(178 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a retractable safety syringe, with no mention of AI or ML components or functionalities.
No
The device is a syringe designed for fluid injection/withdrawal and prevention of needle stick injuries. While it facilitates medical procedures, it does not directly treat or diagnose a disease or condition, which is the primary purpose of a therapeutic device. Its function is to deliver or remove substances, not to provide therapy itself.
No
The device is described as a "Sterile Safety Syringe" used for injecting or withdrawing fluids, with safety features to prevent needle stick injuries. Its intended use focuses on fluid delivery and retrieval for medical purposes, not for diagnosing conditions.
No
The device description clearly outlines physical components (protective cap, needle tube, barrel, plunger, etc.) and mentions sterilization and physical performance testing, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "injecting fluids into or withdrawing fluids from the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details a syringe, which is a tool for administering or collecting substances from a living organism.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests on these samples.
The device described is a medical device used for administering or withdrawing substances from a patient, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Sterile Safety Syringe for Single Use (Ret retractable) is intended to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Sterile Safety Syringe for Single Use (Retractable) is designed to aid in the prevention of needle stick injuries and reduce the potential for syringe reuse. The Sterile Safety Syringe for Single Use (Retractable) is a single use, disposable device, provided sterile.
Product codes (comma separated list FDA assigned to the subject device)
MEG
Device Description
The proposed device, Sterile Safety Syringe for Single Use (Ret retractable), is available in 1ml. The proposed device consists of seven components:(1) protective cap, (2) needle tube, (3) connecting seat, (4) plunger stopper, (5) sliding sleeve, (6) barrel, (7) plunger.
The proposed devices are sterilized by ethylene oxide to achieve a SAL 10-6 and supplied in sterility maintenance small package which could maintain the sterility of the device during the shelf life of 5 years.
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
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)
Biocompatibility:
The proposed device is external communicating device, blood path indirect, contact duration is limited (≤24hrs). The tollowing testing was conducted:
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-4:2017 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
- ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
- ISO 10993-10:20101Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
- ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
- USP 43-NF38:2020 Pyrogen Test (USP Rabbit Test)
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injection and met the USP acceptance criteria.
Sterility, Shipping and Shelf-Life:
- ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
- USP 43-NF38:2020 Bacterial Endotoxins Test
- ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ASTM F1980 - 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- Shelf life of 5 years
Performance Testing:
- ISO 7864:2016 Sterile hypodermic needles for single use-requirements and test method
- ISO 7886-1:2017 Sterile hypodermic syringe for single use- Part 1: Syringes for manual use
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of the medical devicesrequirements and test method
- ISO 23908:2011 Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
In addition, a simulated clinical use study was conducted on the subject device, Sterile Safety Syringe for Single Use (Ret retractable) to evaluate the effect of safety feature per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" issued on August 9, 2005. The test results demonstrated that the subject device complies with the requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font and the word "Administration" in a smaller font.
July 21, 2022
Shanghai Kindly Enterprise Development Group Co., Ltd % Ryan Li RA Manager Shanghai Mind-link Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai, 200040 China
Re: K220183
Trade/Device Name: Sterile Safety Syringe for Single Use (Retractable) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG Dated: June 14, 2022 Received: June 21, 2022
Dear Ryan 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,
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K220183
Device Name
Sterile Safety Syringe for Single Use (Retractable)
Indications for Use (Describe)
The Sterile Safety Syringe for Single Use (Retractable) is intended to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Sterile Safety Syringe for Single Use (Retractable) is designed to aid in the prevention of needle stick injuries and reduce the potential for syringe reuse. The Sterile Safety Syringe for Single Use (Retractable) is a single use, disposable device, provided sterile.
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
PREPARATION DATE: 7/20/2022 l.
II. SUBMITTER:
Shanghai Kindly Enterprise Development Group Co., Ltd. No.658 Gaochao Road, Shanghai, 201803, China Contact Person: Liu Hualong Title: Technical Director Tel: 86-69118232-8125 Email: henry_liu@kdlchina.net Submission Correspondent: Ryan Li Email: Ryan.li@mind-link.net
III. DEVICE
Name of Device: Sterile Safety Syringe for Single Use (Retractable) Regulation Number: 21 CFR PART 880.5860 Common Name: Syringe, Antistick Classification Name: Piston syringe Regulatory Class: II Product Code: MEG
IV. PREDICATE DEVICE
Name of Device: Retractable Safety Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe (Bi)
Regulation Number: 21 CFR 880.5860
Common Name: Syringe, Antistick
Classification Name: Piston syringe
Regulatory Class: II
Product Code: MEG
V. DEVICE DESCRIPTION
The proposed device, Sterile Safety Syringe for Single Use (Retractable), is available in 1ml. The models of syringe and needle are listed in the below table.
