(553 days)
Not Found
No
The summary describes a simple mechanical needle with a safety shield and makes no mention of AI or ML.
No
Explanation: This device is described as a needle used for general purpose injection and aspiration of fluid from vials and ampoules, which is a tool for drug delivery or fluid handling, not a device that provides therapy itself.
No
This device is described as a needle used for "general purpose injection and aspiration of fluid from vials and ampoules," and it includes a safety feature to prevent needle sticks. Its function is to facilitate the transfer of fluids, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description clearly states it is a "Guarded (18g) Needle," which is a physical hardware component used for injection and aspiration. There is no mention of software as the primary or sole component of the device.
Based on the provided information, the MedMate™ Guarded (18g) Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general purpose injection and aspiration of fluid from vials and ampoules." This describes a device used for administering or withdrawing substances from containers, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description reinforces its use for injection and aspiration, not for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The MedMate Guarded Needle's function is purely mechanical for fluid transfer.
N/A
Intended Use / Indications for Use
The MedMate™ Guarded (18g) Needle is used for general purpose injection and aspiration of fluid from vials and ampoules. The device features a shield that prevents accidental needle sticks.
The MedMate Guarded Needle is compatible for use with standard luer-slip and luer-lock syringes.
The MedMate Guarded (18g) Needle is used for general purpose injection of fluid from vials and ampoules.
The MedMate Guarded Needle is compatible for use with standard luer-lock syringes.
Product codes
FMI
Device Description
Advanced Medical Innovations Guarded (18g) Needle is used for general purpose injection and aspiration of fluid from vials and ampoules.
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
No non-clinical tests were performed.
Clinical testing was not performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K130097
1. Submitters Identification:
| Contact Person: | Mike Hoftman |
|---|---|
| Address: | Advanced Medical Innovations, Inc |
| 8741 Shirley Avenue, Northridge, CA 91324 |
| Tel: | 818-701-7180 |
|---|---|
| Fax: | 818-701-9708 |
| Date Prepared: | December 12, 2012 |
| 2. Name of the Device: | MedMate™ Guarded (18g) Needle |
| 3. Common Name: | Hypodermic single lumen needle |
FMI
Regulation: 880.5570
Product Code:
4. Predicate Device Information and Comparison:
| Device Description
510(k) #: K130097 | Predicate Device | 510(k)
Number | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| The MedMate™
Guarded (18g)
Needle is used for
general purpose
injection and
aspiration of fluid
from vials and
ampoules. | The BD Eclipse
Hypodermic Needle
used for general
purpose injection and
aspiration of fluid from
vials, ampoules and
parts of the body below
the surface of the skin. | K010188 | The subject device is
basically identical to the
predicate device with
respect to technological
characteristics and
function. |
NEW REPLACED EXHIBIT #2 Page 1 of 2
1
5. Device Description:
Advanced Medical Innovations Guarded (18g) Needle is used for general purpose injection and aspiration of fluid from vials and ampoules.
6. Intended and Indication for Use:
The MedMate™ Guarded (18g) Needle is used for general purpose injection and aspiration of fluid from vials and ampoules. The device features a shield that prevents accidental needle sticks.
The MedMate Guarded Needle is compatible for use with standard luer-slip and luer-lock syringes.
7. Discussion of Non-Clinical Tests Performed for the Determination of Substantial Equivalence are as follows:
No non-clinical tests were performed.
8. Discussion of Clinical Tests Performed:
Clinical testing was not performed.
9. Conclusions:
Based on the information provided in this submission we conclude that the MedMate Guarded Needle is substantially equivalent to the predicate and is safe and effective for its intended use.
NEW REPLACED EXHIBIT #2 Page 2 of 2
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 22, 2014
Advanced Medical Innovations, Incorporated Mr. Mike Hoftman President 8741 Shirley Avenue Northridge, CA 91324
Re: K130097
Trade/Device Name: MedMate™ Guarded (18g) Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: June 5, 2014 Received: June 11, 2014
Dear Mr. Hoftman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mary Submer -S
Erin 1. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K130097
Device Name
The MedMate Guarded (18g) Needle
Indications for Use (Describe)
The MedMate Guarded (18g) Needle is used for general purpose injection of fluid from vials and ampoules.
The MedMate Guarded Needle is compatible for use with standard luer-lock syringes.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
(1) FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR A CHARRETT A T Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Digitally signed by Richard C. Chapman -S Date: 2014.07.22 09:51:51 -04'00'
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