The SoloPath® Re-Collapsible Access System 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 artery.

Device Description

The SoloPath® Re-Collapsible Access System is a cardiovascular device designed to be used as a guide for catheters and/or devices introduced into the femoral artery. The device is provided sterile for single use. Onset Medical Corporation's SoloPath® Re-Collapsible Access System is a sterile, single use device. It consists of a flexible, reinforced polymer sheath with an external collapsible outer jacket and specially folded, radially-collapsed distal end (the Sheath) pre-mounted over a central balloon dilatation catheter (the Expander), and equipped with a proximal hub assembly incorporating a hemostasis valve. The folded distal region of the Sheath is small in diameter, thus facilitating passage through the vessel. The SoloPath Assembly is inserted percutaneously into the femoral artery, over a guidewire, with the deflated Expander in place. Once positioned into the artery, the Expander balloon, when inflated with liquid, exerts controlled radial force, enlarging the folded distal region of the Sheath and surrounding anatomy. The Expander balloon is deflated and the Expander is removed leaving a large central lumen extending from the proximal end to the distal end of the Sheath, which maintains its expanded size by means of malleable distal reinforcement. The Sheath is designed as a guide for catheters and/or devices introduced into the femoral artery. Prior to removal, the outer jacket is activated with liquid unde pressure, collapsing the outer sheath diameter for ease of removal. The sheath is capable of expanding and actively collapsing.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Specific Test	Acceptance Criteria	Reported Device Performance
Functional Verification	Bend	Not explicitly stated, but implied proper function.	Acceptance criteria met.
	Coating integrity	Not explicitly stated, but implied proper function.	Acceptance criteria met.
	Coating particulate	Not explicitly stated, but implied proper function.	Acceptance criteria met.
	Collapsation	Demonstrated ability to actively collapse.	Acceptance criteria met.
	Dilator burst	Not explicitly stated, but implied structural integrity.	Acceptance criteria met.
	Dilator cycle	Not explicitly stated, but implied durability.	Acceptance criteria met.
	Expansion	Demonstrated ability to expand.	Acceptance criteria met.
	Hemostasis valve leakage	Not explicitly stated, but implied prevention of blood loss.	Acceptance criteria met.
	Sheath jacket burst	Not explicitly stated, but implied structural integrity.	Acceptance criteria met.
	Sheath jacket cycle	Not explicitly stated, but implied durability.	Acceptance criteria met.
	Tensile	Not explicitly stated, but implied strength.	Acceptance criteria met.
	Torque	Not explicitly stated, but implied rotational integrity.	Acceptance criteria met.
	Trackability	Not explicitly stated, but implied ease of navigation.	Acceptance criteria met.
Biocompatibility	Cytotoxicity	Conformance to ISO 10993-1 requirements.	Acceptance criteria met.
	Complement Activation	Conformance to ISO 10993-1 requirements.	Acceptance criteria met.
	Partial Thromboplastin Time (PTT)	Conformance to ISO 10993-1 requirements.	Acceptance criteria met.
	Sensitization	Conformance to ISO 10993-1 requirements.	Acceptance criteria met.
	Intracutaneous Reactivity	Conformance to ISO 10993-1 requirements.	Acceptance criteria met.
	Acute Systemic Toxicity	Conformance to ISO 10993-1 requirements.	Acceptance criteria met.
	Pyrogenicity	Conformance to ISO 10993-1 requirements.	Acceptance criteria met.
	Hemolysis	Conformance to ISO 10993-1 requirements.	Acceptance criteria met.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document mentions that "both the 19Fx35 cm and 24Fx35cm the SoloPath® Re-Collapsible Access System" were tested. This implies testing was conducted on at least two distinct configurations of the device. However, the exact number of units tested for each specific test (e.g., how many sheaths for a burst test) is not provided.
Data Provenance: The study was conducted as in vitro bench studies. There is no mention of human or animal studies, or clinical data. Therefore, there is no country of origin for patient data, and it is entirely retrospective in the sense of being laboratory-based testing, not involving ongoing patient recruitment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the studies conducted were in vitro bench studies and biocompatibility testing. There was no "ground truth" derived from expert interpretation of medical images or patient outcomes. The ground truth was based on pre-defined engineering and biological standards and criteria.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as above. No adjudication method was necessary as these were objective measurements against pre-defined engineering and biological acceptance 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 type of study is relevant for AI-powered diagnostic or assistive devices where human interpretation is involved. The SoloPath® Re-Collapsible Access System is a physical medical device, and its performance is evaluated through bench testing and biocompatibility.

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

No, this is not applicable. The SoloPath® Re-Collapsible Access System is a physical medical device, not an algorithm or software-only device. Its performance is inherent to its physical properties and design, not an algorithm.

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

The ground truth for the bench studies and biocompatibility testing was based on pre-defined engineering specifications, performance standards, and established international biocompatibility standards (ISO 10993-1). It was not derived from expert consensus, pathology, or patient outcomes data.

