(30 days)
Not Found
No
The document describes a mechanical filter system and its delivery kit, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
Yes.
The device is a filter system permanently placed in the vena cava to prevent recurrent pulmonary embolism, which is a therapeutic intervention.
No
The device description clearly states its purpose is for the prevention of recurrent pulmonary embolism via permanent placement of a filter in the vena cava, and its components are designed for delivery and deployment, not for diagnosis.
No
The device description clearly outlines physical components like catheters, dilators, a storage tube, a filter, and a pusher system, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Description: The description clearly states that the G2™ Filter System is a device for permanent placement in the vena cava (a blood vessel within the body). It is used to physically prevent blood clots from traveling to the lungs.
- Intended Use: The intended use describes a therapeutic intervention (preventing pulmonary embolism) performed within the body.
Therefore, the G2™ Filter System is an implantable medical device used for therapeutic purposes, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The G2™ Filter System – Femoral Delivery Kit is 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.
The subject device has the same intended use and indications of use as the predicate device, the G2™ Filter System - Femoral Delivery Kit (K050558, cleared 08/29/05).
Product codes (comma separated list FDA assigned to the subject device)
DTK
Device Description
The G2™ Filter System – Femoral Delivery Kit consists of a 7 French inner diameter (I.D.) introducer catheter and dilator set (Kit A) and a storage tube preloaded with the G2™ Filter and pusher system (Kit B). Kit A (introducer catheter and dilator) is used to gain access to the inferior vena cava using the Seldinger technique. The dilator accepts a 0.038" guidewire and the introducer catheter has 2 radiopaque marker bands on distal end to assist in filter delivery. The pusher system (Kit B), designed to pass through the introducer catheter, consists a grooved segment designed to hold and properly orient the filter legs and a flexible nitinol wire with a pad at the end that pushes on the filter apex.
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™ Filter System – Femoral Delivery Kit met all the 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.
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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Page 64
OCT 2 6 2006
G2™ Filter System - Femoral Delivery Kit 510(k) Summary of Safety and Effectiveness 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 safety and effectiveness information upon which substantial equivalence determination is based as follows:
- Submitter Information: 1.
- Bard Peripheral Vascular, Inc Applicant: 1625 West 3rd Street P.O. Box 1740 Tempe, Arizona 85280
- 480-303-2524 Phone:
- 480-449-2546 Fax:
- Contact: Genevieve Balutowski, Senior Regulatory Affairs Specialist
2. Subject Device Name:
| Device Trade Name: | G2™ Filter System - Femoral
Delivery Kit |
|-----------------------|---------------------------------------------|
| Common or Usual Name: | Vena Cava Filter |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
3. Predicate Device:
G2 ™ Filter System - Femoral Delivery Kit (K050558, cleared 8/29/05)
Summary of Change: 4.
The design modification to the G2™ Filter System - Femoral Delivery Kit, as represented in this submission, is a modification to a component of the current delivery system. The G2TM Filter component of the subject device remains the same as the predicate device.
Image /page/0/Picture/18 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and clear appearance. The overall design is simple and modern, with a focus on readability.
1
Device Description: 5.
The G2™ Filter System – Femoral Delivery Kit consists of a 7 French inner diameter (1.D.) introducer catheter and dilator set (Kit A) and a storage tube preloaded with the G2™ Filter and pusher system (Kit B). Kit A (introducer catheter and dilator) is used to gain access to the inferior vena cava using the Seldinger technique. The dilator accepts a 0.038" guidewire and the introducer catheter has 2 radiopaque marker bands on distal end to assist in filter delivery. The pusher system (Kit B), designed to pass through the introducer catheter, consists a grooved segment designed to hold and properly orient the filter legs and a flexible nitinol wire with a pad at the end that pushes on the filter apex.
Intended Use of Device: 6.
The G2™ Filter System – Femoral Delivery Kit is 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.
The subject device has the same intended use and indications of use as the predicate device, the G2™ Filter System - Femoral Delivery Kit (K050558, cleared 08/29/05).
7. Technological Comparison to Predicate Device:
The technological characteristics of G2™ Filter System - Femoral Delivery Kit are substantially equivalent to those of the predicate device, the G2™ Filter System -Femoral Delivery Kit, in terms of intended use, indication for use, application, user population, basic design, fundamental scientific technology, performance, and sterilization method.
Image /page/1/Picture/15 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The font style is simple and geometric, with straight lines and sharp angles. The image is in black and white.
2
Conclusions: 8.
The G2™ Filter System – Femoral Delivery Kit met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The G2™ Filter System – Femoral Delivery Kit is substantially equivalent to the legally marketed predicate device, the G2™ Filter System – Femoral Delivery Kit.
Bard Peripheral Vascular, Inc.
TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.
Image /page/2/Picture/6 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The letters are evenly spaced and aligned horizontally. The overall impression is clean and professional.
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2006
Bard Peripheral Vascular, Inc. c/o Ms. Genevieve Balutowski Senior Regulatory Affairs Specialist P.O. Box 1740 Tempe, AZ 85280
Re: K062887
Trade Name: G2 Filter System Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular Intravascular Filter Regulatory Class: Class II (two) Product Code: DTK Dated: September 25, 2005 Received: September 26, 2005
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Precautions section of the device's labeling and in promotional materials:
The safety and effectiveness of the G2 Filter System for use as a retrievable or temporary filter have not been established.
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Page 2 - Ms. Genevieve Balutowski
Furthermore, the indication for permanent placement of the G2 Filter System must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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); 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.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under
5
Page 3 - Ms. Genevieve Balutowski
the Act from the Division of Small Manufacturers, International, and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clinton MD for
Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K062887
Device Name: G2TM Filter System – Femoral Delivery Kit
Indications for Use:
The G2™ Filter System – Femoral Delivery Kit is 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.
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)
Page 1 of 1
Druce E. Ladner
ivision of Cardiovascular Devices
510(k) Number_KO67 88 +