(87 days)
The Sterile syringes for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The Sterile Syringes for Single Use with/without Needle is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.
This document is a 510(k) premarket notification for a medical device (Sterile syringes for single use with/without needle). It outlines the performance data provided to support the claim of substantial equivalence to a predicate device, rather than defining novel acceptance criteria for an AI/ML powered device and proving those are met.
Therefore, many of the requested details about acceptance criteria, ground truth establishment, sample sizes for AI/ML training/test sets, expert adjudication, and MRMC studies are not applicable or extractable from this specific document.
The document focuses on demonstrating that the new syringe device performs equivalently to existing legally marketed predicate devices by complying with established international and FDA-recognized standards for mechanical, physical, chemical, and biological properties.
Here's a breakdown of what can be extracted and what cannot:
What can be extracted:
- Device Name: Sterile syringes for single use with/without needle
- Intended Use: "intended to be used for medical purposes to inject fluid into or withdraw fluid from body."
- Study Type: This is a premarket notification (510(k)) which relies on demonstrating substantial equivalence to a predicate device, not necessarily a de novo clinical study proving novel performance criteria for an AI/ML algorithm. The performance data is primarily for physical, chemical, and biological characteristics of the syringe, not AI/ML performance.
- Acceptance Criteria & Reported Performance Table: While not in the typical "AI/ML performance" format, the document lists specific standards and states that "All evaluation acceptance criteria were met."
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-1:2018 (Body contact category: "External communication device – Blood path indirect", contact duration: "Limited (< 24 hours)") | All evaluation acceptance criteria were met. Tests performed included: Cytotoxicity; Skin sensitization; Hemolysis; Intracutaneous reactivity; Acute systemic toxicity; Pyrogenicity. |
| Sterilization: | |
| ISO 11135:2014 (Sterilization validation) | Met (routine control and monitoring parameters determined). |
| ISO 10993-7:2008 (EO residue) | Met |
| ISO 10993-7:2008 (ECH residue) | Met |
| USP <85> Bacterial Endotoxin Test (Pyrogen testing) | Met |
| Shelf-life / Packaging Integrity: | |
| ASTM D4169 (Simulated shipping) | All packaging deemed acceptable for protection of product and sterility maintenance. |
| ASTM F1980-16 (Accelerated aging for shelf life) | Shelf life of 5 years determined. |
| ASTM F88/F88M-15 (Seal strength) | Met |
| ASTM F 1929-2015 (Dye penetration) | Met |
| ASTM D3078-02(2013) (Bubble leak testing) | Met |
| Performance Testing (Syringe/Needle specific): | |
| ISO 7864:2016 (Sterile Safety Hypodermic Needles) | Met |
| ISO 9626:2016 (Stainless Steel Needle Tubing) | Met |
| ISO 80369-7:2021 (Small-bore connectors) | Met |
| ISO 7886-1:2017 (Sterile hypodermic syringes) | Met |
| USP <788> (Particulate Matter in Injections) | Met |
- Ground Truth Type: For this device, the "ground truth" is defined by the established international standards and testing methodologies (e.g., ISO, ASTM, USP) for physical, chemical, and biological properties of syringes, rather than expert labels on medical images or outcomes data.
- Sample Size:
- Test set: The document doesn't explicitly state sample sizes for each test, but implies that sufficient samples were tested to demonstrate compliance with the referenced standards. For example, "The shelf life of 5 year is determined based on stability studies which include ageing test according to FDA recognized standard ASTM F1980-16," which would involve a specific number of samples over time.
- Training set: Not applicable, as this is not an AI/ML device requiring a training set.
- Data Provenance: The manufacturing and testing entities are based in China (Wepon Medical Technology CO., Ltd. in Zhejiang, China, and Shanghai Ling Fu Technology Co., Ltd. in Shanghai, China). The data would be retrospective in the sense that it was collected during product development and validation for submission, rather than a prospective clinical trial.
What cannot be extracted (because it's not an AI/ML device):
- Number of experts used to establish ground truth & qualifications: Not applicable; ground truth is standard compliance.
