(197 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI or ML.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device is a syringe and needle, used for the aspiration and injection of fluids, which are procedural actions, not therapeutic treatments in themselves.
No
The device is a syringe and safety needle intended for aspiration and injection of fluids, not for diagnostic purposes. Its use is limited to fluid management, and there is no mention of analysis or assessment of medical conditions.
No
The device description clearly outlines physical components like syringes, needles, pistons, barrels, plungers, and safety mechanisms, indicating it is a hardware medical device. There is no mention of software as a component or the primary function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "aspiration and injection of fluids for medical purpose." This describes a procedure performed on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description details the physical components of a syringe and needle, designed for delivering or withdrawing fluids from the body. There is no mention of analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, pathogens, etc.)
- Providing diagnostic information about a patient's health status.
The device is clearly intended for direct patient care procedures involving fluid management, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Sterile Syringe with 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 after use to minimize risk of accidental needlesticks.
Sterile Syringe for Single Use is a sterile luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
Sterile Safety Needle for Single Use is intended to be used with a luer lock syringe for 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.
Product codes (comma separated list FDA assigned to the subject device)
MEG, FMF, FMI
Device Description
Sterile Syringe with 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 (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.
Syringe volume: 1ml, 2ml, 5ml, 10ml, 20ml, 30ml, and 50ml;
Needle specification:
Needle Gauge: 18G, 21G, 22G, 23G, 25G
Length: 3/8", 1/2", 5/8", 3/4", 1", 1 1/4", 1 1/2"
Wall type: Thin wall
The Sterile Syringe for Single Use is intended for manual and single use only, which consists of piston, barrel and plunger. The proposed device is available in a variety syringe volume. The syringe is available in luer lock, which is intended to be connected with a hypodermic needle.
Syringe volume: 1ml, 2ml, 5ml, 10ml, 20ml, 30ml, and 50ml;
Sterile 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 needle tube, retractable cartridge, jointing medium and needle hub. The proposed device is available in variety of needle gauge and needle length. According to the needle length, the safety mechanism is available in 2-part cartridge (outer retractable cartridge and inner retractable cartridge) and 3-part cartridge (outer retractable cartridge, middle retractable cartridge and inner retractable cartridge). The proposed device is compatible for use with a luer lock syringe. 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. Needle specification is same as the needle size of Sterile Syringe with Safety needle for Single Use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Conclusion:
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The testing included the following items:
Physical, Mechanical, Chemical testing according to standards such as ISO 7886-1:2017, ISO 7864:2016, ISO 9626:2016. The test results show that the device conforms with the requirements of related standards.
Sterile barrier packaging testing were performed, including visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity.
Sterilization and shelf life testing were performed. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.
Biocompatibility testing: The contact level of the proposed device is blood path, indirect, and the contact duration is limited contact (
§ 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 contains 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 stacked format.
April 10, 2020
Gemtier Medical (Shanghai) Inc. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 Cn
Re: K192679
Trade/Device Name: Sterile Syringe with Safety Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG. FMF. FMI Dated: February 26, 2020 Received: March 12, 2020
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
1
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 CPT 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) K192679
Device Name
Sterile Syringe with Safety needle for Single Use Sterile Syringe for Single Use Sterile Safety Needle for Single Use
Indications for Use (Describe)
Sterile Syringe with 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 after use to minimize risk of accidental needlesticks.
Sterile Syringe for Single Use is a sterile luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
Sterile Safety Needle for Single Use is intended to be used with a luer lock syringe for 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K192679
-
- Date of Preparation: 04/09/2020
-
- 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: lenny.cao@gemtier.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119. Shanghai, 200120. China
Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Sterile Syringe with Safety needle for Single Use Sterile Syringe for Single Use Sterile Safety Needle for Single Use
Regulatory Information Classification Name: Syringe Antistick Classification: II; Product Code: MEG Regulation Number: 21CFR 880.5860 Review Panel: General Hospital;
Classification Name: Syringe, Piston Classification: II; Product Code: FMF Regulation Number: 21CFR 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
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 for Single Use is a sterile luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
Sterile Safety Needle for Single Use is intended to be used with a luer lock syringe for 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.
