(197 days)
U&U Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration/ injection.
U&U Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration.
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.
The provided document is a 510(k) summary for the U&U Sterile Piston Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.
Therefore, the information needed to directly answer many of the questions regarding acceptance criteria, specific study details, and performance metrics for the device itself is not present in this regulatory submission. This document highlights that the device conforms to existing standards but doesn't provide the detailed study results that would typically be associated with performance validation.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document states that the device "Conforms to ISO7886-1" for performances and "Conforms to ISO10993" for biocompatibility. These international standards provide the acceptance criteria for piston syringes and biocompatibility, respectively. The reported performance is that the device meets these standards. Detailed numerical results or specific pass/fail rates for individual tests within these standards are not provided in this summary.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Performance: Conforms to ISO7886-1 (Sterile hypodermic syringes for single use) | Device conforms to ISO7886-1 |
| Biocompatibility: Conforms to ISO10993 (Biological evaluation of medical devices) | Device conforms to ISO10993 |
| Labeling: Meets 21 CFR Part 801 | Device meets 21 CFR Part 801 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The summary refers to the device "conforming" to standards, which implies testing was conducted, but details on sample size, test set design, or data provenance are absent.
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)
This information is not applicable and not provided. This device is a piston syringe, a physical medical instrument, not an AI or diagnostic system that requires expert interpretation for ground truth establishment. Its performance is evaluated against engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the primary mode of evaluation for a piston syringe's performance against ISO standards.
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
This information is not applicable and not provided. This device is a piston syringe and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the technical specifications and test methods defined within the ISO7886-1 and ISO10993 standards. For example, for ISO 7886-1, "ground truth" would be objective measurements of force, leakage, volume accuracy, etc., against predefined limits. For ISO 10993, "ground truth" would be the results of specific biological tests (cytotoxicity, irritation, sensitization, etc.) against established safety thresholds.
8. The sample size for the training set
This information is not applicable and not provided. This device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as above.
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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,ChinaRM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLNHONG 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:
-
- Piston Syringe; Trade Name: 510(K) Number:
BD Single Use, Hypodermic Syringe K110771
- Piston Syringe; Trade Name: 510(K) Number:
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
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[PMN-510(K) SUBMISSION]
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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]
| RefNumber | ModelNumber | 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 DeviceK110771 |
|---|---|---|
| Intended Use | U&U Sterile Piston Syringesis intended for use by healthcare professionals forgeneral purpose fluidaspiration/ injection | The BD Single Use,Hypodermic Syringe isintended for use by healthcare professionals for generalpurpose fluid aspiration/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
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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]
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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,
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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.
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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
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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.
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§ 880.5860 Piston syringe.
(a)
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.(b)
Classification. Class II (performance standards).