(114 days)
The LiiSA Lever Integrated Interventional System Adaptor™ is a Y-Connector and hemostasis valve which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic or interventional devices (i.e., guide wires, balloon catheters, stents) used in angioplasty procedures. It is compatible with guiding catheters 9 F or smaller and 0.014" - 0.038" guide wires.
The LiiSA Lever Integrated Interventional System AdaptorTM is an Adaptor designed for use in all interventional applications where a hemostasis valve is required and has an inner diameter of up to 9 F ( 3.0 mm / 0.118"). It has a seal which can be opened and closed by control of a lever. Pushing the lever will open the seal; releasing the lever will close the seal. The lever can be rested in a partially open position or a fully open position. These positions can easily be identified by the position of the lever and by an audible "click". The lever can be further controlled with great sensitivity to have the optimal seal around the interventional device (i.e., guide wire, balloon catheter, stent). This enables the user to experience a minimum of back bleeding with maximum security for his introduced device. The LiiSA Lever Integrated Interventional System AdaptorTM offers two external arms for the purpose of locking introduced devices (i.e., guide wire) to enable users to introduce additional devices without the need to manually hold and secure the devices already introduced and secured. The LiiSA Lever Integrated Interventional System AdaptorTM has a "Y" side arm to facilitate contrast media injection, saline flush and blood pressure monitoring.
The provided text describes a 510(k) submission for the LiiSA Lever Integrated Interventional System AdaptorTM, a hemostasis valve. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria that would typically involve human readers or AI performance metrics.
Therefore, many of the requested categories related to AI performance, expert review, MRMC studies, and standalone algorithm performance are not applicable to this 510(k) summary. The "acceptance criteria" here refer to demonstrating that the device is as safe and effective as the predicate devices through non-clinical bench tests and analysis.
Here's the information based on the provided text, with explanations for the inapplicable sections:
Acceptance Criteria and Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Substantial Equivalence: Same or similar intended use, indications for use, principle of operation, and performance characteristics as predicate devices. | The LiiSA hemostasis valve has the same or similar intended use, indications for use, principle of operation, and performance characteristics as predicate devices (CoPilot Bleedback Control Valve - K991102 and Y-Click Connector - K060759). |
| Safety and Effectiveness: Demonstration through data collected from nonclinical bench tests and analysis. | The safety and effectiveness of the LiiSA hemostasis valve has been demonstrated through data collected from nonclinical bench tests and analysis. The evaluation does not raise any additional concerns regarding safety and effectiveness and is considered substantially equivalent to the predicate devices. (Specific performance values from the bench tests are not detailed in this 510(k) summary; the summary only states that the data demonstrated safety and effectiveness to meet the equivalence criterion). |
| Compatibility: Guiding catheters 9 F or smaller. | Compatible with guiding catheters 9 F or smaller. |
| Compatibility: Guide wires 0.014" - 0.038". | Compatible with 0.014" - 0.038" guide wires. |
| Hemostasis Maintenance: Ability to maintain hemostasis during introduction, use, and withdrawal of diagnostic or interventional devices. | The device is intended to maintain hemostasis during these procedures, and its substantial equivalence and "performance data" (from bench tests) are stated to have demonstrated this capability. (Specific quantitative results of hemostasis performance are not included in this summary). |
Study Details
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as this was a 510(k) submission relying on non-clinical bench tests and analysis, not a clinical study with a "test set" of patient data in the typical sense. The "test set" would consist of the devices tested during bench assays.
- Data Provenance: The data comes from "nonclinical bench tests and analysis." The country of origin for the data is not specified, but it would have been conducted by or for Device Partners International (USA) to support their submission to the FDA. The nature of these tests is prospective for the purpose of the submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission is for a physical medical device (hemostasis valve) and relies on bench testing and engineering analysis, not expert interpretation of medical images or clinical data to establish a "ground truth." Safety and effectiveness are evaluated based on physical and functional performance criteria.
-
Adjudication method for the test set:
- Not Applicable. See point 2. No expert adjudication of data was performed in the context of this 510(k) summary.
-
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:
- Not Applicable. This is a physical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm or AI system.
-
The type of ground truth used:
- Bench Test Performance Standards/Engineering Specifications. The "ground truth" for this device would be its ability to meet predetermined engineering specifications for sealing, compatibility, durability, and other functional attributes during non-clinical bench testing, as well as adherence to relevant industry standards.
