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.

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. 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.

AI/ML Overview

The provided text describes a 510(k) summary for the Gianturco-Roehm Bird's Nest® Vena Cava Filter. It's important to note that a 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical studies demonstrating novel performance criteria with statistical rigor as seen with new drug applications or software as a medical device (SaMD) clearances.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and conformance testing demonstrating that the modified device (specifically, the introducer system and its tip) maintains the safety and effectiveness of the predicate device regarding its physical performance and biocompatibility. There is no mention of a clinical efficacy study with human subjects, AI components, or complex ground truth establishment for this type of device.

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary of results)
Mechanical Performance
Tensile Testing	Results provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements.
Deployment Testing	Results provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements.
Packaging & Sterilization
Packaging Design Validation	Results provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements.
Bioburden, Residual, and Endotoxin Testing	Results provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements (ensuring appropriate levels for patient safety).

Note: The document states "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." Specific quantitative acceptance criteria (e.g., "tensile strength must be > X N") and their corresponding measured values are not provided in this 510(k) summary, as is typical for public summaries of this nature.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided summary for any of the tests (Tensile, Deployment, Packaging, Bioburden/Residual/Endotoxin). These tests are typically performed on a statistically significant number of manufactured units or relevant components, but the exact numbers are not disclosed here.
Data Provenance: The tests were conducted internally by Cook Incorporated as part of their design and manufacturing quality assurance processes. The data is prospective, generated specifically for this submission to assess the modified device's performance. Country of origin for data generation is within Cook Incorporated's testing facilities (likely in the USA, as the company is based in Bloomington, IN, USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of "ground truth" establishment in the context of expert review for this device. The tests mentioned (tensile, deployment, packaging, bioburden) are engineering and laboratory tests with objective, measurable outcomes against pre-defined specifications, not subjective interpretations requiring expert consensus like imaging studies.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are objective engineering and laboratory evaluations, not subjective clinical assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or software that involves human interpretation, which is not the nature of this physical medical device modification.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical medical implant (vena cava filter) and does not involve an algorithm or AI functionality that would necessitate standalone performance testing in this manner.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed (Tensile Testing, Deployment Testing, Packaging Design Validation, Bioburden, Residual, and Endotoxin Testing) is based on engineering specifications, established industry standards, and regulatory requirements for the performance and safety of medical devices. For example, tensile strength would be compared against a material specification, and bioburden levels against sterilization standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.

Summary

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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:

1. Pulmonary thromboembolism when anticoagulants are contraindicated;
1. Failure of anticoagulant therapy in thromboembolic diseases;
Emergency treatment following massive pulmonary embolism where anticipated 3. benefits of conventional therapy are reduced;
1. 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:

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.

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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.

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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.

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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

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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:

1. Pulmonary thromboembolism when anticoagulants are contraindicated;
1. Failure of anticoagulant therapy in thromboembolic diseases;
1. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced;
1. 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)

Regulation Number and Section

§ 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.”