5
Device Description:
Sterile Syringe with 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 (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.
| Needle Gauge | Length | Wall type |
|---|---|---|
| 18G | 1", 1 1/4", 1 1/2" | Thin wall |
| 21G | 1/2", 5/8", 1", 1 1/4", 1 1/2" | Thin wall |
| 22G | 1/2", 5/8", 1", 1 1/4", 1 1/2" | Thin wall |
| 23G | 1/2", 5/8", 3/4", 1", 1 1/4", 1 1/2" | Thin wall |
| 25G | 3/8", 1/2", 5/8", 3/4", 1", 1 1/4", 1 1/2" | Thin wall |
Syringe volume: 1ml, 2ml, 5ml, 10ml, 20ml, 30ml, and 50ml; Needle specification:
The Sterile Syringe for Single Use is intended for manual and single use only, which consists of piston, barrel and plunger. The proposed device is available in a variety syringe volume. The syringe is available in luer lock, which is intended to be connected with a hypodermic needle. Syringe volume: 1ml, 2ml, 5ml, 10ml, 20ml, 30ml, and 50ml;
Sterile 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 needle tube, retractable cartridge, jointing medium and needle hub. The proposed device is available in variety of needle gauge and needle length. According to the needle length, the safety mechanism is available in 2-part cartridge (outer retractable cartridge and inner retractable cartridge) and 3-part cartridge (outer retractable cartridge, middle retractable cartridge and inner retractable cartridge). The proposed device is compatible for use with a luer lock syringe. 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. Needle specification is same as the needle size of Sterile Syringe with Safety needle for Single Use.
- న్. Identification of Predicate Device
510(k) Number: K170651 Product Name: Sterile Disposable Syringe With Safety Needle; Sterile Disposable Syringe With Needle; Sterile Disposable Syringe; Sterile Disposable Safety Needle; Sterile Disposable Needle
6
6. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was 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.
| General requirements | Clause 5 of ISO 7886-1:2017 |
|---|---|
| Extraneous matter | Clause 6 of ISO 7886-1:2017 |
| Lubricant | Clause 7 of ISO 7886-1:2017 |
| Tolerance on graduated capacity | Clause 8 of ISO 7886-1:2017 |
| Graduated scale | Clause 9 of ISO 7886-1:2017 |
| Barrel | Clause 10 of ISO 7886-1:2017 |
| Piston/plunger assembly | Clause 11 of ISO 7886-1:2017 |
| Nozzle | Clause 12 of ISO 7886-1:2017 |
| Performance | Clause 13 of ISO 7886-1:2017 |
| Cleanliness | Clause 4.3 of ISO 7864:2016 |
| Limits for acidity or alkalinity | Clause 4.4 of ISO 7864:2016 |
| Limits for extractable metals | Clause 4.5 of ISO 7864:2016 |
| Size designation | Clause 4.6 of ISO 7864:2016 |
| Colour coding | Clause 4.7 of ISO 7864:2016 |
| Needle hub | Clause 4.8 of ISO 7864:2016 |
| Needle Cap | Clause 4.9 of ISO 7864:2016 |
| Needle tube | Clause 4.10 of ISO 7864:2016 |
| Needle point | Clause 4.11 of ISO 7864:2016 |
| Bond between hub and needle tube | Clause 4.12 of ISO 7864:2016 |
| Patency of lumen | Clause 4.13 of ISO 7864:2016 |
| Surface finish and appearance | Clause 5.2 of ISO 9626:2016 |
| Cleanliness | Clause 5.3 of ISO 9626:2016 |
| Limits for acidity and alkalinity | Clause 5.4 of ISO 9626:2016 |
| Size designation | Clause 5.5 of ISO 9626:2016 |
| Dimensions | Clause 5.6 of ISO 9626:2016 |
| Stiffness | Clause 5.8 of ISO 9626:2016 |
| Resistance to breakage | Clause 5.9 of ISO 9626:2016 |
| Resistance to corrosion | Clause 5.10 of ISO 9626:2016 |
Sterile barrier packaging testing were performed on the proposed device, which include visual
7
inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity.
