(88 days)
Not Found
No
The device description and intended use are for standard syringes and needles with a safety mechanism, and there is no mention of AI or ML in the provided text.
No.
The device is used to inject medicines and vaccines or withdraw fluids, which are actions associated with diagnostic or procedural support, not direct therapeutic treatment.
No
The device is a syringe with various types of needles, used for injecting medicines/vaccines or withdrawing fluids, or for aspiration from medicine vials. Its function is to administer or collect substances, not to diagnose a condition.
No
The device description clearly outlines physical components (syringe, needle, safety mechanism) and mentions sterilization and physical performance testing, indicating it is a hardware device. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "inject medicines and vaccines into, or withdraw fluids from, the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes on the patient.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a syringe and needle system designed for injecting and withdrawing fluids directly from the body. There is no mention of analyzing samples or performing tests on specimens outside the body.
The device described is a medical device used for administering substances or collecting samples directly from a patient, which falls under the category of general medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Luer Lock Syringe with Exchangeable Needle is used to inject medicines and vaccines into, or withdraw fluids from. the body.
The Luer Lock Syringe with Safety Needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
The Luer Lock Syringe with Blunt Fill Needle is used for aspiration from multi-dose medicine vials.
Product codes (comma separated list FDA assigned to the subject device)
FMF, MEG, FMI
Device Description
The Luer Lock Syringe with Exchangeable Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.
The Luer Lock with Safety Needle is a syringe and needle combination with the safety needle. It contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Safety needle can be pre-attached or aside the syringe.
The Luer Lock Syringe with Blunt Fill Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle. It is used for aspiration from multi-dose medicine vials.
The proposed devices are offered in various gauge sizes and length.
The proposed devices are available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.
The device is for medical professionals use only and for prescription use only.
-
Luer Lock Syringe with Safety Needle (Syringe range: 1ml, 3ml, 5ml,10ml; Needle range: 20G, 21G, 23G, 25G; Needle length from 5/8" to 1 1/2"). The Safety needle can be pre-attached or aside the syringe.
-
Luer Lock Syringe with Exchangeable Needle (Syringe range: 3ml, 5ml, 10ml, Needle range: 20G, 21G, 22G, 23G, 25G; Needle length from 5/8" to 1 1/2").
-
Luer Lock Syringe with Blunt Fill Needle (Syringe range: 3ml, 5ml, 10ml, Needle: 18G, Needle length:1 1/2").
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
medical professionals / 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 Performance Data
To verify that the proposed devices are as safe and effective as the predicate device, representative samples of the proposed device underwent a series of tests including bench testing (syringe and needle performance testing), and biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen, and hemolysis). The test results demonstrated that the proposed device complies with the following standards:
- A ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
- ISO 7864:2016, Sterile hypodermic needles for single use.
- ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices.
- A ISO 10993-5: 2009(R), Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
- A ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- A ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- A ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of A Materials
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical A Package by Dye Penetration
- USP Bacterial Endotoxins Test
- USP Pyrogen Test
- USP Particulate Matter Test
- ISTA 3A Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less.
Clinical Performance Data
No data from human clinical studies have been included to support the substantial equivalence of the proposed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 20, 2024
Sol-Millennium Medical Inc. % Alice Huang, RA manager Shanghai Mind-link Consulting Co., Ltd. 377 Tianzhu Road, Jiading Shanghai, 201821, China
Re: K241821
Trade/Device Name: Luer Lock Syringe with Safety Needle: Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG, FMI Dated: June 18, 2024 Received: September 4, 2024
Dear Alice Huang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Shruti N. Mistry -S
Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241821
Device Name
Luer Lock Syringe with Safety Needle Luer Lock Syringe with Exchangeable Needle Luer Lock Syringe with Blunt Fill Needle
Indications for Use (Describe)
The Luer Lock Syringe with Exchangeable Needle is used to inject medicines and vaccines into, or withdraw fluids from. the body.
The Luer Lock Syringe with Safety Needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
The Luer Lock Syringe with Blunt Fill Needle is used for aspiration from multi-dose medicine vials.
| 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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4
Image /page/4/Picture/0 description: The image shows the logo for Sol M, which is a company focused on building a healthier tomorrow. The logo features a green circle and the text "Sol M" in a dark green font. To the right of the company name is the text "Building a Healthier Tomorrow" in a smaller, lighter font.
