U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
Device Facts
| Record ID | K132553 |
|---|---|
| Device Name | U&U STERILE PISTON SYRINGE WITHOUT NEEDLE |
| Applicant | U&U Medical Technology Co, Ltd. |
| Product Code | FMF · General Hospital |
| Decision Date | Feb 27, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
Indications for Use
U&U Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration/ injection
Device Story
U&U Sterile Piston Syringe is a manual, single-use, non-pyrogenic device consisting of a calibrated hollow barrel, a movable plunger, and a Luer Slip or Luer Lock connector. It is used by healthcare professionals for general purpose fluid aspiration and injection. The device is sterilized via EtO gas. It functions through manual operation by the clinician to draw or expel fluids. No electronic, software, or automated components are involved.
Clinical Evidence
Bench testing only. The device conforms to ISO 7886-1 for performance and ISO 10993 for biocompatibility.
Technological Characteristics
Materials: Polypropylene (barrel), Polyethylene (plunger), Rubber (piston). Lubricant: Silicone oil. Connector: Luer Slip or Luer Lock. Sterilization: EtO gas. Standards: ISO 7886-1 (performance), ISO 10993 (biocompatibility). Operation: Manual.
Indications for Use
Indicated for use by health care professionals for general purpose fluid aspiration.
Regulatory Classification
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
Predicate Devices
- BD Single Use, Hypodermic Syringe (K110771)
Submission Summary (Full Text)
{0}------------------------------------------------
132ss3
U&U Medical Technology Co., Ltd Dongzhou Village, Hengshangiao, Changzhou, Jiangsu, China U&U (HONGKONG) Medical Technology Co., Limited RM C1-D SF WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG [U&U Piston Syringe]
510(k) Submission
FEB 2 7 2014
12/08/13 Rev 0.00
#### 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<br>RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN<br>HONG KONG |
| Contactor Name: | Xuebo Wang |
| TEL: | +86-13564751751 |
| E-mail: | Blackwang@tkmedical.com |
Contract Manufacturer Name: ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD. No 20 south renhe road tianchang, CHINA 239300 Address: 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:
Trade/Proprietary Name: U&U Sterile Piston Syringe without needle Common Name: Piston Syringe Classification name:Piston Syringe. Class: II. Panel: 80. Procodes: FMF - Piston Syringe
#### 3. Predicate Devices Information:
- 1. Piston Syringe; Trade Name: 510(K) Number:
BD Single Use, Hypodermic Syringe K110771
### 4. Devices Description:
#### Sterile Piston Syringes
The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas. And it is a Non-Pyrogenic and single use device. The mainly raw materials are PP, PE and rubber
**00016**
Page 1 of 3
[PMN-510(K) SUBMISSION]
.
{1}------------------------------------------------
U&U Medical Technology Co., Ltd Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China U&U (HONGKONG) Medical Technology Co., Limited RM C1-D SF WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG [U&U Piston Syringe]
