(75 days)
Not Found
No
The device description and performance studies focus on mechanical features and standard biocompatibility/performance testing, with no mention of AI or ML.
No.
The device is a syringe and needle system primarily used for the injection or withdrawal of fluids from the body and for preventing needle-stick injuries, not for treating a disease or condition itself.
No
Explanation: The device, a safety syringe, is used for injecting or withdrawing fluids from the body and for preventing needle stick injuries. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (Barrel, Plunger, Stopper, Luer Assembly, hypodermic needle, etc.) and describes mechanical functions for fluid injection/withdrawal and sharps injury prevention. 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 to "inject fluids into or withdraw fluids from the body" and to "aid in the prevention of needle stick injuries." This describes a device used for direct interaction with the body for therapeutic or diagnostic procedures, not for testing samples in vitro (outside the body).
- Device Description: The description details a syringe and needle, which are instruments for administering or collecting substances from a living organism. It does not describe a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any process that would be performed on a sample outside of the body to provide diagnostic information.
Therefore, the DR Safety Syringe is a medical device, but it falls under the category of devices used for injection and aspiration, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The DR Safety Syringe is used to inject fluids into or withdraw fluids from the body. In addition, the DR Safety Syringe is designed to aid in the prevention of needle stick injuries.
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Product codes
MEG, FMI
Device Description
The DR Safety Syringe is a retractable type piston syringe, designed to aid in the prevention of needle stick injuries. This single-use, disposable syringe provided sterile and consists of the following components for 3ml and 5ml safety syringe: Barrel, Plunger, Stopper, Luer Assembly, hypodermic needle, Locking Ring and O-Ring.
0.5ml and 1ml safety syringe: Barrel, Plunger, Stopper, needle hub, needle tube, protective cap, Locking Ring and O-Ring
The DR Safety Syringe functions in a manner similar to standard syringes for fluid injection/withdrawal. After use, the health care professional fully depresses the plunger to engage the luer assembly/needle hub. Once the luer assembly/needle hub is engaged, pulling back the plunger causes the adapter and the attached needle to be withdrawn into the safety of the barrel. This retraction into the barrel of the syringe can be visually confirmed. Once this safety mechanism has been activated, the syringe is permanently disabled and the needle is completely secured within the barrel. Both the syringe and plunger are discarded in a Sharp's container.
The DR Safety Syringes are available for 0.5mL, 1mL, 3mL, 5mL.
The 0.5ml and 1ml DR Safety Syringes with fixed needle and 3ml, 5ml DR Safety Syringes with exchangeable needle are used to inject fluids into or withdraw fluids from the body. The DR Safety Syringes are designed to aid in the prevention of needle stick injuries
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 and trained care givers / 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)
All necessary bench and non-clinical testing were conducted on DR Safety Syringe to support a determination of substantial equivalence to the predicate devices. The non-clinical, bench testing are conducted according to ISO 7886-1 and ISO 7886-4, USP 788, ISO 23908 and FDA guidance titled: "Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff," included: Appearance, Tolerance on graduated capacity, Graduated scale, Barrel, Plunger stopper/plunge, Syringe needle, Liquid leakage, Air leakage, Syringe with Luer nozzle, Dead space, Re-use prevention feature test, Limits for acidity or alkalinity, Limits for extractable metals, EO residual, Sterility, Bacterial Endotoxin (LAL test), Testing activation of a sharps injury protection feature, Particulate test, ECH residual.
All necessary bench and non-clinical testing were conducted on Fixed needle to support the performance of the needle in safety syringe. The non-clinical, bench testing are conducted according to ISO 9626 included: Appearance, Dimensions of tubing, Stiffness, Bond between hub and needle tube, Resistance to breakage, Limits for acidity or alkalinity, Corrosion resistance.
