(194 days)
No
The device description and performance studies focus on the mechanical safety features and physical characteristics of a needle and tubing system, with no mention of computational analysis, algorithms, or learning processes.
No
This device is intended for intravenous administration of fluids, which is a method of drug delivery. It does not inherently provide therapeutic action itself; it is a delivery system for therapeutic agents.
No
Explanation: The device is intended for the administration of fluids, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical components such as needles, plastic bodies, tubing, Luer lock fittings, and a safety mechanism. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to access the peripheral vascular system for intravenous administration of fluids using a syringe or other compatible / appropriate devices." This describes a device used for delivering substances into the body, not for testing samples taken from the body.
- Device Description: The description details a needle, tubing, and Luer lock fittings designed for intravenous access and fluid administration. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The device described is a medical device used for therapeutic or diagnostic procedures involving direct access to the vascular system, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Delta Fly F20u Micro Bore Winged Safety Needles and the Delta Fly Micro Bore Winged Safety Needles are intended for short term use to access the peripheral vascular system for intravenous administration of fluids using a syringe or other compatible / appropriate devices.
Product codes
FPA
Device Description
The Delta Med Delta Fly Winged Safety Needles are available in four versions, as follows:
- o Delta Fly F20μ Micro Bore Winged Safety Needle 25G x 35 cm
- . Delta Fly F20μ Micro Bore Winged Safety Needle 23G x 35 cm
- Delta Fly Micro Bore Winged Safety Needle 25G x 35 cm ●
- Delta Fly Micro Bore Winged Safety Needle 23G x 35 cm
The devices consist of a stainless steel needle encased in a body of plastic material, attached to a micro bore tube, ending proximally with a female Luer lock fitting closed by a final male Luer lock cap. The female Luer lock fitting includes a 20μ woven mesh filter in the F20μ versions of the device. The devices are equipped with a passive needle stick safety system for covering the tip of the needle upon needle withdrawal, in order to protect the operator from accidental needle stick injury.
To help identification between the two types (with and without filter), the male Luer lock proximal end cap is colored white on the versions with the filter and is transparent on the versions without the filter. To identify the needle size of each version, the winged body of the devices are color-coded blue for the 23G versions and orange for the 25G versions.
The distal end of the device is a stainless steel needle point has a triple bevel design. At the proximal end is a Luer lock fitting. Both device versions (with and without the mesh filter) have a final female connection in compliance with the requirements of ISO 594-2.
Delta Fly Micro Bore Winged Safety Needles are supplied for short term use only, sterile for single use, sterilized with ethylene oxide (EO) gas, and meet the biocompatibility requirements of ISO 10993-1:2009.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular 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
Tests carried out on the Delta Fly devices in accordance with the applicable requirements of the above standards include:
- . Surface testing (ISO 9626)
- Corrosion testing (ISO 9626)
- Gauging (ISO 594-2)
- . Liquid leakage (ISO 594-2)
- Air leakage during aspiration (ISO 594-2)
- Unscrewing torque (ISO 594-2)
- . Separation force (ISO 594-2)
- Easy to assembly ( ISO 594-2)
- Resistance of overriding (ISO 594-2)
- Stress cracking (ISO 594-2) o
- Needle material (ISO 9626)
- Needle stiffness (ISO 96269)
- Resistance of tubing to breakage (ISO 96269)
- Safety winged needle activation (ISO 23908)
- Safety device test (ISO 23908)
Furthermore, to confirm substantial equivalence to the predicate devices, the following tests were performed:
- Tensile strength winged needle (15N x 15 seconds)
- Tensile strength between wings and tube
- Tensile strength between adapter and tube
- Flow rate determination
- Dead space volume
- Air leakage test
In addition a Simulated Clinical Usage test was carried out in accordance with:
- FDA "Guide for Industry and staff – Medical Devices with Sharp injury Prevention Features"
- . ISO 23908:2011 "Sharps injury protection. Requirements and Test method. Sharp protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling".
Delta Med conducted the study at four different hospitals to allow a sufficient number of health care professional who routinely use Winged Needles to provide a meaningful feedback on the device design.