K241821 510(K) Summary
1. Preparation date: September 20, 2024
2. Submitter
Address: 311 S Wacker Drive, Suite 4100, Chicago, Illinois, 60606, United States Contact person: Manu Kalia, Global QARA Director, +1 847-313-9577, mkalia@solm.com Submission correspondent: Alice Alice Huang, RA Manager, +86-15618536177, alice.huang@mind-link.net
3. Device
Common name:
Luer Lock Syringe with Safety Needle
Luer Lock Syringe with Exchangeable Needle
Luer Lock Syringe with Blunt Fill Needle
Trade name:
Sol-Care Luer Lock Syringe with Safety Needle
Sol-M Luer Lock Syringe with Exchangeable Needle
Sol-M Luer Lock Syringe with Blunt Fill Needle
Regulatory Information:
Classification Name: Syringe, Piston
Classification: II Product Code: FMF
Regulation Number: 21CFR 880.5860
Review Panel: General Hospital;
Classification Name: Syringe, Antistick Classification: II Product Code: MEG
5
Image /page/5/Picture/0 description: The image is a logo for Sol M. The logo features an orange circle on the left, followed by the word "Sol" in green, and then the letter "M" in green. To the right of the "M" are the words "Building a Healthier Tomorrow" in a smaller font. The logo is simple and modern, and the colors are bright and inviting.
Regulation Number: 21CFR 880.5860 Review Panel: General Hospital;
Classification Name: Needle, Hypodermic, Single Lumen Classification: II Product Code: FMI Regulation Number: 21CFR 880.5570 Review Panel: General Hospital
4. Predicate device
K221247 Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
5. Device description
The Luer Lock Syringe with Exchangeable Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.
The Luer Lock with Safety Needle is a syringe and needle combination with the safety needle. It contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Safety needle can be pre-attached or aside the syringe.
The Luer Lock Syringe with Blunt Fill Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle. It is used for aspiration from multi-dose medicine vials.
The proposed devices are offered in various gauge sizes and length.
The proposed devices are available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.
The device is for medical professionals use only and for prescription use only.
-
Luer Lock Syringe with Safety Needle (Syringe range: 1ml, 3ml, 5ml,10ml; Needle range: 20G, 21G, 23G, 25G; Needle length from 5/8" to 1 1/2"). The Safety needle can be pre-attached or aside the syringe.
-
Luer Lock Syringe with Exchangeable Needle (Syringe range: 3ml, 5ml, 10ml, Needle range: 20G, 21G, 22G, 23G, 25G; Needle length from 5/8" to 1 1/2").
-
Luer Lock Syringe with Blunt Fill Needle (Syringe range: 3ml, 5ml, 10ml, Needle: 18G,
6
Image /page/6/Picture/0 description: The image shows the logo for Sol M. The logo consists of an orange circle, followed by the text "Sol M" in green. To the right of the "M" is the text "Building a Healthier Tomorrow" in a smaller font size. The logo is simple and modern, and the colors are bright and inviting.
Needle length:1 1/2").
6. Indications for use/Intended use
The Luer Lock Syringe with Exchangeable Needle is used to inject medicines and vaccines into, or withdraw fluids from, the body.
The Luer Lock Syringe with Safety Needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
The Luer Lock Syringe with Blunt Fill Needle is used for aspiration from multi-dose medicine vials.
