Disposable Automatically Retractable Safety Syringes (with detachable needle)
Device Facts
| Record ID | K222452 |
|---|---|
| Device Name | Disposable Automatically Retractable Safety Syringes (with detachable needle) |
| Applicant | Shantou Wealy Medical Instrument Co.,Ltd |
| Product Code | MEG · General Hospital |
| Decision Date | Nov 23, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Automatically Retractable Safety Syringes with detachable needle devices are indicated for use where a safe and reliable method for intramuscular and subcutaneous injection of medication in a patient is desired.
Device Story
Disposable, sterile, single-use piston syringe with detachable needle; intended for intramuscular/subcutaneous medication injection. Operates like conventional syringe; features spring-activated mechanism that retracts contaminated needle into barrel immediately post-injection. Used in hospital settings by medical professionals. Needle remains inside barrel for safe disposal, reducing sharps injury risk. Device includes calibrated barrel, plunger, and detachable needle hub. Benefits include enhanced sharps injury prevention for clinicians.
Clinical Evidence
Bench testing only. Performance evaluated per ISO 7886-1, 7886-4, 7864, 9626, 23908, and 80369-7. Biocompatibility testing performed per ISO 10993 series. Simulated clinical study on sharps injury prevention features demonstrated 99% reliability of device activation.
Technological Characteristics
Materials: PP (barrel, plunger, hub), isoprene rubber (piston), stainless steel (needle), PE (sheath), silicone (O-ring). Energy: Spring-activated mechanical retraction. Connectivity: None. Sterilization: EO (SAL 10^-6). Standards: ISO 7886-1/4, ISO 7864, ISO 9626, ISO 23908, ISO 80369-7, ISO 10993.
Indications for Use
Indicated for intramuscular and subcutaneous injection of medication in patients where a safe and reliable method is desired. No specific age or gender restrictions stated.
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
- AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE (K141640)
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shantou Wealy Medical Instrument CO.,Ltd. % Eva Li Consultant Shanghai SUNGO Management Consulting Co. Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai, 200122 China
Re: K222452
Trade/Device Name: Disposable Automatically Retractable Safety Syringes (with detachable needle) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF, FMF, FMI Dated: October 24, 2022 Received: October 24, 2022
Dear Eva Li:
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,
Courtney
Digitally signed by Courtney Evans -S Date: 2022.11.23 06:45:27
Evans -S -05'00' For 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) K222452
Device Name
Disposable Automatically Retractable Safety Syringes (with detachable needle)
#### Indications for Use (Describe)
The Automatically Retractable Safety Syringes with detachable needle devices are indicated for use where a safe and reliable method for intramuscular and subcutaneous injection of medication in a patient is desired.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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 — K222452
## 1. Submitter Information
Name: Shantou Wealy Medical Instrument CO.,Ltd. Address: North Jinhuan Road(near of Qishan mid-school), Shantou, 515064, Guangdong, China
#### 2. Correspondent Information
Contact: Eva Li Phone: + 86 (215) 881-7802 Email: eatereva@hotmail.com Address: Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave, Shanghai, 200122 CHN
#### 3. Date Prepared - Nov 22nd, 2022
#### 4. Device Information
| Trade name: | Disposable Automatically Retractable Safety<br>Syringes (with detachable needle) |
|----------------------|----------------------------------------------------------------------------------|
| Common name: | Syringe, Antistick Piston Syringe |
| Classification name: | Piston Syringe |
## 5. Predicate Device Information
Trade Name: AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE 510(K) Number: K141640 Company: SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
#### 6. Indications for use
The Automatically Retractable Safety Syringes with detachable needle devices are indicated for use where a safe and reliable method for intramuscular and subcutaneous injection of medication in a patient is desired.
## 7. General Description of the Device and principle of operation
The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are piston syringes, intended for medical purpose and consist of a calibrated hollow barrel and a movable plunger. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the syringe plunger for disposal. The Disposable Automatically Retractable Safety Syringes (with Detachable Needle) devices are sterile, single use, disposable and non-reusable.
