(72 days)
Not Found
Not Found
No
The device description focuses on the mechanical properties and physical design of a vena cava filter, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are also focused on physical and material properties.
Yes
The device is intended for the "prevention of recurrent pulmonary embolism," indicating a therapeutic purpose in managing a health condition.
No
The device is a vena cava filter, which is an implantable medical device used to prevent pulmonary embolism by physically trapping blood clots. It is a therapeutic device, not a diagnostic one.
No
The device description clearly details a physical, implantable medical device made of stainless steel wire with hooks, intended for percutaneous insertion into the vena cava. It also mentions delivery catheters and relies on the shape memory properties of the wire. This is a hardware 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 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 to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Gianturco-Roehm Bird's Nest® Vena Cava Filter is a physical device (a filter) that is implanted directly into the vena cava (a blood vessel) within the patient's body. Its purpose is to physically prevent blood clots from traveling to the lungs.
- Mechanism of Action: The device works mechanically by filtering blood, not by analyzing biological samples outside the body.
- Input: The input is fluoroscopic control, which is an imaging technique used during the implantation procedure, not a biological sample for analysis.
Therefore, the Gianturco-Roehm Bird's Nest® Vena Cava Filter is a therapeutic medical device intended for implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Gianturco-Roehm Bird's Nest® Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:
-
- Pulmonary thromboembolism when anticoagulants are contraindicated;
-
- Failure of anticoagulant therapy in thromboembolic diseases;
- Emergency treatment following massive pulmonary embolism where anticipated 3. benefits of conventional therapy are reduced;
-
- Prophylactically in patients with chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
Product codes
DTK
Device Description
The Bird's Nest® Vena Cava Filter is a permanent cardiovascular intravascular filter intended for percutaneous insertion into the inferior vena cava positioned below the renal veins and above the iliac veins. The Bird's Nest® Vena Cava Filter utilizes a fine-wire stainless steel multiplane filtering system. The Bird's Nest® Vena Cava Filter is placed via standard percutaneous entry (Seldinger) technique with fluoroscopic control.
Access sites include both left and right femoral, and left and right internal jugular veins. The 11.0 French delivery catheters are available in a 45 cm length for femoral vein approach and a 75 cm length for jugular vein approach.
The Bird's Nest® Vena Cava Filter is designed for use in vena cava measuring up to 40 mm in diameter. Caval measurements should be performed prior to filter insertion, and care should be taken to ensure proper strut fixation.
The basic function of the filter relies upon shape memory properties of the stainless steel wire which is used for its construction. Four strands of 0.18 mm stainless steel surgical wire, each 25 cm long before forming, are shaped to have 15-20 fine wave bends formed into each wire. Please refer to Figure 1 for a representative picture of the deployed Bird's Nest® Vena Cava Filter.
Two pairs of hooks, one pair proximal and one pair distal, hold the filter in position. The pairs of hooks are attached to each end of the four wire strands by junction points. The hooks spring out of the catheter and engage the vessel wall. The hooks and the lateral pressure exerted by the preformed curved wires fix the device securely into the vessel wall.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic control
Anatomical Site
vena cava, inferior vena cava, renal veins, iliac veins, femoral vein, jugular vein
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
The proposed Gianturco-Roehm Bird's Nest® Vena Cava Filter was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
- 미 Tensile Testing
- Packaging Design Validation Report ■
- Bioburden, Residual, and Endotoxin Testing
- Deployment Testing
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Gianturco-Roehm Bird's Nest® Vena Cava Filter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
0
1
115 - 7
510(k) SUMMARY
| Submitted By: | Molly Busenbark |
|---|---|
| Cook Incorporated | |
| 750 Daniels Way, P.O. Box 489 | |
| Bloomington, IN | |
| Phone: (812) 339-2235 x 2162 | |
| Fax: (812) 332-0281 |
Device:
| Trade Name: | Vena Cava Filter |
|---|---|
| Proposed Classification: | 21 CFR 870.3375 Class II |
| Cardiovascular Intravascular Filter |
Indications for Use:
The Gianturco-Roehm Bird's Nest® Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:
-
- Pulmonary thromboembolism when anticoagulants are contraindicated;
-
- Failure of anticoagulant therapy in thromboembolic diseases;
- Emergency treatment following massive pulmonary embolism where anticipated 3. benefits of conventional therapy are reduced;
-
- Prophylactically in patients with chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
Predicate Device:
The Gianturco-Roehm Bird's Nest® Vena Cava Filter is similar in terms of intended use, materials of construction, and technological characteristics to the predicate Gianturco-Roehm Bird's Nest® Vena Cava Filter.