7. Summary of Technology Characteristics
Table 1. Substantial equivalent comparison of Standard Luer Lock Syringe with Safety Needle
| Item | Proposed Device
Luer Lock Syringe with
Safety Needle | Predicate Device
Sterile Disposable Syringe
with Safety Needle | Remark | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------|
| K number | K241821 | K221247 | | |
| Classification | Class II | Class II | Same | |
| Product Code | FMF
FMI
MEG | FMF
FMI
MEG | Same | |
| Regulation
Number | 21 CRF 880.5860
21 CRF 880.5570 | 21 CRF 880.5860
21 CRF 880.5570 | Same | |
| Indications for use | The Luer Lock Syringe with
Safety Needle is used to inject
fluids into, or withdraw fluids
from, the body. The safety
mechanism covers the needle
after use. In the activated
position, the protective arm
guards against accidental
needle stick during normal
handling and disposal of the
used needle/syringe
combination. | 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
needle sticks. | Different
Note 1 | |
| Configuration | Barrel, plunger, Gasket, needle
cap, needle tube, needle hub
with safety arm | Barrel, plunger, piston,
needle hub, needle tube,
needle cap, safety
mechanism | Different
Note 2 | |
| Operation Mode | For manual use only | For manual use only | Same | |
| Sterilized | Yes | Yes | Same | |
| Single use | Single use | Single use | Same | |
| Label/Labeling | Complied with 21CFR part 801 | Complied with 21 CFR part 801 | Same | |
| Syringe | Volume | 1ml, 3ml, 5ml, 10ml | 0.5ml, 1ml, 2ml, 3ml, 5ml,
10ml, 20ml, 30ml, 50ml,
60ml | Different
Note 3 |
| | Connect | 1ml: Luer lock, Fixed;
Others: Luer lock | 0.5ml,1ml: Luer Lock, Luer
Slip, Fixed needle;
Others: Luer Lock and
Luer Slip | |
| Needle | Size | 20G, 21G, 22G, 23G, 25G | 18G, 20G, 21G, 22G, 25G,
27G | |
| | Length | 1", 5/8", 11/2" | 1/2", 5/8", 3/4", 1", 1-1/4",
11/2" | |
| Syringe
Performance | | Complied with ISO 7886-1 | Complied with ISO 7886-1 | Same |
| | | | | |
| Needle
Performance | | Complied with ISO 7864,
ISO 9626 | Complied with ISO 7864,
ISO 9626 | Same |
| Luer Connector
Performance | | Complied with ISO 80369-7 | Complied with ISO 80369-7 | Same |
| Barrel | | Polypropylene(PP) | Polypropylene(PP) | Same |
| Plunger | | Polypropylene(PP) | Polypropylene(PP) | Same |
| Gasket/Piston | | IR rubber | Polyisoprene | Different note 4 |
| Needle hub | | Polypropylene(PP) | Polypropylene(PP) | Same |
| Needle tube | | Stainless Steel SUS 304 | Stainless Steel SUS 304 | Same |
| Lubricants | | Silicone oil | Silicone oil | Same |
| Adhesive | | Epoxy glue | UV adhesive | Different note 4 |
| Cytotoxicity | | No cytotoxicity | No cytotoxicity | Same |
| Irritation | | No intracutaneous
reactivity | No intracutaneous
reactivity | Same |
| Sensitization | | No sensitization | No sensitization | Same |
| Systemic Toxicity | | No systemic toxicity | No systemic toxicity | Same |
| Hemolysis | | No Hemolysis | No Hemolysis | Same |
| Pyrogen | | No Pyrogen | No Pyrogen | Same |
7
Image /page/7/Picture/0 description: The image shows the logo for Sol M, a company focused on building a healthier tomorrow. The logo features a blurred green and orange circle followed by the text "Sol M" in a dark green sans-serif font. To the right of "Sol M" is the text "Building a Healthier Tomorrow" in a smaller, lighter font.
8
Image /page/8/Picture/0 description: The image shows the logo for SolM. The logo consists of an orange circle, followed by the text "SolM" in dark green. To the right of the "M" are the words "Building a Healthier Tomorrow" in a smaller, lighter green font. The logo is simple and modern, with a focus on health and the future.
| Sterilization | ||
|---|---|---|
| Method | EO Sterilized | Same |
| SAL | $10^{-6}$ | Same |
| Endotoxin Limit | 20 EU per device | Same |
Discussion in details:
Note 1: Intended Use and Indications for use
Standard Luer Lock Syringe with Safety Needle and Sterile Disposable Syringe with Safety Needle have similar intended use, but are described differently. Both are intended for use in the withdrawal and injection of fluids, and the protective arm can be manually activated to cover the needle after use to minimize risk of accidental needle sticks. These differences do not raise new or different questions of safety and effectiveness when compared to the predicate device.