{4}------------------------------------------------
| | Needle Size | | Length<br>metric system (mm) /British System(in) | | | | | | | | |
|---------------------------------------------------|-------------------|----------------|--------------------------------------------------|-----------|-----------|-----------|-----------|-----------|---------|-------------|-------------|
| metric<br>system | British<br>System | Color | 6<br>1/4 | 8<br>5/16 | 13<br>1/2 | 16<br>5/8 | 19<br>3/4 | 20<br>4/5 | 25<br>1 | 32<br>1 1/4 | 38<br>1 1/2 |
| 0.30 | 30G | Yellow | | | | | | | | | |
| 0.33 | 29G | Red | | | | | | | | | |
| 0.36 | 28G | Blue<br>green | | | | | | | | | |
| 0.40 | 27G | Medium<br>Grey | | | | | | | | | |
| 0.45 | 26G | Brown | | | | | | | | | |
| 0.50 | 25G | Orange | | | | | | | | | |
| 0.55 | 24G | Purple | | | | | | | | | |
| 0.60 | 23G | Deep<br>Blue | | | | | | | | | |
| 0.70 | 22G | Black | | | | | | | | | |
| 0.80 | 21G | Deep<br>Green | | | | | | | | | |
| 0.90 | 20G | Yellow | | | | | | | | | |
| 1.20 | 18G | Pink | | | | | | | | | |
| 1.60 | 16G | White | | | | | | | | | |
| Syringe Sizes<br>0.5ml, 1ml, 3ml, 5ml, 10ml, 20ml | | | | | | | | | | | |
## Disposable Automatically Retractable Safety Syringes (with Detachable Needle)
## 8. Comparison with predicate device
The table below compares the intended use and technological characteristics of the subject and predicate device
| Device | Proposed Device | Predicate Device<br>K141640 | Comparison | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Shantou Wealy Medical<br>Instrument CO.,Ltd. | Shantou Wealy Medical<br>Instrument CO.,Ltd. | Same | |
| Indications for use | The Automatically<br>Retractable Safety Syringes | The Automatically<br>Retractable Safety Syringes | Same | |
| | with Detachable Needle<br>devices are indicated for<br>use where a safe and<br>reliable method for<br>intramuscular and<br>subcutaneous injection of<br>medication in a patient is<br>desired. | with Fixed Needle devices<br>are indicated for use<br>where a safe and reliable<br>method for intramuscular<br>and subcutaneous<br>injection of medication in a<br>patient is desired. | | |
| | Add = North Jinhuan Road(near of Qishan mid-school), Shantou, 515064, Guangdong, China | | | |
| Environment of use | Hospital | Hospital | Same | |
| Proprietary/trade name | Disposable Automatically<br>Retractable Safety<br>Syringes (with detachable<br>needle) | Automatically Retractable<br>Safety Syringes with Fixed<br>Needle | — | |
| Product code | MEG, FMI, FMF | MEG, FMI, FMF | Same | |
| Intended users | Medical professionals | Medical professionals | Same | |
| barrel dimensions | 0.5ml barrel length:<br>83.42mm<br>1ml barrel length:<br>83.42mm<br>3ml barrel length:<br>72.26mm<br>5ml barrel length:<br>73.62mm<br>10ml barrel<br>length:92.36mm<br>20ml barrel length:<br>111.72mm | 0.5ml barrel length:<br>82.10mm<br>1ml barrel length:<br>82.10mm<br>3ml barrel length:<br>72.83mm<br>5ml barrel length:<br>73.62mm<br>10ml barrel length:<br>87.36mm<br>20ml barrel length:<br>106.58mm | Different: The<br>difference in<br>specification does<br>not raise different<br>questions of<br>safety and<br>effectiveness. | |
| plunger<br>dimensions | 0.5ml plunger length:<br>95.51mm<br>1ml plunger length:<br>95.51mm<br>3ml plunger length:<br>88.23mm<br>5ml plunger length:<br>86.80mm<br>10ml plunger length:<br>104.12mm<br>20ml plunger length:<br>128.62mm | 0.5ml plunger length:<br>94.00mm<br>1ml plunger length:<br>94.00mm<br>3ml plunger length:<br>86.80mm<br>5ml plunger length:<br>86.80mm<br>10ml plunger length:<br>100.02mm<br>20ml plunger length:<br>126.60mm | Different: The<br>difference in<br>specification does<br>not raise different<br>questions of<br>safety and<br>effectiveness. | |
| needle sheath<br>dimensions | 39~57mm (subject to the<br>length of the needle tube) | 55mm | Different: The<br>difference in<br>specification does<br>not raise different<br>questions of<br>safety and<br>effectiveness. | |
