The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.

AI/ML Overview

The provided document is an FDA 510(k) premarket notification for an Insulin Syringe. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device, which is implied by your detailed request.

The document describes typical non-AI medical device testing, such as:

Bench Testing: Verifies physical performance characteristics (e.g., needle tube length, bond strength, leakage, fit of plunger, dead space, penetration force, particulate contamination).
Biocompatibility Testing: Assesses biological safety (cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis, pyrogens).
Sterilization and Shelf-life Testing: Validates sterilization method and confirms shelf life.

Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria, performance metrics (like sensitivity, specificity, AUC), sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or training set details because this information is not present in the provided text. The device in question is a physical insulin syringe, not an AI/ML-based diagnostic or therapeutic device.

Summary

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March 2, 2023

Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory affairs manager No. 1388 Cangxing Street, Cangqian Community, Yuhang District Hangzhou City, Zhejiang 311121 China

Re: K223453

Trade/Device Name: Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: January 30, 2023 Received: January 30, 2023

Dear Zearou Yang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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).

Sincerely,

Alan St

CAPT Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223453

Device Name Insulin Syringe

Indications for Use (Describe)

Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. Date Prepared

Feb. 24, 2023

2. Submitter's Information

Name of Sponsor:

Promisemed Hangzhou Meditech Co., Ltd.

Address:

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121

Zhejiang, China

Contact Name: Zearou Yang

Telephone No.:

+86 571 88772985

Fax No.:

+86 571 88772985

Email Address:

zearou.yang@promisemed.ca

3. Trade Name, Common Name, Classification

Trade/Product Name: Insulin Syringe

Common Name: Insulin Syringe

Classification name: Piston syringe

Regulation Number: 880.5680

Device Class: Class II

Product Code: FMF

4. Identification of Predicate Device K110421; Disposable Insulin Syringe

5. Description of the Device

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6. Indications for use

Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.

Similarities and Differences of the Proposed Devices to the Predicate Devices 7.

A detailed comparison to the predicate is provided in Table 1.

Items	Subject Device(K223453)	Predicate Device(K110421)	Comments
Trade Name	Insulin Syringe	Disposable InsulinSyringe
Manufacturer	Promisemed HangzhouMeditech Co., Ltd	Wen Zhou WuzhouImport & Export Co., Ltd.
Device Class	Class II	Class II	Same
Product Code	FMF	FMF	Same
Regulation number	880.5680	880.5680	Same
Regulation Name	Piston syringe	Piston syringe	Same
Intended Use/Indications for Use	Insulin Syringe is intendedfor subcutaneous injectionof U-40 and U-100 insulinin the treatment ofdiabetes.	Disposable insulin syringe is adevice intended for medicalpurposes for the manualaspiration of insulin, and forthe injection of insulin intoparts of the body below thesurface skin.	Same
Type of use	Prescription use and over-the-counter use	Over-the-counter use	Different.1. "Prescription use" ofsubjective device hasbeen cleared withK193273;2. "Over-the-counteruse" is same withPredicate device;The difference of use typedoes not impact safetyand effectiveness.
OperatingPrinciple	The insulin is injected tosubcutaneous tissue bypushing force generatedthroughpushing plunger rod of theinsulin syringe.	The insulin is injected tosubcutaneous tissue bypushing force generatedthroughpushing plunger rod of theinsulin syringe.	Same
Specific druguse	Insulin	Insulin	Same
Length	120mm	120mm	Same
Volume	0.3ml, 0.5ml, 1.0ml	0.3ml, 0.5ml, 1.0ml	Same
Needle length	6mm, 8mm,12mm	5mm, 6mm, 8mm, 12mm	Different.The needle length ofproposed device is coveredby the predicate device.
Needle gauge	32G, 31G, 30G, 29G, 28G	31G, 30G, 29G, 28G	Different.Compared to the predicatedevice, the proposeddevice has an additional32G model needle. 32Gmodel for insulin syringe
			510(K) 223453needle safety andperformance has beenconfirmed by testing. Thisdifference does not raisenew questions of safetyand effectiveness.
Needle tipconfiguration	3 bevels	3 bevels	Same
Nozzle type	Not applicable	Not applicable	Same
Numbering ofscale	At every five units for the0.3mL and 0.5mL syringes,and at every 10units for1.0mL	At every five units for the0.3mL and 0.5mL syringes,and at every 10units for1.0mL	Same
Gradationslegibility	Legible	Legible	Same
Needle coverdimensions	Length:25mm,Diameter: 6mm	Length:25mm,Diameter: 6mm	Same
Needle covercolor	Red (U-40) and orange(U-100)	Red (U-40) and orange(U-100)	Same
Lubricantcomposition	Aminofunctional siloxane	Aminofunctional siloxane	Same
Lubricantamount/cm²	The lubricant is not formpools of fluid on the interiorsurface of the syringe oroutside surfaces of theneedle tube.	The lubricant is not formpools of fluid on the interiorsurface of the syringe oroutside surfaces of theneedle tube.	Same
Barrel transparency	Transparent	Transparent	Same
Needle coverstrength	<15N	<15N	Same
Hub/needle bondstrength	>22N	>22N	Same
Biocompatibility	No cytotoxicityNo irritation reactivityNo significant evidenceof skin sensitizationNo significant evidenceof systemic toxicityNo evidence of HemolysisNo evidence of pyrogens	No cytotoxicityNo irritation reactivityNo significant evidenceof skin sensitizationNo significant evidenceof systemic toxicityNo evidence of HemolysisNo evidence of pyrogens	Same
Configurationand Materials	Needle: Stainless Steel(SUS304)Barrel: PolypropylenePlunger: PolypropylenePiston: PolyisoprenerubberNeedle cap: PolyethyleneProtective end cap (onlytype 8): Polyethylene	Needle: Stainless Steel(SUS304)Barrel: Polypropylene (PP)Plunger: Polypropylene (PP)Piston: Polyisoprene RubberNeedle cover: Polypropylene(PP)Protective end cap:Polypropylene (PP)	Different.The materials of needlecap and protective endcap are differentbetween the subjectdevice and predicatedevice. Thebiocompatibility test ofthe subject device wasconducted todemonstrate that thesubject device met thebiocompatibilityrequirements. Thisdifference does not raiseany new safety and
			effectiveness questions.
Label	Device name,indication, instructionfor use, precaution,warning, shelf life,manufacturer	Device name,indication, instructionfor use, precaution,warning, shelf life,manufacturer	Same
Sterilizationmethod and SAL	Sterilized by ethyleneoxide gas SAL = 10-6	Sterilized by ethyleneoxide gas SAL = 10-6	Same
Sterilization method	EO Sterilization	EO Sterilization	Same
EO and ECH residuestesting	Conform ISO 10993-7	Conform ISO 10993-7	Same

