(191 days)
No
The device description and performance studies focus on the mechanical and material properties of a syringe and needle with a manual safety mechanism. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making.
No.
The device is a syringe and needle intended for aspiration and injection of fluids, which are procedures for delivering or removing substances, not for treating a disease or condition itself.
No
The device is a sterile syringe with a fixed safety needle, intended for aspirating and injecting fluids. Its purpose is to deliver or withdraw substances, not to provide diagnostic information about a patient's condition.
No
The device is a physical syringe with a needle and safety mechanism, not a software application. The 510(k) summary describes hardware components and physical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "aspiration of fluids for medical purpose" and "aspirate and inject of fluids for medical purpose." This describes a device used for collecting or administering substances within the body, not for testing samples outside the body.
- Device Description: The description focuses on the physical components (syringe, needle, safety mechanism) and their function in aspiration and injection. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical, mechanical, chemical, and safety aspects of the syringe and needle, as well as biocompatibility and sterility. These are typical tests for devices used for fluid handling in the body, not for diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, etc.), detecting specific analytes, or providing diagnostic results.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device's function is purely for the physical act of moving fluids into or out of the body.
N/A
Intended Use / Indications for Use
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.
Product codes
MEG, QNQ, QNS
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 |
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
Not Found
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
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:
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 methods ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical devices- Requirements and test methods. |
| Syringe Performance | ISO 7886 Second edition: Sterile Hypodermic syringes for single use- Syringes for manual use. |
| Sharp Injury Protection | ISO 23908 First edition: Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
Simulated Clinical Study: 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 (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 10-6. 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 . 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
- Dye penetration ASTM F1929-15
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features an abstract image of a human figure. To the right of this is the FDA logo, which has the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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) | ||
|---|---|---|---|
| --------------- | ------------------------------------------------------------ | --------------- | ----------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
4
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
5
-
- 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 Safety | |||
| needle for Single Use | |||
| K192679 | Sterile Syringe with Fixed | ||
| Safety Needle for Single Use | |||
| K212652 | |||
| 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 | Barrel | ||
| Plunger | |||
| Piston | |||
| Needle cap | |||
| Needle tube | |||
| Retractable cartridge | |||
| Jointing medium | |||
| Needle hub | Barrel | ||
| Plunger | |||
| Piston | |||
| Needle cap | |||
| Needle tube | |||
| Retractable cartridge | |||
| Jointing 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 | See | |
| comment#2 | |||
| Needle Gauge | 18G, 21G, 22G, 23G, 25G | 21G, 22G, 23G, 25G | See |
| comment#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" | See | |
| comment#3 | |||
| Wall Type | TW | TW, RW | See |
| comment#4 | |||
| Bevel Design | Long bevel, | ||
| bevel angle: 13° | Long bevel, | ||
| bevel angle: 13° | Same | ||
| Maximum low dead space | |||
| volume specification | 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 . 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
10
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.