Sterilization and shelf life testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP 38-NF 33 |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Test |
| were performed on aging samples to verify the | |
| claimed shelf life of the device |
Biocompatibility testing
The contact level of the proposed device is blood path, indirect, and the contact duration is limited contact ( Cytotoxicity,
- A Sensitization,
-
Intracutaneous reactivity,
-
Acute Systemic Toxicity,
-
Hemolysis.
-
Complement activation,
-
Thromboresistance study
- A Pyrogen
-
Particulate testing
Simulated Clinical Study
A simulated clinical study was performed on proposed device according to FDA 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
8
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.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
9
8. Substantially Equivalent (SE) Comparison
Table 1 Comparison of Technology Characteristics for Sterile Syringe with Safety needle for Single Use
| ITEM | Subject Device K192679 | Predicate Device K170651 | Comments |
|---|---|---|---|
| Regulation No. | 21CFR 880.5860 | 21CFR 880.5860 | Same |
| Product Code | MEG | MEG | Same |
| 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. | The Sterile Disposable Syringe with Safety Needle 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 shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks | Same |
| Configuration and material | Barrel (Polypropylene, PP) | ||
| Plunger (Polypropylene, PP) | |||
| Piston (Polyisoprene, Carbon Black) | |||
| Needle cap (Polypropylene, PP) | |||
| Needle tube (Stainless steel) | |||
| Retractable cartridge (Polycarbonate, PC) | |||
| Jointing medium (Methyl methacrylate acrylonitrile butadiene styrene (MABS) | |||
| Needle hub (Polycarbonate, PC) | |||
| Needle tube (Stainless steel SUS304) | |||
| Lubricant (Silicon plastic agent) | |||
| Adhesive (UV Light Cure Adhesive) | |||
| Colorants (MACROLEX Orange 3G, Heliogen Blue K 7090, BAYFERROX 318M, Heliogen Green K 8730, Ranbar | Barrel (Polypropylene, PP) | ||
| Plunger (Polypropylene, PP) | |||
| Piston (Polyisoprene) | |||
| Needle hub (Polypropylene, PP) | |||
| Protective cap (Polypropylene, PP) | |||
| Needle tube (Stainless steel) | |||
| Safety sheath (Polypropylene, PP) | |||
| Needle tube (stainless steel SUS304) | |||
| Needle tube (Stainless Steel SUS304) | |||
| Lubricant (Silicone oil) | |||
| Adhesive (UV glue) | |||
| Colorants (Yellow, Red, White, Black, Blue, Green) | 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. | Slide over the needle to prevent from needle sticks | See Comment #2 |
| Label/labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Syringe Volume | 1ml, 2ml, 5ml, 10ml, 20ml, 30ml, 50ml | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml | See Comment #3 |
| Connect Type | Luer lock | Luer lock and Luer slip | See Comment #4 |
| Needle Gauge | 18G, 21G, 22G, 23G, 25G | 16G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | See Comment #5 |
| Needle Length | Available in 3/8", 1/2", 5/8", 3/4", 1", 1 1/4", 1 1/2" | Available in 5/16", 1/2", 5/8", 3/4", 1 1/4", 1 1/2" | See Comment #6 |
| Single Use | Single Use | Single Use | Same |
| Sterilization | |||
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20EU | 20EU | Same |
10
11
Discussion of Differences
Comment 1
The configuration between proposed device and predicate device is different. However, the basic configurations are same, both of them include barrel, plunger, piston, needle hub, protective or needle cap. The only different is retractable cartridge, jointing medium and safety sheath, which are parts of safety mechanism, and predicate device lubricant adhesive and colorant information unknown. Additionally, the safety mechanism does affect the indication for use. Therefore, this difference does not affect substantially equivalence.
