(128 days)
Not Found
No
The description focuses on the physical components and mechanical performance of a hypodermic needle, with no mention of AI or ML.
No.
The device's intended use is to inject or withdraw fluids, which is a diagnostic or procedural function, not a primary therapeutic action to treat a disease or condition.
No
The 'Intended Use' states the device is for injecting or withdrawing fluids, which are therapeutic or procedural actions, not diagnostic. A diagnostic device would typically involve identifying or monitoring a medical condition.
No
The device description explicitly states it consists of physical components (hub, cannula, protector) and performance studies focus on the mechanical strength of these components, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 device used for direct interaction with the body, not for testing samples in vitro (outside the body).
- Device Description: The description of the device components (hub, cannula, protector) is consistent with a hypodermic needle, which is used for injections and withdrawals from the body.
- Lack of IVD Characteristics: There is no mention of testing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.
Product codes
FMI
Device Description
This device is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin. This device is consist of hub, cannula and protector and has difference hub color per each of gauges.
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
Study Type: Not Found
Sample Size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results: Hub/needle bond strength met standard criteria for all gauges tested according to ISO 7894:1993.
Key Metrics
Hub/needle bond strength:
16G-19G: >69N
20G: >54N
21G: >44N
22G: >40N
23G-24G: >34N
25G-30G: >22N
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
JAN 1 4 2011
8. 510(K) SUMMARY
| 8. 510(K) SUMMARY | |
|---|---|
| Proprietary Name: | IMC Hypodermic Needle |
| Common Name: | HypodermicNeedle |
| Classification Name: | Hypodermic Single Lumen Needle (21 CFR 880.5570) |
| Device Clarification: | Class II |
| Panel Code: | 80 |
| Product Code: | FMI |
| Submitter Information: | International Medsurg Connection |
| 935 N Plum Grove Rd, STE F | |
| Schaumburg, Illinois 60173 | |
| Summary Prepared By: | Peter Kim |
| Director of Quality Assurance | |
| International Medsurg Connection | |
| 935 N Plum Grove Rd, STE F | |
| Schaumburg, Illinois 60173 | |
| Telephone: 847-619-9926 | |
| Fax: 847-619-9927 | |
| e-mail: peterkim@intlmedsurg.com | |
| Date Prepared: | January 4, 2010 |
| Predicate Devices: | • Nipro Medical Corporation (K052474) |
Device Name(s):
IMC Hypodermic Needle (non-sterile and sterile)
Classification Panel:
General Hospital
Legally Marketed Device Under Which Substantial Equivalence is Being Claimed:
International Medsurg Connections, Inc is claiming substantial equivalence of the IMC Hypodermic Needle with the currently marketed:
| Description | 510(k) Number |
|---|---|
| Nipro Hypodermic Needle | K052474 |
Device Description
This device is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.
1
This device is consist of hub, cannula and protector and has difference hub color per each of gauges.
Statement of Intended Use
Indications For Use: This device is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.
| Description | Size | Sterility |
|---|---|---|
| 16 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 17 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 18 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 19 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 20 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 21 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 22 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 23 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 24 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 25 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 26 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 27 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 28 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 29 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 30 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
Name/Descrintion
New Devices as Compared to Marketed Device(s)
The IMC Hypodermic needle and the predicate device (Nipro Hypodermic needle) are intended to be used to inject fluids into or withdraw fluids from parts of the body below the surfince of the skin.