8. The sample size for the training set:

Not applicable. There was no "training set" for this device. This concept is relevant for machine learning or AI algorithms, which are not involved in the SoloPath® Re-Collapsible Access System's evaluation as described.

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

Not applicable. As there was no training set, there was no ground truth for a training set to be established.

Summary

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K121404

510(k) Summary

Onset Medical Corporation, SoloPath® Re-Collapsible Access System

This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807, section 807.92.

General Information

Sponsor's Name and Address:	Onset Medical Corporation13900 Alton Parkway, Suite 120Irvine, CA 92618
Contact Person:	Joseph BishopVice President and Chief Operating OfficerOnset Medical Corporation13900 Alton Parkway, Suite 120Irvine, CA 92618(949) 716-1100
Date Summary Prepared:	April 19, 2013
Device Trade Name:	SoloPath ®Re-Collapsible Access System
Product Code:	DYB
Regulation Number:	21 CFR 870.1340
Classification:	Class II
Common Name:	Catheter Introducer
Predicate Devices	• Onset Medical SoloPath ® Balloon Expandable TransFemoralIntroducer (K092014 and K100819)• GORE® DrySeal Sheath (K093791)

Cook® Extra Large Check-Flo® Introducer (Pre-Amendment device)

Description

Testing was performed to demonstrate the SoloPath® Re-Collapsible Access System device is substantially equivalent to the predicate devices.

Onset Medical Corporation's SoloPath® Re-Collapsible Access System is a sterile, single use device. It consists of a flexible, reinforced polymer sheath with an external collapsible outer jacket and specially folded, radially-collapsed distal end (the Sheath) pre-mounted over a central balloon dilatation catheter (the Expander), and equipped with a proximal hub assembly incorporating a hemostasis valve. The folded distal region of the Sheath is small in diameter, thus facilitating passage through the vessel. The SoloPath Assembly is inserted percutaneously into the femoral artery, over a guidewire, with the deflated Expander in place. Once positioned into the artery, the Expander balloon, when inflated with liquid, exerts controlled radial force, enlarging the folded distal region of the Sheath and surrounding anatomy. The Expander balloon is deflated and the Expander is removed leaving a large central lumen extending from the proximal end to the distal end of the Sheath, which maintains its expanded size by means of malleable distal reinforcement. The Sheath is designed as a guide for catheters and/or devices

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introduced into the femoral artery. Prior to removal, the outer jacket is activated with liquid unde pressure, collapsing the outer sheath diameter for ease of removal.

The SoloPath® Re-Collapsible Access System is equivalent to approved predicate devices currently available as vascular introducers such as the Cook® Extra Large Check-Flo® Introducer which is available in 20F, 22F and 24F configurations with a variable usable lengths and Onset Medical Corporation's SoloPath® Balloon Expandable TransFemoral Introducer which utilizes the same material and balloon expandable dilation feature for vascular introduction. These devices are designed to be advanced over a guidewire, under fluoroscopic or ultrasound guidance. The dilator portion of the introducer assembly is advanced gently into the vasculature and facilitates a clinical conduit through which interventional tools and prostheses can be safely delivered. The devices may contain various hemostasis valve assemblies and hydrophilic-coated surfaces for improved lubricity. The SoloPath® Re-Collapsible Access System is equivalent in regards to materials, indications for use and overall clinical utility. However, like the approved SoloPath® TransFemoral Introducer, the SoloPath® Re-Collapsible Access System consists of a flexible sheath with a specially folded distal segment pre-mounted over a central balloon dilatation catheter (the Expander). The folded distal region of the Sheath is small in diameter, thus facilitating passage through the vessel. The SoloPath® Re-Collapsible Access System is inserted percutaneously into the femoral artery, over a guidewire. Once the device is positioned, the Expander balloon is inflated with liquid and exerts controlled radial dilation, enlarging the folded distal segment of the Sheath to a unidiameter configuration. The Expander balloon is deflated and is removed leaving a large central lumen extending from the proximal end to the distal end of the SoloPath® Re-Collapsible Access System performs the same as previously approved predicate devices and raises no new issues of safety or effectiveness.

The sheath is capable of expanding and actively collapsing.

In Vitro bench studies were conducted to demonstrate that the SoloPath® Re-Collapsible Access System performed as intended in simulated use conditions. Biocompatibility testing was conducted to demonstrate conformance to ISO 10993-1 requirements.