The material of configuration is different between proposed device and predicate device. However, the mainly configurations such as barrel, plunger, piston, needle/protective cap are made of same materials. The only differences are the material of needle hub, safety feature, lubricant, adhesive and colorant. And the MSDS for all related materials has been provided in this submission. Differences in materials of construction are addressed through ISO 10993-1: biocompatibility testing. Additionally, the material of configuration does not affect the indication for use. Therefore, this difference does not affect substantially equivalence.
Comment 2
The safety feature between proposed device and predicate device is different. The safety mechanism for proposed device is retractable cartridge, for predicate, that is safety sheath. Both of them are intended to prevent from needle stick injuries, and which does not affect indication for use. In addition, the safety feature for proposed device has been evaluated and the test result conforms to requirements of ISO 23908:2011 standard. Therefore, this difference does not affect substantially equivalence.
Comment 3
The predicate device has more specification of syringe volume compared predicate device. However, the different syringe volume will be selected by physician per injection requirement and this difference does not affect indication for use. Additionally, the performance of syringe has been evaluated and the test results met the requirements of ISO 7886-1. Therefore, this difference does not affect substantially equivalency on safety and effectiveness.
Comment 4
The connect type between proposed device and predicate device is different. For proposed device, only includes Luer lock, for predicate device, the connect type includes Luer lock and Luer slip. However, the connect type for proposed device is covered by predicate, and the connect type is only used to compatible with needle, and does not affect indication for use. Additionally, the performance of Luer lock has been evaluated and the test results met the requirements of ISO 80369-7.
Comment 5
The needle gauge of predicate device is more than proposed device, and for proposed device, the needle
12
gauge is covered by predicate device. However, this difference is just in needle size. In addition, all the needle gauge of proposed device has been tested. The test results comply with ISO 7864 and ISO 9626. The different specifications are selected by physician according to the patient's conditions. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.
Comment 6
The needle length for proposed device is covered by predicate device. The different length of needles will be selected by physician according different patient's condition, the needle performance has been evaluated and test results comply with ISO 7864 and ISO 9626. This different does not affect the performance of the syringe. Therefore, this difference is considered not to affect substantially equivalency between proposed device and predicate device.
13
| ITEM | Subject Device K192679 | Predicate Device K170651 | Comments |
|---|---|---|---|
| Regulation No. | 21CFR 880.5860 | 21CFR 880.5860 | Same |
| Product Code | FMF | FMF | Same |
| Class | II | II | Same |
| Indication for Use | Sterile Syringe for Single Use is a sterile luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose. | The Sterile Disposable Syringe is a sterile luer lock or luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose. | See Comment #7 |
| Configuration and material | Barrel (Polypropylene, PP) | ||
| Plunger (Polypropylene, PP) | |||
| Piston (Polyisoprene, carbon black) | |||
| Lubricant (Silicon plastic agent) | |||
| Adhesive (UV Light Cure Adhesive) | Barrel (Polypropylene, PP) | ||
| Plunger (Polypropylene, PP) | |||
| Piston (Polyisoprene) | |||
| Needle tube (Stainless Steel SUS304) | |||
| Lubricant (Silicone oil) | |||
| Adhesive (UV glue) | See Comment #8 | ||
| Operation Mode | For manual use only | For manual use only | Same |
| Label/labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Syringe Volume | 1ml, 2ml, 5ml, 10ml, 20ml, 30ml, 50ml | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml | See Comment #9 |
| Connect Type | Luer lock | Luer lock and Luer slip | See Comment #10 |
| Single Use | Single Use | Single Use | Same |
| Sterilization Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20EU | 20EU | Same |
| Table 2 Comparison of Technology Characteristics for Sterile Syringe for Single Use | ||
|---|---|---|
| ------------------------------------------------------------------------------------- | -- | -- |
14
Discussion of Differences
Comment 7
There are some subtle differences in indication for use between proposed device and predicated device. The difference is connect type. For proposed device, only has Luer lock, while for predicate device, has Luer lock and Luer slip (See Comment 10). And the type connect of proposed device is covered by predicate device. In addition, the connect type is only used to compatible with needle, and does not affect aspiration and injection of fluids. The results demonstrated that this difference does not raise new problem on the safety and effectiveness of the proposed device. Therefore, this difference does not affect substantially equivalence.
