(57 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guide catheter extension, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a guide catheter extension intended to facilitate the placement of interventional devices, not to provide therapy itself. Its function is to aid in accessing regions and delivering other devices.
No
Explanation: The device is described as a guide catheter extension intended to facilitate the placement of interventional devices, not to diagnose medical conditions.
No
The device description clearly details a physical, invasive medical device (a guide catheter extension) made of various materials like stainless steel, PTFE, MP35N coil, tantalum core, nylon, Pebax, and silicone fluid. The performance studies listed are all related to the physical properties and functionality of this hardware device. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for accessing and facilitating placement of interventional devices within the coronary and/or peripheral vasculature. This is a direct intervention within the body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical catheter extension designed to be inserted into the body. It describes its physical components, dimensions, and materials. This is consistent with a medical device used for procedural purposes, not for diagnostic testing of biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information based on laboratory testing.
In summary, the LiquID Guide Catheter Extension is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LiquID Guide Catheter Extension is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
Product codes
DQY
Device Description
The LiquID device is a guide catheter extension that is substantially equivalent to currently marketed devices with the distinction of having a larger intraluminal diameter. The device is available in two models: Liquid 061 and LiquID 071 which are designed to fit within 6F and 7F conventional guide catheters, respectively. The device has a 150 cm working length and a 0.018" diameter proximal stainless-steel shaft connected to a 15cm single lumen distal shaft (exchange length).
The LiquID device distal shaft includes an internal PTFE liner, a MP35N coil internally clad with a tantalum core for support and radiopacity, and an exterior nylon-based encapsulation layer. The rounded and atraumatic distal tip includes PTFE and Pebax that is monolithically attached (no joints) to the distal shaft. The distal shaft exterior is wiped with silicone fluid for lubricity.
The transition between the single lumen distal shaft and proximal shaft includes a stainless collar that is welded to the proximal shaft, positioned over the PTFE liner, and encapsulated in polymer. This construction provides a smooth transition and structural integrity.
The LiquID device has proximal positioning marks (laser created oxide marks) that are approximately 95cm and 105cm from the distal tip and has a colored proximal handle that follows the coronary guide catheter size color code. The proximal shaft is not coated.
The LiguID device is packaged in a HDPE hoop within a Tyvek poly sealed pouch. The pouch is contained in an SBS shelf box. Twenty-five (25) shelf boxes are contained within a shipping container. The shipping containers are used for transporting the devices between the manufacturer, the ethylene oxide (EO) sterilization contractor, and the distribution locations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or peripheral vasculature
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)
The LiquID device has been verified through the following tests:
- Shaft Marker Location and Visibility
- Inside Diameter
- Outside Diameter
- Working Length
- Exchange Length
- Distal Tip Length
- Device Preparation
- Functionality with a Hemostasis Valve
- Trackability
- Contrast Injection
- Compatibility with Interventional Devices
- Radiopacity
- Kink Resistance
- Distal and Proximal Flexibility
- Surface Inspection
- Tensile and Torsional Strength
- Push Rod to Attachment Bend
- Burst Pressure
- Corrosion Resistance
- Coating Durability
- Particulate Evaluation
The LiquID device passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Pyrogenicity
- ASTM Hemolysis
- Complement Activation
- Thrombogenicity
The LiquID device has been validated to meet a SAL of 10-9 in accordance with ISO 11135.
The results of these verification tests met the specified acceptance criteria and did not raise new safety or performance issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Seigla Medical, Inc. Chad Kugler President & CEO 7688 5th Street SE Buffalo, Minnesota 55313
Re: K220691
Trade/Device Name: LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 8, 2022 Received: March 9, 2022
Dear Chad Kugler:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Lydia Glaw, Ph.D. Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220691
Device Name
Seigla Medical LiquID Guide Catheter Extension
Indications for Use (Describe)
The LiquID Guide Catheter Extension is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Date Prepared: 08 March 2022 510(k) Number: K220691
Legal Manufacturer:
| Name: | Seigla Medical, Inc. |
|---|---|
| Address: | 7688 5th St SE |
| Buffalo, MN 55313 | |
| Email: | ckugler@seiglamedical.com |
| Contact Person: | Chad Kugler |
| Phone Number: | (763) 615-9058 |
| Facsimile Number: | (612) 453-4774 |
Device Information:
| Classification: | Class II Percutaneous Catheter / DQY / 870.1250 |
|---|---|
| Trade Name: | Seigla Medical LiquID M Guide Catheter Extension |
| Common Name: | Catheter |
Reference Devices:
The Seigla Medical Liquid Guide Catheter Extension is substantially equivalent in intended use, method of operation and technical aspects to the following predicate devices:
Primarv Predicate: K172090 - Vascular Solutions/Teleflex Guideliner V3 Catheters
Additional Reference Devices: K163314 - Boston Scientific Guidezilla II Guide Extension Catheter K183353 - Medtronic Telescope Guide Extension Catheter K160561 - OX Medical Boosting Catheter
Summary Description:
The LiquID device is a guide catheter extension that is substantially equivalent to currently marketed devices with the distinction of having a larger intraluminal diameter. The device is available in two models: Liquid 061 and LiquID 071 which are designed to fit within 6F and 7F conventional guide catheters, respectively. The device has a 150 cm working length and a 0.018" diameter proximal stainless-steel shaft connected to a 15cm single lumen distal shaft (exchange length).