Key Metrics
- During the tests, 100% of the safety mechanism of the devices activated correctly
- No tests failures occurred.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". In the center of the seal are three stylized profiles of human faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2014
Delta Med Spa C/O Mr. Roger Gray VP, Quality and Regulatory Donawa LifeScience Consulting Srl Piazza Albania, Nº 10 Rome, Italy 00153
Re: K140175
Trade/Device Name: Delta Fly F20u Micro Bore Winged Safety Needles and Delta Fly Micro Bore Winged Safety Needles Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 3, 2014 Received: July 8, 2014
Dear Mr. Gray:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
Page 2 - Mr. Gray
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140175
Device Name
Delta Fly F20u Micro Bore Winged Safety Needles and Delta Fly Micro Bore Winged Safety Needles
Indications for Use (Describe)
The Delta Fly F20u Micro Bore Winged Safety Needles and the Delta Fly Micro Bore Winged Safety Needles are intended for short term use to access the peripheral vascular system for intravenous administration of fluids using a syringe or other compatible / appropriate devices.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | |
|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | Image: FDA logo |
| Digitally signed by Richard | |
| C. Chapman -S | |
| Date: 2014.08.04 16:02:40 | |
| -04'00' |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
Image /page/3/Picture/0 description: The image shows the logo for Delta Med Medical Devices. The logo consists of a blue triangle shape on the left, followed by the text "DELTA MED" in gray, with the words "MEDICAL DEVICES" in a smaller font size underneath. Below the company name is the text "Solutions for Health" in a blue, cursive font.
510(k) Summary in accordance with 21 CFR 807.92(c)
| Device name: | Delta Fly F20μ Micro Bore Winged Safety Needles and Delta Fly Micro
Bore Winged Safety Needles |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Type of 510 (k) submission: | Traditional |
| Date of Submission: | 21 January 2014 |
| Manufacturer: | Delta Med SPA
Via Guido Rossa 20
I-46019 Viadana (Mantova)
Italy |
| FDA Registration Number: | 3006846316 |
| 510 (k) Owner: | Delta Med SPA
Via Guido Rossa 20
I-46019 Viadana (Mantova)
Italy |
| Contact Person: | Dr Laura Tellini |
| Phone:
Fax: | +39 03 757 85915
+39 03 757 85201 |
| 510 (k) Contact: | Mr Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Piazza Albania 10
00153 Rome
Italy |
| Phone: | +39 03 757 85915 |
| Fax:
Email: | +39 03 757 85201
rgray@donawa.com |
| FDA Product Code: | FPA |
| FDA Regulation Number: | 880.5440 |
| FDA Classification Name: | Set, Administration, Intravascular |
| Classification panel: | General Hospital and Personal Use Devices |
| Common name: | Intravascular administration set or Winged safety needle |
| FDA Classification: | Class II |
4
Image /page/4/Picture/0 description: The image shows the logo for Delta Med Medical Devices. The logo consists of a blue delta symbol with a curved line underneath it, followed by the text "DELTA MED" in gray, with "MEDICAL DEVICES" in a smaller font size underneath. Below the company name is the text "Solutions for Health" in blue.
- FDA identification: An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion filter, an I.V. set stopcock, fluid delivery tubing, connector between parts of set, a side tube with a cap to serve as injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
- Indications for use: The Delta Fly F20μ Micro Bore Winged Safety Needles and the Delta Fly Micro Bore Winged Safety Needles are intended for short term use to access the peripheral vascular system for intravenous administration of fluids using a syringe or other compatible / appropriate devices.
Device description:
The Delta Med Delta Fly Winged Safety Needles are available in four versions, as follows:
- o Delta Fly F20μ Micro Bore Winged Safety Needle 25G x 35 cm
- . Delta Fly F20μ Micro Bore Winged Safety Needle 23G x 35 cm
- Delta Fly Micro Bore Winged Safety Needle 25G x 35 cm ●
- Delta Fly Micro Bore Winged Safety Needle 23G x 35 cm
The devices consist of a stainless steel needle encased in a body of plastic material, attached to a micro bore tube, ending proximally with a female Luer lock fitting closed by a final male Luer lock cap. The female Luer lock fitting includes a 20μ woven mesh filter in the F20μ versions of the device. The devices are equipped with a passive needle stick safety system for covering the tip of the needle upon needle withdrawal, in order to protect the operator from accidental needle stick injury.
To help identification between the two types (with and without filter), the male Luer lock proximal end cap is colored white on the versions with the filter and is transparent on the versions without the filter. To identify the needle size of each version, the winged body of the devices are color-coded blue for the 23G versions and orange for the 25G versions.
The distal end of the device is a stainless steel needle point has a triple bevel design. At the proximal end is a Luer lock fitting. Both device versions (with and without the mesh filter) have a final female connection in compliance with the requirements of ISO 594-2.
Delta Fly Micro Bore Winged Safety Needles are supplied for short term use only, sterile for single use, sterilized with ethylene oxide (EO) gas, and meet the biocompatibility requirements of ISO 10993-1:2009.
The Delta Fly devices meet the relevant technical requirements of the following standard:
- . ISO 594-2:1998
- ISO 9626:1991 including Amendment 1 ●
- ISO 23908:2011 ●
5
Image /page/5/Picture/0 description: The image is a logo for Delta Med Medical Devices. The logo features a blue abstract symbol on the left, followed by the words "DELTA MED" in gray, with "MEDICAL DEVICES" in smaller gray letters underneath. Below the company name is the text "Solutions for Health" in blue.