- Adjudication method for test set: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) pertains to a conventional medical device (syringes) and demonstrates substantial equivalence by meeting recognized performance standards, not by evaluating an AI/ML algorithm's diagnostic or predictive capabilities.
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September 8, 2023
Wepon Medical Technology CO., Ltd. % Esther Zhang Official Correspondent Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District Shanghai, Shanghai 201102 China
Re: K231729
Trade/Device Name: Sterile syringes for single use with/without needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: June 8, 2023 Received: June 13, 2023
Dear Esther Zhang:
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,
Alan Stath
CAPT Alan Stevens 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) K231729
Device Name
Sterile syringes for single use with/without needle
Indications for Use (Describe)
The Sterile syringes for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
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
K231729
l Submitter
Device submitter: Wepon Medical Technology CO., LTD. Floor 4, Building A, No. 58, Jinhu Road, Chengdong Street, Wenling Zhejiang, CN 317500
Contract manufacturer: Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town, Yuhuan, Zhejiang, 317605, China Registration number: 3015042030
Contact person: Di Zhao Deputy General Manager Phone: 928-5922380 Email: dizhao@wepon-ppe.com
Date: September 8, 2023
II Correspondent
Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District, Shanghai, P.R.China Contact: Esther ZHANG Email: Esther.zhang@llins-tech.com
III Device
| Trade Name: | Sterile syringes for single use with/without needle |
|---|---|
| Common Name: | Piston Syringe |
| Regulation Number: | 21 CFR 880.5860 |
| Regulation Name: | Piston Syringe |
| Device Class: | Class II |
| Product code: | FMF, FMI |
| Review Panel: | General Hospital |
IV Predicate Devices
| Trade name: | Sterile Hypodermic Syringe for Single use with/without |
|---|---|
| Needle | |
| Common name: | Piston Syringe |
| Classification: | Class II, 21 CFR 880.5860 |
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Product Code: FMI Premarket Notification: K112057 Manufacturer: Shanghai Kindly Enterprise Division Group Company
V Device description
The Sterile Syringes for Single Use with/without Needle is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.
VI Indications for use
The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
VII Comparison of technological characteristics with the predicate devices
The Sterile Syringes for Single Use with/without Needle have the same intended use, technology, design and performance specifications are either similar or substantially equivalent to existing legally marketed predicate devices. The differences between the Sterile Syringes for Single Use with/without Needle and predicate devices do not alter suitability of the proposed device for its intended use.
Table 5-1 Substantial equivalence discussion – Sterile syringes for single use with/without
| needle | |||
|---|---|---|---|
| Device feature | Subject Device K231729 | Predicate Device K112057 | Comments |
| Indications for use | The Sterile Syringes forSingle Use with/withoutNeedle is intended to beused for medical purposesto injectfluid into or withdraw fluidfrom body. | The Sterile HypodermicSyringe for Single Usewith/without needle isintended to be used formedical purposes to injectfluid into orwithdraw fluid from body. | Same |
| Product code | FMF, FMI | FMF | Same |
| Regulationnumber | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Principle ofoperation | For manual use only | For manual use only | Same |
| Intended user | Medical professionals and trained care givers | Medical professionals and trained care givers | Same |
| Environment of use | Hospitals and clinics | Hospitals and clinics | Same |
| Nozzle type | Luer slip; Luer lock | Luer slip; Luer lock | Same |
| Lubricant for barrel | Silicone oil | Silicone oil | Same |
| Barrel transparency | Transparent and clear | Transparent and clear | Same |
| Gradations legibility | Legible | Legible | Same |
| Syringe volume | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml, 100ml | 1ml, 3ml, 5ml, 6ml, 10ml, 20ml, 30ml, 35ml and 50ml | Different 1 |
| Needle gauge | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G,27G, 30G | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | |
| Needle length | 1/2", 5/8", 1", 11/4", 11/2" | Not available | |
| Needle hub | Color-coded per ISO 6009 | Color-coded per ISO 6009 | Same |
| Single use | Yes | Yes | Same |
