Insulin Syringe, Insulin Syringe with Safety Retractable

K202570 · Jiangsu Micsafe Medical Technology Co., Ltd. · MEG · Jul 2, 2021 · General Hospital

Device Facts

• Record ID: K202570
• Device Name: Insulin Syringe, Insulin Syringe with Safety Retractable
• Applicant: Jiangsu Micsafe Medical Technology Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Jul 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Insulin Syringe is a sterile, single use and non-reusable, insulin syringe intended for injection of U-100 insulin into the body. The Insulin Syringe with Safety Retractable is a sterile, single use and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while risk of sharps injuries and the potential for insulin syringe reuse.

Device Story

Manual insulin syringes and safety retractable insulin syringes; used for subcutaneous injection of U-100 insulin. Components include barrel, plunger, plunger stopper, needle tube, and needle cap (safety model includes safety shield). Operation is manual; safety model features manual retraction mechanism activated by pushing and rotating safety device. Used in clinical or home settings by patients or healthcare providers. Output is delivery of insulin dose; safety feature reduces risk of sharps injury and syringe reuse. Benefits include accurate insulin delivery and sharps injury prevention.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ISO 7864, ISO 8537, ISO 9626, ISO 23908, and USP <788>. Biocompatibility confirmed per ISO 10993 series.

Technological Characteristics

Materials: Polypropylene (PP), Polyisoprene rubber, SUS304 stainless steel. Manual operation. Sterile (EtO). Shelf-life: 5 years. Sizes: 0.3ml, 0.5ml, 1ml. Needle gauges: 27G-31G. Safety model includes manual retraction mechanism. Conforms to ISO 7864, ISO 8537, ISO 9626, ISO 10993, and ISO 23908.

Indications for Use

Indicated for patients requiring U-100 insulin injections. The safety retractable model is indicated for the same population while providing sharps injury protection.

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

• U&U Insulin Syringe, U&U Insulin Syringe with Safety Retractable Device (K152808)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the agency's name and abbreviation.

October 5, 2022

Jiangsu Micsafe Medical Technology Co., Ltd Tony Yang General Manager Xituan Industrial Park, Dafeng District Yancheng, Jiangsu 224125 China

Re: K202570

Trade/Device Name: Insulin Syringe, Insulin Syringe with Safety Retractable Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: MEG, FMF

Dear Tony Yang:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 2, 2021. Specifically, FDA is updating this SE Letter because it was unsigned as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact CAPT Alan Stevens, OHT3, at alan.stevens(@fda.hhs.gov.

Sincerely.

Alan M.
Stevens -S3

CAPT Alan 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

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July 2, 2021 Jiangsu Micsafe Medical Technology Co., Ltd Tony Yang General Manager Xituan Industrial Park, Dafeng District Yancheng, Jiangsu 224125 China

Re: K202570

Trade/Device Name: Insulin Syringe, Insulin Syringe with Safety Retractable Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF Dated: April 10, 2021 Received: June 4, 2021

Dear Tony 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(@;tda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

For Rumi Young Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration,

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below

510(k) Number (if known) K202570

Device Name

Insulin Syringe. Insulin Syringe with Safety Retractable

Indications for Use (Describe)

The Insulin Syringe is a sterile, single use and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.

The Insulin Syringe with Safety Retractable is a sterile, single use and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while risk of sharps injuries and the potential for insulin syringe reuse.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (6/20)

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Image /page/4/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top two squares being red and the bottom two squares being blue. To the right of the square is the text "Micsafe" in black, with the "i" in "Micsafe" being red. Below "Micsafe" is the text "med" in gray, and to the right of "Micsafe" is a registered trademark symbol.