Intended Use/Indications For Use

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Device Name	SoloPath®Re-CollapsibleAccess System	SoloPath®BalloonExpandableTransFemoralIntroducer	GORE® DrySealSheath	Extra LargeCheck-Flo®Introducer
K#	K121404	K092014 andK100819	K093791	Pre-Amendmentdevice
Manufacturer	Onset MedicalCorporation	Onset MedicalCorporation	Gore Medical	CookIncorporated
Indication for use	The SoloPath®Re-CollapsibleAccess System isintended to beinsertedpercutaneouslyinto the femoralartery, over aguidewire andonce expanded,to be used as aguide forcatheters and/ordevicesintroduced intothe femoralartery.	The SoloPath®BalloonExpandableTransFemoralIntroducer isintended to beinsertedpercutaneouslyinto the femoralartery, over aguidewire, andonce expanded,to provide aguide forcatheters and/ordevicesintroduced intothe femoral iliacarteries.	The GOREDrySeal Sheath isintended to beinserted in thevasculature toprovide aconduit for theinsertion ofendovasculardevices whileminimizing bloodloss associatedwith suchinsertions.	Introducers areintended forintroduction ofballoons, closedand non-taperedend catheters orother diagnosticor interventionaldevices. Theproduct isintended for useby physicianstrained andexperienced indiagnostic andinterventionaltechniques.Standardtechniques forplacement ofvascular accesssheaths shouldbe employed
Device Name	New Device:SoloPath® Re-CollapsibleAccess System	Predicate Device:SoloPath®TransFemoralIntroducer	Predicate Device:GORE® DrySealSheath	Predicate Device:Extra LargeCheck-Flo®Introducer
Placement	Standardtechniques forplacement ofvascular accesssheaths	Standardtechniques forplacement ofvascular accesssheaths	Standardtechniques forplacement ofvascular accesssheaths	Standardtechniques forplacement ofvascular accesssheaths

Device Name	SoloPath®Re-CollapsibleAccess System	SoloPath®BalloonExpandableTransFemoralIntroducer	GORE® DrySealSheath	Extra LargeCheck-Flo®Introducer
Guidewirecompatibility	Can be navigatedover a .035" or.038"compatibleguidewire	Can be navigatedover a .035" or.038" compatibleguidewire	Recommendedto be navigatedover a .035" orsmallerguidewire.	Recommendedto be navigatedover a .035"guidewire.
Radiographic markers	Sheath tip =Radiopaque GoldDistal Marker	Sheath tip =Radiopaque GoldDistal Marker	Sheath tip =distal markerband	Optional
Shaft Materials	• Medical gradeplastic shaftreinforcedwith stainlesssteel ribbon• PET OuterJacket• Coated withhydrophiliccoating	• Medical gradeplastic shaftreinforcedwith stainlesssteel ribbon• Coated withhydrophiliccoating	• Medical gradeplastic shaft• Physicalcharacteristicsare similar tootherpredicatedevices.	• Medical gradeplastic shaft
Device length	25cm - 35cm	25cm - 35cm	28cm	25cm - 55 cm
Available sheath ID's(pre-expansion)	19F - 24F	11F - 21F	12F - 26F	18F - 24F
Available sheath OD's(post-expansion)	23F - 28.5F	14 F - 24 F	NA	NA
Fixed OD (guidewirelumen)	Yes	Yes	Yes	Yes
Variable OD (Capableof expansion)	Yes — viainjecting fluidthough theapplicable port	Yes — viainjecting fluidthough theapplicable port	No	No
Capable of ODcollapsation	Yes — byinjecting fluidinto theapplicable port	Yes - passively;the sheathcollapses duringremoval	No	No
Sterilized by	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide

Comparison of the Technological Characteristics of the New Device and Predicate Devices

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Performance Testing

Results of bench studies conducted on both the 19Fx35 cm and 24Fx35cm the SoloPath® Re-Collapsible Access System demonstrated the System to be as safe and effective as the predicate device based on the biocompatibility of the materials used, sterilization, bench testing. Testing was performed on both EO processed and EO equivalent product, and product accelerated aged to 6 months.

The following studies were conducted and acceptance criteria were met:

Functional Verification

. Bend
. Coating integrity
. Coating particulate
. Collapsation
. Dilator burst
. Dilator cycle
. Expansion
. Hemostasis valve leakage

. Sheath jacket burst
. Sheath jacket cycle
. Tensile
. Torque
. Trackability

Materials tested per ISO 10993-1

. Cytotoxicity
. Complement Activation
. Partial Thromboplastin Time (PTT)
. Sensitization
. Intracutaneous Reactivity
. Acute Systemic Toxicity
. Pyrogenicity, and
. Hemolysis

Conclusion

. The SoloPoth® Re-Collapsible Access System is substantially equivalent to the predicate devices.
. The indication for use for the devices is substantially equivalent.
. The technological design and functional characteristics of the sterile disposable access devices are all substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2013

Onset Medical Corporation Mr. Joseph Bishop Vice President and Chief Operating Officer 13900 Alton Parkway, Suite 120 Irvine, CA 92618

Re: K121404

Trade/Device Name: SoloPath® Re-Collapsible Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 19, 2013 Received: April 24, 2013

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 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

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Page 2 - Mr. Joseph Bishop

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Bram D厚uckerman

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 Statement

510(k) Number (if known): K121404

Device Name: SoloPath® Re-Collapsible Access System

Indications for Use:

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Bram D. Zuckerman
2013.05.03 11:52:54
-04'00'

Concurrence of CDRH, Office of Device Evaluation (ODE)

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).