| | | | effectiveness. | |
| needle length | 6-38mm | 6-38mm | Same | |
| hub/needle bond strength (N) | 11, 22, 34, 40, 44, 54, 69, 69 | 11, 22, 34, 40, 44, 54, 69, 69 | Same | |
| color | Barrel color: transparent<br>Plunger color: white<br>Needle sheath color:<br>transparent Needle hub color see below. | Barrel color: transparent<br>Plunger color: white<br>Needle sheath color:<br>transparent Needle hub color see below. | Same | |
| shelf life | 3 years | 3 years | Same | |
| Principle of Operation | It has a detachable needle with a dedicated fitting.<br>The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the empty syringe barrel for disposal. | It is an integrated needle and piston syringe. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the empty syringe barrel for disposal. | Similar: The proposed device and predicate device has the similar Principle of Operation. Difference is proposed device has detachable needle, and the predicate device has fixed needle. The device meet the requirement of ISO80369-7:2018. It do not raise questions of safety and effectiveness. | |
| syringe type | Plunger, anti-stick with hypodermic needle | Plunger, anti-stick with hypodermic needle | Same | |
| Safety Features | Active safety feature, automatically activated when injection is finished | Active safety feature, automatically activated when injection is finished | Same | |
| tip type | Tri-Beveled Tip | Tri-Beveled Tip | Same | |
| volume | 0.5ml, 1ml, 3ml, 5ml, 10ml, 20ml | 1, 3, 10 ml | Different: The difference in specification does not raise different questions of safety and effectiveness. | |
| needle length | Tolerances on length comply to ISO 7864 | Tolerances on length comply to ISO 7864 | Same | |
| needle gauge | 30G, 29G, 28G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, | 30G, 29G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, 20G | Different: The difference in | |
| | | 20G, 18G, 16G | | specification does<br>not raise different<br>questions of<br>safety and<br>effectiveness. |
| | needle tip<br>configuration | $11°+- 2° /17°+- 2°$ | $11°+- 2°$ | Different: The<br>difference in<br>specification does<br>not raise different<br>questions of<br>safety and<br>effectiveness. |
| | nozzle type | Needle hub Luer<br>connector;<br>Needle & syringe<br>separable | Needle & syringe not<br>separable | Different: The<br>difference meet<br>the requirement<br>of ISO80369-<br>7:2018. It do not<br>raise questions of<br>safety and<br>effectiveness. |
| material | Barrel | PP | PP | Same |
| | Plunger | PP | PP | |
| | Piston | Isoprene rubber | Isoprene rubber | |
| | Needle<br>Hub | PP | PP | |
| | Needle | Stainless Steel | Stainless Steel | |
| | Needle<br>Sheath | PE | PE | |
| | O-ring | Silicone | Silicone | |
| | Biocompatibility | Cytotoxicity<br>Sensitization<br>Irritation<br>Systemic Toxicity<br>Haemocompatibility | Cytotoxicity<br>Sensitization<br>Irritation<br>Systemic Toxicity<br>Haemocompatibility | Same |
| | Sterilization level<br>and method | SAL 10-6 EO sterilization<br>according to ISO 11135 | SAL 10-6 EO sterilization<br>according to ISO 11135 | Same |
{5}------------------------------------------------
{6}------------------------------------------------
Shantou Wealy Medical Instrument CO.,Ltd. Add z North Jinhuan Road(near of Qishan mid-school), Shantou, 515064, Guangdong, China
{7}------------------------------------------------
Shantou Wealy Medical Instrument CO.,Ltd. Add = North Jinhuan Road(near of Qishan mid-school), Shantou, 515064, Guangdong, China
Comparison Summary:
The indication for use of the proposed device and predicate device is same. The proposed and predicate device have different technological features as noted in the table above. These technological differences do not raise different questions of safety or effectiveness.
