The SoloPath™ Balloon Expandable TransFemoral Introducer is intended to be inserted percutaneously into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and /or devices introduced into the femoral iliac arteries.

Device Description

The SoloPath™ Balloon Expandable TransFemoral Introducer is an intravascular catheter introducer and is Intended for travel over a 0.038″ or smaller guidewire. The device includes a flexible Sheath composed of reinforced polymer that is compressed, folded and wrapped around a central, removable balloon dilatation catheter (the Expander). One radiopaque marker is located on the Sheath to indicate the end of the expandable portion of the Sheath.

The Expander balloon is non-compliant and size limited. The Expander has both an inflation lumen and a guidewire lumen. The Expander is configured to be used with standard inflation devices having an appropriate pressure rating, a male Luer lock coupler, and a capacity of 25-CC.

The Sheath is terminated, at its proximal end, by a hub having a straight through hemostasis port capable of accepting catheters equal to the full sheath inner diameter. An aspiration and infusion port, terminated with a 3-way stopcock, permits infusion of heparinized saline into the central port of the Sheath hub, prior to and during the procedure. The Expander incorporates a T connector, the through lumen port being terminated with a hemostasis valve for guidewire introduction, while the right angle port is for inflation of the Expander balloon. A separate aspiration and infusion side port, terminated with a 3-way stopcock, is also provided which permits fluid transfer into or from the guidewire lumen of the Expander.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, not a study involving AI or human readers for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria, study design for AI evaluation, and ground truth establishment is not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The device described is the SoloPath™ Balloon Expandable TransFemoral Introducer, intended for use in the femoral artery. The acceptance criteria are based on demonstrating substantial equivalence to a predicate device (SoloPath™ Balloon Expandable TransFemoral Introducer, K092014) and satisfying product design specifications for its intended use through in vitro bench testing.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance/Conclusion
Biocompatibility	Per ISO 10993-1, including: Cytotoxicity, Complement Activation, PTT, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen, Hemolysis	All biocompatibility tests were conducted to support the safety and effectiveness of the device. (Implied: Passed/Met criteria for substantial equivalence)
Leakage Testing	Hemostasis and Dilator Leakage Testing	Conducted to support safety and effectiveness. (Implied: Passed/Met criteria for substantial equivalence)
Design/Functional Testing	Bend Testing, Inflation/Deflation Testing, Tensile Testing	Conducted to support safety and effectiveness and demonstrate equivalence to the predicate device. (Implied: Passed/Met criteria for substantial equivalence)
Overall Conclusion		"The results of testing demonstrate that the SoloPath™ Balloon Expandable TransFemoral Introducer is substantially equivalent to the predicate device in design, function, and indications for use."

Study Information (as applicable to this type of device submission):

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of units or samples used for each in vitro bench test (e.g., how many devices were bent, inflated, or tested for tensile strength).
- Data Provenance: The tests are in vitro bench tests, meaning they were conducted in a laboratory setting, not on patient data. There is no information regarding country of origin or whether it's retrospective or prospective, as these terms are typically associated with clinical studies involving human subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device submission. The "ground truth" for in vitro bench testing typically involves predefined engineering specifications, regulatory standards (like ISO 10993-1), and performance thresholds. There's no mention of experts establishing a "ground truth" in the diagnostic sense.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are relevant in studies where multiple human readers or algorithms interpret data and discrepancies need to be resolved. For in vitro engineering tests, the results are typically quantitative measurements against known standards.
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:
- This is not applicable. This submission is for a physical medical device (catheter introducer), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. As stated above, this is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance testing is based on pre-defined engineering specifications, international standards (like ISO 10993-1), and successful comparison to the performance characteristics of the legally marketed predicate device. There is no "expert consensus" or "pathology" relevant to the performance evaluation described.
The sample size for the training set:
- This is not applicable. There is no "training set" as this is not a machine learning or AI device.
How the ground truth for the training set was established:
- This is not applicable. No training set was used.

Summary

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510(k) Summary

	6.1 Submitter Information	AUG 0 2 2010
A.	Company Name:	Onset Medical, Inc.
B.	Company Address:	13900 Alton Parkway, Suite 120Irvine, CA, 92618
C.	Company Phone:	(949) 716-1100
D.	Company Facsimile:	(949) 716-1101
E.	Contact Person:	Joseph BishopChief Executive Officerjbishop@onsetmedical.com
	6.2 Device Identification
A.	Device Trade Name:	SoloPath™ Balloon Expandable TransFemoral Introducer
B.	Common Name:	Catheter Introducer
C.	Classification Name(s):	Introducer, Catheter
D.	Classification Regulation(s):	21 CFR 870.1340
E.	Device Class:	Class II
F.	Product Code:	DYB
G.	Advisory Panel:	Cardiovascular

6.3 Identification of Predicate Device

The predicate device is the SoloPath™ Balloon Expandable TransFemoral Introducer, that was cleared for commercial distribution under 510(k) K092014.

6.4 Device Description

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6.5 Indications for Use

6.6 Performance Testing

A program of design verification testing included in vitro bench testing that has been completed to demonstrate that the performance characteristics of the SoloPath™ Balloon Expandable TransFemoral Introducer are equivalent to the predicate device and satisfy the requirements of the product design specifications for its intended use.

The following tests were conducted to support the safety and effectiveness of the product.

Biocompatibility Testing per ISO 10993-1. 1.
- Which includes Cytotoxicity, Complement Activation, PTT, Sensitization, Intracutaneous a. Reactivity, Acute Systemic Toxicity, Pyrogen, and Hemolysis
1. Leakage testing including Hemostasis and Dilator Leakage Testing
Design/Functional Testing: 3.
- Bend Testing a.
- Inflation/Deflation Testing ﻘ
- Tensile Testing ﻦ
- 6.7 Conclusions Drawn from Studies

The results of testing demonstrate that the SoloPath™ Balloon Expandable TransFemoral Introducer is substantially equivalent to the predicate device in design, function, and indications for use.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

AUG 0 2 2010

Onset Medical Corporation c/o Mr. Joseph Bishop Chief Executive Officer 13900 Alton Parkway, Suite 120 Irvine, CA 92618

Re: K100819

Trade/Device Name: SoloPath™ Balloon Expandable TransFemoral Introducer Regulation Number:-21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 29, 2010 Received: June 30, 2010

Dear Mr. Bishop:

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. 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

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Page 2 - Mr. Joseph Bishop

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

una R. h. hmer

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Bram 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):	K100819		AUG 02 2010
Device Name:	SoloPath™ Balloon Expandable TransFemoral Introducer

Indications for Use:

The SoloPath™ Balloon Expandable TransFemoral Introducer is intended to be inserted
percutaneously into the femoral artery, over a guidewire, and once expanded, to
provide a guide for catheters and /or devices introduced into the femoral iliac arteries.

Prescription Use	X	AND/OR	Over the Counter Use _______
(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Richter

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number	K100819
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Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).