ECOMED SCALP VEIN SET

K992145 · Greiner Meditech, Inc. · FPA · Oct 14, 1999 · General Hospital

Device Facts

• Record ID: K992145
• Device Name: ECOMED SCALP VEIN SET
• Applicant: Greiner Meditech, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Oct 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

The Ecomed® Scalp Vein Set is a winged blood collection needle with a tubing used for the collection of venous blood.

Device Story

Ecomed Scalp Vein Set consists of a sterile winged needle bonded to flexible tubing with a female luer adapter and protective cap. Device used for venous blood collection. Operates as a manual blood collection tool. May be used independently or as a kit component with the Greiner VACUETTE Holdex holder. Benefits include standard venous access for blood sampling.

Clinical Evidence

Bench testing only. Non-cytotoxicity testing performed in accordance with ISO 10993; endotoxin testing performed.

Technological Characteristics

Stainless steel needle; rubber needle protector sleeves; extruded plastic needle shields; flexible tubing; female luer adapter. Sterile, single-use device.

Indications for Use

Indicated for the collection of venous blood.

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

• Becton Dickinson's VACUTAINER® Brand Blood Collection Set (K980414)

Reference Devices

• Greiner's VACUETTE® Holdex® holder (K980768)

Submission Summary (Full Text)

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OCT 1 4 1999

## I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) premarket notification for the Ecomed Scalp Vein Set. The Ecomed® Scalp Vein Set is a sterile winged needle bonded to a flexible tubing with a female luer adapter. The female luer is provided with a protective cap on the end.

Greiner is claiming substantial equivalence to Becton Dickinson's VACUTAINER® Brand Blood Collection Set (K980414). Both scalp vein sets (butterfly needles) have the same intended use (i.e. withdrawal of venous blood) and contain the same material of the ECOMED® needle is stainless steel and is the same material used for the BD needle. Both the ECOMED® and BD needle protector sleeves covering the short end of the needle are made from rubber, and both the ECOMED® and BD needle shields are made from extruded plastic.

Non-cytotoxicity was demonstrated in testing which was performed in accordance with the ISO 10993, along with other tests such as endotoxin testing.

The ECOMED® Scalp Vein Set will be marketed separately and as a kit assembled with Greiner's 510k cleared VACUETTE® Holdex® holder (K980768).

Greiner's 510(k) has been submitted on June 25, 1999, by Douglas L. Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, Maryland, 21014 (410-836-8228).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

Mr. Douglas L. Harris Greiner Meditech, Inc. 260 Gateway Dr., Suite 17A Bel Air, MD 21014

Re : K992145 Ecomed® Scalp Vein Set Trade Name: Regulatory Class: II Product Code: FOZ September 15, 1999 Dated: Received: September 20, 1999

## Dear Mr. Harris:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA

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Page 2 - Mr. Harris

may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

f. Susa Ruaros

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known) ________________

Device Name: ECOMED® Scalp Vein Set

Indications for Use: The Ecomed® Scalp Vein Set is a winged blood collection needle with a tubing used for the collection of venous blood.

Prescription Use _X_

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Palacio Curente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number ________________________________________________________________________________________________________________________________________________________________