The Slip Tip and Eccentric Tip Syringe without Needle is a sterile, single-use, standard 3 piece piston. The device is packed individually and EO sterilized with 10-6 SAL.

The proposed device includes different specifications:
1ml Slip Tip Syringe without Needle
3ml Slip Tip Syringe without Needle
5ml Slip Tip Syringe without Needle
10ml Slip Tip Syringe without Needle
20ml Slip Tip Syringe without Needle
30ml Slip Tip Syringe without Needle
60ml Slip Tip Syringe without Needle
10ml Eccentric Tip Syringe without Needle
20ml Eccentric Tip Syringe without Needle
60ml Eccentric Tip Syringe without Needle

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle." It outlines the device, its intended use, comparison to a predicate device, and non-clinical performance testing.

Here's an analysis of the acceptance criteria and study information as requested:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this device are based on compliance with several international and industry standards for medical devices, particularly those related to syringes and their components. The reported device performance indicates compliance with these standards.

Acceptance Criteria (Standard/Test)	Reported Device Performance
ISO 7886-1:2017 (Sterile hypodermic syringes for manual use)	Complied with ISO 7886-1
ISO 80369-7:2021 (Small-bore connectors for intravascular or hypodermic application)	Complied with ISO 80369-7
ISO 80369-20:2015 (Common test methods for small-bore connectors)	Complied with ISO 80369-20
ISO 10993-1:2018 (Biological evaluation - Risk management)	Complied with ISO 10993-1
ISO 10993-4:2017 (Biological evaluation - Interaction with blood)	Complied with ISO 10993-4
ISO 10993-5:2009 (Biological evaluation - In vitro cytotoxicity)	Complied with ISO 10993-5
ISO 10993-7:2008 (Biological evaluation - Ethylene oxide sterilization residuals)	Complied with ISO 10993-7
ISO 10993-10:2010 (Biological evaluation - Irritation and skin sensitization)	Complied with ISO 10993-10
ISO 10993-11:2017 (Biological evaluation - Systemic toxicity)	Complied with ISO 10993-11
USP <788> (Particulate Matter for injection)	Complied with USP <788>
ISO 11135:2014 (Sterilization of health-care products - Ethylene oxide)	Complied with ISO 11135
ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials)	Complied with ASTM F88/F88M-15
ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Package by Dye Penetration)	Complied with ASTM F1929-15

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily refers to compliance with international standards through non-clinical performance testing. It does not provide specific details on sample sizes for each non-clinical test conducted. The tests evaluate the physical, mechanical, chemical, and biological properties of the syringe. Given the nature of these tests, they are typically conducted in a controlled laboratory environment (prospective testing) to ensure adherence to the specified standards for medical devices. The country of origin of the data is not explicitly stated in this FDA submission document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the submission describes non-clinical performance testing against established engineering and biological standards, not clinical studies requiring expert consensus on medical conditions or interpretations. The "ground truth" here is adherence to specified parameters within recognized standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials where expert readers independently review medical images or patient data, and discrepancies are resolved. This submission details non-clinical laboratory testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical study is included in this submission." This device is a basic medical syringe, and such studies are not typically required for its clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical medical instrument (syringe), not an AI algorithm or software. Therefore, there's no "standalone" algorithm performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance testing, the "ground truth" is defined by the specifications and acceptable limits established within the cited international and industry standards. For example, for ISO 7886-1, the ground truth would be the defined force required for plunger operation, or the leakage limits. For biological compatibility tests, the ground truth would be the absence of toxicity or irritation as per ISO 10993 series.

8. The sample size for the training set

This information is not applicable. This is a submission for a physical medical device (syringe), not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Summary

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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 text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

October 22, 2024

Sol-Millennium Medical Inc. % Amy Li, Technology Director Shanghai Mind-link Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Rode Jing'an District, Shanghai, Shanghai 201803, China

Re: K242099

Trade/Device Name: Sol-MIM Slip Tip Syringe without Needle, Sol-MTM Eccentric Tip Syringe without Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: June 27, 2024 Received: September 27, 2024

Dear Amy Li:

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).

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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 OS 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-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).

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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

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Indications for Use

510(k) Number (if known) K242099

Device Name

Sol-M™ Slip Tip Syringe without Needle Sol-M™ Eccentric Tip Syringe without Needle

Indications for Use (Describe)

The syringe without needle is used to inject fluids into, or withdraw fluids from, the body.

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 SolM, which is a company that is building a healthier tomorrow. The logo consists of a green half circle, an orange circle, the word "SolM" in green, and the words "Building a Healthier Tomorrow" in a smaller font. The logo is simple and modern, and it conveys the company's mission of improving health.

