(358 days)
No
The device description focuses on the mechanical and material properties of the access system. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies are bench studies evaluating physical characteristics and biocompatibility.
No.
Explanation: The device is an access system intended to provide a guide for other catheters and/or devices inserted into the femoral artery, rather than directly treating a disease or condition itself.
No
The device is an access system intended to provide a guide for catheters and/or devices into the femoral artery, not to diagnose a condition.
No
The device description clearly outlines a physical, sterile, single-use cardiovascular device consisting of a sheath, expander, and hub assembly. It is designed for percutaneous insertion and manipulation within the femoral artery, which are hardware-based functions.
Based on the provided information, the SoloPath® Re-Collapsible Access System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is "to be inserted percutaneously into the femoral artery... to provide a guide for catheters and/or devices introduced into the femoral artery." This describes a device used in vivo (within the body) for a procedural purpose, not for examining specimens in vitro (outside the body) to obtain diagnostic information.
- Device Description: The description details a physical device designed for insertion into a blood vessel and manipulation within the body. It describes components like a sheath, expander, balloon, and hub assembly, all consistent with an interventional medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The purpose is purely procedural – providing access and guidance.
Therefore, the SoloPath® Re-Collapsible Access System is a medical device, specifically an interventional cardiovascular device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DYB
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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 (Bench Studies):
- 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 (Biocompatibility):
- 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.
Key Metrics
Not Found
Predicate Device(s)
K092014 and K100819, K093791, Pre-Amendment device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Page 1 of 5
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 Corporation
13900 Alton Parkway, Suite 120
Irvine, CA 92618 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph Bishop
Vice President and Chief Operating Officer
Onset Medical Corporation
13900 Alton Parkway, Suite 120
Irvine, 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 TransFemoral
Introducer (K092014 and K100819)
• GORE® DrySeal Sheath (K093791) |
- Cook® Extra Large Check-Flo® Introducer (Pre-Amendment 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.
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
1
K121404
Page 2 of 5
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
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.
2
| Device Name | SoloPath®
Re-Collapsible
Access System | SoloPath®
Balloon
Expandable
TransFemoral
Introducer | GORE® DrySeal
Sheath | Extra Large
Check-Flo®
Introducer |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K121404 | K092014 and
K100819 | K093791 | Pre-Amendment
device |
| Manufacturer | Onset Medical
Corporation | Onset Medical
Corporation | Gore Medical | Cook
Incorporated |
| Indication for use | The SoloPath®
Re-Collapsible
Access System is
intended to be
inserted
percutaneously
into the femoral
artery, over a
guidewire and
once expanded,
to be used as a
guide for
catheters and/or
devices
introduced into
the femoral
artery. | 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. | The GORE
DrySeal Sheath is
intended to be
inserted in the
vasculature to
provide a
conduit for the
insertion of
endovascular
devices while
minimizing blood
loss associated
with such
insertions. | Introducers are
intended for
introduction of
balloons, closed
and non-tapered
end catheters or
other diagnostic
or interventional
devices. The
product is
intended for use
by physicians
trained and
experienced in
diagnostic and
interventional
techniques.
Standard
techniques for
placement of
vascular access
sheaths should
be employed |
| Device Name | New Device:
SoloPath® Re-
Collapsible
Access System | Predicate Device:
SoloPath®
TransFemoral
Introducer | Predicate Device:
GORE® DrySeal
Sheath | Predicate Device:
Extra Large
Check-Flo®
Introducer |
| Placement | Standard
techniques for
placement of
vascular access
sheaths | Standard
techniques for
placement of
vascular access
sheaths | Standard
techniques for
placement of
vascular access
sheaths | Standard
techniques for
placement of
vascular access
sheaths |
| | | | | |
| Device Name | SoloPath®
Re-Collapsible
Access System | SoloPath®
Balloon
Expandable
TransFemoral
Introducer | GORE® DrySeal
Sheath | Extra Large
Check-Flo®
Introducer |
| Guidewire
compatibility | Can be navigated
over a .035" or
.038"compatible
guidewire | Can be navigated
over a .035" or
.038" compatible
guidewire | Recommended
to be navigated
over a .035" or
smaller
guidewire. | Recommended
to be navigated
over a .035"
guidewire. |
| Radiographic markers | Sheath tip =
Radiopaque Gold
Distal Marker | Sheath tip =
Radiopaque Gold
Distal Marker | Sheath tip =
distal marker
band | Optional |
| Shaft Materials | • Medical grade
plastic shaft
reinforced
with stainless
steel ribbon
• PET Outer
Jacket
• Coated with
hydrophilic
coating | • Medical grade
plastic shaft
reinforced
with stainless
steel ribbon
• Coated with
hydrophilic
coating | • Medical grade
plastic shaft
• Physical
characteristics
are similar to
other
predicate
devices. | • Medical grade
plastic 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 (guidewire
lumen) | Yes | Yes | Yes | Yes |
| Variable OD (Capable
of expansion) | Yes — via
injecting fluid
though the
applicable port | Yes — via
injecting fluid
though the
applicable port | No | No |
| Capable of OD
collapsation | Yes — by
injecting fluid
into the
applicable port | Yes - passively;
the sheath
collapses during
removal | No | No |
| Sterilized by | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
Comparison of the Technological Characteristics of the New Device and Predicate Devices
3
K121404
Page 4 of 5
.
·
4
K121404
Page 5 of 5
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.
5
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
6
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
7
Indications for Use Statement
510(k) Number (if known): K121404
Device Name: SoloPath® Re-Collapsible Access System
Indications for Use:
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.
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)