(90 days)
Not Found
No
The device description and performance studies focus on mechanical features and standard testing, with no mention of AI or ML.
No.
The device is described as an "auto-disable syringe" intended for aspiration and injection of fluids, which are procedures for delivering or removing substances, not directly for treating a disease or condition. The primary focus of its "auto-disable" feature is to prevent reuse and sharps injuries, which are safety features, not therapeutic actions.
No.
The device is described as an auto-disable syringe intended for aspiration and injection of fluids, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists physical components such as a needle cap, barrel, plunger, clip, plunger stopper, and needle tube, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "aspiration of fluids" and features an auto-disable mechanism to prevent reuse. This describes a device used for administering or withdrawing substances from the body, not for testing samples in vitro (outside the body).
- Device Description: The description details the physical components of a syringe and its auto-disable feature. It does not mention any components or functions related to analyzing biological samples or performing diagnostic tests.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes (identifying diseases, conditions, etc.)
- Reagents or test kits
The device is clearly a medical device designed for fluid handling and safety through its auto-disable feature.
N/A
Intended Use / Indications for Use
The HWJECT Auto-Disable Syringe is intended for aspiration of fluids. Additionally, it features autodisable feature (no sharp injury protection feature) that involves a design where the syringe automatically becomes inoperable by locking the plunger with clip after injection to prevent syringe reuse.
Product codes
FMF
Device Description
The auto-disable syringe is intended for aspiration and injection of fluids. The subject device is composed of needle cap, barrel, plunger, clip, plunger stopper, and needle tube. The clip cooperates with plunger and barrel to complete self-destruction of the device. It is nonpyrogenic and intended for single use.
The auto-disable feature (no sharp injury) involves a design where the syringe automatically becomes inoperable by locking the plunger with the clip after injection to prevent syringe reuse. The capacity of the auto-disable syringe is available in 0.05 mL, 0.1 mL, 0.3 mL, 0.5 mL and 1 mL. The specification of needle tube ranges from 22G to 27G. The needle length ranges from 10 mm to 38 mm.
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
Not Found
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
Performance Testing: The subject device was tested and demonstrated to be in conformance with ISO 7886-3:2020, ISO 9626 Second edition 2016-08-01, ISO 7864 Fourth edition 2016-08-01. Particulate testing was conducted in accordance with USP .
Biocompatibility Testing: The device was tested in compliance with ISO 10993-1, as the Externally Communicating Device, Blood Path Indirect, Limited Contact (
§ 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 contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
March 19, 2024
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd % Tanya Wang, Technical Manager Shanghai Mind-Link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang District Shanghai, 201114, China
Re: K234024
Trade/Device Name: HWJECT Auto-disable syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: December 6, 2023 Received: December 20, 2023
Dear Tanya Wang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Shruti N. Mistry -S
Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K234024
Device Name HWJECT Auto-disable syringe
Indications for Use (Describe)
The HWJECT Auto-Disable Syringe is intended for aspiration of fluids. Additionally, it features autodisable feature (no sharp injury protection feature) that involves a design where the syringe automatically becomes inoperable by locking the plunger with clip after injection to prevent syringe reuse.
| 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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510(k) Summary
1. Preparation date: February 17, 2024
2. Submitter
Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd Address: No.2 Guanyin Road, Taihu Economic Development Zone Contact person: Xiang Bingyi, 86-556 5129666, hwj1@hongyu-wuzhou.cn Submission correspondent: Tanya Wang, 86-15216694647, tanya.wang@mind-link.net
3. Device
Trading name: HWJECT Auto-disable syringe Common name: Auto-disable syringe Regulation No.: 21 CFR 880.5860 Classification name: Piston Syringe Classification: Class II Product code: FMF
4. Predicate device
Predicate device: K210464, Auto Disable Syringe
5. Device description
The auto-disable syringe is intended for aspiration and injection of fluids. The subject device is composed of needle cap, barrel, plunger, clip, plunger stopper, and needle tube. The clip cooperates with plunger and barrel to complete self-destruction of the device. It is nonpyrogenic and intended for single use.