Performance Data:
Tests carried out on the Delta Fly devices in accordance with the applicable requirements of the above standards include:
- . Surface testing (ISO 9626)
- Corrosion testing (ISO 9626)
- Gauging (ISO 594-2)
- . Liquid leakage (ISO 594-2)
- Air leakage during aspiration (ISO 594-2)
- Unscrewing torque (ISO 594-2)
- . Separation force (ISO 594-2)
- Easy to assembly ( ISO 594-2)
- Resistance of overriding (ISO 594-2)
- Stress cracking (ISO 594-2) o
- Needle material (ISO 9626)
- Needle stiffness (ISO 96269)
- Resistance of tubing to breakage (ISO 96269)
- Safety winged needle activation (ISO 23908)
- Safety device test (ISO 23908)
Furthermore, to confirm substantial equivalence to the predicate devices, the following tests were performed:
- Tensile strength winged needle (15N x 15 seconds)
- Tensile strength between wings and tube
- Tensile strength between adapter and tube
- Flow rate determination
- Dead space volume
- Air leakage test
In addition a Simulated Clinical Usage test was carried out in accordance with:
- FDA "Guide for Industry and staff – Medical Devices with Sharp injury Prevention Features"
- . ISO 23908:2011 "Sharps injury protection. Requirements and Test method. Sharp protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling".
Delta Med conducted the study at four different hospitals to allow a sufficient number of health care professional who routinely use Winged Needles to provide a meaningful feedback on the device design.
The following significant points were resulted:
- During the tests, 100% of the safety mechanism of the devices activated correctly
- No tests failures occurred.
6
Image /page/6/Picture/0 description: The image shows the logo for Delta Med Medical Devices. The logo features a blue stylized delta symbol with a swoosh underneath it. To the right of the symbol, the words "DELTA MED" are written in gray, with the words "MEDICAL DEVICES" written in a smaller font size underneath. Below the company name, the words "Solutions for Health" are written in blue script.
- All the results obtained give a positive evaluation of the Winged Needle safety mechanism. .
Safety Mechanism
The safety device for the Delta Fly Micro Bore Winged Safety Needles is a component formed by a cover permanently connected to a support element which is in contact with patient's skin.
During activation of the safety feature, the cover completely hides the needle in such a way that the needle is completely encapsulated in the internal concave section of the cover.
During withdrawal of the needle at the end of the treatment, the user, with one hand and limited pressure, pulls back the device tube while with the other hand slides and locks the safety feature into place over the needle.
Comparison with predicate devices:
The predicate device selected for comparison with the Delta Fly F20μ Micro Bore Winged Safety Needle is:
| Predicate Device 1 (PD 1): | Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) |
|---|---|
| 510(k) Sponsor: | Terumo Europe NV |
| 510(k) Number: | K070547 |
| Clearance Date: | 25 May 2007 |
| FDA Product Code: | FPA |
| Classification Name: | Set, Administration, Intravascular |
| Regulation No: | 880.5440 |
The predicate device selected for comparison with the Delta Fly Micro Bore Winged Safety Needle is:
Predicate Device 2 (PD 2):...... Surflo Winged Infusion Set with Needle Protection (Surshield) 510(k) Sponsor: .............................................................................................................................................................. 510(k) Number: ......................................... K100946 Clearance Date:............................................................................................................................................................... FDA Product Code: ..................................... FPA Classification Name:...................... Set, Administration, Intravascular Regulation No: ...............................................................................................................................................................
The only significant difference between the subject devices and the predicate devices is that each have a safety feature to help prevent needlestick injuries. Even though differences exist between the methods employed for protecting the needle tip, the subject and predicate devices are equivalent in this and all other respects.
Conclusion:
No other significant differences that could affect device safety or effectiveness exist between the subject devices and the predicate devices, therefore it is concluded that:
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Image /page/7/Picture/0 description: The image shows the logo for Delta Med. The logo consists of a blue triangle with a curved line underneath it, followed by the words "DELTA MED" in gray, with the words "MEDICAL DEVICES" in smaller gray letters underneath. Below that, the words "Solutions for Health" are written in blue.
-
. The Delta Fly F20μ Micro Bore Winged Safety Needle is substantially equivalent to the predicate device Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), which is already in interstate commerce within the USA;
and -
The Delta Fly Micro Bore Winged Safety Needle is substantially equivalent to the predicate . device Terumo Surflo Winged Infusion Set with Needle Protection (Surshield), which is already in interstate commerce within the USA.