(88 days)
Not Found
Not Found
No
The summary describes a physical medical device (vena cava filter) and its delivery system, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is a medical intervention aimed at preventing recurrent pulmonary embolism, which is a therapeutic goal.
No
This device is a vena cava filter, which is an implantable medical device used to prevent pulmonary embolism. Its function is therapeutic (prevention of embolism), not diagnostic (identifying a disease or condition).
No
The device description explicitly states that the system consists of a nitinol vena cava filter and a delivery system, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the prevention of recurrent pulmonary embolism by being permanently placed in the vena cava. This is a therapeutic intervention performed within the body.
- Device Description: The device is a physical filter and delivery system designed for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a medical implant used for treatment.
N/A
Intended Use / 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. Data from removals in a 58 patient study suggests that the device can be safely removed (mean of 60 days; range 1-161 days).
Product codes
DTK
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Recovery Filter System
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
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. Bard
Inc.
1625 West 3rd Street
Tempe, Arizona 85280 |
|------------|-----------------------------------------------------------------------------------------------------------|
| Phone: | 480-303-2640 |
| Fax: | 480-449-2546 |
| Contact: | Mary Edwards, Vice-President |
- B. Device Name:
| Trade Name: | Recovery Filter System |
|---|---|
| Common or | |
| Usual Name: | Percutaneous Vena Cava Filter |
| Classification | |
| Name: | Cardiovascular Intravascular Filter |
- C. Predicate Device Name(s): Recovery Filter System
- D. 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.
1
-
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.
2
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.
3
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
4
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