Comment 8
The configuration between proposed device and predicate device is different. However, the basic configurations are same, both of them include barrel, plunger, and piston. The material of configuration is different between proposed device and predicate device. However, the mainly configurations such as barrel, plunger and piston are made of same materials. And the MSDS for all related materials has been provided in this submission. Differences in materials of construction are addressed through ISO 10993-1: biocompatibility testing. Additionally, the material of configuration does not affect the indication for use. Therefore, this difference does not affect substantially equivalence.
Comment 9
The predicate device has more specification of syringe volume compared predicate device. However, the different syringe volume will be selected by physician per injection requirement and this difference does not affect indication for use. Additionally, the performance of syringe has been evaluated and the test results met the requirements of ISO 7886-1. Therefore, this difference does not affect substantially equivalency on safety and effectiveness.
Comment 10
The connect type between proposed device and predicate device is different. For proposed device, only includes Luer lock, for predicate device, the connect type includes Luer lock and Luer slip. However, the connect type for proposed device is covered by predicate, and the connect type is only used to compatible with needle, and does not affect indication for use. Additionally, the performance of Luer lock has been evaluated and the test results met the requirements of ISO 80369-7.
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| ITEM | Subject Device K192679 | Predicate Device K170651 | Comments | ||||
|---|---|---|---|---|---|---|---|
| Regulation No. | 21CFR 880.5570 | 21CFR 880.5570 | Same | ||||
| Product Code | FMI | FMI | Same | ||||
| Class | II | II | Same | ||||
| Indication for Use | Sterile Safety Needle for Single Use is intended to be used with a luer lock syringe for 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. | The Sterile Disposable Safety Needle is intended for use with a luer slip or luer lock syringe for aspiration and injection 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 needlestick | See Comment #11 | ||||
| Configuration and material | Needle cap (Polypropylene, PP) | ||||||
| Needle tube (Stainless steel) | |||||||
| Retractable cartridge (Polycarbonate, PC) | |||||||
| Jointing medium (Methyl methacrylate acrylonitrile butadiene styrene (MABS) | |||||||
| Needle hub (Polycarbonate, PC) | |||||||
| Needle tube (Stainless Steel SUS304) | |||||||
| Lubricant (Silicon plastic agent) | |||||||
| Adhesive (UV Light Cure Adhesive) | |||||||
| Colorants (MACROLEX Orange 3G, Heliogen Blue K 7090, BAYFERROX 318M, Heliogen Green K 8730, Ranbar red P1400) | Needle hub (Polypropylene, PP) | ||||||
| Protective cap (Polypropylene, PP) | |||||||
| Needle tube (Stainless steel) | |||||||
| Safety sheath (Polypropylene, PP) | |||||||
| Needle tube (Stainless Steel SUS304) | |||||||
| Lubricant (Silicone oil) | |||||||
| Adhesive (UV glue) | |||||||
| Colorants (Yellow, Red, White, Black, Blue, Green) | See Comment #12 | ||||||
| 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 | Slide over the needle to prevent from needle sticks | |
| 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 | Slide over the needle to prevent from needle sticks | |
| 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 | Slide over the needle to prevent from needle sticks | |
| 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 | Slide over the needle to prevent from needle sticks | |
| 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 | Slide over the needle to prevent from needle sticks | See Comment #13 |
| Table 3 Comparison of Technology Characteristics for Sterile Safety needle for Single Use | |||
|---|---|---|---|
| ------------------------------------------------------------------------------------------- | -- | -- | -- |
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| Label/labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same | |
|---|---|---|---|---|
| Connect Type | Luer lock | Luer lock and Luer slip | See | |
| Comment | ||||
| #14 | ||||
| Needle Gauge | 18G, 21G, 22G, 23G, 25G | 16G, 18G, 19G, 20G, 21G, 22G, | ||
| 23G, 24G, 25G, 26G, 27G, 28G, | ||||
| 29G, 30G | See | |||
| Comment | ||||
| #15 | ||||
| Needle Length and wall | ||||
| type | Available in 3/8", 1/2", 5/8", | |||
