient data. The tests are benchtop evaluations of device characteristics. No data provenance in terms of country of origin or retrospective/prospective collection is relevant here.

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

Not applicable. Ground truth, in the context of expert consensus, is not relevant for in-vitro engineering tests. The "ground truth" for these tests would be established by validated test methodologies and measurement equipment against engineering specifications.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring expert adjudication.

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 device is a microcatheter, not an AI-driven diagnostic tool. No MRMC study was performed as no human reader interpretation of AI output is involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm or AI.

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

The "ground truth" for the performance claims is derived from engineering specifications and established test methods for material properties and functional device performance during the in-vitro design verification and validation testing. For example, a "kink resistance test" would have predetermined acceptance criteria for the force or angle at which kinking occurs, and the device's performance is measured against these criteria.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI models, so there is no training set.

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

Not applicable. As there is no training set for an AI model, no ground truth needed to be established for it.

Summary

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K062126

510(k) Summary EmboCath® Plus Infusion Microcatheter BioSphere Medical, Inc.

AUG - 9 2006

1. SUBMITTER/510(K) HOLDER

BioSphere Medical, Inc. 1050 Hingham Street Rockland, MA 02370 USA

Contact Person: Irina Kulinets Sr. Director Regulatory Affairs and Quality Assurance Telephone: 781-681-7900

Fax: 781-681-5093

Date Prepared: July 26, 2006

2. DEVICE NAME

EmboCath® Plus Infusion Microcatheter Proprietary Name: Common/Usual Name: Infusion Catheter Catheter Intravascular Diagnostic (21CFR 870.1200, Classification Name: DQO)

3. PREDICATE DEVICES

. EmboCath Hydrophilic Catheter (K003105)

4. DEVICE DESCRIPTION

The device will be provided in the following configurations:

. Inner Diameter: 0.028 in.
. Outer Diameters: 3 F proximally to 2.8 F distally
Lengths: 100 cm and 135 cm as indicated on product label .

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న. INTENDED USE

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

BioSphere Medical, Inc. bases its claim of the substantial equivalence of the EmboCath® Plus Infusion Microcatheter with the cited predicate device based on intended use, indications for use, fundamental technological characteristics, and fundamental operational characteristics. The function of the EmboCath® Plus Infusion Microcatheter is to facilitate the access of distal vasculature over a guidewire and deliver various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems.

7. PERFORMANCE TESTING

In-vitro design verification and validation testing demonstrates that the EmboCath® Plus Infusion Microcatheter is equivalent to its predicate device and fulfills design and performance specifications.

The following design verification testing were performed:

Visual Inspection ਼
Dimensional Inspection o

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Trackability Test (in simulated anatomy) 0
Kink Resistance Test o
Patency Test (for embolic patency) ಂ
Coating Lubricity Test o
Aspiration Test o
Stiffness Test 0
Tensile Failure Load Test 0
Column Test o
Leak/Burst Test (Static Pressure) o

8. PRODUCT FEATURE COMPARISON

Feature	EmboCath® PlusInfusion MicrocatheterSubject device	EmboCath Hydrophilic InfusionCatheter (K003105)Predicate device
Intended Use	The EmboCath® PlusInfusion Microcatheter isintended for: infusion ofvarious diagnostic,embolic and therapeuticagents into the body'svascular systems(peripheral) guidewireexchange/support; andsuperselectiveangiography of theperipheral vasculatures.	The EmboCath® Plus InfusionMicrocatheter is intended for: infusionof various diagnostic, embolic andtherapeutic agents into the body'svascular systems (neuro, peripheral,coronary) guidewire exchange/support;and superselective angiography of theperipheral and coronary vasculatures.
Design: Length	100 cm and 135 cm	100 cm and 135 cm
Design:InternalDiameter	0.028 in.	0.028 in.
Design OuterDiameter:	0.038 in. distal 30 cm0.039 in. proximal (65 cmand 70 cm)	0.038 in. distal 30 cm0.039 in. proximal (65 cm and 70 cm)
Materials	Predominantly Pebax,Nylon12, Stainless Steel,Polyvinylpyrrolidone(PVP), Polyachrylamide	Predominantly Pebax, Nylon12,Stainless SteelPolyvinylpyrrolidone (PVP)

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9. SUMMARY OF SUBSTANTIAL EQUIVALENCE

Biosphere Medical, Inc determination of substantial equivalence to EmboCath Hydrophilic Catheter (K003105) predicate device is based on the following. The subject catheter is substantially equivalent to EmboCath Hydrophilic Catheter (K003105) with respect to:

o Size
Construction O
Intended use o
Performance characteristics O
Biocompatibility 0
0 Packaging
Sterilization method 0

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2006

BioSphere Medical, Inc. c/o Ms. Irina Kulinets 1050 Hingham Street Rockland, MA 02370

Re: K062126

EmboCath Plus Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (Two) Product Code: DQO Dated: July 26, 2006 Received: July 26, 2006

Dear Ms. Kulinets:

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 such 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. Irina Kulinets

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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

R.Z. M.D.

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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Indications for Use

510(k) Number (if known): KO6 J 126

escription USA

EmboCath® Plus Infusion Microcatheter Device Name: Indications For Use:

The EmboCath® Plus Infusion Microcatheter is intended for:

infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.

(Part 21 CFR 801 Subpart D)	(21 CFR 801 Subpart C)
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(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 Devices
510(k) Number	K062126

Page 1 of 1

AND/OR

er-The-Counter Use

Regulation Number and Section

§ 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).