(49 days)
The AMSINO® I.V. Start Kit is intended for use in performing, and assisting in performing, I.V. start procedures.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding the AMSINO® I.V. Start Kit. This letter does not contain information about acceptance criteria or a study proving device performance against such criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical studies with specified acceptance criteria as might be seen for novel devices or those undergoing a PMA (Premarket Approval) process.
Therefore, I cannot extract the requested information from this document.
Specific reasons why the requested information is not available in the document:
- Acceptance Criteria and Reported Device Performance: This document is an FDA clearance letter, not a study report or a summary of performance data. It states that the device is "substantially equivalent" to a predicate device, which is the regulatory standard for 510(k) clearance. It does not list specific performance metrics or acceptance criteria.
- Sample Size, Data Provenance, Experts for Ground Truth, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Size, and Training Set Ground Truth: All these items pertain to the design and results of a clinical or performance study. The provided document does not contain any details about studies of this nature. It primarily focuses on the regulatory decision of substantial equivalence.
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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.
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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 (301) 594-0101
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597, 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
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Ansino International, Inc. 855 Towne Center Drive Pomona CA 91767, USA
Tel: (909) 626-5888 Fax: (909) 626-9006 Toll Free: 1-800-63-umsino c-mail: amsino@amsino.com www.amsino.com
AMSINO
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| 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)
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: : LAVO
§ 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).