The FirmGrip 101 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

The FirmGrip™ peripherally inserted catheter includes a typical midline catheter encapsulated in a specially designed protective sleeve, to produce a self-contained clean catheter insertion field. The catheter contains a stiffening guidewire for additional contribution to ease of insertion and for catheter's internal air volume reduction. Both the catheter and guidewire remain protected throughout the entire catheter insertion procedure and is not exposed to the outer environment or to any hand contact. The protective sleeve back side is closed with a Tortuous Path Disc (TP Disc) which closed it and provides additional protection. Being the catheter protected by the sleeve, may save the need of using a sterile sheet since the sleeve may replace it. The protective sleeve enables manipulation and insertion of the catheter without interfering the protective sleeve's internal clean field. Once the catheter is properly placed in the blood vessel, both protective sleeve and the guidewire are removed and discarded. The FirmGrip™ is packed in an individual sterile pack and is sterilized by EtO. A needle assembly unit contains a specially designed adapter, called "PeelGuard", and a PeelAway needle introducer is supplied with the FirmGrip or separately. The needle assembly unit has its own individual package and is sterilized by EtO as well. The operation mechanism for the modified device is the same as the original device. The protective sleeve's handgrip portion, in its front side, has an accordion-shape which helps to promote the catheter with each intermittent grasping and pushing it forward. Once both the sleeve and the wire are removed, the catheter remains inside the vein. The catheter luer connector and a short portion of the catheter remain outside of the body and used as an access port for the medical treatment. The soft materials used for the catheter and PeelGuard make the connections more flexible, easy to use for the medical staff and more convenient for the patient.

AI/ML Overview

The provided document describes a 510(k) submission for the FirmGrip™ Peripherally Inserted Catheter Device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through extensive clinical trials as might be seen for a new drug or a PMA device.

Therefore, the information regarding acceptance criteria and study details will be limited to what is relevant for establishing substantial equivalence for a Class II device of this nature.

Here's an analysis of the provided text with respect to your requested information:

1. A table of acceptance criteria and the reported device performance

The document states: "The modified device was tested with according to Flexicath's legally marketed device specification and all acceptance criteria were met."
However, no specific acceptance criteria or detailed reported device performance are provided within this document. This is typical for a 510(k) summary, which generally does not include proprietary testing details or internal specifications. The conclusion paragraph indicates that nonclinical tests demonstrated the device's safety and effectiveness compared to the predicate.

Acceptance Criteria	Reported Device Performance
Not specified in document	All acceptance criteria were met as per Flexicath's legally marketed device specifications.

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

The document mentions "New device verification and validation tests" and "nonclinical performance data," but it does not specify the sample size used for the test set, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature). Given that this is a nonclinical performance study for a device, the "data provenance" would typically refer to the testing lab and the conditions under which the tests were performed (e.g., in-house, third-party lab).

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 type of information (experts for ground truth) is not relevant for a nonclinical performance study of a peripherally inserted catheter device. Ground truth established by experts is typically a concept applied to diagnostic devices or AI algorithms that interpret medical images or data. For a catheter, performance is evaluated through engineering tests, biocompatibility tests, and potentially animal or human cadaver studies, not by expert consensus on clinical findings.

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

Similar to point 3, adjudication methods are not applicable to the nonclinical performance testing described for this device. Adjudication is used to resolve disagreements in interpretations, often in clinical trials or studies involving human judgment (e.g., reading medical images).

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 comparative effectiveness study was done, nor would it be expected for this type of medical device. MRMC studies are specific to diagnostic imaging devices or AI-powered interpretative tools where human "readers" (e.g., radiologists) review cases. This device is a catheter, not an interpretive tool. No mention of AI assistance is made.

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

This question is not applicable to the FirmGrip™ Peripherally Inserted Catheter Device. This device is a physical medical instrument, not an algorithm or an AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

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

For this device, "ground truth" would refer to the established engineering specifications and performance benchmarks for catheter functionality (e.g., tensile strength, flow rate, insertion force, biocompatibility, sterility). The document states testing was done "according to Flexicath's legally marketed device specification," implying that the ground truth was established by these internal specifications and relevant industry standards for catheter performance and safety. It would not be based on expert consensus, pathology, or outcomes data in the same way an imaging or diagnostic device would.

