(129 days)
The Sterile Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only. It consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The subject device is available in a variety of syringe volumes and needle sizes. The safety sheath is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The provided FDA 510(k) summary (K211753) is for a Sterile Syringe with Safety Needle. This document outlines the premarket notification for a Class II medical device, comparing it to a predicate device (K193526) to demonstrate substantial equivalence.
It's important to note that this document does not describe AI/ML device performance or studies proving such performance. This is a traditional medical device submission, focusing on compliance with established engineering and safety standards for the physical product.
Therefore, many of the requested elements pertaining to AI/ML device performance, such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models, are not applicable to this document.
The document primarily focuses on:
- Indications for Use: The device is for aspiration and injection of fluids, with a safety shield to prevent needle sticks.
- Technological Characteristics: Comparison of physical attributes like syringe volume, needle gauge, length, and material.
- Performance Standards: Compliance with international standards for syringes, needles, luer connectors, and sterilization.
- Biocompatibility: Leveraged from a previously cleared device (K163161) due to identical patient contact materials.
However, I can extract information related to the physical device's "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of this traditional medical device submission.
Here's the breakdown based on the provided text, focusing on the physical device performance and safety, not AI/ML:
Acceptance Criteria and Study for Sterile Syringe with Safety Needle (K211753)
The acceptance criteria for this device are primarily defined by compliance with recognized international and national standards for medical devices, particularly those related to syringes, needles, luer connectors, biocompatibility, and sterility. The studies proving the device meets these criteria are non-clinical bench tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Device Performance (How compliance was demonstrated) |
|---|---|---|
| Syringe Performance | ISO 7886-1: 2017 | Tested and demonstrated conformance to the standard. |
| Needle Performance | ISO 7864: 2016 | Tested and demonstrated conformance to the standard. |
| ISO 9626:2016 | Tested and demonstrated conformance to the standard. | |
| Luer Connector Performance | ISO 80369-7: 2016 | Tested and demonstrated conformance to the standard for small-bore connectors. |
| ISO 80369-20: 2015 | Used for common test methods for small-bore connectors. | |
| Sharps Injury Protection | ISO 23908: 2011 | Tested and demonstrated conformance (for sharps protection features for single-use hypodermic needles). |
| Biocompatibility | ISO 10993 standards | Leveraged existing data from predicate device K163161 due to identical patient contact materials and manufacturing processes. Implies no cytotoxicity, no intracutaneous reactivity, no sensitization, no systemic toxicity, no hemolysis, no pyrogenicity. (Specific tests for K163161 not detailed in K211753) |
| USP <85> Bacterial Endotoxins Test | Bacterial endotoxin limit evaluated on proposed device. | |
| USP <788> Particulate Matter in Injections | Particulate testing evaluated on proposed device. | |
| Sterility | ISO 11135:2014, Annex B | EO Sterilized with a SAL of 10^-6 validated via an overkill method. |
| Packaging Integrity | ASTM F1886/1886M-16 | Visual inspection performed. |
| ASTM F88/F88-15 | Seal strength tested. | |
| ASTM F1929-15 | Dye penetration tested. | |
| Shipping Performance | ASTM D4169-16 | Simulated transportation testing performed. |
| Shelf-life | ASTM F1980-16 | Shelf life of 3 years validated using accelerated aging. |
| EO Residuals | ISO 10993-7:2008 | EO ECH residue testing performed. |
| Labeling | 21 CFR part 801 | Complies with regulations. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical bench test. These are typically defined by the testing standards (e.g., ISO, ASTM).
- Data Provenance: The tests were conducted to demonstrate compliance with international standards (ISO, ASTM, USP). The manufacturing entity is Jiangxi Hongda Medical Equipment Group Ltd. in China. The testing would have been conducted by the manufacturer or a certified testing laboratory. The data is retrospective in the sense that the testing was completed prior to submission for clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a traditional medical device (syringe with safety needle), not an AI/ML device relying on expert consensus for ground truth. Compliance is determined by objective physical and chemical testing against established engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is a traditional medical device; "adjudication" in the context of clinical reads or expert consensus for AI models is not relevant here. Test results are compared directly against the quantitative and qualitative requirements of the referenced standards.
