(28 days)
No
The summary describes a physical catheter device for pressure measurement and contrast delivery, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is indicated for diagnostic purposes (delivery of contrast medium and pressure measurements), not for treating a disease or condition.
Yes
The device is indicated for "simultaneous pressure measurement from two sites," which is useful in "determining transvalvular, intravascular and intraventricular pressure gradients." Measuring these gradients provides information about a patient's physiological state for diagnostic purposes.
No
The device description clearly details a physical catheter with lumens, sideholes, a side port, extension tube, stopcock assembly, and the ability to accommodate a guidewire. It also mentions sterilization with ethylene oxide and performance testing related to physical properties like aspiration, liquid leak, tensile strength, static burst, and flow rate. These are all characteristics of a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites." This is a procedure performed within the body (in vivo) to visualize blood vessels and measure physiological parameters.
- Device Description: The description details a catheter designed to be inserted into the body for these in vivo procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro), such as blood, urine, or tissue samples, which is the defining characteristic of an IVD.
Therefore, this device is a medical device used for in vivo procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Each Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.
Product codes
DQO
Device Description
The Langston dual lumen catheters have two lumens, both with distal sideholes, to allow simultaneous pressure measurements from two sites. The high-pressure inner lumen, which extends the entire length of the catheter, can be used for pressurement and rapid delivery of contrast medium. The outer lumen ends proximal to the distal end of the catheter and is used for pressure measurement only. A side port fitted with an extension tube and a stopcock assembly is used for fluid flow and pressure measurement within the outer lumen. The Langston dual lumen catheter will accommodate a standard ≤ 0.038" diameter guidewire and is supplied with a single use pigtail straightener. The Langston dual lumen catheter is sterilized with ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Risk assessment was performed according to ISO 14971, "Medical Devices - Application of Risk Management to Medical Devices. The following tests were performed to evaluate the design and performance of the modified Langston dual lumen catheters and to demonstrate substantial equivalence to the predicate device:
Performance Testing- Bench
The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence that the Langston dual lumen catheter is substantially equivalent to the predicate device. The modified device was verified through the following tests:
- Aspiration
- Liquid Leak
- Hub to Shaft Tensile
- Static Burst
- Flow Rate
The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety or effectiveness.
Biocompatibility Testing
Biocompatibility was leveraged from previous testing and demonstrated that the biocompatibility evaluation for the modified Langston dual lumen catheter complies with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
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June 17, 2022
Vascular Solutions LLC Becky Astrup Pr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K221470
Trade/Device Name: Langston dual lumen catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: May 19, 2022 Received: May 20, 2022
Dear Becky Astrup:
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 medical devices and radiation-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,
Lydia Glaw 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
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Indications for Use
510(k) Number (if known)
Device Name Langston dual lumen catheter
Indications for Use (Describe)
Each Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the Vascular Solutions logo at the top, which includes a stylized graphic above the company name. Below the logo, the text "510(k) SUMMARY" is prominently displayed in a large, bold font. The text is likely the title or heading of a document or section related to a 510(k) submission, which is a premarket submission made to the FDA to demonstrate that a medical device is safe and effective.
[As required by 21 CFR 807.92]
K221470 510(k) Number:
Date Prepared: May 19, 2022
SUBMITTER
Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Phone: 763-656-4300 Contact Person: Becky Astrup, Pr. Regulatory Product Specialist
DEVICE
Name of Device: Langston dual lumen catheter Common or Usual Name: Catheter Classification Name: Diagnostic intravascular catheter (21 CFR 870.1200) Regulatory Class: II Product Code: DQO
PREDICATE AND REFERENCE DEVICES
The legally marketed predicate device to which substantial equivalence is claimed is the Langston dual lumen pressure monitoring catheter, K051395, cleared June 24, 2005. The Langston dual lumen catheter, K170544, cleared November 17, 2017, is used as a reference device.
DEVICE DESCRIPTION
The Langston dual lumen catheters have two lumens, both with distal sideholes, to allow simultaneous pressure measurements from two sites. The high-pressure inner lumen, which extends the entire length of the catheter, can be used for pressurement and rapid delivery
4
of contrast medium. The outer lumen ends proximal to the distal end of the catheter and is used for pressure measurement only. A side port fitted with an extension tube and a stopcock assembly is used for fluid flow and pressure measurement within the outer lumen. The Langston dual lumen catheter will accommodate a standard ≤ 0.038" diameter guidewire and is supplied with a single use pigtail straightener. The Langston dual lumen catheter is sterilized with ethylene oxide.
INDICATIONS FOR USE
Each Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device is substantially equivalent to the predicate device with respect to indications for use, principle of operation, fundamental design principles, performance, sterilization, and packaging. The reason for submitting this Special 510(k) is to implement a design modification to the strain relief to hub bond.
PERFORMANCE DATA
Risk assessment was performed according to ISO 14971, "Medical Devices - Application of Risk Management to Medical Devices. The following tests were performed to evaluate the design and performance of the modified Langston dual lumen catheters and to demonstrate substantial equivalence to the predicate device:
Performance Testing- Bench
The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence that the Langston dual lumen catheter is substantially equivalent to the predicate device. The modified device was verified through the following tests:
-
Aspiration ●
-
Liquid Leak .
-
Hub to Shaft Tensile ●
-
Static Burst ●
-
. Flow Rate
The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety or effectiveness.
5
Biocompatibility Testing
Biocompatibility was leveraged from previous testing and demonstrated that the biocompatibility evaluation for the modified Langston dual lumen catheter complies with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
CONCLUSION
The subject Langston dual lumen catheter is substantially equivalent to the predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The results of design verification tests do not raise new or different questions of safety and effectiveness; therefore, the Langston dual lumen catheter is substantially equivalent to the predicate device.