All necessary bench and non-clinical testing were conducted on proposed sterile hypodermic needle to support a determination of substantial equivalence to the predicate devices. The non-clinical, bench testing are conducted according to ISO 7864 included: Appearance, Colour coding, Tolerances on length, Bond between hub and needle tube, Patency of lumen, The penetration force and drag force for needles, Limits for acidity or alkalinity, Limits for extractable metals.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
September 29, 2021
Zhuhai DR Medical Instruments Co., Ltd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K212226
Trade/Device Name: DR Safety Syringe, Sterile Hypodermic needle for Single use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: MEG, FMI Dated: July 15, 2021 Received: July 16, 2021
Dear Prithul Bom:
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Alan M. 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)
Device Name DR Safety Syringe; Sterile Hypodermic needle for Single use
Indications for Use (Describe)
The DR Safety Syringe is used to inject fluids into or withdraw fluids from the body. In addition, the DR Safety Syringe is designed to aid in the prevention of needle stick injuries.
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
| 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
Section 3- 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the guidance The 510(k) Program, 21 CFR 880.5860 and 21 CFR 880.5570.
510(k) Number: K212226
-
- Date of Submission: August, 06, 2021
2. Submitter
Zhuhai DR Medical Instruments Co., Ltd. Room 502, 5th Floor, Building C, No. 288, Airport East Road, Sanzao Town, Jinwan District,Zhuhai,519000,China Establishment Registration Number: Contact Person: Xu Jianhai Position: Management Representative Tel.:086-0756-7770668 Email: xujianhai@kdlchina.com
3. Proposed Device
510(k) Number: K212226
Trade Name: DR Safety Syringe Review Panel: General Hospital Regulation Number: 21 CFR 880.5860 Classification name: Piston Syringe with Safety Syringe Regulation Class: Class II Product Code: Safety Syringe: MEG
Trade Name: Sterile Hypodermic needle for Single use Review Panel: General Hospital Regulation Number: 21 CFR 880.5570 Classification name: Syringe, Piston Regulation Class: Class II Product Code: Safety Syringe: FMI
4. Predicate device
a. Predicate device
510(k) Number: K092430 Product Name: InviroSnap Safety Syringe
4
Review Panel: General Hospital Regulation Number: 21 CFR 880.5860 Classification name: Piston Syringe with Safety Syringe Regulation Class: Class II Product Code: MEG
b. The Secondary Predicate Device
510(k) Number: K190002 Trade Name: Sterile Hypodermic needle for Single use Review Panel: General Hospital Regulation Number: 21 CFR 880.5570 Classification name: Syringe, Piston Regulation Class: Class II Product Code: FMF and FMI
5. Device description
The DR Safety Syringe is a retractable type piston syringe, designed to aid in the prevention of needle stick injuries. This single-use, disposable syringe provided sterile and consists of the following components for 3ml and 5ml safety syringe: Barrel, Plunger, Stopper, Luer Assembly, hypodermic needle, Locking Ring and O-Ring.
0.5ml and 1ml safety syringe: Barrel, Plunger, Stopper, needle hub, needle tube, protective cap, Locking Ring and O-Ring
The DR Safety Syringe functions in a manner similar to standard syringes for fluid injection/withdrawal. After use, the health care professional fully depresses the plunger to engage the luer assembly/needle hub. Once the luer assembly/needle hub is engaged, pulling back the plunger causes the adapter and the attached needle to be withdrawn into the safety of the barrel. This retraction into the barrel of the syringe can be visually confirmed. Once this safety mechanism has been activated, the syringe is permanently disabled and the needle is completely secured within the barrel. Both the syringe and plunger are discarded in a Sharp's container.
The DR Safety Syringes are available for 0.5mL, 1mL, 3mL, 5mL.
The 0.5ml and 1ml DR Safety Syringes with fixed needle and 3ml, 5ml DR Safety Syringes 皿-2 Version 1
5
with exchangeable needle are used to inject fluids into or withdraw fluids from the body. The
DR Safety Syringes are designed to aid in the prevention of needle stick injuries
6. Indications for Use
DR Safety Syringe:
The DR Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the DR Safety Syringe is designed to aid in the prevention of needle stick injuries.
Sterile Hypodermic needle for Single use:
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Substantially Equivalent comparison 7.