| Feature/ Characteristic | IMC Hypodermic Needle | Nipro Hypodermic Needle: K052474
(Predicate) |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Intended Use | is device is intended for use to inject
fluids into or withdraw fluids from
parts of the body below the surface
of the skin | ipro Hypodermic Needles are intended
for use to inject fluids into or withdraw
fluids from the parts of the body |
| Material | | |
| Hub of Needle | Polypropylene (PP) | Polypropylene (PP) |
| Protector | Polypropylene (PP) | Polypropylene (PP) |
| Feature/ Characteristic | IMC Hypodermic Needle | Nipro Hypodermic Needle: K052474
(Predicate) |
| Cannula | SUS 304 | SUS 304 |
| Adhesive. | Epoxy Resin | Epoxy Resin |
| colors | | |
| 16G | White color | White color |
| 17G | Red-violet color | Mauve color |
| 18G | Pink color | Pink color |
| 19G | Cream color | Cream color |
| 20G | Yellow color | Yellow color |
| 21G | Deep green color | Green color |
| 22G | Black color | Black color |
| 23G | Deep Blue color | Blue color |
| 24G | Medium purple color | Purple color |
| 25G | Orange color | Orange color |
| 26G | Brown color | Brown color |
| 27G | Medium gray color | Gray color |
| 28G | Blue-green color | Blue-green color |
| 29G | Red color | Red color |
| 30G | Yellow color | Yellow color |
| Length | ½", 5/8", ¾", 7/8", 1", 1 ¼" and
1 ½" | ½", 5/8", ¾", 7/8", 1", 1 ¼" and
1 ½" |
| Gauge | 16G, 17G, 18G, 20G, 21G, 22G, 23G,
24G, 25G, 26G, 27G, 28G, 29G & 30G | 16G, 17G, 18G, 20G, 21G, 22G, 23G,
24G, 25G, 26G, 27G, 28G, 29G & 30G |
| Cover dimension | ½" size: 40mm | ½" size: 42mm |
| | 5/8" size: 40mm | 5/8" size: 42mm |
| | ¾" size: 40mm | ¾" size: 42mm |
| | 7/8" size: 40mm | 7/8" size: 42mm |
| | 1" size: 40mm | 1" size: 42mm |
| | 1 ¼" size: 56mm | 1 ¼" size: 55mm |
| | 1 ½" size: 56mm | 1 ½" size: 55mm |
| | All gauges have the same dimension. | |
| Cover color | Clear (for all gauges) | Clear (for all gauges) |
| Tip configuration | Bevel | Bevel |
2
.
.
·
3
Performance Data:
| Performance Characteristics | Test Method | Acceptance
Criteria | IMC Hypodermic
Needle | Nipro Hypodermic
Needle
K052474 |
|-----------------------------|-----------------|----------------------------------------------------------------------------------------|----------------------------|---------------------------------------|
| Hub/needle bond strength | ISO 7894 : 1993 | 16G-19G: >69N
20G: >54N
21G: >44N
22G: >40N
23G-24G: >34N
25G-30G: >22N | Meets Standard
Criteria | Meets Standard
Criteria |
Conclusions:
The indications for use, technology, specification, safety of the IMC Hypodermic needle and the predicate devices K052474 are essentially the same. The differences between the hypodermic needle are minor and do not raise new issues of safety or effectiveness. Hence, the IMC Hypodermic needles are substantially equivalent to the predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Peter Kim Director of Quality Assurance International Medsurg Connection 935 North Plum Grove Road, Suite F Schaumburg, Illinois 60173
JAN 1 4 2011
Re: K102584
Trade/Device Name: IMC Hypodermic Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 10, 2010 Received: December 20, 2010
Dear Mr. Kim:
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. Kim
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 /ucm 115809.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
Jum J. Robert
for
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
Enclosure
6
Indications for Use
Kio2584
510(k) Number :
Device Name: IMC Hypodermic needle
Indications For Use: This device is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.
| Gauge | Size | Sterility |
|---|---|---|
| 16 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 17 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 18 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 19 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 20 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 21 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 22 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 23 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 24 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 25 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 26 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 27 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 28 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 29 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
| 30 Gauge Hypodermic needle | ½", 5/8", ¾", 7/8", 1", 1 ¼" and 1 ½" | Sterile & Non-sterile |
Name/Description
X Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
filter for the River Richard as Appines of (Division Sign-Off) Division of Anesthesiology, General Hospital Page 13 Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________