(100 days)
Not Found
No
The device description and performance studies focus on a mechanical spring-action retraction mechanism, with no mention of AI or ML.
No.
The device is a syringe used for injection of medication, not for direct therapeutic treatment itself. Its primary function is a delivery mechanism, focusing on safety features for the user rather than a therapeutic effect on the patient.
No
Explanation: The device is described as a syringe for administering medication, not for diagnosing medical conditions. Its function is for injection, not for detection or analysis of disease.
No
The device description clearly describes a physical syringe with a mechanical needle retraction mechanism, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intramuscular and subcutaneous injection of medication in a patient." This describes a device used on a patient for administering substances, not for testing samples from a patient to diagnose or monitor a condition.
- Device Description: The description details a syringe for injecting medication, focusing on the safety mechanism for needle retraction. This aligns with a device used for direct patient care, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's function is to safely deliver medication into the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MEG, FMF, FMF, FMI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals / Hospital
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)
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 use (Limits for acidity or alkalinity, Limits for extractable metals, Lubricant, Tolerance on graduated capacity, Scale, Numbering of scales, Position of Scale, Barrel dimensions, Barrel flanges, Plunger stopper/plunger assembly, Conical fitting, Position of nozzle on end of barrel, Nozzle lumen, Dead space, Freedom from air and liquid leakage past plunger stopper, Force to operate the piston, 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 (Cleanliness, Limits for acidity and alkalinity, Limits for extractable metals, Size designation, Color coding, Needle tube, Freedom from defects, Lubricant, Needle point, bond between hub and needle tube, Patency of lumen, 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, Resistance to corrosion)
- ISO 23908:2011 Sharps Injury Prevention (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, Resistance to Separation from Unscrewing, Resistance to Separation from Axial Load, Resistance to Overriding)
- Accelerated aging testing
- Package verification
- Simulated transportation testing
Biocompatibility tests include: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Haemocompatibility.
Other tests: USP Particulate matter in injection, USP42-NF 37 Pyrogen Test, Ethylene Oxide(EO) residue test, Ethylene Oxide(EO) sterilization validation.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99% reliability of device activation
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). 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) | |
|---|---|
| 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 — 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
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
metric system (mm) /British System(in) | | | | | | | | |
|---------------------------------------------------|-------------------|----------------|--------------------------------------------------|-----------|-----------|-----------|-----------|-----------|---------|-------------|-------------|
| metric
system | British
System | Color | 6
1/4 | 8
5/16 | 13
1/2 | 16
5/8 | 19
3/4 | 20
4/5 | 25
1 | 32
1 1/4 | 38
1 1/2 |
| 0.30 | 30G | Yellow | | | | | | | | | |
| 0.33 | 29G | Red | | | | | | | | | |
| 0.36 | 28G | Blue
green | | | | | | | | | |
| 0.40 | 27G | Medium
Grey | | | | | | | | | |
| 0.45 | 26G | Brown | | | | | | | | | |
| 0.50 | 25G | Orange | | | | | | | | | |
| 0.55 | 24G | Purple | | | | | | | | | |
| 0.60 | 23G | Deep
Blue | | | | | | | | | |
| 0.70 | 22G | Black | | | | | | | | | |
| 0.80 | 21G | Deep
Green | | | | | | | | | |
| 0.90 | 20G | Yellow | | | | | | | | | |
| 1.20 | 18G | Pink | | | | | | | | | |
| 1.60 | 16G | White | | | | | | | | | |
| Syringe Sizes
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
K141640 | Comparison | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Shantou Wealy Medical
Instrument CO.,Ltd. | Shantou Wealy Medical
Instrument CO.,Ltd. | Same | |
| Indications for use | The Automatically
Retractable Safety Syringes | The Automatically
Retractable Safety Syringes | Same | |
| | 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. | with Fixed Needle devices
are indicated for use
where a safe and reliable
method for intramuscular
and subcutaneous
injection of medication in a
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
Retractable Safety
Syringes (with detachable
needle) | Automatically Retractable
Safety Syringes with Fixed
Needle | — | |
| Product code | MEG, FMI, FMF | MEG, FMI, FMF | Same | |
| Intended users | Medical professionals | Medical professionals | Same | |
| barrel dimensions | 0.5ml barrel length:
83.42mm
1ml barrel length:
83.42mm
3ml barrel length:
72.26mm
5ml barrel length:
73.62mm
10ml barrel
length:92.36mm
20ml barrel length:
111.72mm | 0.5ml barrel length:
82.10mm
1ml barrel length:
82.10mm
3ml barrel length:
72.83mm
5ml barrel length:
73.62mm
10ml barrel length:
87.36mm
20ml barrel length:
106.58mm | Different: The
difference in
specification does
not raise different
questions of
safety and
effectiveness. | |
| plunger
dimensions | 0.5ml plunger length:
95.51mm
1ml plunger length:
95.51mm
3ml plunger length:
88.23mm
5ml plunger length:
86.80mm
10ml plunger length:
104.12mm
20ml plunger length:
128.62mm | 0.5ml plunger length:
94.00mm
1ml plunger length:
94.00mm
3ml plunger length:
86.80mm
5ml plunger length:
86.80mm
10ml plunger length:
100.02mm
20ml plunger length:
126.60mm | Different: The
difference in
specification does
not raise different
questions of
safety and
effectiveness. | |
| needle sheath
dimensions | 39~57mm (subject to the
length of the needle tube) | 55mm | Different: The
difference in
specification does
not raise different
questions of
safety and
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
Plunger color: white
Needle sheath color:
transparent Needle hub color see below. | Barrel color: transparent
Plunger color: white
Needle sheath color:
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.
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
not raise different
questions of
safety and
effectiveness. |
| | needle tip
configuration | $11°+- 2° /17°+- 2°$ | $11°+- 2°$ | Different: The
difference in
specification does
not raise different
questions of
safety and
effectiveness. |
| | nozzle type | Needle hub Luer
connector;
Needle & syringe
separable | Needle & syringe not
separable | Different: The
difference meet
the requirement
of ISO80369-
7:2018. It do not
raise questions of
safety and
effectiveness. |
| material | Barrel | PP | PP | Same |
| | Plunger | PP | PP | |
| | Piston | Isoprene rubber | Isoprene rubber | |
| | Needle
Hub | PP | PP | |
| | Needle | Stainless Steel | Stainless Steel | |
| | Needle
Sheath | PE | PE | |
| | O-ring | Silicone | Silicone | |
| | Biocompatibility | Cytotoxicity
Sensitization
Irritation
Systemic Toxicity
Haemocompatibility | Cytotoxicity
Sensitization
Irritation
Systemic Toxicity
Haemocompatibility | Same |
| | Sterilization level
and method | SAL 10-6 EO sterilization
according to ISO 11135 | SAL 10-6 EO sterilization
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 – |
| Part 4: Selection of tests for interactions with blood | |
| Sensitization | |
| Irritation | ISO 10993-5:2009 Biological evaluation of medical devices – |
| Part 5: Tests for in vitro cytotoxicity | |
| Systemic Toxicity | ISO 10993-11:2006 Biological evaluation of medical devices – |
| Part 11: Tests for systemic toxicity | |
| Haemocompatibility | ISO 10993-10:2002/Amd1:2006 Biological evaluation of medical |
| devices — Part 10: Tests for irritation and skin sensitization |
- USP Particulate matter in injection
- USP42-NF 37 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.