### K202570 510(k) Summary

(As required by 21 CFR 807.92(a))

Date Prepared: June 30, 2021

### 7.1 Submitter Information

- . Company: Jiangsu Micsafe Medical Technology Co., Ltd
- . Address: Xituan Industrial Park, Dafeng District, Yancheng City,

Jiangsu Province, 224125, China

- . Phone: [phone]
- . Email: [e-mail]
- . Contact: Tony Yang, General Manager

### 7.2 Device Information

- Trade/Device Name: Insulin Syringe
Insulin Syringe with Safety Retractable

- . Common Name: Syringe, Antistick Piston Syringe
- . Classification:

Regulation Name: Piston Syringe

Regulation Number: 21 CFR 880.5860

Product Code: MEG and FMF

Device Class: II

Type of Use: Prescription use only

### 7.3 Predicate Device Information

U&U Insulin Syringe, U&U Insulin Syringe with Safety Retractable Device

510(k) Number: K152808

### 7.4 Device Description

(1) Insulin Syringe

This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel,

plunger, plunger stopper, needle tube and needle cap.

Page 1 of 9

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Image /page/5/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square symbol on the left, followed by the text "Micsafe" in a bold, italicized font. Below "Micsafe" is the word "med" in a smaller, non-italicized font. To the right of "Micsafe" is the registered trademark symbol.

The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.

Product Contact Classification:

Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24

h to 30 d).

Models:

| | Barrel Item | Specification of Needle | Length of Needle |
|-----------------|-------------|-------------------------|------------------|
| Insulin Syringe | 0.3ml | 29G | 1/2" |
| | | 30G | 5/16" |
| | | 31G | 1/2" |
| | | | 1/4" |
| | | | 5/16" |
| | 0.5ml | 28G | 1/2" |
| | | 29G | 1/2" |
| | | 30G | 1/2" |
| | | | 5/16" |
| | | 31G | 1/4" |
| | | | 5/16" |
| | 1ml | 27G | 1/2" |
| 28G | | 1/2" | |
| 29G | | 1/2" | |
| 30G | | 1/2" | |
| | | 5/16" | |
| 31G | | 1/4" | |
| | | 5/16" | |

(2) Insulin Syringe with Safety Retractable

This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel, plunger, plunger stopper, needle tube, safety shield and needle cap.

The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.

Product Contact Classification:

Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24 h to 30 d).

Models:

| Insulin Syringe with<br>Safety Retractable | Barrel Item | Specification of Needle | Length of Needle |
|--------------------------------------------|-------------|-------------------------|------------------|
| 0.5ml | 28G | 1/2" | |
| 0.5ml | 29G | 1/2" | |

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Image /page/6/Picture/0 description: The image shows the logo for Micsafe med. The logo consists of four squares, two red and two blue, arranged in a 2x2 grid. To the right of the squares is the text "Micsafe" in bold, black letters, with a small red dot above the "i". Above the "e" is a small circled R. Below "Micsafe" is the word "med" in a smaller font.

| | | 30G | 1/2" |
|--|-----|-----|-------|
| | | | 5/16" |
| | | 31G | 1/4" |
| | | | 5/16" |
| | 1ml | 27G | 1/2" |
| | | | 28G |
| | | | 29G |
| | | | 30G |
| | | | |
| | | | 31G |
| | | | 5/16" |

### 7.5 Indications for Use

(1) Insulin Syringe

The Insulin Syringe is a sterile, single use and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.

### (2) Insulin Syringe with Safety Retractable

The Insulin Syringe with Safety Retractable is a sterile, single use and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

### 7.6 Comparison of Technological Characteristics with the Predicate Device

- (1) Insulin Syringe

| Comparison<br>Item | Subject Device<br>(K20257) | Predicate Device<br>(K152808) | Remark |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--------|
| Identification | Insulin Syringe | U&U Insulin Syringe | |
| Classification | Product Code: MEG and FMF<br>Class: II | Product Code: MEG and FMF<br>Class: II | Same |
| Indications for<br>Use | Indicated:<br>The Insulin Syringe is a<br>sterile, single use and<br>non-reusable, insulin<br>syringe intended for<br>injection of U-100 | Indicated:<br>The U&U insulin<br>syringe is a sterile,<br>single use, disposable<br>and non-reusable, insulin<br>syringe intended for | Same |

