Insulin Syringe

K223453 · Promisemed Hangzhou Meditech Co., Ltd. · FMF · Mar 2, 2023 · General Hospital

Device Facts

• Record ID: K223453
• Device Name: Insulin Syringe
• Applicant: Promisemed Hangzhou Meditech Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Mar 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Insulin Syringe is a sterile, single-use, manual piston syringe used for subcutaneous insulin delivery. Device consists of a calibrated plastic barrel, plunger with polyisoprene piston, and integrated non-retractable stainless steel needle. Operated by patient or clinician via manual pushing force on plunger rod to deliver insulin. Device features include 0.3ml, 0.5ml, and 1.0ml volumes and needle gauges from 28G to 32G. Lubricated with aminofunctional siloxane for smooth movement. Used in home or clinical settings. Output is the controlled delivery of insulin to subcutaneous tissue, facilitating diabetes management.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ISO 8537 requirements including needle dimensions, bond strength, leakage, dead space, and graduation accuracy. Biocompatibility confirmed per ISO 10993-1, -4, -5, -10, -11, and ASTM F 756-17. Sterilization validated per ISO 11135.

Technological Characteristics

Materials: Stainless steel (SUS304) needle, polypropylene barrel/plunger, polyisoprene piston, polyethylene caps. Principle: Manual piston syringe. Energy: Manual. Dimensions: 120mm length; 0.3-1.0ml volume. Connectivity: None. Sterilization: Ethylene oxide (SAL 10^-6).

Indications for Use

Indicated for subcutaneous injection of U-40 and U-100 insulin in patients with diabetes.

Regulatory Classification

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.

Predicate Devices

• Disposable Insulin Syringe (K110421)

Reference Devices

• Insulin Syringe (K193273)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

> 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.:

[phone]

Fax No.:

[phone]

Email Address:

[e-mail]

### 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

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.

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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<br>(K223453) | Predicate Device<br>(K110421) | Comments |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Insulin Syringe | Disposable Insulin<br>Syringe | |
| Manufacturer | Promisemed Hangzhou<br>Meditech Co., Ltd | Wen Zhou Wuzhou<br>Import & 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/<br>Indications for Use | Insulin Syringe is intended<br>for subcutaneous injection<br>of U-40 and U-100 insulin<br>in the treatment of<br>diabetes. | Disposable insulin syringe is a<br>device intended for medical<br>purposes for the manual<br>aspiration of insulin, and for<br>the injection of insulin into<br>parts of the body below the<br>surface skin. | Same |
| Type of use | Prescription use and over-<br>the-counter use | Over-the-counter use | Different.<br>1. "Prescription use" of<br>subjective device has<br>been cleared with<br>K193273;<br>2. "Over-the-counter<br>use" is same with<br>Predicate device;<br>The difference of use type<br>does not impact safety<br>and effectiveness. |
| Operating<br>Principle | The insulin is injected to<br>subcutaneous tissue by<br>pushing force generated<br>through<br>pushing plunger rod of the<br>insulin syringe. | The insulin is injected to<br>subcutaneous tissue by<br>pushing force generated<br>through<br>pushing plunger rod of the<br>insulin syringe. | Same |
| Specific drug<br>use | 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.<br>The needle length of<br>proposed device is covered<br>by the predicate device. |
| Needle gauge | 32G, 31G, 30G, 29G, 28G | 31G, 30G, 29G, 28G | Different.<br>Compared to the predicate<br>device, the proposed<br>device has an additional<br>32G model needle. 32G<br>model for insulin syringe |
| | | | 510(K) 223453<br>needle safety and<br>performance has been<br>confirmed by testing. This<br>difference does not raise<br>new questions of safety<br>and effectiveness. |
| Needle tip<br>configuration | 3 bevels | 3 bevels | Same |
| Nozzle type | Not applicable | Not applicable | Same |
| Numbering of<br>scale | At every five units for the<br>0.3mL and 0.5mL syringes,<br>and at every 10units for<br>1.0mL | At every five units for the<br>0.3mL and 0.5mL syringes,<br>and at every 10units for<br>1.0mL | Same |
| Gradations<br>legibility | Legible | Legible | Same |
| Needle cover<br>dimensions | Length:25mm,<br>Diameter: 6mm | Length:25mm,<br>Diameter: 6mm | Same |
| Needle cover<br>color | Red (U-40) and orange<br>(U-100) | Red (U-40) and orange<br>(U-100) | Same |
| Lubricant<br>composition | Aminofunctional siloxane | Aminofunctional siloxane | Same |
| Lubricant<br>amount/cm² | The lubricant is not form<br>pools of fluid on the interior<br>surface of the syringe or<br>outside surfaces of the<br>needle tube. | The lubricant is not form<br>pools of fluid on the interior<br>surface of the syringe or<br>outside surfaces of the<br>needle tube. | Same |
| Barrel transparency | Transparent | Transparent | Same |
| Needle cover<br>strength | <15N | <15N | Same |
| Hub/needle bond<br>strength | >22N | >22N | Same |
| Biocompatibility | No cytotoxicity<br>No irritation reactivity<br>No significant evidence<br>of skin sensitization<br>No significant evidence<br>of systemic toxicity<br>No evidence of Hemolysis<br>No evidence of pyrogens | No cytotoxicity<br>No irritation reactivity<br>No significant evidence<br>of skin sensitization<br>No significant evidence<br>of systemic toxicity<br>No evidence of Hemolysis<br>No evidence of pyrogens | Same |
| Configuration<br>and Materials | Needle: Stainless Steel<br>(SUS304)<br>Barrel: Polypropylene<br>Plunger: Polypropylene<br>Piston: Polyisoprene<br>rubber<br>Needle cap: Polyethylene<br>Protective end cap (only<br>type 8): Polyethylene | Needle: Stainless Steel<br>(SUS304)<br>Barrel: Polypropylene (PP)<br>Plunger: Polypropylene (PP)<br>Piston: Polyisoprene Rubber<br>Needle cover: Polypropylene<br>(PP)<br>Protective end cap:<br>Polypropylene (PP) | Different.<br>The materials of needle<br>cap and protective end<br>cap are different<br>between the subject<br>device and predicate<br>device. The<br>biocompatibility test of<br>the subject device was<br>conducted to<br>demonstrate that the<br>subject device met the<br>biocompatibility<br>requirements. This<br>difference does not raise<br>any new safety and |
| | | | effectiveness questions. |
| Label | Device name,<br>indication, instruction<br>for use, precaution,<br>warning, shelf life,<br>manufacturer | Device name,<br>indication, instruction<br>for use, precaution,<br>warning, shelf life,<br>manufacturer | Same |
| Sterilization<br>method and SAL | Sterilized by ethylene<br>oxide gas SAL = 10-6 | Sterilized by ethylene<br>oxide gas SAL = 10-6 | Same |
| Sterilization method | EO Sterilization | EO Sterilization | Same |
| EO and ECH residues<br>testing | 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.