(29 days)
Not Found
No
The device description focuses on a mechanical safety mechanism for needle retraction and does not mention any computational or learning-based components.
No.
The device is described as a peripherally inserted catheter for repeated access to the peripheral venous system for infusion, injection therapies, and/or blood sampling. While it facilitates the administration of therapies, the device itself is a delivery mechanism, not a therapeutic agent or device that directly treats a condition.
No
The device is a peripherally inserted catheter used for infusing or injecting intravenous therapies and/or blood sampling, which are therapeutic and collection functions, not diagnostic.
No
The device description clearly details physical components like a needle unit assembly, a safety needle mechanism, a tubular housing, a spring, a locking clip, and connectors, indicating it is a hardware device with a safety feature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling." This describes a device used in vivo (within the body) for delivering substances or collecting blood directly from a patient.
- Device Description: The description details a catheter and needle assembly designed for insertion into a vein. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, analyzers, or other components used to test blood, urine, tissue, or other biological samples.
Therefore, the SNM FirmGrip™ - Peripherally Inserted Catheter Device is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
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.
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 applicable standards. All acceptance criteria were met.
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: 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 107 | |
| Tel Aviv 67443 | |
| Israel | |
| Tel.: | +972 (7) 75055525 |
| Fax: | +972 (7) 72055529 |
| 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.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 | Product
Code | 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
1
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.
2
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.
..............................................................................................................................................................................
3
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.
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); 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
5
Image /page/5/Figure/0 description: The image shows the text "F L E I C A T H Ltd." The text is in a rectangular box. There is a line going through the letters "E" and "I".
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:
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.
(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)
OR
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