## 9. Non-Clinical Tests performed on the subject device
The proposed devices were tested per the following standards, to evaluate its performance.
• ISO7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual
{8}------------------------------------------------
use
- ▶ Limits for acidity or alkalinity
- > Limits for extractable metals
- ▶ Lubricant
- ▶ Tolerance on graduated capacity
- レ Scale
- V Numbering of scales
- レ Position of Scale
- > Barrel dimensions
- レ Barrel flanges
- ▶ Plunger stopper/plunger assembly
- レ Conical fitting
- レ Position of nozzle on end of barrel
- レ Nozzle lumen
- レ Dead space
- D Freedom from air and liquid leakage past plunger stopper
- ▶ Force to operate the piston
- D Fit of plunger stopper/plunger in barrel
• ISO 7886-4:2006 Sterile hypodermic syringes for single use -- Part 4: Syringes with re-use prevention feature
- > Self-destructive performance
- · ISO7864:2016 Sterile hypodermic needles for single use
- D Cleanliness
- Limits for acidity and alkalinity D
- > Limits for extractable metals
- V Size designation
- レ Color coding
- レ Needle tube
- V Freedom from defects
- レ Lubricant
- ♪ Needle point
- > bond between hub and needle tube
- > Patency of lumen
- D Fragmentation test for medical needles
- > Determination of flow rate through the needle
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices.
- ► Surface finish and visual appearance testing
- ► Cleanliness
- ► Limits for acidity and alkalinity
- ► Size designation
- ► Dimensions
- ► Stiffness
- ► Resistance to breakage
{9}------------------------------------------------
- ► Resistance to corrosion
- ISO 23908:2011 Sharps Injury Prevention
- D Force applied on the plunger to activate the retractable mechanism
- > Testing simulated clinical use
• ISO80369-7:2018 Small-bore connectors for liquids and gases in healthcare applications-
Part 7: Connectors for intravascular or hypodermic applications
- > Fluid leakage
- Sub-atmospheric Pressure Air Leakage >
- ▶ Stress Cracking
- レ Resistance to Separation from Unscrewing
- > Resistance to Separation from Axial Load
- ▶ Resistance to Overriding
- Accelerated aging testing
- Package verification
- · Simulated transportation testing
#### 10. Biocompatibility
| Test | Standards |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | ISO 10993-4: 2017 Biological evaluation of medical devices –<br>Part 4: Selection of tests for interactions with blood |
| Sensitization | |
| Irritation | ISO 10993-5:2009 Biological evaluation of medical devices –<br>Part 5: Tests for in vitro cytotoxicity |
| Systemic Toxicity | ISO 10993-11:2006 Biological evaluation of medical devices –<br>Part 11: Tests for systemic toxicity |
| Haemocompatibility | ISO 10993-10:2002/Amd1:2006 Biological evaluation of medical<br>devices — Part 10: Tests for irritation and skin sensitization |
- USP<788> Particulate matter in injection
- USP42-NF 37<151> Pyrogen Test ●
- . Ethylene Oxide(EO) residue test
- . Ethylene Oxide(EO) sterilization validation
## 11. The Simulated Clinical Study Summary
Simulated clinical testing on the sharps injury prevention features was conducted as recommended in FDA guidance document for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features. It can support a conclusion that 99% reliability of device activation is achievable.
## 12. Conclusion:
Based on the Indications for use, technology characteristics, and performance testing, the subject device and the predicate devices are substantially equivalent.
