(191 days)
Sterile Syringe with Fixed Safety Needle for Single Use is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately to minimize risk of accidental needlesticks.
Sterile Syringe with Fixed Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of syringe and fixed needle with a safety mechanism. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
The proposed device is available in a variety combination of syringe volume and needle size.
| Syringe volume | Needle Gauge | Length | Wall type |
|---|---|---|---|
| 1ml | 21G | 5/8", 1" | TW |
| 1ml | 22G | 5/8", 1" | TW |
| 1ml | 23G | 5/8", 1" | TW |
| 1ml | 25G | 5/8", 1" | RW |
This document is a 510(k) Premarket Notification from Gemtier Medical (Shanghai) Inc. for a "Sterile Syringe with Fixed Safety Needle for Single Use." The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about an AI/ML-driven medical device. The acceptance criteria and study described are for a physical medical device (syringe and safety needle), focusing on its mechanical, material, and safety performance, rather than an AI algorithm's performance on data.
Therefore, I cannot provide the detailed information requested in the prompt, as it pertains to AI/ML acceptance criteria and studies (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types).
The document specifically mentions:
- No clinical study is included in this submission. (Page 10)
- The studies performed are non-clinical tests verifying the physical device's specifications, such as needle performance according to ISO standards, syringe performance, sharp injury protection, simulated clinical study for the safety feature, biocompatibility testing, sterility, shipping, and shelf-life. (Pages 8-9)
Because the provided text is about a physical medical device and not an AI/ML product, the questions related to AI/ML device performance and evaluation methodologies are not applicable.
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March 2, 2022
Gemtier Medical (Shanghai) Inc. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai. 200120 China
Re: K212652
Trade/Device Name: Sterile Syringe with Fixed Safety Needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, QNQ, QNS Dated: January 27, 2022 Received: January 31, 2022
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.
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
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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 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 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) K212652.
Device Name
Sterile Syringe with Fixed Safety Needle for Single Use
Indications for Use (Describe)
Sterile Syringe with Fixed Safety Needle for Single Use is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately to minimize risk of accidental needlesticks.
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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K212652.510(k) Summary
-
- Date of Preparation: March 2, 2022
2. Sponsor Identification
Gemtier Medical (Shanghai) Inc.
No.18 Jianding Road, Fengjing Town, Jinshan District, Shanghai, 201502, China Establishment Registration Number: 3009746425 Contact Person: Lenny Cao Position: Sales manager Tel: +86-21-67360886 Fax: +86-21-57365666 Email: sales@gemtier.com
Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person)
Ms. Tingting Su (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 Proposed Device
Trade Name: Sterile Syringe with Fixed Safety Needle for Single Use
Regulatory Information Classification Name: Piston Syringe Classification: II; Product Code: MEG, QNQ, QNS Regulation Number: 21CFR 880.5860 Review Panel: General Hospital;
Indication for Use:
Sterile Syringe with Fixed Safety Needle for Single Use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately to minimize risk of accidental needlesticks.
Device Description:
Sterile Syringe with Fixed Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of syringe and fixed needle with a safety mechanism. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks.
The proposed device is available in a variety combination of syringe volume and needle size.
| Syringe volume | Needle Gauge | Length | Wall type |
|---|---|---|---|
| 1ml | 21G | 5/8", 1" | TW |
| 1ml | 22G | 5/8", 1" | TW |
| 1ml | 23G | 5/8", 1" | TW |
| 1ml | 25G | 5/8", 1" | RW |
- న. Identification of Predicate Device and Reference Device Predicate 510(k) Number: K192679 Predicate Product Name: Sterile Syringe with Safety needle for Single Use
Reference Devices Reference Device 510(k) Number: K210443 Reference Device Product Name: PLPT LDV (Low Dead Volume) Sterile Syringe
Reference Device 510(k) Number: K210444 Reference Device Product Name: EZ-Injec LDV Sterile Safety Needle
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-
- Technological Characteristic
The table below includes a comparison of the Technological characteristics between the new device and those of the predicate.