The auto-disable feature (no sharp injury) involves a design where the syringe automatically becomes inoperable by locking the plunger with the clip after injection to prevent syringe reuse. The capacity of the auto-disable syringe is available in 0.05 mL, 0.1 mL, 0.3 mL, 0.5 mL and 1 mL. The specification of needle tube ranges from 22G to 27G. The needle length ranges from 10 mm to 38 mm.
| Table 1 Device specification | ||
|---|---|---|
| Syringe volume | Needle Gauge | Needle Length |
| 0.05 mL | 27G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, 28 mm |
| 26G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, 28 mm | |
| 0.1 mL | 27G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, 28 mm, 30 mm, 32 mm, 38 mm |
| 26G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 25G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 24G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 23G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 22G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 0.3 mL | 27G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 26G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 25G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 24G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 23G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 22G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 0.5 mL | 27G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 26G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 25G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 24G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 23G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 22G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 1 mL | 27G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 26G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 25G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 24G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 23G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm | ||
| 22G | 10 mm, 13 mm, 16 mm, 20 mm, 25 mm, | |
| 28 mm, 30 mm, 32 mm, 38 mm |
Table 1 Device specification
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6. Indications for use
The HWJECT Auto-Disable Syringe is intended for aspiration and injection of fluids. Additionally, it features auto-disable feature (no sharp injury protection feature) that involves a design where the syringe automatically becomes inoperable by locking the plunger with clip after injection to prevent syringe reuse.
7. Comparison of technological characters between proposed and predicate device
7.1 Comparison of technological characters Table Characters comparison
| Characters | Subject device, (K234024, HWJECT
Auto-disable syringe) | Predicate device, (K210464,Auto
Disable Syringe) | Remark |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Product code | FMF | FMF | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Classification | II | II | Same |
| Indications for
use | The HWJECT Auto-Disable Syringe
is intended for aspiration and
injection of fluids. Additionally, it
features auto-disable feature (no
sharp injury protection feature)
that involves a design where the
syringe automatically becomes
inoperable by locking the plunger
with clip after injection to prevent
syringe reuse. | The AUTO DISABLE SYRINGE is
intended for use in the suction
and injection of vaccine for
medical purposes. Additionally,
after injection to the body, the
plunger can be automatically
locked by the triggered
mechanism to prevent the re-use
of this syringe. | Different
#1 |
| Principle of
operation | The subject device has auto-disable
feature that avoids reuse of syringe
by locking the plunger with metal
clip after injection. The metal clip
cooperates with plunger and barrel
to complete self-destruction of the
auto-disable syringe. | The syringe consists of a
calibrated hollow barrel, a
movable plunger, a rubber
stopper assembled at the end of
the plunger, and a steel clip
installed between the barrel and
the plunger that functions to
prevent re-use of the syringe. | Different
#2 |
| Single-use | Single-use | Single-use | Same |
| Labeling | Meet the requirements of 21 CFR
Part 801 | Meet the requirements of 21 CFR
Part 801 | Same |
| Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | Same |
| Sterilization
method | EO sterilization | EO sterilization | Same |
| SAL 10-6 | 10-6 | 10-6 | Same |
| Capacity | 0.05 mL, 0.10 mL, 0.3 mL, 0.5 mL, 1
mL | 0.05 mL, 0.10 mL, 0.20 mL, 0.25
mL, 0.30 mL, 0.40 mL, 0.50 mL,
1.0 mL | Same |
6
| Gauge size | 22G, 23G, 24G, 25G, 26G, 27G | 23G, 24G, 25G, 26G, 27G, 28G,
