The SafeFlo® Vena Cava Filter set is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior 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; and
Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

Device Description

The SafeFlo Filter is a Nitinol filter designed for simple, stable and safe implantation in the inferior vena cava to allow blood flow towards the heart while preventing the passage of emboli into the pulmonary arteries. The SafeFlo Filter set comprises the vena cava filter unit and a delivery system kit, provided in separate packages.
The SafeFlo Filter is inserted through a 6F (ID) delivery system. The filter is divided into two functional parts, the Double Ring Platform and the Filter Element. The Double Ring Platform is a fixator, which anchors itself in the vessel wall by over-sizing of the rings with respect to the circular diameter of the vessel. The Double Ring Platform has been designed to exit the delivery sheath and rotate through 90° to be positioned perpendicular to the vessel wall. This method of fixation does not utilize individual hooks and therefore vessel trauma is minimized and repositioning is possible.
The Filter Element is the functional unit of the filter; it is shaped from the continuation of the wires of the Double Ring Platform and is thereby supported securely within the bloodstream. The Filter Element's unique double strand structure forms an Outer Support Ring and an inner 5-leafed filtration configuration whose design allows relatively unhindered blood flow and traps clinically significant migrating emboli. The Filter Element's size (diameter) is designed to be up to 3mm smaller than the diameter of the IVC.

AI/ML Overview

Here's an analysis of the provided text regarding the SafeFlo® Vena Cava Filter, focusing on acceptance criteria and the supporting study information.

Note: The provided document is a 510(k) summary, which is a premarket notification to the FDA. It declares substantial equivalence to previously cleared devices rather than a de novo approval requiring extensive clinical efficacy studies to establish new performance criteria. Therefore, the information regarding acceptance criteria and detailed study methodology is limited compared to what might be found for a novel device.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format as might be expected for a device proving novel efficacy. Instead, it relies on demonstrating substantially equivalent performance to predicate devices through bench, animal, and clinical testing. The "acceptance criteria" can be inferred as the device functioning as intended and its results being "as expected" and comparable to predicate devices in areas of safety and effectiveness.

Performance Characteristic (Inferred Acceptance Criterion)	Reported Device Performance
Function as Intended	Demonstrated in bench, animal, and clinical testing.
Safety (e.g., minimize vessel trauma, secure anchoring)	"vessel trauma is minimized" due to fixation method; "fixator, which anchors itself in the vessel wall by over-sizing of the rings... does not utilize individual hooks"
Effectiveness (e.g., prevent emboli, allow blood flow)	"prevents the passage of emboli into the pulmonary arteries;" "unique double strand structure forms an Outer Support Ring and an inner 5-leafed filtration configuration whose design allows relatively unhindered blood flow and traps clinically significant migrating emboli."
Substantial Equivalence to Predicate Devices	"The SafeFlo Filter is as safe and effective as the Predicate Devices."

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The document does not specify a distinct "test set" sample size in the context of human data. It mentions "clinical testing" but does not provide details on the number of patients. The focus is on demonstrating equivalence, not necessarily a large-scale efficacy trial with a specific test cohort.
Data Provenance: Not explicitly stated for specific clinical data. Given the "Submitter's Name, Address, Telephone Number, Contact Person" points to a Delaware address but a phone number with a +972 prefix (Israel), it's possible clinical data (if any was collected on humans for this submission) could be from Israel or other international sites, but this is not confirmed. The study includes "bench, animal, and clinical testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The 510(k) summary does not detail the methodology for establishing ground truth or expert involvement in clinical (or even animal) study evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are typically detailed in clinical study protocols, which are not included in this summary.

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

No MRMC study was done. This device is a physical medical implant (vena cava filter), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC comparative effectiveness study regarding "human readers improving with AI" is not applicable.

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

Not applicable. This device is an implantable filter, not a software algorithm. Its "performance" is its physical function in the body to trap emboli and remain securely in place, as demonstrated through bench and animal testing, and presumably limited human observations if a clinical study was performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document implies ground truth would be established through:
- Bench Testing: Engineering measurements, physical properties, flow dynamics.
- Animal Testing: In-vivo observation of anchoring, emboli trapping, and biological response.
- Clinical Testing: (implicitly) Patient outcomes related to pulmonary embolism recurrence, complications, and filter integrity. However, specific methods for outcome analysis are not detailed.

8. The sample size for the training set

Not applicable / Not provided. This is a physical device, so there isn't a "training set" in the sense of machine learning algorithms. If there were design optimization iterations, they would be part of engineering development rather than a formally defined training set for an algorithm.

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

Not applicable. As above, there is no "training set" in the context of an AI algorithm. Ground truth for device design and testing would be established through engineering specifications, scientific principles, and preclinical validation methods (bench, animal).

