MICROFLO-SAFE SCALP VEIN SET

K043328 · Dks Loversan Industria Biomedica Spa · FPA · Apr 15, 2005 · General Hospital

Device Facts

• Record ID: K043328
• Device Name: MICROFLO-SAFE SCALP VEIN SET
• Applicant: Dks Loversan Industria Biomedica Spa
• Product Code: FPA · General Hospital
• Decision Date: Apr 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

Device Story

Winged blood collection needle; used for venipuncture to collect blood specimens or for intravenous fluid administration. Features manual needle safety shield activated post-withdrawal to minimize accidental needlestick risk. Operated by clinicians in clinical settings. Device includes luer adaptor for fluid administration; removable for syringe attachment. Benefits patient by providing secure venous access and protects healthcare workers via integrated safety mechanism.

Clinical Evidence

bench testing only

Technological Characteristics

Winged needle set with integrated manual safety shield. Materials include standard medical-grade plastics and stainless steel needle. Connectivity: None. Energy source: None (manual operation). Sterilization: Not specified.

Indications for Use

Indicated for venipuncture to collect blood specimens or for intravenous fluid administration in patients of any age or gender, provided patient size, therapy duration, and solution appropriateness are considered.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Surshield Safety Winged Blood Collection Set - Terumo Medical Products (K031279)
• Unlok Plus Infusion Set - Myco Medical Supplies, Inc. (K000592)
• VacuFlow + Safe Collection Set - MED-PRO Technologies (K000714)

Submission Summary (Full Text)

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# 4043328

## APR 1 5 2005

# 510(K) SUMMARY (as required by 807.92(c))

| Submitter of 510(k): | DKS Loversan Industria Biomedica SPA<br>via g. borghi 24<br>gemonio (va), ITALY 21036<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alessandro Corradi |
| Date of Summary: | November 1, 2004 |
| Trade/Proprietary Name: | MICROFLO-SAFE Scalp Vein Set |
| Classification Name: | Set, Administration, Intravascular |
| Product Code: | FPA |
| Predicate Device: | |

| Surshield Safety Winged Blood Collection Set -- Terumo Medical Products | K031279 |
|-------------------------------------------------------------------------|---------|
| Unlok Plus Infusion Set - Myco Medical Supplies, Inc. | K000592 |
| VacuFlow + Safe Collection Set - MED-PRO Technologies | K000714 |

#### Intended Use:

The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy line.

Public Health Service

APR 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DKS Loversan Industria Biomedica SPA C/O Mr. Arthur Ward Consultant AJW Technology Consultants, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572

Re: K043328

Trade/Device Name: MICROFLO-SAFE Scalp Vein Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 10, 2005 Received: March 14, 2005

Dear Mr. Ward:

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 - Mr. Ward

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

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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### Indications for Use

510(k) Number (if known): AON 3328

Device Name: MICROFLO-SAFE Scalp Vein Set

Indications for Use:

The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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