(201 days)
TK Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspirations injection.
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.
The provided text is a 510(k) summary for a medical device called "TK Sterile Piston Syringe without Needle." It outlines the device's characteristics and compares them to a legally marketed predicate device (U&U Sterile Piston Syringe without Needle) to establish substantial equivalence.
However, the provided document DOES NOT contain information about a study that uses an AI/ML algorithm or requires ground truth established by experts. It describes a conventional medical device (syringe) and its testing against established international standards for physical, chemical, and biological properties. Therefore, I cannot generate the requested table and study details related to acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies in the context of an AI/ML study.
The document focuses on demonstrating that the new syringe complies with performance standards through non-clinical performance testing (e.g., liquid leakage, air leakage, conical fitting integrity), sterility testing, and biocompatibility testing.
Here's what I can extract and present based on the provided text, reinterpreting "acceptance criteria" in the context of a non-AI/ML medical device's performance testing:
Acceptance Criteria and Device Performance (for a non-AI/ML device)
The device, "TK Sterile Piston Syringe without Needle," is a conventional medical device. Its acceptance criteria are based on compliance with established international standards for syringes, rather than AI/ML performance metrics. The study described focuses on demonstrating equivalence to these standards and to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Element of Performance | Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|---|
| Functional Performance | ||
| General Requirements | ISO 7886-1:2017 Sterile Hypodermic syringes for single use - Part 1: Syringes for manual use, and ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications | Complies |
| Liquid Leakage | ISO 7886-1:2017 | Complies |
| Air Leakage | ISO 7886-1:2017 | Complies |
| Dead Space | ISO 7886-1:2017 | Complies |
| Nozzle Conical Fitting | ISO 80369-7:2016 | Complies |
| Leakage by Pressure | ISO 80369-7:2016 | Complies |
| Sub-atmospheric Air Leakage | ISO 80369-7:2016 | Complies |
| Stress Cracking | ISO 80369-7:2016 | Complies |
| Resistance to Separation | ISO 80369-7:2016 | Complies |
| Resistance to Unscrewing | ISO 80369-7:2016 | Complies |
| Resistance to Overriding | ISO 80369-7:2016 | Complies |
| Bonding Strength | ISO 80369-7:2016 | Complies |
| Sterility | USP<71> and ISO 11135:2014, ISO 11607-1:2006, ISO 11607-2, ISO 10993-7:2008 | No microbial growth observed; in line with requirements. |
| Chemical Properties | ISO 7886-1 (limits for acidity/alkalinity, extractable metals) | Results conform to ISO 7886-1. |
| Biocompatibility | ISO 10993-1:2018; specific tests: 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>) | The evaluation of the above testing items meets the requirements. |
| Labeling | 21 CFR Part 801 | Meets the requirements of 21 CFR Part 801. |
| Material Equivalence | Key materials: Barrel (PP), Plunger (PP), Piston (Polyisoprene Rubber); Lubricant (Dow corning 360 medical fluid silicone oil 0.02mg/cm²) to be equivalent or justify differences from predicate. | Barrel (PP) and Plunger (PP) are identical. Piston material changed from TPE (Rubber) to Polyisoprene Rubber, but equivalence is implicitly demonstrated by meeting performance and biocompatibility standards. Lubricant is identical. |
| Physical Appearance | Transparent and Clear Barrel, Legible Gradations. | Transparent and Clear, Legible. |
Regarding the AI/ML specific questions:
- Sample sizes used for the test set and the data provenance: Not applicable. This document is for a physical medical device, not an AI/ML algorithm. Testing involves physical samples of syringes.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a syringe's performance is established by objective physical, chemical, and biological measurements against established standards, not expert consensus on an AI's output.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like those listed are used for human reader studies with AI, not for physical device testing.
- 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/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" for performance is defined by the objective pass/fail criteria of the various ISO and USP standards referenced (e.g., specific thresholds for fluid leakage, absence of microbial growth, acceptable levels for extractable metals, absence of adverse biological reactions).
- The sample size for the training set: Not applicable. This applies to AI/ML devices.
- How the ground truth for the training set was established: Not applicable. This applies to AI/ML devices.
Conclusion stated by the submitter:
"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."