| Performance specifications | Complies with ISO 7886-1:2017 SterileHypodermic syringes for single use - Part 1:Syringes for manual use | Complies with ISO 7886-1:2017 SterileHypodermic syringes for single use - Part 1:Syringes for manual use | Same |
| Sterilization | EO | EO | Same |
| SAL | 10-6 | 10-6 | Same |
| Materials | Barrel: PP Plunger: PPPiston: Silicone RubberNeedle: Stainless 304Needle hub: PP | Barrel: PP Plunger: PPPiston: Isoprene RubberNeedle: Stainless 304Needle hub: PP | Different 2 |
| Pyrogen | Non-pyrogenic | Non-pyrogenic | Same |
| Biocompatibility | The biocompatibility evaluation for the subject device was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: | The biocompatibility evaluation for the subject device was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1. | Same |
| Labeling | Evaluation and TestingWithin a Risk ManagementProcess," as recognized byFDA and the "Use ofInternational Standard ISO10993-1 "Biologicalevaluation of medicaldevices- Part 1: Evaluationand testing within a riskmanagement process",June 16, 2016. The syringeof testing included thefollowing tests:Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of the abovetesting items meet therequirements | Evaluation and TestingWithin a Risk ManagementProcess," as recognized byFDA and the "Use ofInternational Standard ISO10993-1 "Biologicalevaluation of medicaldevices- Part 1: Evaluationand testing within a riskmanagement process",June 16, 2016. The syringeof testing included thefollowing tests: Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of the abovetesting items meets therequirements | Same |
| Meet the requirements of21 CFR Part 801 | Meet the requirements of21 CFR Part 801 |
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Discussion:
Different 1
The syringe volume, needle gauge and length of subject devices are different from the predicate device. The differences do not raise new questions of safety and effectiveness.
Different 2
The material of subject device is similar as predicate device. However, the
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subjected products were tested and demonstrated that they complied with ISO 10993 series standards. The differences on material does not affect substantially equivalence on safety and effectiveness.
VIII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Sterile syringes for single use with/without needle was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device – Blood path indirect" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity; Skin sensitization; Hemolysis; Intracutaneous reactivity; Acute systemic toxicity; Pyrogenicity. All evaluation acceptance criteria were met.
Sterilization and shelf-life testing
The sterilization method has been validated to ISO11135:2014, which has thereby determined the routine control and monitoring parameters.
The testing is performed according to the following standards:
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Pyrogen testing | USP <85> Bacterial Endotoxin Test |
| Simulated shipping per | ASTM D4169 |
Package integrity testing was conducted on the final, packaged, and sterile devices after environmental conditioning and simulated transportation. All packaging deemed acceptable for protection of product and sterility maintenance. The shelf life of 5 year is determined based on stability studies which include ageing test according to FDA recognized standard ASTM F1980-16.
The testing is performed according to the following standards:
| Seal strength | ASTM F88/F88M-15 |
|---|---|
| Dye penetration | ASTM F 1929-2015 |
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Bubble leak testing
ASTM D3078-02(2013)
Performance testing
Performance testing is performed according to the following standards:
- A ISO 7864:2016 Sterile Safety Hypodermic Needles for Single Use — Requirements and test methods
- ) ISO 9626:2016, Stainless Steel Needle Tubing for The Manufacture of Medical Devices
-
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
-
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1:
Syringes for manual use.
- A USP <788> Particulate Matter in Injections
IX Conclusion
The predicate device submission was cleared with Sterile Hypodermic Syringe for Single use with/without Needle, Sterile Insulin Syringe for single use, with needle and Sterile Hypodermic Needle for single use. The subject device is being compared to only the predicate Sterile Hypodermic Syringe for Single use with/without Needle. The subject device, Sterile Syringes for Single Use with/without Needle, is substantially equivalent to its predicate devices (Sterile Hypodermic Syringe for Single use with/ without Needle). The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device. Therefore, it is substantially equivalent.
§ 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).