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 document refers to a physical medical device (syringe), not an AI/ML diagnostic or assistive tool. MRMC studies are irrelevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm or software component described in this submission that would require standalone performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench Testing Standards and Specifications: The "ground truth" for this device is its adherence to the performance requirements stipulated in the referenced international and national standards (e.g., ISO 7886-1 for syringe performance, ISO 9626 for needle tubing, ISO 80369-7 for luer connectors, ISO 10993 for biocompatibility, etc.). These standards define the acceptable mechanical, physical, chemical, and biological properties of the device.
8. The sample size for the training set
- Not Applicable. This is a hardware medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, there is no AI/ML training set.
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October 14, 2021
Jiangxi Hongda Medical Equipment Group Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K211753
Trade/Device Name: Sterile Syringe with Safety Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, MEG Dated: September 8, 2021 Received: September 14, 2021
Dear Diana Hong:
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.
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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 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.
For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211753
Device Name Sterile Syringe with Safety Needle
Indications for Use (Describe)
The Sterile Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
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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K211753.510KSummary
-
- Date of Preparation: 10/14/2021
-
- Sponsor Identification
Jiangxi Hongda Medical Equipment Group Ltd. No. 39 South Shengli Road, Jinxian County, Nanchang City, Jiangxi Province, 331700, China
Contact Person:
Yang Xiaohua Position: Vice-general Manager Tel: +86-791-85628918 Fax: +86-791-85628881 Email: yxh2821006@126.com
3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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| 4. | Identification of Subject Device: | Trade Name: Sterile Syringe with Safety Needle |
|---|---|---|
| Common Name: | Safety Piston Syringe with Needle | |
| Classification Name: | Syringe Antistick | |
| Classification: | II | |
| Product Code: | MEG | |
| Regulation Number: | 21 CFR 880.5860 | |
| Review Panel: | General Hospital | |
| Classification Name: | Piston Syringe | |
| Classification: | II | |
| Product Code: | FMF | |
| Regulation Number: | 21 CFR 880.5860 | |
| Review Panel: | General Hospital | |
| Classification Name: | Hypodermic single lumen needle | |
| Classification: | II | |
| Product Code: | FMI | |
| Regulation Number: | 21 CFR 880.5570 | |
| Review Panel: | General Hospital | |
| 5. | Predicate Device | K193526, Syringe with Safety Needle |
Device Description 6.
The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only. It consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The subject device is available in a variety of syringe volumes and needle sizes. The safety sheath is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
| Gauge | Length | Wall Type |
|---|---|---|
| 26G | 13mm, 16mm | RW |
| 25G | 16mm, 25mm, 38mm | RW |
| 24G | 16mm, 25mm, 38mm | RW |
| 23G | 25mm, 32mm, 38mm | TW |
| 22G | 25mm, 32mm, 38mm | TW |
| 21G | 25mm, 32mm, 38mm | TW |
| 20G | 25mm, 32mm, 38mm | TW |
| 18G | 25mm, 32mm, 38mm | TW |
7. 7. Indication for Use
| Characteristics | Subject Device | Predicate |
|---|---|---|
| ----------------- | ---------------- | ----------- |
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| Sterile Syringe with Safety NeedleK211753 | Syringe with Safety NeedleK193526 | |
|---|---|---|
