(88 days)
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.
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").
The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the typical sense of algorithm performance. The device referenced is a "Luer Lock Syringe with Safety Needle: Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle."
Therefore, most of the requested information (sample size, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance, training set details) is not applicable as this is a physical medical device clearance, not an AI/algorithm-driven device.
However, I can extract the acceptance criteria (standards the device complies with) and the reported device performance (test results indicating compliance).
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| ISO 7886-1:2017 (Sterile hypodermic syringes for manual use) | Complied with ISO 7886-1 |
| ISO 7864:2016 (Sterile hypodermic needles for single use) | Complied with ISO 7864 |
| ISO 9626:2016 (Stainless steel needle tubing) | Complied with ISO 9626 |
| ISO 10993-5: 2009(R) (Cytotoxicity) | No cytotoxicity |
| ISO 10993-10:2010 (Irritation and skin sensitization) | No intracutaneous reactivity, No sensitization |
| ISO 10993-11:2017 (Systemic toxicity) | No systemic toxicity |
| ISO 10993-7:2008 (Ethylene Oxide Sterilization Residuals) | EO Sterilized, SAL 10⁻⁶, Endotoxin Limit 20 EU per device |
| ASTM F756-17 (Assessment of Hemolytic Properties) | No Hemolysis |
| ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | (Implicitly compliant for packaging) |
| ASTM F1929-15 (Detecting Seal Leaks by Dye Penetration) | (Implicitly compliant for packaging) |
| USP <85> (Bacterial Endotoxins Test) | No Pyrogen (implied by this and USP <151>) |
| USP <151> (Pyrogen Test) | No Pyrogen |
| USP <788> (Particulate Matter Test) | (Implied compliant) |
| ISTA 3A (Packaged-Products for Parcel Delivery System Shipment) | (Implied compliant for shipping) |
| ISO 80369-7 (Luer Connectors) | Complied with ISO 80369-7 |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of non-clinical performance tests detailed in the "8. Performance Data" section. These tests were conducted on representative samples of the proposed devices to demonstrate compliance with the listed international and ASTM standards and USP monographs.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each test. The document mentions "representative samples" were used.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). As these are bench tests and biocompatibility assessments for a physical device, the concept of "country of origin of data" in the AI sense is less relevant. The studies were non-clinical performance and biocompatibility tests conducted to industry standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This is a clearance for a physical medical device, not an AI/algorithm-driven device requiring expert consensus for ground truth. The "ground truth" here is compliance with established performance standards for syringes and needles.
4. Adjudication Method for the Test Set:
- Not Applicable. As above, this is for a physical device. Test results are typically objective measurements against a standard, not subjective expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is relevant for AI/imaging algorithms, not for physical syringes and needles. The document explicitly states: "No data from human clinical studies have been included to support the substantial equivalence of the proposed device."
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- Not Applicable. This is a physical device; there is no embedded algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for this device is compliance with internationally recognized scientific and engineering standards and biological safety standards as listed (e.g., ISO 7886-1, ISO 10993 series, ASTM, USP). The tests performed (e.g., cytotoxicity, pyrogenicity, seal strength, fluid dynamic performance) provide objective measurements against these predefined standards.
8. Sample Size for the Training Set:
- Not Applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. (See point 8).
