(151 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and material standards of a hypodermic needle, with no mention of AI or ML.
No
Explanation: A therapeutic device is designed to treat or alleviate a disease or condition. This device is a hypodermic needle intended for injecting or withdrawing fluids, which is a delivery method, not a treatment itself.
No
Explanation: The device is a sterile hypodermic needle used for injecting or withdrawing fluids, which are procedures, not diagnostic functions. It does not perform any analysis or interpretation of bodily information to identify a disease or condition.
No
The device description clearly outlines physical components (stainless steel cannula, polypropylene hub, needle cap/shield) and manufacturing processes (sterilization by Ethylene Oxide Gas), indicating it is a hardware medical device, not software-only.
Based on the provided information, the Sol-M Exchangeable Needles are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin." This describes a direct interaction with the human body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Device Description: The description details a standard hypodermic needle, which is a tool for accessing the body directly.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the living organism) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly interact with the body itself in the way a hypodermic needle does.
N/A
Intended Use / Indications for Use
The Sol-M Exchangeable Needles are sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Product codes
80 FMI
Device Description
The Sol-M Exchangeable Needles are a sterile, single use, standard hypodermic needle. The device is available in 16 to 31 gauge and in lengths from 5/16" to 1-1/2". In addition, the needle tip is available in a regular or short bevel.
Each needle device consists of a stainless steel cannula sealed with epoxy glue into a polypropylene hub. The assembly has a protective polypropylene needle cap/shield.
The Sol-M Exchangeable Needles are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin
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
The Sol-M Exchangeable Needles met the appropriate requirements contained in the following standards:
-
- ISO 7864, Sterile Hypodermic Needles for Single Use;
-
- ISO 594, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment;
-
- ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices;
-
- ISO 6009, Hypodermic Needles for Single Use Colour Coding for Identification;
The device has been tested and found to meet all product specifications and requirements. Accelerated aging was used to verify the performance of the product over the life of the device.
- ISO 6009, Hypodermic Needles for Single Use Colour Coding for Identification;
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
K112777 page 1 of
510(k) Summary (As required by 21 CFR 807.92(a)) FEB 2 4 2012
September 19, 2011 Date Prepared:
Submitter Information A.
Sol-Millennium Medical, Inc. 5415 Sugarloaf Parkway Suite 2203 Lawrenceville, GA 30043
Phone Number: Contact:
404-973-2200 Karen Dunlap President
Trade Name:
Sol-M Exchangeable Needles
- Device Information B.
| Trade/Proprietary Name: | Sol-M Exchangeable Needles |
|---|---|
| Common name of device: | Syringe Cannula |
| Classification Name: | Needle, Hypodermic, Single |
| Lumen | |
| Product Code: | 80 FMI |
| Regulatory Class: | II |
| Classification Number: | 880.5570 |
| Reason for 510(k): | New Device |
1
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|
|---|-----------------------------|
| l | |
| | . . |
| C. | Predicate Device: | DuoPross Needles |
|---|---|---|
| Predicate 510(k) #: | K052445 | |
| Predicate product code: | FMI |
D. Device Description
The Sol-M Exchangeable Needles are a sterile, single use, standard hypodermic needle. The device is available in 16 to 31 gauge and in lengths from 5/16" to 1-1/2". In addition, the needle tip is available in a regular or short bevel.
Each needle device consists of a stainless steel cannula sealed with epoxy glue into a polypropylene hub. The assembly has a protective polypropylene needle cap/shield.
The Sol-M Exchangeable Needles are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
E. Statement of Indications for Use
The Sol-M Exchangeable Needles are sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
:
2
-
F. Comparison of Required Technological Characteristics:
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the Sol-M Exchangeable Needles and the DuoPross Needles. This included: -
- Label Review
- Both devices had similar device descriptions a.
- b. Both devices were labeled as EO Sterilized, non pyrogenic, non toxic, single use, latex free and with a five year shelf life.
-
- Intended Use Comparison
- a. The intended use for both devices is the same.
-
- Material Comparison
- a. Both devices are fabricated from the same materials.
-
- Physical, mechanical and biological specifications
- a. A comparison of physical, mechanical and biological specifications showed that the Sol-M Exchangeable Needles are substantially equivalent to the predicate device.
-
Summary and Conclusion of Nonclinical and Clinical Tests: G.
The Sol-M Exchangeable Needles met the appropriate requirements contained in the following standards:
-
- ISO 7864, Sterile Hypodermic Needles for Single Use;
-
- ISO 594, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment;
-
- ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices;
-
- ISO 6009, Hypodermic Needles for Single Use Colour Coding for Identification;
3
page 4 of 4
H. Discussion of Clinical Tests:
None submitted
- Conclusions Demonstrating Safety, Effectiveness and I. Performance:
The device has been tested and found to meet all product specifications and requirements. Accelerated aging was used to verify the performance of the product over the life of the device.
Instructions for Use detail how to use the devices and the conditions of use. Product labeling clearly shows that the device is for single patient use only.
The Sol-M Exchangeable Needles have been found to be safe and effective for their intended use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sol-Millennium Medical, Inc. C/O Mr. Jim Barley President Abrimed Consulting 33822 Malaga Drive Dana Point, California 92629
FEB 2 4 2012
Re: K112777
Trade/Device Name: Sol-M Exchangeable Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 27, 2011 Received: February 22, 2012
Dear Mr. Barley:
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.
5
Page 2 - Mr. Bartley
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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 Small Manufacturers, International and Consumer Assistance 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,
ef
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications For Use
510(k) Number (if known):
Device Name: Sol-M Exchangeable Needles
Indications For Use:
The Sol-M Exchangeable Needles are sterile hypodermic needles intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rijl M. for R-Z-C feb 22, 2012
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K112777 510(k) Number:
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