(87 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a syringe, with no mention of AI or ML.
No.
The device is a syringe used for fluid aspiration and injection, which are procedures, not therapeutic actions themselves.
No
The device is a syringe used for fluid injection and aspiration, which are treatment or procedural actions, not diagnostic ones. It does not identify or detect a disease or condition.
No
The device description clearly outlines a physical syringe with various hardware components (barrel, stopper, plunger rod, needle connector). The performance studies also focus on physical and material properties, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy." This describes a device used for administering substances into or withdrawing substances from the body, which is a typical function of a medical device, not an IVD.
- Device Description: The description details a syringe with a barrel, stopper, and plunger rod, designed for mechanical action (aspirating and injecting). This aligns with the description of a medical device used for drug delivery or fluid aspiration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs typically involve reagents, calibrators, controls, or instruments used to analyze biological samples.
Therefore, this device is a medical device used for injection and aspiration, not an IVD.
N/A
Intended Use / Indications for Use
The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMF, FMI
Device Description
The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, 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. The main principle of the syringe is that after the injection is completed, the plunger can be locked for self-locking.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Below the surface of the skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals and trained care givers / Hospitals and clinics
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)
Biocompatibility testing
In accordance with ISO 10993-1, the device is classified as Externally Communicating Device, Blood Path Indirect, Limited Contac (
Sterilization, Shipping, and shelf-life testing
- EO sterilization validation per ISO11135:2014
- Pyrogen testing per USP Bacterial Endotoxin Test
- EO residuals per ISO 10993-7
- Simulated shipping per ASTM D4169
- Sterile Barrier Package testing performed on the proposed device:
- Seal Strength ASTM F88/F88M-2015
- Bubble leak testing ASTM D3078-02(2013)
- Dye Penetration ASTM F1929-2015
- Shelf life of 5 years validated using FDA recognized standards ASTM F1980-16. Standard Guide for Accelerated Aging of sterile barrier Systems for Medical Devices
Performance testing
Performance testing is performed according to the following standards:
- ISO 7864:2016 Sterile 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 7886-4:2018 sterile hypodermic syringes for single use — part 4: syringes with re-use prevention feature.
- ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use
Key Results: The performance data provided support the substantial equivalence determination. Differences in needle gauges and bevel were addressed through ISO 9626 and ISO 7864 testing. Biocompatibility testing confirmed the device is biocompatible despite material differences.
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".
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: K231727
Trade/Device Name: Sterile Auto-Disable Syringes with/without Needle for Single Use 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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 Guth
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
2
Indications for Use
510(k) Number (if known) K231727
Device Name
Sterile Auto-Disable syringes with/without needle for single use
Indications for Use (Describe)
The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.
| 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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3
510(k) summary
K231727
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 of Device: Sterile Auto-Disable syringes with/without needle for single use Common Name: Piston Syringe Regulation Number: 21 CFR 880.5860 21 CFR 880.5570 Regulation Name: Piston Syringe Regulatory Class: II Product code: FMF, FMF, FMI Review Panel: General Hospital
IV Predicate Devices
| Trade name: | Safety Auto-Disable Syringe with Needle (Auto-Lock) |
|---|---|
| Common name: | Piston Syringe |
4
| Classification: | Class II, 21 CFR 880.5860 |
|---|---|
| Product Code: | MEG, FMF, FMI |
| Premarket Notification: | K143497 |
| Manufacturer: | Guangdong Intmed Medical Appliance Co., Ltd. |
V Device description
The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, 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. The main principle of the syringe is that after the injection is completed, the plunger can be locked for self-locking.
| Syringe Size | Needle Gauge | Needle Length |
|---|---|---|
| Available in 1ml, 3ml, 5ml | ||
| and 10ml. | Available in 18G, 19G, 20G, | |
| 21G, 22G, 23G, 24G, 25G, | ||
| 26G, 27G, 30G | Available in 1/2", 5/8", 1", 1 1/4", 1 1/2" |
VI Indications for use
The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.
VII Comparison of technological characteristics with the predicate devices
The Sterile Auto-Disable syringes with/without needle for single use have the same intended use, technology, design, and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Sterile Auto-Disable syringes with/without needle for single use and predicate devices do not alter suitability of the proposed device for its intended use.