6
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| K212226(Traditional 510K) | K092430 (Traditional 510K) | ||
| Manufacturer | Zhuhai DR Medical Instruments Co., Ltd. | INVIRO MEDICAL DEVICES, INC. | / |
| Product code | MEG | MEG | Same |
| DeviceClassification: | Class II, 21 CFR 880.5860 | Class II, 21 CFR 880.5860 | Same |
| Indications forUse | The DR Safety Syringe is used to inject fluids into or withdraw fluids from the body. In addition, the DR Safety Syringe is designed to aid in the prevention of needle stick injuries. | The InviroSnap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the Inviro Snap Safety Syringe is designed to aid in the prevention of needle stick injuries. | Same |
| Principle ofOperation | After use, the plunger is fully retracted into the barrel providing protection against needle sticks, rendering the device unusable. | After use, the plunger is fully retracted into the barrel providing protection against needle sticks, rendering the device unusable. | Same |
| Environment ofuse | Hospital | Hospital | Same |
| Syringe Volume | 0.5ml, 1ml, 3ml, 5ml | 1ml, 3ml, 5ml, 10 ml, 20 ml | See comment 1 |
| Needle Gauge | 18G-30G | 20-23G, 25G, 28-30G | See comment 2 |
| Needle Wall | Regular Wall | Unknown | See comment 2 |
| DeviceConfiguration | Barrel, Plunger, Stopper, Luer Assembly; Hypodermic Needle/needle tube, needle hub, cap: Locking Ring and O-Ring | Barrel, Plunger, Stopper, Luer Assembly, Cannula, cap, Locking Ring and O-Ring | Similar |
| Tip type | Fixed needle and Luer Lock | Fixed needle and Luer Lock | Same |
| Material | Barrel, lunger, Locking Ring, Luer | ||
| Assembly(luer lock), Cap: PP | |||
| O-Ring: Silicone | |||
| Stopper: Polyisoprene rubber | |||
| Needle: Stainless steel: | |||
| Luer Assembly(Snap Ring): PE | |||
| Scale line: Ink, Quick-drying water: | |||
| Lubricant: Silicone oil, Thinning agent | Plunger, Barrel, Cap -Polypropylene | ||
| Stopper – Santoprene, Thermoplastic | |||
| Elastomer | |||
| Needle- Stainless steel | Comment 3 | ||
| Biocompatibility | • Cytotoxicity | ||
| • Sensitization Study | |||
| • Irritation Test/Intracutaneous Reactivity | |||
| • Systemic Toxicity Studies | |||
| • Haemolysis test | |||
| • Pyrogenicity | |||
| • Complement activity (C3a,SC5b-9) test | |||
| • In Vivo Thrombogenicity Test | • Cytotoxicity | ||
| • Sensitization Study | |||
| • Irritation Test/Intracutaneous Reactivity | |||
| • Systemic Toxicity Studies | |||
| • Haemolysis test | Similar, we conduct | ||
| more test than | |||
| predicate device, | |||
| and this difference | |||
| doesn't raise | |||
| different questions | |||
| of safety and | |||
| effectiveness. | |||
| Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Method of | |||
| supply | Sterile and single use | Sterile and single use | Same |
| Sterilization | |||
| Method | EO | EO | Same |
| Sterility | |||
| Assurance Level | 10-6 | 10-6 | Same |
Table 1 Comparison of Technology Characteristics of Sterile Safety Syringe for Single Use
7
Discussion of Technological characteristics
The following differences do not raise different questions of safety and effectiveness,
8
Comment 1
Differences in syringe volume between the predicate and subject device were addressed through ISO 7886-4 syringe performance testing.
Comment 2
Differences in needle gauge, wall between the predicate and subject device were addressed through ISO 7864 and ISO 9626 needle performance testing.