Note 2: Configuration
The component names of the proposed device is different to that of the predicate device; however, the components share the same configuration and function. Therefore, this difference in name will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
Note 3: Syringe volume, Needle gauge and Needle length
The syringe volume, needle gauge and needle length of the proposed device is less than that of predicate devices. This difference in syringe and needle size will not affect the performance of the syringe and needle. In addition, the syringe and needle size of the proposed device has been tested. The test results comply with ISO 7864 and ISO 9626 standards requirements. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
Note 4: Patient-contacting Material
Although the material of the proposed and the predicate device is different, biocompatibility of the proposed device complies to the ISO 10993 series of standards. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
Table 2. Substantial equivalence comparison of Luer Lock Syringe with Exchangeable Needle
| Item | Proposed Device | Predicate Device | Remark | |
|---|---|---|---|---|
| Luer Lock Syringe with | Sterile Disposable Syringe | |||
| Exchangeable Needle | with Needle | |||
| K number | K241821 | K221247 | ||
| Classification | Class II | Class II | Same | |
| Product Code | FMF | |||
| FMI | FMF | |||
| FMI | Same | |||
| Regulation | ||||
| Number | 21 CRF 880.5860 | |||
| 21 CRF 880.5570 | 21 CRF 880.5860 | |||
| 21 CRF 880.5570 | Same | |||
| Indications for use | The Luer Lock Syringe with | |||
| Exchangeable Needle is used | ||||
| to inject medicines and | ||||
| vaccines into, or withdraw | ||||
| fluids from, the body. | The Sterile Disposable | |||
| Syringe with Needle is | ||||
| intended for use in the | ||||
| aspiration and injection of | ||||
| fluids for medical purpose. | Different | |||
| Note 1 | ||||
| Configuration | Barrel, plunger, Gasket, needle | |||
| cap, needle tube, needle hub | Barrel (Luer lock/Luer | |||
| slip/fixed needle), plunger, | ||||
| piston, needle hub, needle | ||||
| tube, needle cap | Different | |||
| Note 2 | ||||
| Operation Mode | For manual use only | For manual use only | Same | |
| Sterilized | Yes | Yes | Same | |
| Single use | Single use | Single use | Same | |
| Label/Labeling | Complied with 21CFR part 801 | Complied with 21 CFR | ||
| part 801 | Same | |||
| Syringe Volume | 1ml, 3ml, 5ml, 10ml | 0.5ml, 1ml, 2ml, 3ml, 5ml, | ||
| 10ml, 20ml, 30ml, 50ml, | ||||
| 60ml | Different | |||
| Note 3 | ||||
| Needle size | 20G, 21G, 22G, 23G, 25G | 18G, 20G, 21G, 22G, 25G, | ||
| 27G | Different | |||
| Note 3 | ||||
| Length | 1", 5/8", 11/2" | 1/2", 5/8", 3/4", 1", 1-1/4", | ||
| 11/2" | ||||
| Syringe | ||||
| Performance | Complied with ISO 7886-1 | Complied with ISO 7886-1 | Same | |
| Needle | ||||
| Performance | Complied with ISO 7864, | |||
| ISO 9626 | Complied with ISO 7864, | |||
| ISO 9626 | Same | |||
| Luer Connector | ||||
| Performance | Complied with ISO 80369-7 | Complied with ISO 80369-7 | Same | |
| Barrel | Polypropylene(PP) | Polypropylene(PP) | Same | |
| Plunger | Polypropylene(PP) | Polypropylene(PP) | Same | |
| Gasket/Piston | IR rubber | Polyisoprene | Different Note 4 | |
| Needle hub | Polypropylene(PP) | Polypropylene(PP) | Same | |
| Needle tube | Stainless Steel SUS 304 | Stainless Steel SUS 304 | Same | |
| Needle cap | Polypropylene(PP) | Polypropylene(PP) | Same | |
| Lubricants | Silicone oil | Silicone oil | Same | |
| Adhesive | Epoxy glue | UV adhesive | Different Note 4 | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same | |
| Irritation | No intracutaneous | |||
| reactivity | No intracutaneous | |||
| reactivity | Same | |||
| Sensitization | No sensitization | No sensitization | Same | |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | Same | |