| Indication forUse | The Sterile Syringe with SafetyNeedle is intended for use in theaspiration and injection of fluids formedical purpose. After withdrawal ofthe needle from the body, theattached needle safety shield can bemanually activated to cover theneedle immediately after use tominimize risk of accidental needlesticks. | The Sterile Disposable Syringe withSafety Needle is intended for use inthe aspiration and injection of fluidsfor medical purpose. Afterwithdrawal of the needle from thebody, the attached needle safetyshield can be manually activated tocover the needle immediately afteruse to minimize risk of accidentalneedle sticks. |
| PrescriptionOnly or Overthe counter | Prescription Only | Prescription Only |
-
- Technological Characteristics
| Table 1 Comparison of Technology Characteristics | |
|---|---|
| ITEM | Subject Device K211753 | Predicate Device K193526 | Remark |
|---|---|---|---|
| Product Code | FMFFMIMEG | FMFFMIMEG | Same |
| Regulation No. | 21 CFR 880.586021 CFR 880.5570 | 21 CFR 880.586021 CFR 880.5570 | Same |
| Class | Class II | Class II | Same |
| Indication for Use | The Sterile Syringe with SafetyNeedle is intended for use in theaspiration and injection of fluids formedical purpose. After withdrawalof the needle from the body, theattached needle safety shield can bemanually activated to cover theneedle immediately after use tominimize risk of accidental needlesticks. | The Sterile Disposable Syringewith Safety Needle is intendedfor use in the aspiration andinjection of fluids for medicalpurpose. After withdrawal ofthe needle from the body, theattached needle safety shieldcan be manually activated tocover the needle immediatelyafter use to minimize risk ofaccidental needle sticks. | Same |
| Configuration | BarrelPlungerPistonNeedle hubProtective capNeedle tube | BarrelPlungerPistonNeedle hubProtective capNeedle tube | Same |
| Safety sheath | Safety sheath | ||
| Operation Mode | For manual use only | For manual use only | Same |
| Safety Feature | Slide over the needle to preventfrom needle sticks | Slide over the needle to preventfrom needle sticks | Same |
| Single Use | Yes | Yes | Same |
| Label/Labeling | Complies with 21 CFR part 801 | Complies with 21 CFR part 801 | Same |
| Syringe Volume | 1ml, 3ml, 5ml, 10ml | 1ml, 2ml, 3ml, 5ml, 10ml,20ml, 30ml, 50ml, 60ml | Different/ SeeComment #1 |
| Connector Type | Luer Lock/ Luer slip | Luer Lock | Different/ SeeComment #2 |
| SyringePerformance | Complied with ISO 7886-1 | Complied with ISO 7886-1 | Same |
| Needle Gauge | 18G, 20G, 21G, 22G, 23G, 24G,25G, 26G | 16G, 18G, 19G, 20G, 21G,22G, 23G, 25G, 26G, 27G,28G, 29G, 30G, 31G | Different/ SeeComment #3 |
| Needle Length | 13mm, 16mm, 25mm, 32mm,38mm | 13mm, 16mm, 20mm, 25mm,32mm, 38mm | Different/ SeeComment #4 |
| Wall Type | TW: 18G, 20G, 21G, 22G, 23GRW: 24G, 25G, 26G | TW: 16G, 18G, 19G, 20G, 21G,22G, 23G, 25G, 26G, 27G,28G, 29G, 30G, 31GRW: 16G, 18G, 19G, 20G, 21G,22G, 23G, 25G, 26G, 27G,28G, 29G, 30G, 31G | Different/ SeeComment #5 |
| Bevel Design | LB | LB/SB | Different/ SeeComment #6 |
| NeedlePerformance | Complies withISO 7864ISO 9626 | Complies withISO 7864ISO 9626 | Same |
| Luer ConnectorPerformance | Complied withISO 80369-7 | Complied withISO 80369-7 | Same |
| Patient contact material | |||
| Barrel | Polypropylene (PP) | Polypropylene (PP) | |
| Plunger | Polypropylene (PP) | Polypropylene (PP) | Same |
| Piston | Polyisoprene | Polyisoprene | Same |
| Needle tube | Stainless Steel, SUS304 | Stainless Steel, SUS304 | |
| Biocompatibility | |||
| Cytotoxicity | Comply with ISO 10993 standards,biocompatibility was leveraged onthe data of K163161 | No cytotoxicity | Same |
| Irritation | No intracutaneous reactivity | ||
| Sensitization | No skin sensitization | ||
| Systemic Toxicity | No systemic toxicity | ||
| Hemolysis | No Hemolysis | ||
| Pyrogen | No Pyrogen | ||
| Sterilization | |||
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
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Comment 1 - Syringe Volume
The syringe specification for the subject device is less than the predicate device. However, the specification can be covered by the predicate device. In addition, the syringe performance has been tested and test results demonstrate that the syringe meets the requirements of ISO 7886. Therefore, this difference is not considered to affect substantial equivalence.
