Who is the manufacturer of TK Sterile Piston Syringe without Needle?

Anhui Tiankang Medical Technology Co., Ltd. filed the 510(k) submission for TK Sterile Piston Syringe without Needle (K191642).

What is the FDA product code for TK Sterile Piston Syringe without Needle?

FMF. It is classified under 21 CFR 880.5860 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for TK Sterile Piston Syringe without Needle?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TK Sterile Piston Syringe without Needle?

U&U Sterile Piston Syringe without Needle (K132553).

Who can help prepare an FDA 510(k) submission like TK Sterile Piston Syringe without Needle?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TK Sterile Piston Syringe without Needle

K191642 · Anhui Tiankang Medical Technology Co., Ltd. · FMF · Jan 6, 2020 · General Hospital

Device Facts

Record ID	K191642
Device Name	TK Sterile Piston Syringe without Needle
Applicant	Anhui Tiankang Medical Technology Co., Ltd.
Product Code	FMF · General Hospital
Decision Date	Jan 6, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5860
Device Class	Class 2
Attributes	Therapeutic

Intended Use

TK Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspiration/ injection.

Device Story

Sterile, single-use piston syringe; consists of calibrated hollow barrel and movable plunger; features male Luer Slip or Luer Lock connector for attachment to hypodermic needles or other female Luer devices. Used by healthcare professionals in clinical settings for fluid aspiration or injection. Device is sterilized via EtO gas; labeled non-pyrogenic. Provides manual fluid delivery/aspiration mechanism; healthcare provider manually operates plunger to draw or expel fluids. Benefits patient by providing sterile, reliable means for medication administration or fluid sampling.

Clinical Evidence

Bench testing only. Performance testing included ISO 7886-1:2017 (manual syringe requirements), ISO 80369-7:2016 (small-bore connectors), and ISO 80369-20:2015 (test methods). Biocompatibility testing per ISO 10993-1:2018 included cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, and hemocompatibility. Sterility validated per ISO 11135:2014. Particulate matter testing performed per USP <788>.

Technological Characteristics

Materials: Polypropylene (PP) barrel and plunger, polyisoprene rubber piston. Lubricant: Dow Corning 360 medical fluid silicone oil (0.02mg/cm²). Connector: Luer Slip or Luer Lock. Sterilization: EtO gas. Standards: ISO 7886-1:2017, ISO 80369-7:2016, ISO 80369-20:2015. Dimensions: 1mL to 60mL capacities.

Indications for Use

Indicated for use by health care professionals for general purpose fluid aspiration and injection.

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

U&U Sterile Piston Syringe without Needle (K132553)

Related Devices

K133493 — SINGLE USE STERILE SYRINGE WITH NEEDLE · Jiangxi Kelun Medical Devices Manufacturing Co.,Lt · Mar 27, 2014
K231729 — Sterile syringes for single use with/without needle · Wepon Medical Technology Co., Ltd. · Sep 8, 2023
K221079 — Sterile Hypodermic Syringes for Single Use · Sichuan Prius Biotechnology Co., Ltd. · Oct 4, 2022
K151766 — BD Single Use, Hypodermic Syringe · Becton, Dickinson and Company · Sep 2, 2015
K213811 — Sterile Hypodermic Syringes for Single Use · Berpu Medical Technology Co., Ltd. · May 12, 2022

Submission Summary (Full Text)

{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<71>, and the results are in line with requirements of USP<71>: No microbial growth was observed. | Sterility inspection is based on the methods stipulated in USP<71>, and the results are in line with requirements of USP<71>: 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<788>) ## 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.