8. The sample size for the training set

There is no "training set" for this device in the context of machine learning or AI. Training sets are used to develop and refine algorithms. This is a physical medical device, and its development involves engineering design, material science, and manufacturing processes, not algorithmic training.

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

As there is no "training set" for this device, this question is not applicable.

Summary

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Section 14: 510(k) Summary

K080793

્ર I C A T H Ltd. F L E/)

510(K) SUMMARY

OCT 1 6 2008

for FirmGrip™ Peripherally Inserted Catheter Device

Date Prepared: 28 February, 2008

510(k) owner name:

Company name:	Flexicath Ltd.
Address:	120 Yigal Alon St.California Building, Suite 107Tel Aviv 67443ISRAEL
Tel.:	+972 (4) 8500076
Fax:	+972 (4) 8500684
E-mail:	mail@flexicath.com

Contact person:

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

Device Name:

Common or usual name: Peripherally Inserted Catheter
Proprietary/Trade name: FirmGrip™ - Peripherally Inserted Catheter Device

Classification name: 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

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Predicate Device:

Modified FirmGrip™ - Peripherally Inserted Catheter Device is substantially equivalent to the original FirmGrip™ Peripherally Inserted Catheter Device, cleared under 510(k) number K063363.

Device description:

Both the catheter and guidewire remain protected throughout the entire catheter insertion procedure and is not exposed to the outer environment or to any hand contact. The protective sleeve back side is closed with a Tortuous Path Disc (TP Disc) which closed it and provides additional protection. Being the catheter protected by the sleeve, may save the need of using a sterile sheet since the sleeve may replace it. The protective sleeve enables manipulation and insertion of the catheter without interfering the protective sleeve's internal clean field. Once the catheter is properly placed in the blood vessel, both protective sleeve and the guidewire are removed and discarded.

The FirmGrip™ is packed in an individual sterile pack and is sterilized by EtO.

A needle assembly unit contains a specially designed adapter, called "PeelGuard", and a PeelAway needle introducer is supplied with the FirmGrip or separately. The needle assembly unit has its own individual package and is sterilized by EtO as well.

The operation mechanism for the modified device is the same as the original device. The protective sleeve's handgrip portion, in its front side, has an accordion-shape which helps to promote the catheter with each intermittent grasping and pushing it forward.

Once both the sleeve and the wire are removed, the catheter remains inside the vein. The catheter luer connector and a short portion of the catheter remain outside of the body and used as an access port for the medical treatment. The soft materials used for the catheter and PeelGuard make the connections more flexible, easy to use for the medical staff and more convenient for the patient.

Intended use:

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Technological characteristics and Substantial Equivalence:

The modified FirmGrip™ - Peripherally Inserted Catheter is substantially equivalent the original FirmGrip 100 that was previously cleared under 510(k) number K063363. Both new and predicate devices have the same indication for use, same basic shape, design and characteristics. All changes that differs the modified device from the original (predicate) device were fully evaluated.

The modifications performed do not affecting the device's intended us and do not alter the device's fundamental scientific technology. New device verification and validation tests showed that it is as safe and as effective as the predicate device.

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 all acceptance criteria were met.

Conclusions:

The evaluation of Flexicath's FirmGrip - Peripherally Inserted Catheter Device nonclinical 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings, rendered in black. The bird is positioned to the right of the text, which is arranged in a circular fashion around the left side of the image. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

OCT 1 6 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K080793

Trade/Device Name: FirmGrip™ Peripherally Inserted Catheter Device Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: August 6, 2008 Received: August 12, 2008

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 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. 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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Sincerely yours,

Chiu Lin, Ph.D.

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
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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K080793

Device Name: FirmGrip™ Peripherally Inserted Catheter Device

Indications for use:

The 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

(and

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

510(k) Number: K080797 Page 1 of 1

(Posted November 13, 2003)

Flexicath FirmGrip Special 510(k)

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— CONFIDENTIAL -

Page 18 of 38

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).