(114 days)
Not Found
No
The device description and intended use focus on mechanical components and their function (lever, seal, arms, Y-side arm) for hemostasis and device management during angioplasty. There is no mention of AI, ML, data processing, or any computational analysis of data.
No
The device is described as an adaptor and hemostasis valve used to maintain hemostasis during the introduction, use, and withdrawal of diagnostic or interventional devices in angioplasty procedures. It does not directly treat a condition.
No
The device is described as an adaptor and hemostasis valve, intended to maintain hemostasis during procedures, not to diagnose a condition. It is used with diagnostic or interventional devices.
No
The device description clearly outlines a physical Y-Connector and hemostasis valve with mechanical components (lever, seal, arms). It is a hardware device used in angioplasty procedures.
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 used during angioplasty procedures to maintain hemostasis and facilitate the introduction and withdrawal of interventional devices. This is a direct interaction with the patient's circulatory system during a medical procedure.
- Device Description: The description details a mechanical device (Y-connector, hemostasis valve with a lever) designed for use in interventional applications. It manages blood flow and device insertion/withdrawal.
- 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 for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used in vivo (within the body) during a medical procedure.
N/A
Intended Use / Indications for Use
The LiiSA Lever Integrated Interventional System AdaptorTM 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.
Product codes (comma separated list FDA assigned to the subject device)
DTL
Device Description
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.
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
The safety and effectiveness of the LiiSA hemostasis valve has been demonstrated through data collected from nonclinical bench tests and analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of the LiiSA hemostasis valve has been Performance Data: demonstrated through data collected from nonclinical bench tests and analysis.
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
§ 870.4290 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.
0
| 510(k) Summary | K073260 | |
|---|---|---|
| Applicant: | Device Partners International | |
| 4305 Enterprise Drive, Suite E | ||
| Winston-Salem, NC 27106 | MAR 13 2008 | |
| Contact Person: | Monica Early Dougherty | |
| 4305 Enterprise Drive, Suite E | ||
| Winston-Salem, NC 27106 | ||
| Phone: 210-957-2083 | ||
| Date Prepared: | November 20, 2007 | |
| Device: | Device Trade Name: LiiSA Lever Integrated Interventional System | |
| AdaptorTM | ||
| Device Common Name: Hemostatic Valve | ||
| Device Classification Name: Adaptor, Stopcock, Manifold, Fitting, | ||
| Cardiopulmonary Bypass | ||
| Classification: Class II | ||
| Product Code: DTL | ||
| Regulation Number: 870.4290 | ||
| Predicate Devices: | Predicate devices used to demonstrate substantial equivalence are the | |
| CoPilot 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 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. | ||
| Indication for use: | The LiiSA Lever Integrated Interventional System AdaptorTM is a Y- | |
| Connector and hemostasis valve which is intended to maintain hemostasis | ||
| during the introduction, use and withdrawal of diagnostic or interventional |
1
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.
2
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.
3
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
4
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)
h
(Division Sign-Off) Division of Cardlovascular Dovices 510(k) Number Ko 7 3200 4-4444 -----------------------------------------------------------------------------------------------------------------------------------------------------------------------
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