| Hemolysis | No Hemolysis | No Hemolysis | Same | |
| Pyrogen | No Pyrogen | No Pyrogen | Same | |
| Sterilization | ||||
| Method | EO Sterilized | EO Sterilized | Same | |
| SAL | 10-6 | 10-6 | Same | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same | |
| Item | Proposed Device | |||
| Luer Lock Syringe with Blunt | ||||
| Fill Needle | Predicate Device | |||
| Sterile Disposable Syringe | ||||
| with Needle | Remark | |||
| K number | K241821 | K221247 | ||
| Classification | Class II | Class II | Same | |
| Product Code | FMF | |||
| FMI | FMF | |||
| FMI | Same | |||
| Regulation | ||||
| Number | 21 CRF 880.5860 | |||
| 21 CRF 880.5570 | 21 CRF 880.5860 | |||
| 21 CRF 880.5570 | Same | |||
| Indications for use | The Luer Lock Syringe with | |||
| Blunt Fill Needle is used for | ||||
| aspiration from multi-dose | ||||
| medicine vials. | The Sterile Disposable | |||
| Syringe with Needle is | ||||
| intended for use in the | ||||
| aspiration and injection of | ||||
| fluids for medical purpose. | Different | |||
| Note 1 | ||||
| Configuration | Barrel, plunger, Gasket, needle | |||
| cap, needle tube, needle hub | Barrel (Luer lock/Luer | |||
| slip/fixed needle), plunger, | ||||
| piston, needle hub, needle | ||||
| tube, needle cap | Different | |||
| Note 2 | ||||
| Operation Mode | For manual use only | For manual use only | Same | |
| Sterilized | Yes | Yes | Same | |
| Single use | Single use | Single use | Same | |
| Label/Labeling | Complied with 21CFR part 801 | Complied with 21 CFR | ||
| part 801 | Same | |||
| Syringe | Volume | 3ml, 5ml, 10ml | 0.5ml, 1ml, 2ml, 3ml, 5ml, | |
| 10ml, 20ml, 30ml, 50ml, | ||||
| 60ml | Different | |||
| Note 3 | ||||
| Needle | size | 18G | 18G, 20G, 21G, 22G, 25G, | |
| 27G | Different | |||
| Note 3 | ||||
| Length | 11/2" | 1/2", 5/8", 3/4", 1", 1-1/4", | ||
| 11/2" | ||||
| Syringe | ||||
| Performance | Complied with ISO 7886-1 | Complied with ISO 7886-1 | Same | |
| Needle | ||||
| Performance | Complied with ISO 7864, | |||
| ISO 9626 | Complied with ISO 7864, | |||
| ISO 9626 | Same | |||
| Luer Connector | ||||
| Performance | Complied with ISO 80369-7 | Complied with ISO 80369-7 | Same | |
| Barrel | Polypropylene(PP) | Polypropylene(PP) | Same | |
| Plunger | Polypropylene(PP) | Polypropylene(PP) | Same | |
| Gasket/Piston | IR rubber | Polyisoprene | Different Note 4 | |
| Needle hub | Polypropylene(PP) | Polypropylene(PP) | Same | |
| Needle tube | Stainless Steel SUS 304 | Stainless Steel SUS 304 | Same | |
| Needle cap | Polypropylene(PP) | Polypropylene(PP) | Same | |
| Lubricants | Silicone oil | Silicone oil | Same | |
| Adhesive | Epoxy glue | UV adhesive | Different Note 4 | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same | |
| Irritation | No intracutaneous | |||
| reactivity | No intracutaneous | |||
| reactivity | Same | |||
| Sensitization | No sensitization | No sensitization | Same | |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | Same | |
| Hemolysis | No Hemolysis | No Hemolysis | Same | |
| Pyrogen | No Pyrogen | No Pyrogen | Same | |
| Sterilization | ||||
| Method | EO Sterilized | EO Sterilized | Same | |
| SAL | 10-6 | 10-6 | Same | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
9
Image /page/9/Picture/0 description: The image shows the logo for Sol M, a company focused on building a healthier tomorrow. The logo features a blurred green and orange circle followed by the text "Sol M" in a dark green sans-serif font. To the right of "Sol M" is the text "Building a Healthier Tomorrow" in a smaller, lighter font.
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Image /page/10/Picture/0 description: The image shows the logo for Sol M. The logo consists of a green circle with a small green triangle cut out of the left side, followed by the text "Sol M" in green. To the right of the "M" are the words "Building a Healthier Tomorrow" in a smaller font size.
