FIRMGRIP

K080793 · Flexicath , Ltd. · FOZ · Oct 16, 2008 · General Hospital

Device Facts

• Record ID: K080793
• Device Name: FIRMGRIP
• Applicant: Flexicath , Ltd.
• Product Code: FOZ · General Hospital
• Decision Date: Oct 16, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

FirmGrip is a peripherally inserted catheter featuring a midline catheter encapsulated in a protective sleeve to maintain a clean insertion field. The device includes a stiffening guidewire to facilitate insertion and reduce internal air volume. The protective sleeve, which includes an accordion-shaped handgrip for incremental advancement, allows for catheter manipulation without hand contact. A Tortuous Path Disc (TP Disc) seals the sleeve. The system is used by medical staff for venous access; once placed, the sleeve and guidewire are removed and discarded, leaving the catheter in the vein. A needle assembly with a 'PeelGuard' adapter and PeelAway needle introducer is provided. The device provides a sterile, self-contained insertion environment, potentially eliminating the need for separate sterile sheets and improving convenience for both staff and patients.

Clinical Evidence

Bench testing only. Nonclinical performance tests were conducted according to device specifications; all acceptance criteria were met, supporting labeling claims and substantial equivalence.

Technological Characteristics

Peripherally inserted midline catheter; includes protective sleeve with accordion-shaped handgrip and Tortuous Path Disc; stiffening guidewire; PeelAway needle introducer with PeelGuard adapter. Sterilized by EtO. Standalone device.

Indications for Use

Indicated for patients requiring repeated peripheral venous access for infusion, injection therapies, or blood sampling.

Regulatory Classification

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.

Predicate Devices

• FirmGrip™ Peripherally Inserted Catheter Device (K063363)

Submission Summary (Full Text)

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Section 14: 510(k) Summary

K080793

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## 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.<br>California Building, Suite 107<br>Tel Aviv 67443<br>ISRAEL |
| Tel.: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

#### Contact person:

| Name: | Tali Hazan |
|----------|----------------------|
| Address: | Ramot-Naftali, 13830 |
| | ISRAEL |
| Tel.: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

#### 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 | Product<br>Code | 21 CFR Ref. | Panel |
|-----------------------------------------------------------------------|-----------------|-------------|------------------|
| Catheter, Intravascular, Therapeutic,<br>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:

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.

#### Intended use:

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.

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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 [phone]. 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 [phone] or [phone] 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 |
|-----------------------------------------|
|-----------------------------------------|

#### 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

OR

(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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