(110 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a syringe and needle, with no mention of software, algorithms, or data processing related to AI/ML.
No
The descriptions state the device is used to "inject fluids into, or withdraw fluids from, the body," which are diagnostic or procedural functions, not directly therapeutic.
No
The device is described as a syringe used for injecting or withdrawing fluids from the body, with no mention of diagnosing conditions.
No
The device description clearly indicates it is a physical syringe with or without a needle, which is a hardware medical device. There is no mention of any software component.
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 fluids into, or withdraw fluids from, the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details a standard syringe with different needle configurations and safety features. This aligns with devices used for administering substances or collecting samples directly from a living organism.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.) in vitro.
- Reagents or test kits.
- Diagnostic testing performed on collected samples.
- Any process that involves examining biological specimens outside of the body to provide information about a patient's health.
The device is a medical device used for administering or collecting substances directly from the body, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Luer Lock/Slip Tip Syringe (Low Dead Space) without needle is to inject fluids into, or withdraw fluids from, the body.
The Luer Lock/Slip Tip Syringe (Low Dead Space) with exchangeable is used to inject fluids into, or withdraw fluids from, the body.
The Luer Lock Syringe (Low Dead Space) 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.
Product codes
QNQ
Device Description
The Luer Lock and Slip Tip syringe (Low Dead Space) without Needle is a sterile, single-use, standard 3-piece piston hypodermic syringe.
The Luer lock and Slip Tip syringe (Low Dead Space) with exchangeable needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.
The Luer Lock Syringe (Low Dead Space) with Safety Needle is a Low Dead Space syringe in combination with a safety needle. The safety needle 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical testing was performed based on the following standards:
- ISO 7886-1:2017: Sterile hypodermic syringes for single use-Part 1: Syringes for manual use.
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices-Requirements and test methods
- ISO 7864:2016 Sterile hypodermic needles for single use-Requirements and test methods
- ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
- ISO 23908: 2011 Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needle used for blood sampling.
- Biocompatibility testing was conducted in compliance with ISO 10993-1, as the Externally Communicating Device, Blood Path Indirect, 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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.
November 20, 2024
Sol-Millennium Medical Inc. % Tanya Wang, Technical Manager Shanghai Mind-link Consulting Co. Ltd 1399 Jiangyue Road. Minhang Shanghai, Shanghai 201114, China
Re: K242291
Trade/Device Name: SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QNQ Dated: October 22, 2024
Received: October 22, 2024
Dear Tanya Wang:
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.
1
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).
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 Rule"). 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/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,
Shruti N. Mistry -S
Shruti Mistry 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
3
Indications for Use
510(k) Number (if known) K242291
Device Name
SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle
Indications for Use (Describe)
The Luer Lock/Slip Tip Syringe (Low Dead Space) without needle is to inject fluids into, or withdraw fluids from, the body.
The Luer Lock/Slip Tip Syringe (Low Dead Space) with exchangeable is used to inject fluids into, or withdraw fluids from, the body.
The Luer Lock Syringe (Low Dead Space) 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.
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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K242291 510(k) Summary
1. Preparation date: November 20, 2024
2. Submitter
Manufacturer: Sol-Millennium Medical Inc. Address: 311 S Wacker Drive Suite 4100 Contact person: Manu Kalia, +1 847-313-9577, mkalia@sol-m.com Submission correspondent: Tanya Wang, +86-15216694647, tanya.wang@mind-link.net
3. Device
Trading name: SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle SOL-M Slip Tip Syringe (Low Dead Space) w/o needle SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle
Common name: Luer Lock Syringe (Low Dead Space) with Safety Needle Luer Lock Syringe (Low Dead Space) with Exchangeable Needle Slip Tip Syringe (Low Dead Space) with Exchangeable Needle Luer Lock Syringe (Low Dead Space) without Needle Slip Tip Syringe (Low Dead Space) without needle
Regulation No.: 21 CFR 880.5860 Regulation name: Piston Syringe Classification: Class II Product code: QNQ
4. Predicate device
K232943. Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe
5. Device description
The Luer Lock and Slip Tip syringe (Low Dead Space) without Needle is a sterile, single-use, standard 3-piece piston hypodermic syringe.
The Luer lock and Slip Tip syringe (Low Dead Space) with exchangeable needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.
The Luer Lock Syringe (Low Dead Space) with Safety Needle is a Low Dead Space syringe in combination with a safety needle. The safety needle 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.
6. Indications for use
The Luer Lock/Slip Tip Syringe (Low Dead Space) without needle is to inject fluids into, or withdraw fluids from, the body.
5
The Luer Lock/Slip Tip Syringe (Low Dead Space) with exchangeable needle is used to inject fluids into, or withdraw fluids from, the body.