29G, 30G | Different #3 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------|
| Needle length | 10 mm, 13 mm, 16 mm, 20 mm, 25
mm, 28 mm, 30 mm, 32 mm, 38
mm | 10 mm, 13 mm, 25 mm | Different #4 |
| Tip Type | Fixed Needle | Fixed Needle | Same |
| Needle bonding
strength | 62-100 N
Conforming to the requirements of
ISO 7864:2016 | Conforming to the requirements
of ISO 7864:2016 | Same |
| Configuration
and materials | Barrel: PP
Plunger: PP
Needle: stainless steel
Piston: Synthetic
rubber(Polyisoprene Rubber)
Clip: stainless steel | Barrel: PP
Plunger: PP
Piston: Latex Free
(Polyisoprene Rubber)
Needle: stainless steel
Clip: stainless steel | Same |
| Reuse
Prevention
(Safety Feature) | Activation force: 2-4 N
Auto-disabled, prevents syringe re-
use | Auto-disabled, prevents syringe
re-use | Same |
| Lubricant for
barrel | Silicone oil | Silicone oil | Same |
| Barrel
transparency | Clear | Clear | Same |
| Graduation
Legibility | Bold Markings | Bold Markings | Same |
| Performance | Conforming to the requirements of
ISO 7886-3, ISO 7886-1, ISO 9626,
and ISO 7864 | Conforming to the requirements
of ISO 7886-3, ISO 7886-1, ISO
9626, and ISO 7864 | Same |
| Biocompatibility | • Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Pyrogenicity
• Hemocompatibility | • Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Pyrogenicity
• Hemocompatibility | Same |
| Shelf life | 5 years | 5 years | Same |
7.2 Substantial equivalence analysis
Different #1
The indications for use are generally identical, while the predicate device provides additional details for vaccine injection. However, both the predicate device and the subject device have the same configuration. The non-clinical performance testing has been conducted to verify the similarity.
In conclusion, the subject device and the predicate device are substantially equivalent.
7
Different #2
The principle of operation for the subject device and predicate device are generally identical. The metal clip cooperates with the plunger and barrel to complete the self-destruction of the auto-disable syringe. This difference does not raise new questions of safety and effectiveness when compared to the predicate device.
Different #3
The 22G needle gauge of the subject device isn't within the range of the predicate device. The subject device of the above needle gauge is in accordance with ISO 9626. The performance of the 22G subject device has been conducted to verify that this difference does not raise new questions of safety and effectiveness when compared to the predicate device. In conclusion, the subject device and the predicate device are substantially equivalent.
Different #4
The needle length of the subject device is different from the predicate device, that has extra specifications. Both of them fulfill the requirements of ISO 9626 and ISO 7864. The non-clinical performance testing has been conducted to verify that the subject device's extra specifications do not raise new questions of safety and effectiveness of the when compared to the predicate device.
In conclusion, the subject device and the predicate device are substantially equivalent.
8. Non-clinical testing
Performance Testing
The subject device was tested and demonstrated to be in conformance with the following FDA-recognized standards. The performance testing results met the requirements of the following standards demonstrating that the device is substantially equivalent to the predicate device.
ISO 7886-3:2020: Sterile hypodermic syringes for single use Part 3: Auto-disabled syringes for fixed-dose immunization
- Limits for acidity or alkalinity
- Limits for extractable metals
- Lubricant
- Tolerance on nominal capacity
- Graduated scale
- Barrel
- Design
- Fit of the plunger stopper/plunger in the barrel
- Fiducial line
- Dead space
- Freedom from air and liquid leakage
- Auto-disable syringe feature
ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of
8
medical devices-Requirements and test methods
- Stiffness ●
- Resistance to breakage
- Resistance to corrosion
- Needle O.D.
- Needle inner diameter
ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use-Requirements and test methods
- . Needle point
- Bond between hub and needle tube
- Patency of lumen
- . Cleanliness
- Needle length ●
- Testing for measuring the penetration force and drag force for needles
Particulate testing was conducted in accordance with USP . The testing results met the USP acceptance criteria.
Biocompatibility Testing
The proposed device was tested in compliance with ISO 10993-1, as the Externally Communicating Device, Blood Path Indirect, Limited Contact (