(201 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard syringe, with no mention of AI or ML capabilities.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is a general-purpose fluid aspiration and injection syringe, not designed for therapeutic intervention.
No
The intended use of the TK Sterile Piston Syringe is for general purpose fluid aspirations and injections, not for diagnosing medical conditions.
No
The device description clearly outlines a physical medical device (syringe) with a barrel, plunger, and Luer connector, and the performance studies focus on physical and chemical properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for general purpose fluid aspirations injection." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description details a syringe for injecting or aspirating fluids directly from or into the body. This is a medical device used for treatment or procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This syringe does not fit that description.
N/A
Intended Use / Indications for Use
TK Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspirations injection.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
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 is labeled Non-Pyrogenic. The device is intended for single use only.
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
health care professionals
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)
Non Clinical Performance Testing included: Functional Performance Testing (General requirements for syringe (ISO 7886-1:2017, ISO 80369-7:2016), Liquid leakage (ISO 7886-1:2017), Air leakage (ISO 7886-1:2017), Dead space (ISO 7886-1:2017), Nozzle Conical fitting (ISO 80369-7:2016), Leakage by pressure (ISO 80369-7:2016), Sub atmospheric pressure air leakage (ISO 80369-7:2016), Stress cracking (ISO 80369-7:2016), Resistance to separation (ISO 80369-7:2016), Resistance to unscrewing (ISO 80369-7:2016), Resistance to overriding (ISO 80369-7:2016), Bonding strength (ISO 80369-7:2016)); Sterility testing (EO sterilization testing conducted (ISO 11135: 2014, ISO 11607-1:2006, ISO 11607-2, ISO 10993-7:2008)); Biocompatibility Testing (ISO 10993-1:2018) including Cytotoxicity (ISO 10993-5:2017), Sensitization (ISO 10993-10:2017), Irritation (ISO 10993-10:2017), Acute Systemic Toxicity (ISO 10993-11:2017), Pyrogenicity (ISO 10993-4:2017), Hemocompatibility (ISO 10993-4:2017), and Particulate matter testing (USP). The results conform to the respective ISO standards.
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
§ 880.5860 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
January 6, 2020
Anhui Tiankang Medical Technology Co.,Ltd. Bai Baodong RA Manager No.228 Weiyi Road, Economic Development Zone Tianchang, 239300 Cn
Re: K191642
Trade/Device Name: TK Sterile Piston Syringe without Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 28, 2019 Received: December 4, 2019
Dear Bai Baodong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For CAPT Alan Stevens Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191642
Device Name
TK Sterile Piston Syringe without Needle
Indications for Use (Describe)
TK Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspirations injection.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
510(K) Summary: K191642
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR క్తి807.92
Date prepared: 05.16.2019
1. Submitter Name and Address:
| Owner Name: | Anhui Tiankang Medical Technology Co.,Ltd. |
|---|---|
| Address: | No.228 Weiyi Road .Economic Development Zone |
| ,Tianchang City.Anhui,China | |
| Contactor Name: | Bai Baodong |
| TEL: | +86-550-7309187 |
| E-mail: | tkaualitv@126.com |
| Manufacturer Name: | Anhui Tiankang Medical Technology Co.,Ltd |
|---|---|
| Address: | No.228 Weiyi Road ,Economic Development Zone |
| Tianchang City,Anhui,China |
US Aaent:
| US Agent: | James H . Liao |
|---|---|
| Address: | 6775 Verde Ridge Rd Rancho Palos Verdes, CA 90275 |
| TEL: | 310 3758169 Ext |
| Email: | James@Sino2us.Com |
2. Submission Devices Information:
Trade/Proprietary Name: TK Sterile Piston Syringe without Needle Regulation: 21CFR 880.5860 Classification name: Piston Syringe. Class: II. Product codes: FMF Submission Type: 510(K) Panel: 80.
3. Predicate Devices Information:
Company 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 Trade Name: U&U Sterile Piston Syringe without Needle 510(K) Number: K132553
4
◆Devices Description:
4.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 is labeled Non-Pyrogenic. The device is intended for single use only.
| Ref Number | Model | Description | Size |
|---|---|---|---|
| TKSLS001 | TKSLS | Piston syringe (LUER SLIP) | lcc/m |
| TKSLS002 | TKSLS | Piston syringe (LUER SLIP) | 2cc/m |
| TKSLS003 | TKSLS | Piston syringe (LUER SLIP) | 3cc/m |
| TKSLS004 | TKSLS | Piston syringe (LUER SLIP) | 5cc/m |
| 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 |
| Ref Number | Model | Description | Size |
|---|---|---|---|
| TKSLL001 | TKSLL | Piston syringe (LUER | |
| LOCK) | 1cc/m | ||
| L | |||
| TKSLL002 | TKSLL | Piston syringe (LUER | |
| LOCK) | 2cc/m | ||
| L | |||
| TKSLL003 | TKSLL | Piston syringe (LUER | |
| LOCK) | 3cc/m | ||
| L | |||
| TKSLL004 | TKSLL | Piston syringe (LUER | |
| LOCK) | 5cc/m | ||
| L | |||
| 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.Indications for use:
TK Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration/ injection.
