(210 days)
Not Found
No
The device description focuses on mechanical components and materials for catheter insertion and protection. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is for accessing the peripheral venous system for therapies and blood sampling, not for providing therapy itself.
No
The device is intended for providing repeated access to the peripheral venous system for infusion, injection, and blood sampling, which are therapeutic and access functions, not diagnostic.
No
The device description clearly details physical components such as a catheter, protective sleeve, guidewire, needle assembly unit, and adapter, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for accessing the peripheral venous system for infusion, injection, and blood sampling. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic sample collection purposes, not for performing tests on samples outside the body.
- Device Description: The description details a catheter and its insertion mechanism. It focuses on the physical process of placing the catheter within the vein.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological samples in vitro, or any other components or functions typically associated with in vitro diagnostics.
IVDs are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to obtain the specimen (blood sampling) or deliver substances (infusion/injection), but it does not perform the diagnostic test itself.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral venous system
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Section 14: 510(k) Summary
્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 107 | |
| Tel Aviv 67443 | |
| ISRAEL | |
| 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 | Product
Code | 21 CFR Ref. | Panel |
|-----------------------------------------------------------------------|-----------------|-------------|------------------|
| Catheter, Intravascular, Therapeutic,
Short-Term Less Than 30 Days | FOZ | 880.5200 | General Hospital |
1
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.
2
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.
..............................................................................................................................................................................
3
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.
4
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
5
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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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— CONFIDENTIAL -
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