Discussion in details:
Note 1: Intended Use and Indications for use
The Standard Luer Lock Syringe with Exchangeable Needle and Sterile Disposable Syringe with Needle have similar intended uses, which are intended for use in the aspiration and injection of fluids. This difference does not raise new or different questions of safety and effectiveness when compared to the predicate device.
Note 2: Configuration
The component names of proposed devices are different to that of the predicate device; however, the components share the same configuration and function. Therefore, this difference in name will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
Note 3: Syringe volume, Needle gauge and Needle length
The syringe volume, needle gauge and needle length of the proposed device is less than that of predicate devices. This difference in syringe and needle size will not affect the performance of the syringe and needle. In addition, the syringe and needle size of the proposed device has been tested. The test results comply with ISO 7864 and ISO 9626 standards requirements. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
Note 4: Patient-contacting Material
Although the material of the proposed and the predicate device is different, the patient-contacting material of the proposed device conforms to the ISO 10993 series of standards. Therefore, this difference will not affect the Substantial Equivalence (SE)
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Image /page/11/Picture/0 description: The image shows the logo for Sol M, which is a company that is building a healthier tomorrow. The logo consists of an orange circle, followed by the word "Sol" in green, and then the letter "M" in green. To the right of the letter "M" is the phrase "Building a Healthier Tomorrow" in a smaller font.
between the proposed and predicate device.
Table 3. Substantial equivalent comparison of Luer Lock Syringe with Blunt Fill Needle
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Image /page/12/Picture/0 description: The image shows the logo for Sol M, which includes a green half-circle, an orange circle, and the text "Sol M" in green. To the right of "Sol M" is the text "Building a Healthier Tomorrow" in a smaller font size. The logo is simple and modern, with a focus on the company's name and its mission.
Discussion in details:
Note 1: Intended Use and Indications for use
The Indications for use of subject device and predicate device are different, but the intended use of the subject device is within the range of the predicate device. There are no new intended uses. This difference does not raise new or different questions of safety and effectiveness when compared to the predicate device.
Note 2: Configuration
The component names of the proposed devices are different to that of the predicate device; however, the components share the same configuration and function. Therefore, this difference in name will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
Note 3: Syringe volume, Needle gauge and Needle length
The syringe volume, needle gauge and needle length of the proposed device is less than that of predicate devices. This difference in syringe and needle size will not affect the performance of the syringe and needle. In addition, the syringe and needle size of the proposed device has been tested. The test results comply with ISO 7864 and ISO 9626 standards requirements. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
13
Image /page/13/Picture/0 description: The image shows the logo for Sol M. The logo consists of an orange circle, followed by the text "Sol M" in green. To the right of the "M" is the text "Building a Healthier Tomorrow" in a smaller font, also in green. The logo is simple and modern, with a focus on health and wellness.
Note 4: Patient-contacting Material
Although the material of the proposed and the predicate device is different, the patient-contacting material of the proposed device conforms to the ISO 10993 series of standards. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
8. Performance Data
Non-Clinical Performance Data
To verify that the proposed devices are as safe and effective as the predicate device, representative samples of the proposed device underwent a series of tests including bench testing (syringe and needle performance testing), and biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen, and hemolysis). The test results demonstrated that the proposed device complies with the following standards:
- A ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
-
ISO 7864:2016, Sterile hypodermic needles for single use.
- ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices. A
- A ISO 10993-5: 2009(R), Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
- A ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- A ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- A ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of A Materials
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier
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Image /page/14/Picture/0 description: The image shows the logo for Sol M, which is a company that is building a healthier tomorrow. The logo consists of an orange circle, followed by the text "Sol M" in green. To the right of the text is the phrase "Building a Healthier Tomorrow" in a smaller font, also in green. The logo is simple and modern, and it conveys the company's mission of improving health.
Materials.
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical A Package by Dye Penetration
-
USP Bacterial Endotoxins Test
- USP Pyrogen Test >
- USP Particulate Matter Test >
-
ISTA 3A Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less.
- Clinical Performance Data
No data from human clinical studies have been included to support the substantial equivalence of the proposed device.
10. Conclusion
The differences between the predicate and the proposed devices do not raise any new or different questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate device.