K242099 510(k) Summary

1. Date of preparation: October 22, 2024
1. Submitter information

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: Amy.li, Technology director, +86 15721449974, amy.li@mind-link.net

1. Subject Device
  Trade name: Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle Common name: Piston Syringe Regulation: 21 CFR § 880.5860 Product code: FMF Classification: Class II Review Pannel: General Hospital
1. Predicate Device
  K221079 Trade Name: Sterile Hypodermic Syringes for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Review Panel: General hospital
1. Indication for use statement
  The syringe without needle is used to inject fluids into, or withdraw fluids from, the body
1. Device description
  The Slip Tip and Eccentric Tip Syringe without Needle is a sterile, single-use, standard 3 piece piston. The device is packed individually and EO sterilized with 10-6 SAL.
6.1 The proposed device includes different specifications.
- 1ml Slip Tip Syringe without Needle
- 3ml Slip Tip Syringe without Needle
- 5ml Slip Tip Syringe without Needle
- 10ml Slip Tip Syringe without Needle
- 20ml Slip Tip Syringe without Needle
- 30ml Slip Tip Syringe without Needle
- 60ml Slip Tip Syringe without Needle
- 10ml Eccentric Tip Syringe without Needle

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Image /page/5/Picture/0 description: The image shows the logo for Sol M. The logo consists of a green half circle, an orange circle, the text "Sol M" in green, and the text "Building a Healthier Tomorrow" in a smaller font size. The text "Sol M" is in a bold, sans-serif font. The logo is simple and modern.

20ml Eccentric Tip Syringe without Needle
60ml Eccentric Tip Syringe without Needle
6.2 Label requirement
- The label shall meet the requirements of 21 CFR Part 801
1. Comparison of technological characteristics with the predicate devices

The subject device has the same intended use, technology, and design; and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the subject device and predicate devices do not alter suitability of the proposed device for its intended use.

Item	Proposed Device Slip Tip Syringewithout Needle, Eccentric TipSyringe without Needle	Predicate Device Sterile HypodermicSyringes for Single UseK221079	Remark
Indication for Use	The syringe without needle isused to inject fluids into, orwithdraw fluids from, the body.	The Sterile Hypodermic Syringes for SingleUse are intended to be used for medicalpurpose to inject fluid into or withdrawfluid from body.	Same
Prescription or OTC(over the counter)	Prescription use	Prescription use	Same
Configuration	Barrel	Barrel	Same
Configuration	Plunger	Plunger	Same
Configuration	Piston	Piston	Same
Operation Mode	For manual use only	For manual use only	Same
Single Use	Single Use	Single Use	Same
Syringeperformance	Complied with ISO 7886-1	Complied with ISO 7886-1	Same
Luer ConnectorPerformance	Complied with ISO 80369-7	Complied with ISO 80369-7	Same
Volume	Slip tip:1ml, 3ml, 5ml, 10ml,20ml, 30ml, 60mlEccentric tip: 10ml, 20ml, 60ml	1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml,50ml, 60ml, 100ml	Similar.Analysis 1
Connector Type	Luer slip(Slip tip, Eccentric tip)	Luer slip/Luer lock	Similar.Analysis 2
Barrel	Polypropylene(PP)	Polypropylene(PP)	Same
Plunger	Polypropylene(PP)	Polypropylene(PP)	Same
Piston	Polyisoprene rubber(IR)	Polyisoprene	Same
Lubricant	Polydimethylsiloxane	Polydimethylsiloxane	Same
Sterilization	EO Sterilized	EO Sterilized	Same
Shelf life	5 years	5 years	Same

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Image /page/6/Picture/0 description: The image shows the logo for Sol M, a company focused on building a healthier tomorrow. The logo features a green dot, an orange circle, and the text "Sol M" in a dark green, sans-serif font. To the right of "Sol M" are the words "Building a Healthier Tomorrow" in a smaller, lighter font.

Analvsis 1:Volume

The subject device has less volume compared with the predicate device. but the predicate device has additional volumes 2ml and 100ml. However, all syringe performance was tested in accordance with ISO 7886-1 and ISO 80369-7. Therefore, this difference in syringe volume will not affect the Substantial Equivalence (SE) between the proposed device and the predicate device.

Analysis 2: Connector Type

The subject device has the same connector type compared with the predicate device, but the predicate device has an additional Luer lock type. However, the Luer connector performance complies with ISO 80369-7. Therefore, this difference in connector type will not affect the Substantial Equivalence (SE) between the proposed device and the predicate device.

8. Non-clinical Performance Testing

Non-clinical tests were conducted to verify that the proposed device meets all design specifications. The test results demonstrated that the proposed device complies with the following standards:

8.1 ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use.
8.2 ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare application -- Part 7: Connectors for intravascular or hypodermic application
8.3 ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
8.4 ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
8.5 ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
8.6 ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
8.7 ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
8.8 ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
8.9 ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
8.10 USP <788> Particulate Matter for injection
8.11 ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
8.12ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials
8.13 ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration

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Image /page/7/Picture/0 description: The image is a logo for Sol M, a company that is building a healthier tomorrow. The logo features a green circle with a portion cut out, an orange circle, and the text "Sol M" in green. To the right of the "M" is the text "Building a Healthier Tomorrow" in a smaller font.

9. Clinical Testing

No clinical study is included in this submission.

10.Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject device is substantially equivalent to the predicate device Sterile Hypodermic Syringes for Single Use (K221079).

Regulation Number and Section

§ 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).