(142 days)
Not Found
No
The description focuses on the mechanical design and delivery system of a vena cava filter, with no mention of AI or ML capabilities.
Yes
The device is indicated for the prevention and treatment of pulmonary embolism, which are conditions that impact a patient's health and require medical intervention.
No
Explanation: The device is a G2 EXPRESS™ Filter System, which is a medical implant designed to prevent recurrent pulmonary embolism by permanently placing a filter in the vena cava. It is a therapeutic device, not a diagnostic one, as its purpose is to treat or prevent a medical condition rather than to identify or diagnose it.
No
The device description clearly details physical components like filters, catheters, dilators, and delivery systems, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The G2 EXPRESS™ Filter System is a physical device designed for permanent placement within the vena cava (a blood vessel inside the body). Its purpose is to prevent recurrent pulmonary embolism by filtering blood clots in vivo (inside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of specimens, laboratory testing, or diagnostic purposes based on samples taken from the body.
Therefore, the G2 EXPRESS™ Filter System is an implantable medical device used for therapeutic purposes, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The G2 EXPRESS™ Filter System – Femoral and Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:
- . Pulmonary thromboembolism when anticoagulants are contraindicated.
- . Failure of anticoagulant therapy for thromboembolic disease.
- Emergency treatment following massive pulmonary embolism where anticipated . benefits of conventional therapy are reduced.
- . Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
- . G2 EXPRESS™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.
Product codes (comma separated list FDA assigned to the subject device)
DTK
Device Description
The G2 EXPRESS™ Filter consists of 12 shape-memory nitinol wires emanating from a central nitinol sleeve with a snare tip. These 12 wires form two levels of emboli filtration: the legs provide the lower level of filtration and the arms provide the upper level of filtration. The G2 EXPRESS™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.
The G2 EXPRESS™ Filter System - Femoral Delivery Kit consists of a 7 French inner diameter (I.D.) introducer catheter and dilator set and a storage tube preloaded with the G2 EXPRESS™ Filter and pusher system. The introducer catheter and dilator are used to gain access to the inferior vena cava via a femoral approach using the Seldinger technique. The dilator accepts a 0.038" guidewire and the introducer catheter has two radiopaque marker bands on the distal end to assist in filter delivery. The pusher system is designed to pass through the introducer catheter.
The G2 EXPRESS™ Filter System – Jugular/Subclavian Delivery Kit consists of a 10 French I.D. introducer sheath and dilator set and a delivery device preloaded with the G2 EXPRESS™ Filter. The introducer sheath and dilator are used to gain access to the inferior vena cava via a jugular approach using the Seldinger technique. The dilator accepts a 0.038" guidewire and enables a contrast medium power injection up to 800 psi maximum pressure. The introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The delivery device fits within the introducer sheath and consists of a side port for saline infusion and a delivery mechanism to deploy the G2 EXPRESS™ Filter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vena cava
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 G2 EXPRESS™ Filter System – Femoral and Jugular/Subclavian Delivery Kits met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs.
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.
Recovery® G2® Filter System - Femoral Delivery Kit (K073090), Recovery® G2® Filter System - Jugular/Subclavian Delivery Kit (K073090)
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
§ 870.3375 Cardiovascular intravascular filter.
(a)
Identification. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.(b)
Classification. Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and
(2) FDA's:
(i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and
(ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”
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G2 EXPRESS™ Filter System – Femoral and Jugular/Subclavian Delivery Kits 510(k) Summary 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the information upon which substantial equivalence determination is based as follows:
-
- Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc
1625 West 3rd Street
PO Box 1740
Tempe, Arizona 85280 | JUL 30 2008 |
|------------|----------------------------------------------------------------------------------------------|-------------|
| Phone: | 480-303-2524 | |
| Fax: | 480-449-2546 | |
| Contact: | Genevieve Balutowski | |
Associate Project Manager, Regulatory Affairs
2. Subject Device:
| Device Trade Name: | G2 EXPRESS™ Filter System - Femoral Delivery Kit
and G2 EXPRESS™ Filter System -
Jugular/Subclavian Delivery Kit |
|-----------------------|------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Filter, Intravascular, Cardiovascular |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
3. Predicate Devices:
Recovery® G2® Filter System - Femoral Delivery Kit (K073090)
Recovery® G2® Filter System - Jugular/Subclavian Delivery Kit (K073090)
Image /page/0/Picture/11 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The word is horizontally oriented and appears to be a logo or brand name. The font style gives the word a strong and modern appearance.
