(49 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The device description is also not available, which would be the primary place to find such information.
No
The device is described as an "I.V. Start Kit" intended for "performing, and assisting in performing, I.V. start procedures." This indicates it's a tool for a medical procedure, but it doesn't intrinsically provide therapy or directly treat a disease or condition. It facilitates the administration of other therapeutic agents or fluids.
No
Explanation: The device is an "I.V. Start Kit" used for performing I.V. start procedures, which is a treatment procedure, not a diagnostic one. It does not mention identifying, analyzing, or monitoring health conditions.
No
The 510(k) summary describes an "I.V. Start Kit," which is a collection of physical components used for starting an intravenous line. This is inherently a hardware-based medical device, not software-only.
Based on the provided information, the AMSINO® I.V. Start Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "performing, and assisting in performing, I.V. start procedures." This describes a procedure performed directly on a patient, not a test performed on a sample taken from a patient in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
An I.V. start kit typically contains items like needles, catheters, dressings, and other supplies needed to initiate an intravenous line. These are devices used in vivo (within the body) for a medical procedure.
N/A
Intended Use / Indications for Use
The AMSINO® I.V. Start Kit is intended for use in performing, and assisting in performing, I.V. start procedures.
Product codes
LRS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 (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
2
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
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__________________________________________________________________________________________________________________________________________________________
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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: : LAVO