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Insulin Syringe

510(k) 223453

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Insulin Syringe

510(k) 223453

8. Performance Testing Summary

The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. The data are provided in submission, K193273.

Performance Testing:

The Insulin Syringes have been designed and successfully tested (relying on K193273 submission) to meet the applicable requirements outlined in ISO 8537, such as:

Needle tube length; -
-Diameter of needle tube;
Bond between hub and needle tube; -
-Needle points;
-Freedom from defects;
-Lubrication;
-Fit of plunger stopper in barrel;
-Dead space;
-Freedom from leakage at needle;
-Freedom from leakage past plunger stopper;
-Tolerance on graduated capacity;
-Limits for acidity or alkalinity;
-Limits for extractable metals;
-Fragmentation;
-Penetration force ;
-Particulate contamination;

Biocompatibility testing:

The material of the Insulin Syringes have successfully passed testing as outlined in ISO 10993-1 for devices categorized as External communicating devices, Limited exposure.

ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro

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cytotoxicity

ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Test for Irritation and

Sensitization

ISO 10993-11: 2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity

ISO 10993-4:2017 Biological evaluation of medical devices -Part 4: Selection of tests for interactions with blood.

ASTM F 756-17 Standard Practice for Assessment of Hemolytic Properties of Materials

The United States Pharmacopeia <151> (Pyrogen test), method of limulus amebocyte lysate [LAL].

Sterilization and Shelf-life Testing:

Sterilization of the Insulin Syringes has been validated according to ISO 11135 with half-cycle method.

Testing demonstrated maximum levels of residues of ethylene oxide (≤9mg/d) and ethylene chlorohydrins (≤4mg/d) met with the limits presented in ISO 10993-7. Shelf-life testing supports a shelf life of 5-years after sterilization.

Clinical study 9.

No prospective clinical trials were conducted in support of this 510(K).

10. Colorants

The colorant used in the needle cap was listed as below:

Component	Color code	Colorant
Needle cap (U-100)	Orange	PE-M2766
Needle cap (U-40)	Red	PE-M2282

11. Conclusion

Based on the information provided within this 510(k) submission, the proposed subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.

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).