| Syringe
| volume(ml) | Matched needle | |||
|---|---|---|---|---|
| Needle gauge | ||||
| (G) | Needle length | |||
| (mm) | Needle wall | Bevel | ||
| 1 mL | 23G | 25 | RW | 11±2° |
Table 5-1 Models of syringe and needle
4
| 25G | 25 | RW | 11±2° |
|---|---|---|---|
| 26G | 13 | RW | 11±2° |
| 27G | 13 | RW | 11±2° |
| 28G | 13 | RW | 11±2° |
| 29G | 13 | RW | 11±2° |
| 30G | 8, or 13 | TW | 11±2° |
| 31G | 6, or 8 | TW | 11±2° |
The proposed device consists of seven components:(1) protective cap, (2) needle tube, (3) connecting seat, (4) plunger stopper, (5) sliding sleeve, (6) barrel, (7) plunger.
The proposed devices are sterilized by ethylene oxide to achieve a SAL 10-6 and supplied in sterility maintenance small package which could maintain the sterility of the device during the shelf life of 5 years.
VI. INDICATIONS FOR USE/INTENDED USE
The Sterile Safety Syringe for Single Use (Retractable) is intended to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Sterile Safety Syringe for Single Use (Retractable) is designed to aid in the prevention of needle stick injuries and reduce the potential for syringe reuse. The Sterile Safety Syringe for Single Use (Retractable) is a single use, disposable device, provided sterile.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Sterile Safety Syringe for Single Use (Retractable) is compared with the predicate device, Retractable Safety Syringe, Retractable Safety Tuberculin Syringe, and Retractable Safety Allergy Syringe (K191490). The results are shown below in the Technological Characteristics Comparison Table:
| DEVICE | Proposed device | Predicate device | Remark |
|---|---|---|---|
| Sterile Safety Syringe for | Retractable Safety Syringe, Retractable | ||
| Single Use (Retractable) | Safety Tuberculin Syringe, Retractable Safety | ||
| Allergy Syringe (K191490) | |||
| Indications for | |||
| Use/Intended | |||
| use | The Sterile Safety Syringe | ||
| for Single Use | |||
| (Retractable) is intended | |||
| to provide a safe and | |||
| reliable method of | |||
| injecting fluids into or | |||
| withdrawing fluids from | The Retractable Safety Syringe works like a | ||
| conventional hypodermic syringe except for | |||
| its ability to retract the contaminated needle | |||
| inside of the syringe immediately after | |||
| patient injection. Needle retraction is | |||
| activated by the syringe user. Because the | |||
| contaminated needle is automatically | |||
| the body. The Sterile | |||
| Safety Syringe for Single | |||
| Use (Retractable) is | |||
| designed to aid in the | |||
| prevention of needle stick | |||
| injuries and reduce the | |||
| potential for syringe reuse. | |||
| The Sterile Safety Syringe | |||
| for Single Use | |||
| (Retractable) is a single | |||
| use, disposable device, | |||
| provided sterile. | withdrawn into the syringe plunge, the | ||
| syringe user is protected from accidental | |||
| needle sticks. These accidental needle sticks | |||
| would occur between removing the needle | |||
| from the patient and disposing of the syringe | |||
| in a sharps disposable container. | |||
| For general injection use: The function of | |||
| Retractable Safety Syringe is to provide a safe | |||
| and reliable method of injecting fluids into or | |||
| withdrawing fluids from the body. The | |||
| Retractable Safety Syringe is designed to aid | |||
| in the prevention of needle stick injuries and | |||
| reduce the potential or syringe reuse. The | |||
| syringe contains various capacity, such as 1ml, | |||
| 2.5ml, 3ml, 5ml and 10ml. | |||
| For allergy use: The 1ml Retractable Safety | |||
| Allergy Syringe is intended for the | |||
| preparation/mixing of allergenic extracts/ | |||
| prescribed substances, the manual aspiration | |||
| of fluids, and for the injection of fluids into | |||
| parts of the body below the surface of the | |||
| skin. The Retractable Safety Syringe is | |||
| designed to aid in the prevention of needle | |||
| stick injuries and reduce the potential or | |||
| syringe reuse. | |||
| For Tuberculin use: The 1ml Retractable | |||
| Safety Tuberculin Syringe is intended for the | |||
| delivery of Tuberculin. The Retractable Safety | |||
| Syringe is designed to aid in the prevention of | |||
| needle stick injuries and reduce the potential | |||
| or syringe reuse. | |||
| Classification | MEG | MEG | Same |
| Product Code | |||
| Prescription | |||
| Only or Over the | |||
| Counter | Prescription | Prescription | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Configuration | Plunger stopper | Piston | Same |
| Plunger | Plunger | ||
| Barrel (graduated) | Barrel (graduated) | ||
| Safety feature | Safety feature | ||
| Sterility | EO Sterilized | EO Sterilized | Same |
| Environment of | Hospital | Hospital | Same |
| use | |||
| Safety feature | Sliding sleeve activation | Spring retraction | Different |
| principle | Note 2 | ||
| Volume | 1ml | Retractable Safety Syringe: 1ml, 2.5mL, 3mL, | Different |
| 5mL, 10mL | Note 3 | ||
| Retractable Safety Tuberculin Syringe/ | |||
| Retractable Safety Allergy Syringe: 1mL | |||
| Needle gauge | 23G,25G,26G,27G,28G, | 24G, 25G, 26G, 27G, 28G, 29G, 30G and 31G | Different |
