(91 days)
Not Found
No
The device description and intended use are for a standard hypodermic needle, and there is no mention of AI, ML, or any related technologies in the provided text.
No
The device is a hypodermic needle used for fluid injection/aspiration, which is not considered a therapeutic device because it does not directly treat or cure a disease or condition.
No
The device is described as a hypodermic needle for fluid injection/aspiration, which is a therapeutic or delivery device, not one used for diagnosis.
No
The device description clearly states it is a physical hypodermic needle, which is a hardware component. There is no mention of any software functionality.
Based on the provided information, the U&U Sterile Hypodermic Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for use with syringes and injection devices for general purpose fluid injection/ aspiration." This describes a device used for administering or withdrawing substances directly from the body, not for testing samples outside the body.
- Device Description: The description focuses on the physical characteristics of a needle used for injection/aspiration. There is no mention of reagents, test strips, or any components used for analyzing biological samples in vitro.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information based on sample analysis
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The U&U Sterile Hypodermic Needle is a tool for accessing the body for injection or aspiration, which is a different function.
N/A
Intended Use / Indications for Use
U&U Sterile Hypodermic Needle Is intended for use with syringes and Injection devices for general purpose fluid injection/aspiration.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The U&U Sterile Hypodermic Needle is a hypodermic single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection / aspiration. The U&U Sterile Hypodernic Needle are offered in various gauge sizes and needle lengths. The U&U Sterile Hypodermic Needle is sterilized by EtO gas. The U&U Sterile Hypodermic Needle is Non-Pyrogenic, disposable and intended for single use.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KI32 SS2
610(k) Submission
U&U Medical Technology Co., Ltd Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China U&U (HONGKONG) Medica! Technology Co., Limited RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG
..
(U&U Hypodermic Needle)
Rev 0.00 12/08/13
Section_005 510(K) Summary
. ......... ... ..............................................................................................................................................................
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
Date Prepared: 12, 08,2013
1. Submitter Name and Address:
| Owner Name: | U&U Medical Technology Co., Ltd |
|---|---|
| Address: | Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China |
| RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN | |
| HONG KONG | |
| Contactor Name: | Xuebo Wang |
| TEL: | +86-13564751751 |
| E-mail: | Blackwang@tkmedical.com |
Contract Manufacturer Name; ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD. Address: No 20 south renhe road tianchang, CHINA 239300 Web: www.tkmedical.com
US Agent:
| US Agent: | Pan Angels Corp. |
|---|---|
| Address: | 3330 Fowler Street, Los Angeles, CA 90063,U.S.A |
| TEL: | (323)422-8581 |
| Contact person : | Mr. Michael Kim |
2. Submission Devices Information:
NOV 1 3 2013
Trade/Proprietary Name: U&U Sterile Hypodermic Needle Common Name: Hypodermic Needle Classification name: Hypodermic Needle. Class: 2. Panel: 80. Product codes: FMI - Hypodermic Single Lumen Needle Submission Type; 510(k) Regulation Number: 880 5570
3. Predicate Devices Information:
Hypodermic Needle: BD Hypoint™ Hypodermic Needle. Trade Name: K070440 510(K) Number:
4. Devices Description:
U&U Sterile Hypodermic Needle
The U&U Sterile Hypodermic Needle is a hypodermic single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection / aspiration. The U&U Sterile Hypodernic Needle are offered in various gauge sizes and needle lengths. The U&U Sterlie
1
510(k) Submission
U&U Medical Technology Co., Ltd Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China U&U (HONGKONG) Medical Technology Co., Limited RM C1-D BIF WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG [U&U Hypodermic Needle]
Rev 0.00 12/08/13
Hypodermic Needle is sterilized by EtO gas. The U&U Sterile Hypodermic Needle is Non-Pyrogenic, disposable and intended for single use.
| Ref
Number | Model
Number | Description | Length | Gauge |
|---------------|-----------------|---------------------------------|-------------|-------|
| TKHN_001 | TKHN | Hypodermic Needle Normal-walled | 1/2 to 1" | 30G |
| TKHN_002 | TKHN | Hypodermic Needle Normal-walled | 1/2 to 1" | 29G |
| TKHN_003 | TKHN | Hypodermic Needle Normal-walled | 1/2 to 1" | 28G |
| TKHN_004 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 27G |
| TKHN_005 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 26G |
| TKHN_006 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 25G |
| TKHN_007 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 24G |
| TKHN_008 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 23G |
| TKHN_009 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 22G |
| TKHN_010 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 21G |
| TKHN_011 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 20G |
| TKHN_012 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 19G |
| TKHN_013 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 18G |
| TKHN_014 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 17G |
| TKHN_015 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 16G |
5. Intended Use:
U&U Sterile Hypodernic Needle Is intended for use with syringes and Injection devices for general purpose fluid injection/aspiration.
6. Technological Characteristics:
Through compansons between the submitted devices with the predicate devices as follows tables. We believe the applicant devices are substantially equivalent with the predicate devices.
| Element of Comparison | Submission Device | Predicate Device
K110771 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | U&U Sterile Hypodermic Needle is
intended for use with syringes and
injection devices for general
purpose fluid injection/aspiration | The BD HypointTM Hypodermic
Needle is intended for use with
Syringes and injection devices
for general purpose fluid
aspiration/ injection. |
| Principle of Operation | Normal | Normal |
| Needle Gauge and Length | Various Sizes | Various Sizes |
| Lubricant for Needle | Silicone Oil | Silicone Oil |
| Adhesive | UV Glue | Epoxy Resin |
| Needle Hub Colors | Various Colors | Various Colors |
| Tip configuration | Bevel | Bevel |
| Materials | | |
| Needle Hub | PP | PP |
| Needle | Stainless Steel | Stainless Steel |
| Needle Cover | PP | PE |
| Performances | Conforms to ISO7864 | Conforms to ISO7864 |
| Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 |
| Labeling | Meet the requirements of 21 CFR | Meet the requirements of 21 |
· 000017
[PMN-510(K) SUBMISSION]
2
| U&U Medical Technology Co., Ltd | 510(k) Submission |
|---|---|
| Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China | |
| U&U (HONGKONG) Medical Technology Co., Limited | |
| RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG | |
| [U&U Hypodermic Needle] | Rev 0.00 12/08/13 |
| Part 801 | CFR Part 801 |
|---|---|
| ---------- | -------------- |
.
………
7. Conclusion:
The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent.
END
ﺮ ﺍ
· 000018
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
ood and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
November 13, 2013
U&U Medical Technology Company, Limited Mr. Xuebo Wang Dongzhou Village, Hengshanqiao, Changzhou, Jiangsu, China RM C1-D 6/F Wing Hing Industrial 14 Hing Yip Street Kwun Tong KIn HONG KONG
Re: K132552
Trade/Device Name: U&U Sterile Hypodermic Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Il Product Code: FMI Dated: August 12, 2013 Received: August 13, 2013
Dear Mr. Wang:
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 10 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.
4
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
MarylFDAer-S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132552
Device Name U&U Sterile Hypodermic Needles
Indications for Use (Describe)
U&U Sterile Hypodermic Needles is intended for use with syringes and injection devices for general purpose fluid injection/ aspiration.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
- TEN FOR FOR FOR FOR FOR USE ONLY - THE WINE THE THE THE WORLD AND ترقى تختلف المنتدى ال ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Richard C. Chapman 2013.11.13 13:26:42 -05'00'
FORM FDA 3881 (9/13)