6. Comparison of technological characteristics with the predicate:
5
The following table provides a comparison to the predicate device:
6
Sterile Piston Hypodermic Syringes Comparison Table
| Element of Comparison | SUBJECT DEVICE | PREDICATE DEVICE K132553 |
|---|---|---|
| Indication for Use | TK Sterile Piston Syringes is | |
| intended for use by health care | ||
| professionals for general purpose | ||
| fluid aspiration/ injection. |
The TK Sterile Syringes indications for use is the same as the U&U Sterile Piston
Syringes indications for use without any differents. | The U&U Sterile Piston Syringes is
intended for use by health care
professionals for general purpose fluid
aspiration/ injection. |
| Syringe Capacity | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml,
50ml, 60ml | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml,
50ml, 60ml |
| Nozzle Type | Luer Slip & Luer Lock | Luer Slip & Luer Lock |
| Lubricant for Barrel | Dow corning 360 medical fluid silicone
oil (0.02mg/cm²) | Dow corning 360 medical fluid silicone
oil (0.02mg/cm2) |
| Barrel Transparency | Transparent and Clear | Transparent and Clear |
| Gradations Legibility | Legible | Legible |
| Materials: | | |
| Barrel | PP | PP |
| Plunger | PP | PP |
| Piston | Polyisoprene Rubber | TPE (Rubber) |
| Performances | Complies with ISO 7886-1:2017 Sterile
Hypodermic syringes for single use-
Part 1: Syringes for manual use
Complies with ISO 80369-7:2016
Small-bore connectors for liquids and
gases in healthcare applications-- Part
7: Connectors for intravascular or
hypodermic applications
Complies with ISO 80369-20:2015
Small-bore connectors for liquids and
gases in healthcare applications-- Part
20: Common test methods | Complies with ISO 7886-1:1993
Sterile Hypodermic syringes for
single use-Part 1: Syringes for
manual use
Complies with ISO 594-1:1993
Conical fittings with a 6% (luer)
taper for syringes, needles, and
certain other medical equipment-
Part 1: General requirements
Complies with ISO 594-2:1998
Conical fittings with a 6% (luer)
taper for syringes, needles, and
certain other medical equipment-
Part 1: Lock fittings |
| | | |
| Sterility | Sterility inspection is based on the
methods stipulated in USP, and
the results are in line with
requirements of USP: No
microbial growth was observed. | Sterility inspection is based on the
methods stipulated in USP, and
the results are in line with
requirements of USP: No
microbial growth was observed. |
| Chemical properties | Chemical performances inspection are
based on ISO7886-1, inspection items
are as follows:
Limits for acidity or alkalinity,Limits
for extractable metals.Results conform
to ISO7886-1. | Chemical performances inspection are
based on ISO7886-1, inspection items
are as follows:
Limits for acidity or alkalinity,Limits
for extractable metals.Results
conform to ISO7886-1. |
| Biocompatibility | The biocompatibility evaluation for
the TK Sterile Piston Syringe without
needle was conducted in accordance
with the International Standard ISO
10993-1 "Biological Evaluation of
Medical Devices - Part 1: Evaluation
and Testing Within a Risk
Management Process," as recognized
by FDA and the "Use of International
Standard ISO 10993-1 "Biological
evaluation of medical devices- Part 1:
Evaluation and testing within a risk
management process", June 16, 2016.
The syringe of testing included the
following tests:
Cytotoxicity
endotoxin
Skin sensitization
Hemolysis
Intracutaneous reactivity
Acute systemic toxicity
Pyrogenicity
The evaluation of the above testing
items meets the requirements. | The biocompatibility evaluation for
the TK Sterile Piston Syringe without
needle was conducted in accordance
with the FDA Blue Book
Memorandum #G95-1 "Use of
International Standard ISO-10993,
'Biological Evaluation of Medical
Devices Part 1: Evaluation and
Testing," May 1, 1995, and
International Standard ISO 10993-1
"Biological Evaluation of Medical
Devices - Part 1: Evaluation and
Testing Within a Risk Management
Process," as recognized by FDA.
The syringe of testing included the
following tests:
Cytotoxicity
endotoxin
Skin sensitization
Hemolysis
Intracutaneous reactivity
Acute systemic toxicity
Pyrogenicity
The evaluation of the above testing
items meets the requirements. |
| Labeling | Meet the requirements of 21 CFR
Part 801 | Meet the requirements of 21 CFR
Part 801 |
7
8
7. Non Clinical Performance Testing
Functional Performance Testing General requirements for syringe (ISO 7886-1:2017, ISO 80369-7:2016) Liquid leakage (ISO 7886-1:2017) Air leakage (ISO 7886-1:2017) Dead space (ISO 7886-1:2017) Nozzle Conical fitting (ISO 80369-7:2016) Leakage by pressure (ISO 80369-7:2016) Sub atmospheric pressure air leakage (ISO 80369-7:2016) Stress cracking (ISO 80369-7:2016) Resistance to separation (ISO 80369-7:2016) Resistance to unscrewing (ISO 80369-7:2016) Resistance to overriding (ISO 80369-7:2016) Bonding strength (ISO 80369-7:2016)
Sterility
EO sterilization testing conducted (ISO 11135: 2014, ISO 11607-1:2006, ISO 11607-2, ISO 10993-7:2008)
Biocompatibility Testing (ISO 10993-1:2018): Cytotoxicity (ISO 10993-5:2017) Sensitization (ISO 10993-10:2017) Irritation (ISO 10993-10:2017) Acute Systemic Toxicity (ISO 10993-11:2017) Pyrogenicity (ISO 10993-4:2017) Hemocompatibility (ISO 10993-4:2017) Particulate matter testing (USP)
8. Conclusions:
The TK Sterile Piston Syringe without Needle is substantially equivalent to the U&U Sterile Piston Syringe without Needle. The materials, performance, and operational features of both the subject device and the predicate device are substantially equivalent.