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4. Summary of Change:
The modification from the predicate device, the Recovery® G2® Filter System - Femoral and Jugular/Subclavian Delivery System, to the subject device, the G2 EXPRESS™ Filter System Femoral and Jugular/Subclavian Delivery System, was adding a snare to the tip of the filter. Additionally, minor dimensional modifications were made to the delivery systems to accommodate the snare tip.
5. Device Description:
The G2 EXPRESS™ Filter consists of 12 shape-memory nitinol wires emanating from a central nitinol sleeve with a snare tip. These 12 wires form two levels of emboli filtration: the legs provide the lower level of filtration and the arms provide the upper level of filtration. The G2 EXPRESS™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.
The G2 EXPRESS™ Filter System - Femoral Delivery Kit consists of a 7 French inner diameter (I.D.) introducer catheter and dilator set and a storage tube preloaded with the G2 EXPRESS™ Filter and pusher system. The introducer catheter and dilator are used to gain access to the inferior vena cava via a femoral approach using the Seldinger technique. The dilator accepts a 0.038" guidewire and the introducer catheter has two radiopaque marker bands on the distal end to assist in filter delivery. The pusher system is designed to pass through the introducer catheter.
The G2 EXPRESS™ Filter System – Jugular/Subclavian Delivery Kit consists of a 10 French I.D. introducer sheath and dilator set and a delivery device preloaded with the G2 EXPRESS™ Filter. The introducer sheath and dilator are used to gain access to the inferior vena cava via a jugular approach using the Seldinger technique. The dilator accepts a 0.038" guidewire and enables a contrast medium power injection up to 800 psi maximum pressure. The introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The delivery device fits within the introducer sheath and consists of a side port for saline infusion and a delivery mechanism to deploy the G2 EXPRESS™ Filter.
Image /page/1/Picture/8 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The word is slightly distorted, with the "A" appearing to be tilted to the left.
2
6. Indication for Use of Device:
The G2 EXPRESS™ Filter System – Femoral and Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:
- . Pulmonary thromboembolism when anticoagulants are contraindicated.
- . Failure of anticoagulant therapy for thromboembolic disease.
- Emergency treatment following massive pulmonary embolism where anticipated . benefits of conventional therapy are reduced.
- . Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
- . G2 EXPRESS™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.
7. Technological Comparison to Predicate Device:
The technological characteristics of the subject device, the G2 EXPRESS™ Filter System - Femoral and Jugular/Subclavian Delivery Kits, are substantially equivalent to those of the predicate devices, the Recovery® G2® Filter System - Femoral and Jugular/Subclavian Delivery Kits (K073090), in terms of intended use, indications for use, application, user population, basic design, fundamental scientific technology, performance, and sterilization method.
8. Conclusions:
The G2 EXPRESS™ Filter System – Femoral and Jugular/Subclavian Delivery Kits met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The G2 EXPRESS™ Filter System - Femoral and Jugular/Subclavian Delivery Kits is substantially equivalent to the legally marketed predicate device, the Recovery® G2® Filter System - Femoral and Jugular/Subclavian Delivery Kits.
TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.
BARD
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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 2008
Bard Peripheral Vascular, Inc. c/o Genevieve Balutowski, RAC Associate Project Manager, Regulatory Affairs 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280
Re: K080668
Trade/Device Name: G2 Express Filter System - Femoral Delivery Kit and G2 Express Filter System -Jugular/Subclavian Delivery Kit Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II Product Code: DTK Dated: July 2, 2008 Received: July 3, 2008
Dear Ms. Balutowski:
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.
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
4
Page 2 - Ms. Genevieve Balutowski
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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
5
Indications for Use
510(k) Number (if known):
Device Name: G2 EXPRESS™ Filter System – Femoral and Jugular/Subclavian Delivery Kits
Indications for Use:
The G2 EXPRESS™ Filter System – Femoral and Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated. .
- Failure of anticoagulant therapy for thromboembolic disease. .
- Emergency treatment following massive pulmonary embolism where anticipated . benefits of conventional therapy are reduced.
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed . or is contraindicated.
- G2 EXPRESS™ Filter may be removed according to the instructions supplied . under the section labeled: Optional Procedure for Filter Removal.
| Prescription Use | X (Part21 CFR 801 Subpart D) |
|---|---|
| AND/OR | |
| Over-The-Counter Use (21CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K090668 |
|---|---|
| --------------- | --------- |
Page 1 of 1
TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.
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