{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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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 DeviceLuer Lock Syringe withSafety Needle | Predicate DeviceSterile Disposable Syringewith Safety Needle | Remark | |
|---|---|---|---|---|
| K number | K241821 | K221247 | ||
| Classification | Class II | Class II | Same | |
| Product Code | FMFFMIMEG | FMFFMIMEG | Same | |
| RegulationNumber | 21 CRF 880.586021 CRF 880.5570 | 21 CRF 880.586021 CRF 880.5570 | Same | |
| Indications for use | The Luer Lock Syringe withSafety Needle is used to injectfluids into, or withdraw fluidsfrom, the body. The safetymechanism covers the needleafter use. In the activatedposition, the protective armguards against accidentalneedle stick during normalhandling and disposal of theused needle/syringecombination. | The Sterile DisposableSyringe with Safety Needleis intended for use in theaspiration and injection offluids for medical purpose.After withdrawal of theneedle from the body, theattached needle safety shieldcan be manually activated tocover the needleimmediately after use tominimize risk of accidentalneedle sticks. | DifferentNote 1 | |
| Configuration | Barrel, plunger, Gasket, needlecap, needle tube, needle hubwith safety arm | Barrel, plunger, piston,needle hub, needle tube,needle cap, safetymechanism | DifferentNote 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 | DifferentNote 3 |
| Connect | 1ml: Luer lock, Fixed;Others: Luer lock | 0.5ml,1ml: Luer Lock, LuerSlip, Fixed needle;Others: Luer Lock andLuer 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" | ||
| SyringePerformance | Complied with ISO 7886-1 | Complied with ISO 7886-1 | Same | |
| NeedlePerformance | Complied with ISO 7864,ISO 9626 | Complied with ISO 7864,ISO 9626 | Same | |
| Luer ConnectorPerformance | 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 intracutaneousreactivity | No intracutaneousreactivity | 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 | FMFFMI | FMFFMI | Same | |
| RegulationNumber | 21 CRF 880.586021 CRF 880.5570 | 21 CRF 880.586021 CRF 880.5570 | Same | |
| Indications for use | The Luer Lock Syringe withExchangeable Needle is usedto inject medicines andvaccines into, or withdrawfluids from, the body. | The Sterile DisposableSyringe with Needle isintended for use in theaspiration and injection offluids for medical purpose. | DifferentNote 1 | |
| Configuration | Barrel, plunger, Gasket, needlecap, needle tube, needle hub | Barrel (Luer lock/Luerslip/fixed needle), plunger,piston, needle hub, needletube, needle cap | DifferentNote 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 CFRpart 801 | Same | |
| Syringe Volume | 1ml, 3ml, 5ml, 10ml | 0.5ml, 1ml, 2ml, 3ml, 5ml,10ml, 20ml, 30ml, 50ml,60ml | DifferentNote 3 | |
| Needle size | 20G, 21G, 22G, 23G, 25G | 18G, 20G, 21G, 22G, 25G,27G | DifferentNote 3 | |
| Length | 1", 5/8", 11/2" | 1/2", 5/8", 3/4", 1", 1-1/4",11/2" | ||
| SyringePerformance | Complied with ISO 7886-1 | Complied with ISO 7886-1 | Same | |
| NeedlePerformance | Complied with ISO 7864,ISO 9626 | Complied with ISO 7864,ISO 9626 | Same | |
| Luer ConnectorPerformance | 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 intracutaneousreactivity | No intracutaneousreactivity | 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 DeviceLuer Lock Syringe with BluntFill Needle | Predicate DeviceSterile Disposable Syringewith Needle | Remark | |
| K number | K241821 | K221247 | ||
| Classification | Class II | Class II | Same | |
| Product Code | FMFFMI | FMFFMI | Same | |
| RegulationNumber | 21 CRF 880.586021 CRF 880.5570 | 21 CRF 880.586021 CRF 880.5570 | Same | |
| Indications for use | The Luer Lock Syringe withBlunt Fill Needle is used foraspiration from multi-dosemedicine vials. | The Sterile DisposableSyringe with Needle isintended for use in theaspiration and injection offluids for medical purpose. | DifferentNote 1 | |
| Configuration | Barrel, plunger, Gasket, needlecap, needle tube, needle hub | Barrel (Luer lock/Luerslip/fixed needle), plunger,piston, needle hub, needletube, needle cap | DifferentNote 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 CFRpart 801 | Same | |
| Syringe | Volume | 3ml, 5ml, 10ml | 0.5ml, 1ml, 2ml, 3ml, 5ml,10ml, 20ml, 30ml, 50ml,60ml | DifferentNote 3 |
| Needle | size | 18G | 18G, 20G, 21G, 22G, 25G,27G | DifferentNote 3 |
| Length | 11/2" | 1/2", 5/8", 3/4", 1", 1-1/4",11/2" | ||
| SyringePerformance | Complied with ISO 7886-1 | Complied with ISO 7886-1 | Same | |
| NeedlePerformance | Complied with ISO 7864,ISO 9626 | Complied with ISO 7864,ISO 9626 | Same | |
| Luer ConnectorPerformance | 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 intracutaneousreactivity | No intracutaneousreactivity | 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 |
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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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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.
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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 <85> Bacterial Endotoxins Test
- USP<151> Pyrogen Test >
- USP <788> 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.
§ 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).