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The sample size for the training set:
- Not Applicable. This is a physical device, not a machine learning model. There is no "training set" in the context of AI development.
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
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| 510(k) Summary | K073260 | |
|---|---|---|
| Applicant: | Device Partners International4305 Enterprise Drive, Suite EWinston-Salem, NC 27106 | MAR 13 2008 |
| Contact Person: | Monica Early Dougherty4305 Enterprise Drive, Suite EWinston-Salem, NC 27106Phone: 210-957-2083 | |
| Date Prepared: | November 20, 2007 | |
| Device: | Device Trade Name: LiiSA Lever Integrated Interventional SystemAdaptorTMDevice Common Name: Hemostatic ValveDevice Classification Name: Adaptor, Stopcock, Manifold, Fitting,Cardiopulmonary BypassClassification: Class IIProduct Code: DTLRegulation Number: 870.4290 | |
| Predicate Devices: | Predicate devices used to demonstrate substantial equivalence are theCoPilot Bleedback Control Valve marketed by Guidant /Abbott Vascular(K991102) and theY-Click Connector marketed by Elcam Medical(K060759). | |
| Device description: | The LiiSA Lever Integrated Interventional System AdaptorTM is anAdaptor designed for use in all interventional applications where ahemostasis valve is required and has an inner diameter of up to 9 F ( 3.0mm / 0.118"). It has a seal which can be opened and closed by control of alever. Pushing the lever will open the seal; releasing the lever will closethe seal. The lever can be rested in a partially open position or a fully openposition. These positions can easily be identified by the position of thelever and by an audible "click". The lever can be further controlled withgreat sensitivity to have the optimal seal around the interventional device(i.e., guide wire, balloon catheter, stent). This enables the user toexperience a minimum of back bleeding with maximum security for hisintroduced device. The LiiSA Lever Integrated Interventional SystemAdaptorTM offers two external arms for the purpose of locking introduceddevices (i.e., guide wire) to enable users to introduce additional deviceswithout the need to manually hold and secure the devices alreadyintroduced and secured. The LiiSA Lever Integrated Interventional SystemAdaptorTM has a "Y" side arm to facilitate contrast media injection, salineflush and blood pressure monitoring. | |
| Indication for use: | The LiiSA Lever Integrated Interventional System AdaptorTM is a Y-Connector and hemostasis valve which is intended to maintain hemostasisduring the introduction, use and withdrawal of diagnostic or interventional |
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devices (i.e., guide wires, balloon catheters, stents) used in angioplasty procedures. It is compatible with guiding catheters 9 F or smaller and 0.014" - 0.038" guide wires.
- Substantial Equivalence: The LiiSA hemostasis valve has the same or similar intended use, indications for use, principle of operation, and performance characteristics as predicate devices and is, therefore, substantially equivalent to the predicate devices.
- The safety and effectiveness of the LiiSA hemostasis valve has been Performance Data: demonstrated through data collected from nonclinical bench tests and analysis.
- Conclusion: The evaluation of the LiiSA Lever Integrated Interventional System Adaptor does not raise any additional concerns regarding safety and effectiveness and may therefore is considered substantially equivalent to the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2008
Device Partners International c/o Ms. Monica Dougherty Director, Regulatory Affairs 4305 Enterprise Drive, Suite E Winston-Salem, NC 27106
Re: K073260
LiiSA Lever Integrated Interventional System Adapter Regulation Number: 21 CFR 870.4290 Regulation Name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DTL Dated: January 16, 2008 Received: January 17, 2008
Dear Ms. Dougherty:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Monica Dougherty
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
510(k) Number: K073260
Device Name: LiiSA Lever Integrated Interventional System Adaptor™
Indications For Use:
The LiiSA Lever Integrated Interventional System Adaptor™ is a Y-Connector and hemostasis valve which is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic or interventional devices (i.e., guide wires, balloon catheters, stents) used in angioplasty procedures. It is compatible with guiding catheters 9 F or smaller and 0.014" - 0.038" guide wires.
Prescription Use X (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)
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(Division Sign-Off) Division of Cardlovascular Dovices 510(k) Number Ko 7 3200 4-4444 -----------------------------------------------------------------------------------------------------------------------------------------------------------------------
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§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.