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 Hypodermic Needle is sterilized by EtO gas. The U&U Sterile Hypodermic Needle is Non-Pyrogenic, disposable and intended for single use.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the U&U Sterile Hypodermic Needle. This submission focuses on demonstrating substantial equivalence to a predicate device, the BD Hypoint™ Hypodermic Needle (K070440).

However, the provided document does not describe a study involving an algorithm or AI. It is a regulatory submission for a physical medical device (a hypodermic needle). Therefore, many of the requested categories related to algorithm performance, training, and ground truth are not applicable.

Here's the information that is available based on the provided text, with a clear indication of what is not applicable:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implied by the comparison to the predicate device and adherence to international standards. The "reported device performance" is essentially that it conforms to these standards and exhibits similar technological characteristics to the predicate.

Element of Comparison	Predicate Device (Acceptance Criteria)	Submitted Device (Reported Performance)
Intended Use	Fluid injection/aspiration	Fluid injection/aspiration
Principle of Operation	Normal	Normal
Needle Gauge/Length	Various Sizes	Various Sizes
Lubricant for Needle	Silicone Oil	Silicone Oil
Adhesive	Epoxy Resin	UV Glue
Needle Hub Colors	Various Colors	Various Colors
Tip configuration	Bevel	Bevel
Needle Hub Material	PP	PP
Needle Material	Stainless Steel	Stainless Steel
Needle Cover Material	PE	PP
Performances	Conforms to ISO7864	Conforms to ISO7864
Biocompatibility	Conforms to ISO10993	Conforms to ISO10993
Labeling	Meets 21 CFR Part 801	Meets 21 CFR Part 801

(Note: The 'Acceptance Criteria' column above represents what the predicate device achieves, which the submitted device aims to be substantially equivalent to or meet similar standards for.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document is for a physical hypodermic needle, not an algorithm. There is no "test set" in the context of an algorithm's performance data. The device itself undergoes various testing (e.g., performance, biocompatibility) to meet ISO standards, but the specifics of sample sizes for these tests are not detailed in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. There is no "ground truth" to be established by experts for an algorithm in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No algorithm performance data is being adjudicated.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm. The device, a hypodermic needle, is a standalone physical product.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable. This is not an algorithm. For the physical device, compliance with established performance standards (ISO7864) and biocompatibility standards (ISO10993) serves as the "ground truth" for its safety and effectiveness.

8. The sample size for the training set

Not Applicable. This is not an algorithm.

9. How the ground truth for the training set was established

Not Applicable. This is not an algorithm.

Summary

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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

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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.

RefNumber	ModelNumber	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 DeviceK110771
Intended Use	U&U Sterile Hypodermic Needle isintended for use with syringes andinjection devices for generalpurpose fluid injection/aspiration	The BD HypointTM HypodermicNeedle is intended for use withSyringes and injection devicesfor general purpose fluidaspiration/ 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]

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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

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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.

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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

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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)

Regulation Number and Section

§ 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).