The Recovery Filter System 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.
-Recovery filter may be removed according to the instructions supplied in the Section labeled: Optional Procedure for Filter Removal. Data from removals in a 58 patient study suggests that the device can be safely removed (mean of 60 days; range 1-161 days).

Device Description

The Recovery Filter System consists of a nitinol vena cava filter and a delivery system. The filter has two levels of filtration and is prepackaged in a storage tube. The delivery system consists of a 7 Fr ID introducer sheath and dilator and a pusher system. Both components of the system are packaged in Tyvek/film pouches.

AI/ML Overview

The provided text indicates that the Recovery Filter System is "identical to the cited predicate device with the exception of the removal of labeling limitations and the addition of specific instructions to allow for safe removal of the device." Therefore, the primary acceptance criterion is safe removal of the device.

Here's the information about the study that proves the device meets this acceptance criterion, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Safe removal of the device	Demonstrated in a series of animal and clinical testing.
	Confirmatory experience of 58 patients showing the filter "may be safely retrieved."
	Mean retrieval time of 60 days (range 1-161 days).
	Conclusion that "the benefit of this procedure outweighs the potential associated risks."

2. Sample size used for the test set and the data provenance:

Sample Size: 58 patients.
Data Provenance: Clinical testing. The document doesn't specify the country of origin, but it's presented in a US FDA submission, implying compliance with US regulatory standards. It's a prospective study as it involves the removal of the device in these patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The study focuses on the "confirmatory experience" of patients regarding the safety of removal, implying observational data rather than a judgment based on a specific ground truth as would be established by experts for diagnostic performance.

4. Adjudication method for the test set:

This information is not provided in the document. Given the nature of the study (safety of device removal), an adjudication method in the form of multiple expert reviews might not have been directly applicable. The "safety" would likely be assessed through clinical outcomes and adverse events.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This was not a MRMC comparative effectiveness study. The device is an intravascular filter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This was not a standalone performance study. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

The ground truth for the safety of removal was based on clinical outcomes and observations in patients, specifically the successful and safe retrieval of the filter, as well as the absence of unacceptable risks. Animal testing (including histology) also contributed to the safety assessment.

8. The sample size for the training set:

This information is not applicable/not provided. The study described is a clinical validation of device safety, not a machine learning model, and therefore does not have a "training set" in that context. There were "animal and clinical testing" which would have informed the device design and instructions for removal, but these wouldn't be referred to as a "training set" in this context.

9. How the ground truth for the training set was established:

This information is not applicable/not provided as there is no "training set" in the context of device approval for an intravascular filter. Safety was established through a combination of animal and clinical testing.

Summary

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JUL 2 5 2003

K 03 | 328

SECTION VIII

510(k) Summary of Safety and Effectiveness Information

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 follows:

Submitter Information: A.

Applicant:	Bard Peripheral Vascular, a division of C.R. BardInc.1625 West 3rd StreetTempe, Arizona 85280
Phone:	480-303-2640
Fax:	480-449-2546
Contact:	Mary Edwards, Vice-President

B. Device Name:

Trade Name:	Recovery Filter System
Common orUsual Name:	Percutaneous Vena Cava Filter
ClassificationName:	Cardiovascular Intravascular Filter

C. Predicate Device Name(s): Recovery Filter System
D. Device Description:

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Statement of Intended Use: E.
The Recovery Filter System 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.
-Recovery filter may be removed according to the instructions supplied in the Section labeled: Optional Procedure for Filter Removal. Data from removals in a 58 patient study suggests that the device can be safely removed (mean of 60 days; range 1-161 days).
Substantial Equivalence: F.

Recovery Filter is identical to the cited predicate device with the exception of the removal of labeling limitations and the addition of specific instructions to allow for safe removal of the device.

The safety of removal was addressed in a series of animal and clinical testing. The results of animal testing (including histology) and the confirmatory experience of 58 patients (mean 60 days to removal; range 1-161 days) show that the Recovery Filter may be safely retrieved and that the benefit of this procedure outweighs the potential associated risks.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's wings. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2003

Bard Peripheral Vascular c/o Ms. Mary Edwards Vice President, Regulatory & Clinical Affairs 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740

Re: K031328

Bard® Recovery® Filter System RF-048F Regulation Number: 21 CFR 870.3375 Regulation Name: Filter, Intravascular, Cardiovascular Regulatory Class: Class II Product Code: DTK Dated: April 25, 2003 Received: April 28, 2003

Dear Ms. Edwards:

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. Mary Edwards

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 (OS) 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 (301) 594-4692. 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 Smail 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 yours,

Brom D. Zuckerman, M.D.

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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ATTACHMENT A

INDICATIONS FOR USE STATEMENT

Device Name: Recovery Filter System

Indications for Use:

The Recovery Filter System 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
Recovery filter may be removed according to the instructions supplied in the Section . labeled: Optional Procedure for Filter Removal.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use __

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031328

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.”