The Luer Lock Syringe (Low Dead Space) 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.
| Characters | Subject device (K242291)
Luer Lock/Slip Tip Syringe (Low
Dead Space) without needle or with
Exchangeable Needle | Predicate device (K232943)
Hypodermic Needle-Pro® EDGE™
Safety Device with Low Dead Space
Syringe | Remark |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| | Luer Lock Syringe (Low Dead
Space) with Safety needle | | |
| Regulation No. | 21 CFR 880. 5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Indications for use | The Luer Lock/Slip Tip Syringe
(Low Dead Space) without needle is
to inject fluids into, or withdraw
fluids from, the body.
The Luer Lock/Slip Tip Syringe
(Low Dead Space) with
exchangeable needle is used to
inject fluids into, or withdraw fluids
from, the body.
The Luer Lock Syringe (Low Dead
Space) 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 device is intended for use to inject
fluids or withdraw fluids from the body.
The needle protection device covers the
needle after use to help prevent needle
sticks. | Different
#1 |
| Syringe
configuration and
material | (1) Plunger stopper (IR rubber)
(2) Plunger (PP)
(3) Barrel (PP)
(4) Lubricant (Silicone) | (1) Plunger stopper (IR rubber)
(2) Plunger (PP)
(3) Barrel (PP)
(4) Lubricant (Silicone) | Same |
| Needle material (for
devices containing
needles) | SUS 304 | SUS 304 | Same |
| Syringe volume | 1 mL | 1 mL, 3 mL | Different
#2 |
| Luer lock | Luer lock or Luer slip (Slip Tip) | Luer lock or Luer slip (Slip Tip) | Same |
| Luer compliance | ISO 80369-7 | ISO 80369-7 | Same |
| Needle gauge and
length | 23G, 25G, 27G, 30G
1/2", 5/8", 1", 1 1/2" | 23G, 25G
5/8", 1", 1 1/2" | Different
#3 |
| Sharps prevention
function | Active safety feature for
configurations with Safety Needle
No safety features in configurations
without Safety Needle | Active safety feature | Different
#4 |
| Needle performance | Conforming with ISO 9626 and ISO
7864 | Conforming with ISO 9626 and ISO
7864 | Same |
| Syringe performance | Conforming with ISO 7886-1 | Conforming with ISO 7886-1 | Same |
| Dead space
specification | Syringe: Low Dead Space Max:
0.02mL
Needle: Dead Space not calculated | Syringe: Low Dead Space Max:
0.015mL
Needle: Unknown | Different
#5 |
| Sterility method | EO Sterilization | EO Sterilization | Same |
| Biocompatibility | Conforms with ISO 10993-1 | Conforms with ISO 10993-1 | Same |
| Shelf Life | 5 years | Unknown | N/A |
7. Comparison of technological characters between subject and predicate device
6
Substantial equivalence analysis
Different #1
Both the subject device and the predicate device are used to inject fluids or withdraw fluids from the body. The safety mechanism is present in configurations of the subject device that is packaged with a Safety mechanism for said devices conforms with ISO 23908:2011. This difference does not have an impact on the performance of the subject device.
Different #2 Different #3
The syringe volume, needle gauge, and length of the subject device are different from the predicate device. The performance tests of the subject device have been performed per ISO 7864 and ISO 9626. Therefore, this difference in configuration will not affect the Substantial Equivalence (SE) between the subject and predicate device.
Different #4
The safety mechanism is available in certain configuration in the subject devices containing Safety Needles, the safety mechanism of the subject device and predicate device conform to ISO 23908. This does not impact the substantial equivalence between the subject device Low Dead Space syringe and predicate device.
Different #5
Although the Low Dead Space maximum limits are different, both limits of the subject and predicate devices are significantly below the ISO 7886-1 maximum dead space of 0.07mL for a 1 mL syringe. The subject device's dead space specification (0.02mL maximum) is similar to other previously cleared low dead space volume specifications. This difference does not impact the substantial equivalence between the subject device Low Dead Space syringe and predicate device.
7
8. Non-clinical testing
Performance Testing
The subject device was tested and demonstrated to be in conformance with the following FDA-recognized standards. The performance testing results met the requirements of the following standards demonstrating the device's substantial equivalence.
- ISO 7886-1:2017: Sterile hypodermic syringes for single use-Part 1: Syringes for manual use .
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices-Requirements and . test methods
- ISO 7864:2016 Sterile hypodermic needles for single use-Requirements and test methods
- ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications Part 7: . Connectors for intravascular or hypodermic applications
- ISO 23908: 2011 Sharps injury protection-Requirements and test methods-Sharps protection features ● for single-use hypodermic needles, introducers for catheters and needle used for blood sampling.
Biocompatibility Testing
The subject device was tested in compliance with ISO 10993-1, as the Externally Communicating Device, Blood Path Indirect, Limited Contact (