| Table 5-1 Substantial equivalence discussion – Sterile Auto-Disable syringes with/without |
|---|
| needle for single use |
| Device feature | Subject Device K231727 | Predicate Device K143497 | Comment |
|---|---|---|---|
| Indications for use | The Sterile Auto-Disable | ||
| syringes with/without needle | |||
| for single use is used for | |||
| aspiration of fluids from vials | |||
| and ampoules and a variety of | The Safety Auto-Disable | ||
| Syringe with Needle | |||
| (Auto-Lock) is used for | |||
| aspiration of fluids from vials | |||
| and ampoules and a variety of | Different | ||
| Comment #1 | |||
| Device feature | Subject Device K231727 | Predicate Device K143497 | Comment |
| fluid injections below the | |||
| surface of the skin except | |||
| phlebotomy. | fluid injections below the | ||
| surface of the skin except | |||
| phlebotomy. | |||
| It has a detachable needle with | |||
| a dedicated fitting. The Safety | |||
| Auto-Disabled Syringe with | |||
| Needle (Auto-Lock) contains an | |||
| inner mechanism used to allow | |||
| the needle to be retracted | |||
| inside the plunger rod of the | |||
| syringe after the operator's | |||
| thumb force released. After | |||
| activation the needle is fully | |||
| contained inside the syringe | |||
| guarding against accidental | |||
| needle sticks during normal | |||
| handling and disposal of the | |||
| used needle/syringe | |||
| combination. | |||
| Product code | FMF, FMI | MEG, FMF, FMI | Different |
| Comment #2 | |||
| Regulation | |||
| number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Principle of | |||
| operation | For manual use only | For manual use only | Same |
| Safety Features | Active safety feature, manually | ||
| activated by user | Active safety feature, manually | ||
| activated by user | 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 |
| Syringe volume | 1 ml, 3 ml, 5 ml, 10 ml | 1 ml, 3 ml, 5 ml, 10 ml | Same |
| Nozzle type | Luer slip; Luer lock | Needle hub Luer connector | Same |
| Lubricant | Silicone oil | PDMS | Same |
| Barrel | |||
| transparency | Transparent and clear | Clear as required by | |
| ISO 7886-1 | Same | ||
| Gradations | |||
| legibility | Legible | Legible according to | |
| ISO 7886-1 | Same | ||
| Device feature | Subject Device K231727 | Predicate Device K143497 | Comment |
| Needle Length | 1/2", 5/8", 1", 1 1/4", 1 1/2" | 12-38mm | Same |
| Needle Gauge | 18G, 19G, 20G, 21G, 22G, | ||
| 23G, 24G, 25G, 26G, 27G, | |||
| 30G | 21G, 22G, 23G, 24G, 25G, | ||
| 26G, 27G, 28G | Different | ||
| Comment #3 | |||
| Configuration of | |||
| the tip | Short bevel, long bevel. | 15 °C regular point | Different |
| Comment #4 | |||
| Needle hub | Color-coded per ISO 6009 | Colorless according to ISO | |
| 7864 | Same | ||
| Single use | Yes | Yes | Same |
| Performance | |||
| specifications | Complies with ISO 7864, ISO | ||
| 7886-1, ISO 7886-4 | Conforms to ISO 7864, ISO | ||
| 7886-1, ISO 7886-4 | Same | ||
| Sterilization | EO | EO | Same |
| SAL | 10-6 | 10-6 | Same |
| Materials | Barrel: PP | ||
| Plunger: PP | |||
| Piston: Silicone Rubber | |||
| Needle: Stainless steel | |||
| Needle hub: PP | Barrel: Polypropylene | ||
| Plunger: Polypropylene | |||
| Piston: Isoprene rubber | |||
| Needle Hub: Polypropylene | |||
| Needle: Stainless Steel | |||
| Needle Sheath: Stainless Steel | |||
| O Ring : Silicone rubber | Different | ||
| Comment #5 | |||
| Pyrogen | Non-pyrogenic | Non-pyrogenic | Same |
| Biocompatibility | Conforms to ISO 10993 See | ||
| below | Conforms to ISO10993 | Same | |
| Labeling | Meet the requirements of 21 | ||
| CFR Part 801 | Meet the requirements of 21 | ||
| CFR Part 801 | Same |
5
6
Comment #1
The subject device does not have a needle safety feature, but has a disc on the plunger which could be stuck by the buckle of the syringe to prevent re-use of the syringe. The subject device and the predicate device both have the same intended use, this difference does not affect the clinical safety of the subject device.
Comment #2
The subject device and the predicate device are both syringes that render the syringe unusable after injection, the predicate device also has a needle safety feature.
Comment #3
The subject device is available in gauges 18g-30g and the predicate device is available in 21g-28g. Performance testing was done per ISO 9626 and ISO 7864 done to demonstrate that the differences in needle gauges do not affect the clinical safety or
7
effectiveness of the devices.
Comment #4
The bevel of subject device is different from the predicate device. However, this difference does not affect intended use. The difference was addressed through ISO 9626 and ISO 7864. Therefore, the differences on bevel do not raise different question of safety and effectiveness.
Comment #5
The material of subject device is different from the predicate device. The piston of subject device is silicone rubber while the predicate device is isoprene rubber. And the configurations of subject device do not include Needle Sheath compared with predicate device, which does not affect its intended use and does not introduce new materials. However, biocompatibility testing was performed with the subject device and found it to be biocompatible. Therefore, the differences on materials do not raise new questions about safety and effectiveness.
VIII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
In accordance with ISO 10993-1, the device is classified as Externally Communicating Device, Blood Path Indirect, Limited Contac (
Sterilization, Shipping, and shelf-life testing
- . EO sterilization validation per ISO11135:2014
- Pyrogen testing per USP Bacterial Endotoxin Test .
- EO residuals per ISO 10993-7 .
- Simulated shipping per ASTM D4169 ●
- . Sterile Barrier Package testing performed on the proposed device:
- Seal Strength ASTM F88/F88M-2015 o
8
- Bubble leak testing ASTM D3078-02(2013) o
- Dye Penetration ASTM F1929-2015 o
- Shelf life of 5 years validated using FDA recognized standards ASTM F1980-16 . Standard Guide for Accelerated Aging of sterile barrier Systems for Medical Devices
Performance testing
Performance testing is performed according to the following standards:
- ISO 7864:2016 Sterile hypodermic needles for single use Requirements and test A methods
- A 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
- A ISO 7886-4:2018 sterile hypodermic syringes for single use — part 4: syringes with re-use prevention feature.
- ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for A manual use
IX Conclusion
The differences between the predicate and subject device do not raise any new or different questions of safety and effectiveness. The Sterile Auto-Disable syringes with/without needle for single use are substantially equivalent to The Safety Auto-Disable Syringe with Needle (Auto-Lock) with respect to indications for use, target population, and technological characteristics.