The LiquID device distal shaft includes an internal PTFE liner, a MP35N coil internally clad with a tantalum core for support and radiopacity, and an exterior nylon-based encapsulation layer. The rounded and atraumatic distal tip includes PTFE and Pebax that is monolithically attached (no joints) to the distal shaft. The distal shaft exterior is wiped with silicone fluid for lubricity.
4
The transition between the single lumen distal shaft and proximal shaft includes a stainless collar that is welded to the proximal shaft, positioned over the PTFE liner, and encapsulated in polymer. This construction provides a smooth transition and structural integrity.
The LiquID device has proximal positioning marks (laser created oxide marks) that are approximately 95cm and 105cm from the distal tip and has a colored proximal handle that follows the coronary guide catheter size color code. The proximal shaft is not coated.
The LiguID device is packaged in a HDPE hoop within a Tyvek poly sealed pouch. The pouch is contained in an SBS shelf box. Twenty-five (25) shelf boxes are contained within a shipping container. The shipping containers are used for transporting the devices between the manufacturer, the ethylene oxide (EO) sterilization contractor, and the distribution locations.
Indication for Use:
The LiquID Guide Catheter Extension is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
Comparison to Predicate Devices:
The LiquID Guide Catheter Extension is substantially equivalent to the Vascular Solutions/Teleflex Guideliner V3 Catheters (K172090). In addition, the Boston Scientific Guidezilla II Guide Extension Catheter (K163314), Medtronic Telescope Guide Extension Catheter (K183353) and the OX Medical Boosting Catheter (K160561) are included as reference devices.
Guide catheter extensions are designed to facilitate the placement of interventional devices. They are placed within the interior lumen and advanced beyond the distal tip of conventional guide catheters. These devices allow physicians to achieve deeper vascular intubation providing enhanced placement and support for subsequent interventional device delivery.
The LiquID device and, the predicate device, and the reference devices include a PTFE lined single lumen distal shaft that is metal (coil or braid) supported with an exterior polymer encapsulation layer. The device distal shafts have an exterior coating for lubricity and include radiopaque features. The devices transition from the distal shaft to a push rod with designs that allow the introduction of interventional devices from the guide catheter and into the device distal shaft. The device transitions are also designed for strength. The devices are EO sterilized and are conventionally packaged (hoop, pouch, and box).
5
Summary:
Based upon the intended use, descriptive information, and performance evaluation provided in this premarket notification, the Seigla LiquID Guide Catheter Extension device has been shown to be substantially equivalent to a currently marketed predicate device and reference devices.
-
- The LiquID device has been verified through the following tests:
- Shaft Marker Location and Visibility ●
- Inside Diameter ●
- Outside Diameter ●
- Working Length ●
- Exchange Length
- Distal Tip Length
- Device Preparation
- Functionality with a Hemostasis Valve
- Trackability
- Contrast Injection
- Compatibility with Interventional Devices
- Radiopacity
- Kink Resistance
- Distal and Proximal Flexibility
- Surface Inspection
- Tensile and Torsional Strength
- . Push Rod to Attachment Bend
- Burst Pressure ●
- Corrosion Resistance ●
- Coating Durability ●
- Particulate Evaluation .
-
- The LiguID device passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Systemic Toxicity
- Pyrogenicity ●
- ASTM Hemolysis ●
- Complement Activation .
- Thrombogenicity ●
-
- The LiquID device has been validated to meet a SAL of 10-9 in accordance with ISO 11135.
The results of these verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the LiquID device is a guide catheter extension that is substantially equivalent to the predicate devices.