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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
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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
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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)
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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 ZoneTianchang 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
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◆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 (LUERLOCK) | 1cc/mL |
| TKSLL002 | TKSLL | Piston syringe (LUERLOCK) | 2cc/mL |
| TKSLL003 | TKSLL | Piston syringe (LUERLOCK) | 3cc/mL |
| TKSLL004 | TKSLL | Piston syringe (LUERLOCK) | 5cc/mL |
| TKSLL005 | TKSLL | Piston syringe (LUERLOCK) | 10cc/mL |
| TKSLL006 | TKSLL | Piston syringe (LUERLOCK) | 20cc/mL |
| TKSLL007 | TKSLL | Piston syringe (LUERLOCK) | 30cc/mL |
| TKSLL008 | TKSLL | Piston syringe (LUERLOCK) | 50cc/mL |
| TKSLL009 | TKSLL | Piston syringe (LUERLOCK) | 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:
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The following table provides a comparison to the predicate device:
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Sterile Piston Hypodermic Syringes Comparison Table
| Element of Comparison | SUBJECT DEVICE | PREDICATE DEVICE K132553 |
|---|---|---|
| Indication for Use | TK Sterile Piston Syringes isintended for use by health careprofessionals for general purposefluid aspiration/ injection.The TK Sterile Syringes indications for use is the same as the U&U Sterile PistonSyringes indications for use without any differents. | The U&U Sterile Piston Syringes isintended for use by health careprofessionals for general purpose fluidaspiration/ 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 siliconeoil (0.02mg/cm²) | Dow corning 360 medical fluid siliconeoil (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 SterileHypodermic syringes for single use-Part 1: Syringes for manual useComplies with ISO 80369-7:2016Small-bore connectors for liquids andgases in healthcare applications-- Part7: Connectors for intravascular orhypodermic applicationsComplies with ISO 80369-20:2015Small-bore connectors for liquids andgases in healthcare applications-- Part20: Common test methods | Complies with ISO 7886-1:1993Sterile Hypodermic syringes forsingle use-Part 1: Syringes formanual useComplies with ISO 594-1:1993Conical fittings with a 6% (luer)taper for syringes, needles, andcertain other medical equipment-Part 1: General requirementsComplies with ISO 594-2:1998Conical fittings with a 6% (luer)taper for syringes, needles, andcertain other medical equipment-Part 1: Lock fittings |
| Sterility | Sterility inspection is based on themethods stipulated in USP<71>, andthe results are in line withrequirements of USP<71>: Nomicrobial growth was observed. | Sterility inspection is based on themethods stipulated in USP<71>, andthe results are in line withrequirements of USP<71>: Nomicrobial growth was observed. |
| Chemical properties | Chemical performances inspection arebased on ISO7886-1, inspection itemsare as follows:Limits for acidity or alkalinity,Limitsfor extractable metals.Results conformto ISO7886-1. | Chemical performances inspection arebased on ISO7886-1, inspection itemsare as follows:Limits for acidity or alkalinity,Limitsfor extractable metals.Resultsconform to ISO7886-1. |
| Biocompatibility | The biocompatibility evaluation forthe TK Sterile Piston Syringe withoutneedle was conducted in accordancewith the International Standard ISO10993-1 "Biological Evaluation ofMedical Devices - Part 1: Evaluationand Testing Within a RiskManagement Process," as recognizedby FDA and the "Use of InternationalStandard ISO 10993-1 "Biologicalevaluation of medical devices- Part 1:Evaluation and testing within a riskmanagement process", June 16, 2016.The syringe of testing included thefollowing tests:CytotoxicityendotoxinSkin sensitizationHemolysisIntracutaneous reactivityAcute systemic toxicityPyrogenicityThe evaluation of the above testingitems meets the requirements. | The biocompatibility evaluation forthe TK Sterile Piston Syringe withoutneedle was conducted in accordancewith the FDA Blue BookMemorandum #G95-1 "Use ofInternational Standard ISO-10993,'Biological Evaluation of MedicalDevices Part 1: Evaluation andTesting," May 1, 1995, andInternational Standard ISO 10993-1"Biological Evaluation of MedicalDevices - Part 1: Evaluation andTesting Within a Risk ManagementProcess," as recognized by FDA.The syringe of testing included thefollowing tests:CytotoxicityendotoxinSkin sensitizationHemolysisIntracutaneous reactivityAcute systemic toxicityPyrogenicityThe evaluation of the above testingitems meets the requirements. |
| Labeling | Meet the requirements of 21 CFRPart 801 | Meet the requirements of 21 CFRPart 801 |
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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.
§ 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).