The SNM FirmGrip™ - Peripherally Inserted Catheter Device is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling.

Device Description

Flexicath's SNM FirmGrip™ is actually the same device cleared under K080793 except for the addition of Safety Needle Mechanism (SNM) to the Cleared Needle Unit Assemblv. The Safety Needle Mechanism is a unique feature enables needle retraction into a tubular housing once it is taken out from the patient vein. Once the needle is withdrawn from the vein, the safety mechanism is activated by a simple press on the safety mechanism Activation Button (Locking Clip). The SNM has a male connector which is used to be inserted into the FirmGrip™ PeelGuard's female connector when being integrated with the FirmGrip™ Catheter and Catheter Sleeve at the Catheter insertion stage. The compressed spring is being restrained by a Locking clip which used to hold it in place until safety mechanism is activated. Once the Locking clip button is pushed, the SNM is being activated and the needle is being retracted and fully covered. At this stage the FirmGrip Needle Unit Assembly and the SNM are ready to be disposed.

AI/ML Overview

The provided text describes a Special 510(k) submission for the SNM FirmGrip™ Peripherally Inserted Catheter Device, which is a modification of an already cleared device. The key change is the addition of a Safety Needle Mechanism (SNM).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
According to Flexicath's legally marketed device specification and applicable standards	"All acceptance criteria were met."

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

Sample Size: Not explicitly stated. The document mentions "non-clinical tests" but does not detail the number of units tested.
Data Provenance: Not explicitly stated (e.g., country of origin). The company is based in Israel ("Tel Aviv 67443 Israel"), but the origin of the test data is not specified beyond being "non-clinical performance data." The tests were conducted to support claims for a device intended for the US market. The study is retrospective in the sense that it's a verification and validation of a modified existing device.

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

Not applicable. This was a non-clinical device performance study, not one requiring expert human interpretation of medical images or data for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical device performance study, not one requiring human 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 explicitly mentioned or indicated. The study focused on the non-clinical performance of the device's safety mechanism and its substantial equivalence to a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

While the term "standalone" is typically used for AI/algorithm performance, in the context of this device, the non-clinical performance tests can be considered "standalone" in that they evaluated the device's physical and functional characteristics without human intervention as a variable in the performance assessment itself. The tests were purely mechanical/functional.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests would be defined by the device's design specifications and applicable industry standards. The device's performance was compared against these established technical requirements (e.g., strength, retraction mechanism functionality, material integrity, etc.).

8. The Sample Size for the Training Set

Not applicable. This is not a study involving a "training set" in the context of machine learning or AI. It is a device performance verification and validation study.

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

Not applicable, as there was no "training set." The performance was evaluated against engineering and design specifications.

Summary

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K092629

Section 14: Special 510(k) Summary
------------------------------------

F L E/I C A T H Ltd.

SEP 2 5 2009

Special 510(K) Summary

For SNM Firmgrip™ Peripherally Inserted Catheter Device *SNM - Safety Needle Mechanism

Date Prepared: 24 August, 2009

510(k) owner name:

Company name:	Flexicath Ltd.
Address:	120 Yigal Alon St.California Building, Suite 107Tel Aviv 67443Israel
Tel.:	+972 (7) 75055525
Fax:	+972 (7) 72055529
E-mail:	mail@flexicath.com

Contact person:

Name:	Tali Hazan
Address:	Ramot-Naftali, 13830Israel
Tel.:	+972-50-5292304
Fax:	+972-151508963806
E-mail:	tali.hazan@012.net.il

..............................................................................................................................................................................

Device Name:

Common or usual name: Peripherally Inserted Catheter Proprietary/Trade name: SNM FirmGrip 14 Peripherally Inserted Catheter Device

Classification name: SNM FirmGrip™ has been classified as Class II device under the following classification name:

Name	ProductCode	21 CFR Ref.	Panel
Catheter, Intravascular, Therapeutic,Short-Term Less Than 30 Days	FOZ	880.5200	General Hospital

Special 510(k) for Flexicath FirmGrip Needle Unit Assembly SAFETY NEEDLE MECHANISM - CONFIDENTIAL -Page 38 of 42

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Predicate Device:

Modified SNM FirmGrip™ - Peripherally Inserted Catheter Device is substantially equivalent to the original FirmGrip™ Peripherally Inserted Catheter Device, cleared under 510(k) number K080793.

Device description:

Flexicath's SNM FirmGrip™ is actually the same device cleared under K080793 except for the addition of Safety Needle Mechanism (SNM) to the Cleared Needle Unit Assemblv.

The Safety Needle Mechanism is a unique feature enables needle retraction into a tubular housing once it is taken out from the patient vein. Once the needle is withdrawn from the vein, the safety mechanism is activated by a simple press on the safety mechanism Activation Button (Locking Clip).

The SNM has a male connector which is used to be inserted into the FirmGrip™ PeelGuard's female connector when being integrated with the FirmGrip™ Catheter and Catheter Sleeve at the Catheter insertion stage.

The compressed spring is being restrained by a Locking clip which used to hold it in place until safety mechanism is activated. Once the Locking clip button is pushed, the SNM is being activated and the needle is being retracted and fully covered. At this stage the FirmGrip Needle Unit Assembly and the SNM are ready to be disposed.

Intended use:

The SNM FirmGrip™ Peripherally Inserted Catheter Device is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling.

Technological characteristics and Substantial Equivalence:

The modified SNM FirmGrip™ - Peripherally Inserted Catheter is substantially equivalent the FirmGrip™ that was previously cleared under 510(k) number K080793. Both new and predicate devices have the same indication for use, same basic shape, design and characteristics. The new device has the addition of the Safety Needle Mechanism which intends to protect both patient and medical staff from needlesticks. All changes that differs the modified device from the original (predicate) device were fully addressed and evaluated.

The modifications performed do not affecting the device's intended use and do not alter the device's fundamental scientific technology.

New device's verification and validation tests showed that it is as safe and as effective as the predicate device.

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None clinical performance data:

Tests results are supporting all labeling claims and substantial equivalency. The modified device was tested with according to Flexicath's legally marketed device specification and applicable standards. All acceptance criteria were met.

Conclusions:

The evaluation of Flexicath's SNM FirmGrip - Peripherally Inserted Catheter Device non-clinical tests, demonstrates that the device is as safe and as effective as the predicate device. Therefore, we believe it is substantially equivalent to Flexicath's legally marketed device.

..............................................................................................................................................................................

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center -- WO66-G609 Silver Spring, MD 20993-0002

SEP 2 5 2009

Ms. Tali Hazan Regulatory Affairs Advisor Flexicath, Limited 120 Yigal Alon Street. Suite 107 California Building Tel Aviv 67443 ISRAEL

Re: K092629

Trade/Device Name: SNM FirmGrip™ - Peripherally Inserted Catheter Device SNM-Safety Needle Mechanism Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: August 24, 2009 Received: August 27, 2009

Dear Ms Hazan:

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 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. Hazan

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Anston Jr.

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indication For Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: SNM FirmGrip™ - Peripherally Inserted Catheter Device *SNM - Safety Needle Mechanism

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)

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

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

(Posted November 13, 2003)

510(k) Number: K972621

Special 510(k) for Flexicath FirmGrip Needle Unit Assembly SAFETY NEEDLE MECHANISM - CONFIDENTIAL -Page 18 of 42

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).