Device Description:
The Bird's Nest® Vena Cava Filter is a permanent cardiovascular intravascular filter intended for percutaneous insertion into the inferior vena cava positioned below the renal veins and above the iliac veins. The Bird's Nest® Vena Cava Filter utilizes a fine-wire stainless steel multiplane filtering system. The Bird's Nest® Vena Cava Filter is placed via standard percutaneous entry (Seldinger) technique with fluoroscopic control.
Access sites include both left and right femoral, and left and right internal jugular veins. The 11.0 French delivery catheters are available in a 45 cm length for femoral vein approach and a 75 cm length for jugular vein approach.
1
The Bird's Nest® Vena Cava Filter is designed for use in vena cava measuring up to 40 mm in diameter. Caval measurements should be performed prior to filter insertion, and care should be taken to ensure proper strut fixation.
The basic function of the filter relies upon shape memory properties of the stainless steel wire which is used for its construction. Four strands of 0.18 mm stainless steel surgical wire, each 25 cm long before forming, are shaped to have 15-20 fine wave bends formed into each wire. Please refer to Figure 1 for a representative picture of the deployed Bird's Nest® Vena Cava Filter.
Two pairs of hooks, one pair proximal and one pair distal, hold the filter in position. The pairs of hooks are attached to each end of the four wire strands by junction points. The hooks spring out of the catheter and engage the vessel wall. The hooks and the lateral pressure exerted by the preformed curved wires fix the device securely into the vessel wall.
Substantial Equivalence:
The existing filter has not been modified. In this submission, Cook Incorporated is extending the length of the introducer system and modifying the tip of the introducer.
Cook Incorporated currently markets the predicate Gianturco-Roehm Bird's Nest® Vena Cava Filter, which is substantially equivalent to the Gianturco-Roehm Bird's Neste Vena Cava Filter, subject of this submission. The similar indications for use and technological characteristics of the Gianturco-Roehm Bird's Nest® Vena Cava Filter as compared to the predicate device support a determination of substantial equivalence.
Test Data:
The proposed Gianturco-Roehm Bird's Nest® Vena Cava Filter was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
- 미 Tensile Testing
- Packaging Design Validation Report ■
- Bioburden, Residual, and Endotoxin Testing
- Deployment Testing
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
FEB 27 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cook Incorporated c/o Ms. Molly Busenbark Regulatory Affairs Specialist P.O. Box 489 Bloomington, IN 47402
Re: K073528
Gianturco-Roehm Bird's Nest Vena Cava Filter Regulation Number: 21 CFR 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: Class II (two) Product Code: DTK Dated: January 25, 2008 Received: January 28, 2008
Dear Ms. Busenbark:
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. Molly Busenbark
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 may be obtained 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/dsma/dsmamain.html
Sincerely vours.
Blomman for
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 (if known): | K07 3528 |
|---|---|
| Device Name: | Gianturco-Roehm Bird's Nest® Vena Cava Filter |
Indications for Use:
The Gianturco-Roehm Bird's Nest® Vena Cava Filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:
-
- Pulmonary thromboembolism when anticoagulants are contraindicated;
-
- Failure of anticoagulant therapy in thromboembolic diseases;
-
- Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced;
-
- Prophylactically in patients with chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.
B. Kummer
Division of Cardiovascular Device
Prescription Use XX (Part 21 CFR 801 Subpart D) OR Over-the-Counter Use (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)