(132 days)
Not Found
No
The description focuses on the mechanical and material properties of a balloon expandable introducer and does not mention any computational or algorithmic components.
No
The device is described as an introducer to guide other catheters and devices, rather than directly treating a condition itself.
No
The device is an introducer used to guide catheters and devices into arteries for interventional procedures, not to diagnose a condition.
No
The device description clearly details physical components like a sheath, balloon dilatation catheter, hubs, ports, and stopcocks, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "inserted percutaneously into the femoral artery... to provide a guide for catheters and /or devices introduced into the femoral iliac arteries." This describes a device used in vivo (within the body) for a procedural purpose (introducing other devices).
- Device Description: The description details a physical device (introducer sheath, balloon catheter, hubs, ports) designed for insertion into blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body internally for procedural purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery, femoral iliac arteries
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
-
- Leakage testing including Hemostasis and Dilator Leakage Testing
- Design/Functional Testing: 3.
- Bend Testing a.
- Inflation/Deflation Testing
- Tensile Testing
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
| 6.1 Submitter Information | AUG 0 2 2010 | |
|---|---|---|
| A. | Company Name: | Onset Medical, Inc. |
| B. | Company Address: | 13900 Alton Parkway, Suite 120 |
| Irvine, CA, 92618 | ||
| C. | Company Phone: | (949) 716-1100 |
| D. | Company Facsimile: | (949) 716-1101 |
| E. | Contact Person: | Joseph Bishop |
| Chief Executive Officer | ||
| jbishop@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
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.
1
6.5 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.
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
-
- 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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
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
3
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
Image /page/3/Picture/8 description: The image shows a black and white abstract drawing. The drawing appears to be a stylized signature or symbol. It consists of curved lines and strokes that intersect and overlap, creating a fluid and dynamic design. The overall impression is one of simplicity and elegance.
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 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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