- Technological Characteristic
| ITEM | Predicate Device | Subject Device | Comments |
|---|---|---|---|
| Sterile Syringe with Safetyneedle for Single UseK192679 | Sterile Syringe with FixedSafety Needle for Single UseK212652 | ||
| Regulation No. | 21CFR 880.5860 | 21CFR 880.5860 | Same |
| Product Code | MEG | MEG, QNQ, QNS | Comment 6 |
| Class | II | II | Same |
| Indication for Use | Sterile Syringe with Safety needle for Single Use is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. | Sterile Syringe with Fixed Safety Needle for Single Use is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately to minimize risk of accidental needlesticks. | Same |
| Configuration | BarrelPlungerPistonNeedle capNeedle tubeRetractable cartridgeJointing mediumNeedle hub | BarrelPlungerPistonNeedle capNeedle tubeRetractable cartridgeJointing medium | See comment#1 |
| Operation Mode | For manual use only | For manual use only | Same |
| Safety Feature | The needle is withdrawn into safety mechanism, the safety mechanism is fixed via latch lock to prevent arbitrary moving. | The needle is withdrawn into safety mechanism, the safety mechanism is fixed via latch lock to prevent arbitrary moving. | Same |
| Label/labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Single Use | Single Use | Single Use | Same |
| Syringe Volume | 1ml, 2ml, 5ml, 10ml, 20ml,30ml, 50ml | 1ml | Seecomment#2 |
| Needle Gauge | 18G, 21G, 22G, 23G, 25G | 21G, 22G, 23G, 25G | Seecomment#3 |
| Needle Length | Available in 3/8", 1/2", 5/8",3/4", 1", 1 1/4", 1 1/2" | Available in 5/8", 1" | Seecomment#3 |
| Wall Type | TW | TW, RW | Seecomment#4 |
| Bevel Design | Long bevel,bevel angle: 13° | Long bevel,bevel angle: 13° | Same |
| Maximum low dead spacevolume specification | <0.07ml | <0.015mL | Seecomment#6 |
| Performance Test | Complied withISO 7886-1,ISO 7864ISO 9626ISO 80369-7 | Complied withISO 7886-1,ISO 7864,ISO 9626 | Seecomment#5 |
| Material | |||
| Barrel | Polypropylene (PP) | Polypropylene (PP) | See |
| Plunger | Polypropylene (PP) | Polypropylene (PP) | comment#7 |
| Piston | Polyisoprene | Polyisoprene | |
| Needle tube | Stainless steel (SUS304) | Stainless steel (SUS304) | |
| Needle cap | Polypropylene (PP) | Polypropylene (PP) | |
| Jointing medium | Methyl methacrylateacrylonitrile butadiene styrene(MABS) | Acrylonitrile butadiene styrene(ABS) | |
| Outer retractable cartridge | Polycarbonate (PC) | Polycarbonate (PC) | |
| Middleretractablecartridge | Polycarbonate (PC) | Polycarbonate (PC) | |
| Inner retractable cartridge | Polycarbonate (PC) | Polycarbonate (PC) | |
| Lubricant | Silicon plastic agent | Silicon plastic agent | |
| Adhesive | UV Light Cure Adhesive | UV Light Cure Adhesive | |
| Biocompatibility | |||
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same |
| Irritation | No intracutaneous reactivity | No intracutaneous reactivity | |
| Sensitization | No sensitization | No sensitization | |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | |
| Hemolysis | No Hemolysis | No Hemolysis | |
| Pyrogen | No Pyrogen | No Pyrogen | |
| Complement Activation | Not show potentials to activate complete system | Not show potentials to activate complete system | |
| In vivo Thrombogenicity | No thrombogenicity | No thrombogenicity | |
| Sterilization | |||
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20EU | 20EU | Same |
Table 1 Comparison of Technology Characteristics
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Discussion of differences in Technological characteristics Comment 1- Configuration
The configuration between proposed device and predicate is different. However, the basic configurations are same, both of them include barrel, plunger, piston, needle, needle cap, retractable cartridge and jointing medium. The only different is that the proposed device has a fixed needle, so there is no needle hub. Whether there is a needle hub does not affect the use of the device. Therefore, the difference on configuration will not raise new questions on safety and effectiveness of the proposed device.
