(178 days)
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.
The proposed device, Sterile Safety Syringe for Single Use (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.
The provided document is a 510(k) premarket notification for a medical device: "Sterile Safety Syringe for Single Use (Retractable)". It declares the device's substantial equivalence to a predicate device.
However, the document does not contain the acceptance criteria and performance data for a study proving the device meets those criteria in the format requested (i.e., a table of "acceptance criteria vs. reported device performance").
Instead, it lists various standard tests and their respective ISO/ASTM/USP standards that were applied to the device to demonstrate its safety and effectiveness and its substantial equivalence to the predicate device. These tests primarily focus on:
- Biocompatibility: Adhering to ISO 10993 standards for biological evaluation.
- Sterility, Shipping and Shelf-Life: Meeting ISO 10993-7, USP, and ASTM standards for sterilization residuals, bacterial endotoxins, packaging integrity (seal strength, leak detection), and accelerated aging for a 5-year shelf life.
- Performance Testing: Conforming to ISO 7864 (hypodermic needles), ISO 7886-1 (hypodermic syringes for manual use), ISO 9626 (stainless steel needle tubing), and ISO 23908 (sharps injury protection features).
- Simulated Clinical Use Study: Conducted to evaluate the effect of the safety feature per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" and stated that "The test results demonstrated that the subject device complies with the requirements."
Therefore, I cannot extract the requested table of acceptance criteria and reported device performance from this document as it is not presented in that specific comparative format. The document primarily asserts compliance with established regulatory standards and guidelines through various tests, rather than detailing specific quantitative acceptance criteria and their corresponding empirical results in a side-by-side comparison for each performance aspect.
Moreover, the document explicitly states: "No clinical study is included in this submission." This means that information regarding human-in-the-loop performance, multi-reader multi-case studies, sample sizes for test sets involving human readers, expert consensus for ground truth, or adjudication methods are not applicable and thus not provided in this document. The device's safety feature validation was done through a simulated clinical use study, not a true clinical study with human subjects.
Given the limitations of the provided document, I can only state what is addressed and what is not:
Based on the provided document, here's what can be inferred and what information is absent:
1. A table of acceptance criteria and the reported device performance:
- Not explicitly provided in the requested comparative "acceptance criteria vs. reported performance" table format. The document lists the standards and guidances that the device was tested against (e.g., ISO 7864, ISO 7886-1, ISO 9626, ISO 23908, ISO 10993 series, USP standards, ASTM standards). It generally states that the device "met" acceptance criteria or "complies with the requirements" of these standards.
- Example from text: "Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injection and met the USP acceptance criteria." This implies the acceptance criteria are those defined by USP <788>, and the reported performance was "met" these criteria, but specific quantitative values are not given.
- Example from text: "The safety feature of the proposed device has been validated to verify the prevention function." and "a simulated clinical use study was conducted on the subject device... to evaluate the effect of safety feature per FDA Guidance... The test results demonstrated that the subject device complies with the requirements." This indicates compliance with FDA guidance on sharps injury prevention.
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the performance tests (e.g., ISO 7864, ISO 7886-1 tests, biocompatibility tests). Standard industrial testing often relies on predefined sample sizes per standard, but these are not enumerated here.
- Data Provenance: The manufacturing entity, Shanghai Kindly Enterprise Development Group Co., Ltd., is based in China. The location where the testing was performed (country of origin of the data) is not explicitly stated, but it's implied to be associated with the manufacturer or their chosen testing labs. The studies are pre-market notification tests to demonstrate substantial equivalence, implying they are conducted for regulatory submission. Whether specific tests were retrospective or prospective is not detailed, but routine device testing for regulatory submission is typically prospective for the purpose of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document states "No clinical study is included in this submission." Ground truth, in the context of expert consensus, is typically established for diagnostic or screening devices evaluated in clinical settings, often for image interpretation or diagnosis. This document pertains to a medical device (syringe) where performance is assessed against engineering standards and simulated use.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As there's no clinical study involving human interpretation or subjective assessment, adjudication methods are not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a syringe, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm. Performance tests are inherently "device only" without human-in-the-loop performance in terms of interpretation, but involve human operation for mechanical tasks.
7. The type of ground truth used:
- Engineering Standards and Specifications: The "ground truth" for the device's performance is established by the specified international (ISO), national (USP, ASTM), and FDA standards/guidances (e.g., ISO 7864 for needle requirements, ISO 7886-1 for syringe performance, ISO 23908 for sharps injury protection, FDA guidance on sharps injury prevention). The device's physical and functional properties are tested against the objective, measurable criteria defined within these standards.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. No training set exists for this device.
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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
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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
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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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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.
| Syringevolume(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
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| 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 SafetyAllergy Syringe (K191490) | ||
| Indications forUse/Intendeduse | The Sterile Safety Syringefor Single Use(Retractable) is intendedto provide a safe andreliable method ofinjecting fluids into orwithdrawing fluids from | The Retractable Safety Syringe works like aconventional hypodermic syringe except forits ability to retract the contaminated needleinside of the syringe immediately afterpatient injection. Needle retraction isactivated by the syringe user. Because thecontaminated needle is automatically | |
| the body. The SterileSafety Syringe for SingleUse (Retractable) isdesigned to aid in theprevention of needle stickinjuries and reduce thepotential for syringe reuse.The Sterile Safety Syringefor Single Use(Retractable) is a singleuse, disposable device,provided sterile. | withdrawn into the syringe plunge, thesyringe user is protected from accidentalneedle sticks. These accidental needle stickswould occur between removing the needlefrom the patient and disposing of the syringein a sharps disposable container.For general injection use: The function ofRetractable Safety Syringe is to provide a safeand reliable method of injecting fluids into orwithdrawing fluids from the body. TheRetractable Safety Syringe is designed to aidin the prevention of needle stick injuries andreduce the potential or syringe reuse. Thesyringe contains various capacity, such as 1ml,2.5ml, 3ml, 5ml and 10ml.For allergy use: The 1ml Retractable SafetyAllergy Syringe is intended for thepreparation/mixing of allergenic extracts/prescribed substances, the manual aspirationof fluids, and for the injection of fluids intoparts of the body below the surface of theskin. The Retractable Safety Syringe isdesigned to aid in the prevention of needlestick injuries and reduce the potential orsyringe reuse.For Tuberculin use: The 1ml RetractableSafety Tuberculin Syringe is intended for thedelivery of Tuberculin. The Retractable SafetySyringe is designed to aid in the prevention ofneedle stick injuries and reduce the potentialor syringe reuse. | ||
| Classification | MEG | MEG | Same |
| Product Code | |||
| PrescriptionOnly or Over theCounter | 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 |
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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
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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
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and delayed-type hypersensitivity
- . ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
- USP 43-NF38:2020 <151> Pyrogen Test (USP Rabbit Test)
Particulate matter testing was conducted in accordance with USP <788> 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 <85> 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.
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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.
§ 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).