AMSINO I.V. START KIT

K050654 · Amsino International, Inc. · LRS · May 2, 2005 · General Hospital

Device Facts

• Record ID: K050654
• Device Name: AMSINO I.V. START KIT
• Applicant: Amsino International, Inc.
• Product Code: LRS · General Hospital
• Decision Date: May 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The AMSINO® I.V. Start Kit is intended for use in performing, and assisting in performing, I.V. start procedures.

Device Story

AMSINO® I.V. Start Kit is a collection of medical components used to facilitate intravenous (I.V.) catheter insertion. The kit is intended for use by healthcare professionals in clinical settings to perform or assist in I.V. start procedures. It includes various supplies necessary for site preparation and catheter securement. The device does not involve electronic processing, algorithms, or software. It functions as a procedural convenience kit to streamline the I.V. insertion process, potentially reducing preparation time and ensuring necessary materials are readily available for the clinician.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Procedural kit containing various medical components. No electronic, sensing, or software components. Sterilization method not specified.

Indications for Use

Indicated for use in performing or assisting in I.V. start procedures. No specific patient population, age, or gender restrictions provided.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 0 2 2005

Ching Ching Seah, Ph.D. Director of Research, Development and Regulatory Affairs AMSINO International, Inc. 855 Towne Center Drive Pomona, California 91767

Re: K050654

Trade/Device Name: AMSINO® I.V. Start Kit Regulatory Class: Unclassified Product Code: LRS Dated: February 15, 2005 Received: March 14, 2005

Dear Dr. Seah:

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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.

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.

{1}------------------------------------------------

Page 2 - Ching Ching Seah, Ph.D.

In addition, we have determined that your device kit contains PVP Prep Pad which is subject to regulation as drug.

Our substantially equivalent determination does not apply to the drug component of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component. For information on applicable Agency requirements for marketing this drug, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 [phone]

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

Eula. K

M
As

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Ansino International, Inc. 855 Towne Center Drive Pomona CA 91767, USA

Tel: [phone] Fax: [phone] Toll Free: 1-800-63-umsino c-mail: [e-mail] www.amsino.com

## AMSINO

Page 1 of 1

| 510(k) Number: (if known) | k050654 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------|
| Device Name: | AMSINO® I.V. Start Kit |
| Indications for Use: | The AMSINO® I.V. Start Kit is intended for use in performing, and assisting in performing, I.V. start procedures. |

Prescription Use × (Per 21 CFR 801. 109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED NOT WRITE BELOW THIS NEFFIC NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

: : LAVO