| 29G, 30G and 31G | Note 4 | ||
| Needle length | 6mm, 8mm, 13mm, and | 8mm,10mm,13mm,16mm, 20mm, 25mm | Different |
| 25mm | Note 4 | ||
| Needle wall | Regular wall, Thin wall | Regular wall | Different |
| Note 4 | |||
| Bevel | $11±2°$ | $11±2°$ | Same |
| Single use | Yes | Yes | Same |
| Operation mode | For Manual Use Only, For | For Manual Use Only, For Single Use only | Same |
| Single Use only | |||
| Materials | Barrel/Plunger/Sliding | Plunger/Barrel/Needle cap/Plunger lid/ | Different |
| sleeve: Polypropylene | Barrel barb: PP | Note 5 | |
| Plunger stopper: | Piston: Polyisoprene, | ||
| Polyisoprene | Sealing plug: TPE+PP, | ||
| Connecting seat: | Needle tube/Spring: Stainless Steel, | ||
| Polycarbonate | Hub: MABS | ||
| Protective cap: | Lubricant: Polydimethylsiloxane | ||
| Polyethylene | |||
| Needle tube: Stainless | |||
| steel | |||
| Lubricant: Silicone oil |
5
6
Discussion in details:
Note 1: In terms of the difference between proposed device and predicate device, the predicate device is a buddled submission device that contains Retractable Safety Syringe, Retractable Safety
7
Tuberculin Syringe and Retractable Safety Allergy Syringe, and each device have different indications for use.
The proposed device is the same as the Retractable Safety Syringe that is included in the predicate device. Overall, they both have the same indications for use/intended use, that inject fluid into or withdraw fluid from the body and aid in prevention of needle stick injures and reuse of the syringe. As a result, this difference will not affect the subject device's safety and effectiveness.
Note 2: The structures of safety features of the proposed and the predicate device are different. The proposed device uses a plastic sleeve that pulls forward to cover the needle after use. The predicate device uses a needle retraction structure that the needle is encapsulated into the barrel after use. Although they use a different mechanical structure, they are both intended to prevent the needle stick injury during use and prevent harm to end-user. The safety feature of the proposed device has been validated to verify the prevention function. As a result, this difference will not affect the subject device's safety and effectiveness.
Note 3: The predicate device has a wider range of models (1ml, 2.5mL, 3mL, 10mL) than the proposed device (1mL). Meanwhile, the performance of all models of the proposed device is tested by following ISO 7886-1, to demonstrate the substantial equivalence.
Note 4: Although the needle gauge, needle length and needle wall type is different from the predicate device, the 7864-1 needle test report of the proposed device could demonstrate it is as safe and effective as the predicate device.
Note 5: Although the materials of the proposed device are slightly different from the predicate device, the biocompatibility test reports of the proposed device could demonstrate it is as safe and effective as the predicate device.
VII PERFORMANCE DATA
Biocompatibility
The proposed device is external communicating device, blood path indirect, contact duration is limited (≤24hrs). The tollowing testing was conducted: ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- . ISO 10993-4:2017 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
- . ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
- ISO 10993-10:20101Biological evaluation of medical devices- Part 10: Test for irritation
8
and delayed-type hypersensitivity
- . ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
- USP 43-NF38:2020 Pyrogen Test (USP Rabbit Test)
Particulate matter testing was conducted in accordance with USP Particulate Matter in Injection and met the USP acceptance criteria.
Sterility, Shipping and Shelf-Life
- . ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
- . USP 43-NF38:2020 Bacterial Endotoxins Test
- ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ASTM F1980 - 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- . Shelf life of 5 years
Performance Testing
- ISO 7864:2016 Sterile hypodermic needles for single use-requirements and test method
- ISO 7886-1:2017 Sterile hypodermic syringe for single use- Part 1: Syringes for manual use
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of the medical devicesrequirements and test method
- . ISO 23908:2011 Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
In addition, a simulated clinical use study was conducted on the subject device, Sterile Safety Syringe for Single Use (Retractable) to evaluate the effect of safety feature per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" issued on August 9, 2005. The test results demonstrated that the subject device complies with the requirements.
Clinical Test Conclusion
No clinical study is included in this submission.
9
VIII. CONCLUSION
The differences between the predicate device and the subject device do not raise any new or different questions of safety or effectiveness. The Sterile Safety Syringe for Single Use (Retractable) is substantially equivalent to the Retractable Safety Syringe with respect to the indications for use and technological characteristics.