| Ref<br>Number | Model<br>Number | Description | Size |
|---------------|-----------------|----------------------------|---------|
| TKSLS001 | TKSLS | Piston syringe (LUER SLIP) | 1cc/ml |
| TKSLS002 | TKSLS | Piston syringe (LUER SLIP) | 2cc/ml |
| TKSLS003 | TKSLS | Piston syringe (LUER SLIP) | 3cc/ml |
| TKSLS004 | TKSLS | Piston syringe (LUER SLIP) | 5cc/ml |
| TKSLS005 | TKSLS | Piston syringe (LUER SLIP) | 10cc/ml |
| TKSLS006 | TKSLS | Piston syringe (LUER SLIP) | 20cc/ml |
| TKSLS007 | TKSLS | Piston syringe (LUER SLIP) | 30cc/ml |
| TKSLS008 | TKSLS | Piston syringe (LUER SLIP) | 50cc/ml |
| TKSLS009 | TKSLS | Piston syringe (LUER SLIP) | 60cc/ml |
| TKSLL001 | TKSLL | Piston syringe (LUER LOCK) | 1cc/ml |
| TKSLL002 | TKSLL | Piston syringe (LUER LOCK) | 2cc/ml |
| TKSLL003 | TKSLL | Piston syringe (LUER LOCK) | 3cc/ml |
| TKSLL004 | TKSLL | Piston syringe (LUER LOCK) | 5cc/ml |
| TKSLL005 | TKSLL | Piston syringe (LUER LOCK) | 10cc/ml |
| TKSLL006 | TKSLL | Piston syringe (LUER LOCK) | 20cc/ml |
| TKSLL007 | TKSLL | Piston syringe (LUER LOCK) | 30cc/ml |
| TKSLL008 | TKSLL | Piston syringe (LUER LOCK) | 50cc/ml |
| TKSLL009 | TKSLL | Piston syringe (LUER LOCK) | 60cc/ml |
#### 5. Intended Use:
# Sterile Piston Syringes
U&U Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration/ injection
### 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.
### Sterile Piston Hypodermic Syringes Comparison Table
| Element of Comparison | Submission Device | Predicate Device<br>K110771 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | U&U Sterile Piston Syringes<br>is intended for use by health<br>care professionals for<br>general purpose fluid<br>aspiration/ injection | The BD Single Use,<br>Hypodermic Syringe is<br>intended for use by health<br>care professionals for general<br>purpose fluid aspiration/<br>injection. |
| Principle of Operation | Normal | Normal |
| Syringe Capacity | Various Sizes | Various Sizes |
| Nozzle Type | Luer Slip & Luer Lock | Luer Slip & Luer Lock |
| Lubricant for Barrel | Silicone Oil | Silicone Oil |
| Barrel Transparency | Transparent and Clear | Transparent and Clear |
| Gradations Legibility | Legible | Legible |
[PMN-510(K) SUBMISSION]
Page 2 of 3
000017
{2}------------------------------------------------
U&U Medical Technology Co., Ltd Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China U&U (HONGKONG) Medical Technology Co., Limited RM C1-D 8/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG [U&U Piston Syringe]
Rev 0.00 12/08/13
| Materials | | |
|------------------|------------------------------------------|------------------------------------------|
| Barrel | PP | PP |
| Plunger | PE | PE |
| Piston | Rubber | Rubber |
| Performances | Conforms to ISO7886-1 | Conforms to ISO7886-1 |
| Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 |
| Labeling | Meet the requirements of 21 CFR Part 801 | Meet the requirements of 21 CFR Part 801 |
## 7. Conclusion:
The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent.
END
Kubo usac
Aug. 12. 2013
[PMN-510(K) SUBMISSION]
Pege 3 of 3
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
## February 27, 2014
U&U Medical Technology Company, Limited Xuebo Wang Regulatory Affairs Manager Dongzhou Village, Hengshanqiao Town, Changzhou Jiangsu, China 213119
Re: K132553
Trade/Device Name: U&U Sterile Piston Syringe without Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: December 8, 2013 Received: January 29, 2014
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 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,
{4}------------------------------------------------
Page 2 - Mr. Wang
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 15809.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 vours.
Image /page/4/Picture/6 description: The image shows the name "Kwame Ulmer's" in a stylized font. The letters are black and bold, and they are arranged in two rows. The first row contains the word "Kwame", and the second row contains the word "Ulmer's". The letters are partially obscured by a geometric design that is made up of lines, circles, and triangles. The design is also black and bold, and it is arranged in a way that it appears to be behind the letters.
for
Erin I. Keith, M.S. Acting 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) K132553
Device Name
U&U Sterile Piston Syringes Without Needle
#### Indications for Use (Describe)
U&U Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration.
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.
Image /page/5/Figure/11 description: The image shows a document with the heading "FOR FDA USE ONLY" and the title "Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)". It includes the FDA logo and indicates that the document was digitally signed by Richard C. Chapman on February 25, 2014, at 09:02:57 -05'00'. The document is identified as FORM FDA 3881 (9/13) and is labeled as Page 1 of 2.
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
{6}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