Comment 3
Differences in materials between the predicate and subject device were addressed through ISO 10993-1 biocompatibility testing.
| Item | Proposed Device | The Secondary Predicate Device | Remark |
|---|---|---|---|
| K212226(Traditional 510K) | K190002 (Traditional 510K) | ||
| Manufacturer | Zhuhai DR Medical Instruments Co., Ltd. | Shanghai Kohope Medical Devices Co., Ltd | / |
| Product name | Sterile Hypodermic needle for Single use | Sterile Hypodermic needle for Single use | Same |
| Product code | FMI | FMI | Same |
| Device | |||
| Classification | Class II, 21 CFR 880.5570 | Class II, 21 CFR 880.5570 | Same |
| Indications for | |||
| Use | The Sterile Hypodermic Needle for single use | ||
| is intended for use with syringes and injection | |||
| devices for general purpose fluid | |||
| injection/aspiration. | The Sterile Hypodermic Needle for single use | ||
| is intended for use with syringes and injection | |||
| devices for general purpose fluid | |||
| injection/aspiration. | Same | ||
| Environment of | |||
| use | Hospital | Hospital | Same |
| Intended users | Medical professionals and trained care givers | Medical professionals and trained care givers | Same |
| Operation mode | For Manual Use Only, For | ||
| Single Use only | For Manual Use Only, For | ||
| Single Use only | Same | ||
| Configuration | Protective cap; Needle tube; Adhesives; Needle hub | Protective cap; Needle tube; Adhesives; Needle hub | Same |
| Material | Protective cap: PP | ||
| Needle tube: Stainless steel (SUS304) | |||
| Adhesives: Epoxy resin | |||
| Needle hub: PP | Protective cap: PP | ||
| Needle tube: Stainless steel (SUS304) | |||
| Adhesives: Epoxy resin | |||
| Needle hub: PP | Same | ||
| Needle Gauge | 18G,19G,20G,21G,22G,23G,24G,25G, | ||
| 26G,27G,28G,29G,30G | 18G,19G,20G,21G,22G,23G,24G,25G, | ||
| 26G,27G,28G,29G,30G | Same | ||
| Needle lengths | 16mm, 25mm, 38mm | 4 – 38 mm | See comment 1 |
| Needle Wall | Regular Wall | Regular wall, thin wall and extra thin wall | Similar |
| Needle Bevel | $17^{\circ}\pm 2^{\circ}$ | Long bevel, short bevel, ultra-treatment bevel | See comment 2 |
| Lubrication | |||
| Amount/cm2 | ASTM F1608 ASTM F 88 ASTM F 1929 Physical, Mechanical, Chemical, Package Tests were performed on aging samples to verify the claimed shelf life of the device. |
10. Clinical Test
No clinical study is included in this submission.
11. Performance data
All necessary bench and non-clinical testing were conducted on DR Safety Syringe to support a determination of substantial equivalence to the predicate devices.
The non-clinical, bench testing are conducted according to ISO 7886-1 and ISO 7886-4, USP 788, ISO 23908 and FDA guidance titled: "Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff," included:
- 1 Appearance
- 2 Tolerance on graduated capacity
- 3 Graduated scale
- 4 Barrel
- 5 Plunger stopper/plunge
- 6 Syringe needle
- 7 Liquid leakage
- 8 Air leakage
12
- 9 Syringe with Luer nozzle
- 10 Dead space
- 11 Re-use prevention feature test
- 12 Limits for acidity or alkalinity
- 13 Limits for extractable metals
- 14 EO residual
- 15 Sterility
- 16 Bacterial Endotoxin (LAL test)
- 17 Testing activation of a sharps injury protection feature
- 18 Particulate test,
- 19 ECH residual
All necessary bench and non-clinical testing were conducted on Fixed needle to support the performance of the needle in safety syringe.
The non-clinical, bench testing are conducted according to ISO 9626 included:
- 1 Appearance
- 2 Dimensions of tubing
- 3 Stiffness
- 4 Bond between hub and needle tube
- 5 Resistance to breakage
- 6 Limits for acidity or alkalinity
- 7 Corrosion resistance
All necessary bench and non-clinical testing were conducted on proposed sterile hypodermic needle to support a determination of substantial equivalence to the predicate devices. The non-clinical, bench testing are conducted according to ISO 7864 included:
- 1 Appearance
- 2 Colour coding
- 3 Tolerances on length
- 4 Bond between hub and needle tube
- 5 Patency of lumen
- 6 The penetration force and drag force for needles
- 7 Limits for acidity or alkalinity
- 8 Limits for extractable metals
12. Biocompatibility Testing Summary
Biocompatibility testing was conducted in compliance with ISO 10993-1, for externally communicating devices with limited exposure (