Comment 2- Syringe Volume
The syringe volume for proposed device is covered by predicate device syringe volume. This difference will not raise new questions on safety and effectiveness of the proposed device.
Comment 3-Needle Gauge and Needle Length
The needle gauge and needle length of predicate device is more than proposed device, and for proposed device, the needle gauge and needle length are covered by predicate device. This difference will not raise new questions on safety and effectiveness of the proposed device.
Comment 4-Wall Type
The wall type between proposed device and predicate device is different, the proposed device has two wall types: normal wall and thin wall, while the predicate device only has thin wall. This difference will not raise new questions on safety and effectiveness of the proposed device.
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Comment 5-Performance Test
The proposed device is syringe with fixed needle, so the ISO 80369-7 connector test of proposed device is not applicable. This difference will not raise new questions on safety and effectiveness of the proposed device.
Comment 6-Maximum low dead space volume specification
The maximum low dead space volume specification of predicate device is greater than proposed device. Smaller dead cavities have smaller resulting in less fluid loss. In addition, the dead space volume has been evaluated and test results comply with ISO 7886. Therefore, this difference will not raise new questions on safety and effectiveness of the proposed device.
The dead volume specification is comparable to the reference devices' dead volume specifications (syringe and needle combined dead space) and were used as a reference value for adding the QNQ and QNS product codes. Performance data supported the specification of <0.015 mL maximum dead space.
Comment 7- Material
The material for the propose device is different from predicate device. This difference will not raise new questions on safety and effectiveness of the proposed device.
-
- Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate device. The testing included the following items:
- Non-Clinical Test Conclusion
Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device. The test results show that the device conforms with the requirements of related standards.
| Test | STANDARD |
|---|---|
| Needle Performance | ISO7864:2016 Fourth edition; Sterile hypodermic needles for single use-Requirements and Test methodsISO 9626 Second edition: Stainless steel needle tubing for the manufacture ofmedical devices- Requirements and test methods. |
| Syringe Performance | ISO 7886 Second edition: Sterile Hypodermic syringes for single use- Syringes formanual use. |
| Sharp InjuryProtection | ISO 23908 First edition: Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers forcatheters and needles used for blood sampling |
Simulated Clinical Study
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A simulated clinical study was performed on proposed device according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908:2011 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
Safety Feature Test
The safety feature test was performed on both proposed device and predicate device to determine its safety feature. The results demonstrated that both the proposed device and predicate device meet the acceptance criteria.
Biocompatibility testing
In accordance with ISO10993-1 the syringe and needle are classified as: Externally Communicating Device, Blood Path Indirect, Limited Contact (< 24hrs). The following testing was conducted:
- Cytotoxicity ●
- Irritation ●
- Skin Sensitization ●
- . Acute Systemic Toxicity
- . Material-Mediated Pyrogenicity
- Hemocompatibility
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
The proposed device sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 106). EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 20 EU/device in accordance with USP <85>. Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 3 year shelf-life.
- . Package integrity test - after environmental conditioning, simulated transportation testing in accordance to ASTM D4169-16 on final, packaged, and sterile device.
- . Sterile Barrier Packaging performed on the proposed device:
- Seal Strength ASTM F88/F88-15 o
- Dye penetration ASTM F1929-15 o
. Shelf-life of 3-years is validated using FDA recognized standard ASTM F 1980 -16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
-
- Clinical Test Conclusion
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No clinical study is included in this submission.
- Conclusion 9.
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 Fixed Safety Needle for Single Use is substantially equivalent to the Sterile Syringe with Safety needle for Single Use 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).