Summary

{0}------------------------------------------------

K081138

p1/2

510(k) SUMMARY

Rafael Medical Technologies, Inc.'s SafeFlo® Vena Cava Filter

Submitter's Name, Address, Tclephone Number, Contact Person and Date Prepared

MAY - 7 2009

Rafael Medical Technologies, Inc. 3500 South Du Pont Highway Dover, Delaware 19901

Phone: +972-4-6270375 Facsimile: +972-4-6270376

Contact Person: Aaron Feldman

Date Prepared: April 17, 2008

Name of Device

SafeFlo® Vena Cava Filter

Common or Usual Name

Vena Cava Filter

Classification Name,

Cardiovascular Intravascular Filter

Predicate Devices

. Simon Nitinol Filter (C.R. Bard, Inc.)
OptEase Permanent Vena Cava Filter (Cordis Corp.) ●

Intended Use / Indications for Use

The SafeFlo® Vena Cava Filter set is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior 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; and
Chronic, recurrent pulmonary embolism where anticoagulant therapy has . failed or is contraindicated.

{1}------------------------------------------------

Technological Characteristics

The SafeFlo Filter is inserted through a 6F (ID) delivery system. The filter is divided into two functional parts, the Double Ring Platform and the Filter Element. The Double Ring Platform is a fixator, which anchors itself in the vessel wall by over-sizing of the rings with respect to the circular diameter of the vessel. The Double Ring Platform has been designed to exit the delivery sheath and rotate through 90° to be positioned perpendicular to the vessel wall. This method of fixation does not utilize individual hooks and therefore vessel trauma is minimized and repositioning is possible.

The Filter Element is the functional unit of the filter; it is shaped from the continuation of the wires of the Double Ring Platform and is thereby supported securely within the bloodstream. The Filter Element's unique double strand structure forms an Outer Support Ring and an inner 5-leafed filtration configuration whose design allows relatively unhindered blood flow and traps clinically significant migrating emboli. The Filter Element's size (diameter) is designed to be up to 3mm smaller than the diameter of the IVC.

Performance Data

Data from bench, animal and clinical testing demonstrates that the SafeFlo Filter functioned as intended and results were as expected.

Substantial Equivalence

The SafeFlo Filter is as safe and effective as the Predicate Devices. The SafeFlo Filter has the same intended uses and indications as well as similar technological characteristics, and principles of operation as its Predicate Devices. The minor technological differences between the SafeFlo Filter and its Predicate Devices raise no new issues of safety or effectiveness. Performance data demonstrate that the SafeFlo Filter is as safe and effective as the Predicate Devices. Thus, the SafeFlo Filter is substantially equivalent.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2009

Rafael Medical Technologies, Inc. c/o Ms. Janice Hogan Hogan and Hartson LLP 1835 Market Street 28" Floor Philadelphia, PA 19103

Re: K081138

Trade/Device Name: SafeFlo Vena Cava Filter Regulation Number: 870.3375 Regulation Name: Cardiovascular intravascular filter Regulatory Class: II Product Code: DTK Dated: May 1, 2009 Received: May 1, 2009

Dear Ms. Hogan:

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 device's labeling:

The safety and effectiveness of the SafeFlo Vena Cava Filter for use as a retrievable or temporary filter have not been established.

{3}------------------------------------------------

Page 2 - Ms. Janice Hogan

Furthermore, the indication for permanent placement of the SafeFio Vena Cava Filter must be runnermore, the multion for permained ding pouch box, and carton labels, instructions for promiliently displayed in an harening, include 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. I totas note that the act 10 hoursed 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 I ho i Dr rinding or basefication for your device and permits your device to proceed to the devreet . This letter will allow you to begin marketing your device as described in your Section niaker. " This letter will ation 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 I loase of actived that 12-11 bistian that your device complies with other requirements of the Act that I Dr has made a deter mailations administered by other Federal agencies. You must Or any I outlar the Act's requirements, including, but not limited to: registration and listing (21 oompry ... labeling (21 CFR Part 801); medical device reporting (reporting of medical OI K Fat 607), lacemig (21 CFR 803); good manufacturing practice requirements as set device related develop ovence) (2 regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you don't speer for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (210) 210 0156. Innov (21CFR Part 807.97). For questions regarding the reporting of adverse premation internetion (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

{4}------------------------------------------------

Page 3 - Ms. Janice Hogan

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sinccrely yours,

Nil R.P. Ogden for

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: SafeFlo® Vena Cava Filter

Indications for Use:

The SafeFlo® Vena Cava Filter set is indicated for the prevention of recurrent pulmonary embolism via percutaneous placement in the inferior 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; and
Chronic, recurrent pulmonary embolism where anticoagulant therapy has ● failed or is contraindicated.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

eemee

(Division Sign Off) Division of Cardiovascular Devices KOBII38 510(k) Number

Page of

\\PH - 070999/000060 - 36396 v1

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.”