| 3/4", 1", 1 1/4", 1 1/2" | ||||
| Wall type: TW | Available in 5/16", 1/2", 5/8", | |||
| 3/4", 1 1/4", 1 1/2" | ||||
| Wall type: TW or RW | See | |||
| Comment | ||||
| #16 | ||||
| Single Use | Single Use | Single Use | ||
| Sterilization | ||||
| Method | EO Sterilized | EO Sterilized | Same | |
| SAL | 10-6 | 10-6 | Same | |
| Endotoxin Limit | 20EU | 20EU | Same |
Discussion of Differences
Comment11
The only difference for predicate device and proposed device is connect type. For proposed device, only has Luer lock, while for predicate device, has Luer slip (See Comment 14). The type connect of proposed device is covered by predicate device. In addition, the connect type is only used to compatible with syringe, and does not affect aspiration and injection of fluids. Additionally, both of them have safety feature. 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 results demonstrated that this difference does not raise new problem on the safety and effectiveness of the proposed device. Therefore, this difference does not affect substantially equivalence.
Comment 12
The configuration between proposed device and predicate device is different. However, the basic configurations are same, both of them include, protective or needle tube, and needle hub. The only different is retractable cartridge, jointing medium and safety sheath, which are parts of safety mechanism. Additionally, the safety mechanism does affect the indication for use and is just used to prevent from needle sticks. Therefore, this difference does not affect substantially equivalence.
The material of configuration is different between proposed device and predicate device. However, the mainly configurations such as needle tube, needle/protective cap are materials. The only differences are the material of needle hub, safety feature, adhesive and colorant. However, these configurations not contact with patient, and the materials are not novel materials. And the MSDS for all related materials has been provided in this submission. Differences in materials of construction are addressed through ISO 10993-1: biocompatibility testing. Additionally, the material of configuration does not affect the
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indication for use. Therefore, this difference does not affect substantially equivalence.
Comment 13
The safety feature between proposed device and predicate device is different. The safety mechanism for proposed device is retractable cartridge, for predicate, that is safety sheath. Both of them are intended to prevent from needle stick injuries, and which does not affect indication for use. In addition, simulated clinical use testing per FDA guidance Medical Devices with Sharps Injury Prevention Features. The simulated clinical test demonstrated that the safety features were found to meet the predetermined requirements and were acceptable. .Therefore, this difference does not affect substantially equivalence
Comment 14
The connect type between proposed device and predicate device is different. For proposed device, only includes Luer lock, for predicate device, the connect type includes Luer lock and Luer slip. However, the connect type for proposed device is covered by predicate, and the connect type is only used to compatible with needle, and does not affect indication for use. Additionally, the performance of Luer lock has been evaluated and the test results met the requirements of ISO 80369-7.
Comment 15
The needle gauge of predicate device is more than proposed device, and for proposed device, the needle gauge is covered by predicate device. However, this difference is just in needle size. In addition, all the needle gauge of proposed device has been tested. The test results comply with ISO 7864 and ISO 9626. The different specifications are selected by physician according to the patient's conditions. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.
Comment 16
The needle length and wall type for proposed device is covered by predicate device. The different length of needles and wall type will be selected by physician according different patient's condition. In addition, the needle performance has been evaluated and test results comply with ISO 7864 and ISO 9626. This different does not affect the performance of the syringe. Therefore, this difference is considered not to affect substantially equivalency between proposed device and predicate device.
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9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.