Comment 2 - Luer Connector
The subject device is available in luer slip and luer lock two types connectors and luer lock connector is not covered by the predicate device. However, the luer connector has been tested per ISO 80369-7 and the test results demonstrate that the luer connector meets the requirements of ISO 80369-7. Therefore, this difference is not considered to affect substantial equivalence.
Comment 3 - Needle Gauge
The subject device has the additional gauge 24G compared to the predicate device, while other gauges can be covered by the predicate device. The needle performance has been tested and results demonstrate that the needle meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference is not considered to affect substantial equivalence.
Comment 4 - Needle Length
The length specification of the subject device is within the range covered by the predicate device. In addition, the needle performance has been tested and the results demonstrate that the syringe meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference is not considered to affect substantial equivalence.
Comment 5 - Wall Type
The wall type of the subject device under the same needle gauge can be covered by the predicate device. In addition, the needle performance has been tested and results demonstrate that the syringe meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference is not considered to affect substantial equivalence.
Comment 6 - Bevel Design
The bevel design of the subject device can be covered by the predicate device. In addition, the needle performance has been tested and the results demonstrate that the syringe meets the requirements of ISO 7864 and ISO 9626. Therefore, this difference is not considered to affect substantial equivalence.
Non-Clinical Test Conclusion 9.
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A. Syringe
The sterile, single piston syringe described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- A ISO 7886-1: 2017 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use
B. Anti- Stick Needle
The Sterile Antistick Needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
-
ISO 7864: 2016, Sterile Hypodermic Needles for Single Use.
-
ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Devices
- A ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications
-
ISO 80369-20: 2015 Small-bore connectors for liquids and gases in healthcare applications -Part 20: Common test methods
-
ISO 23908: 2011 Sharps injury protection-Requirements and test methods-Sharp protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
C. Biocompatibility
The patient contact materials of the subject device, Sterile Syringe with Safety Needle, are identical to the material of Sterile Single-Use Syringe With Needle as it was cleared in K163161in 03/20/2017. There are no differences in formulation, processing and sterilization, and no other chemicals have been added. (e.g., plasticizers, filters, cleaning agents, mold release agents, etc.). Therefore, new biocompatibility test was not conducted on the proposed device. Bacterial endotoxin limit and particulate testing were evaluated on the proposed device per following standards
-
USP <85> Bacterial Endotoxins Test
-
USP <788> Particulate Matter in Injections
D. Sterility, Shipping, and Shelf-life
The subject devices were sterilized by Ethylene Oxide Gas to achieve a SAL of 106 and the sterilization method was validated per over kill method as qualified in accordance ISO 11135:2014, Annex B.
Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169-16, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
Sterile Barrier Packaging Testing performed on the subject device:
○ Visual inspection ASTM F1886/1886M-16
o Seal strength ASTM F88/F88-15
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oDye penetration ASTM F1929-15
Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Device
The EO ECH residue testing was performed on the subject device:
- A ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
-
- Conclusions
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Sterile Syringe with Safety Needle is substantially equivalent to the Syringe with Safety Needle with respect to the indications for use, target populations, treatment method, 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).