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Image /page/7/Picture/1 description: The image contains the logo for "Micsafe med". The logo consists of a square made of four smaller squares, with the top left and top right squares being red, and the bottom left and bottom right squares being blue. To the right of the square is the word "Micsafe" in bold, black letters, with a registered trademark symbol above the "e". Below "Micsafe" is the word "med" in a smaller, non-bold font.

| | insulin into the body. | injection of U-100 insulin into the body. | |
|---------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|---------------------------|
| | | | |
| Configuration | Needle Cap (PP) | Needle Sheath (PP) | Same |
| | Needle Tube (SUS304) | Needle (Stainless Steel) | Same |
| | Plunger Stopper<br>(Polyisoprene Rubber) | Piston (TPE) | Different<br>(Comment #1) |
| | Barrel (PP) | Barrel (PP) | Same |
| | Plunger (PP) | Plunger (PP) | Same |
| Size | 0.3cc/ml Needle 29G to<br>31G | 0.3cc/ml Needle 27G to<br>31G | Different<br>(Comment #2) |
| | 0.5cc/ml Needle 28G to<br>31G | 0.5cc/ml Needle 27G to<br>31G | |
| | 1cc/ml Needle 27G to<br>31G | 1cc/ml Needle 27G to<br>31G | |
| | | | |
| Sterile | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Conforms to the<br>requirement of ISO<br>10993 series Standards | Conforms to the<br>requirement of ISO<br>10993 series Standards | Same |
| | No cytotoxicity | No cytotoxicity | Same |
| | No irritation to skin | No irritation to skin | Same |
| | No significant evidence<br>of sterilization | No significant evidence<br>of sterilization | Same |
| | No systemic toxicity | No systemic toxicity | Same |
| | No hemolysis | No hemolysis | Same |
| | No pyrogen | No pyrogen | Same |
| | | | |
| Performance | Conforms with the | Conforms with the | Same |
| Safety &<br>Effectiveness | requirements of ISO<br>7864 and ISO 8537 | requirements of ISO<br>7864 and ISO 8537 | |

### Brief Summary

The subject device has identical classification with the predicate device and boasts the same indications for use with the predicate device.

The two devices enjoy similar technological characteristics, such as they are both sterile and for single use. Though they differ slightly in configuration and sizes, such differences have been further verified by FDA recognized standards – ISO 7864 and ISO 8537, which ensures that the subject device is safe and effective for usage. Such facts further support that two devices are substantial equivalent.

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Image /page/8/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top two squares being red and the bottom two squares being blue. To the right of the square is the text "Micsafe" in a bold, sans-serif font, with the "i" in "Micsafe" being red. Below "Micsafe" is the text "med" in a smaller, sans-serif font.

The biocompatibility of both devices has been ensured by relevant ISO 10993 standards, which ensures that the subject device will be as safe for use as the predicate device.

Comment #1

The difference between subject device and predicate device is the materials of plunger stopper. However, the biocompatibility test for the subject device has been tested and the results comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantial equivalence on safety and effectiveness.

Comment #2

The needle gauge and length of between the subjective device and predicate device is different. However, the difference is just in dimension. Different gauge and length device will be selected by the end user. This difference does not affect raise new or different questions of safety or effectiveness.

| Comparison<br>Item | Subject Device<br>(K202570) | Predicate Device<br>(K152808) | Remark |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Identification | Insulin Syringe with<br>Safety Retractable | U&U Insulin Syringe<br>with Safety Retractable<br>Device - | |
| Classification | Product Code: MEG and<br>FMF<br>Class: II | Product Code: MEG and<br>FMF<br>Class: II | Same |
| Indications for<br>Use | Indicated:<br>The Insulin Syringe with<br>Safety Retractable is a<br>sterile, single use and<br>non-reusable, manual<br>retractable safety insulin<br>syringe intended for<br>injection of U-100<br>insulin into the body,<br>while reducing the risk<br>of sharps injuries and<br>the potential for insulin<br>syringe reuse. | Indicated:<br>The U&U Insulin Syringe<br>with Safety Retractable<br>Device a sterile, single<br>use, disposable and non-<br>reusable, manual<br>retractable safety insulin<br>syringe intended for<br>injection of U-100 insulin<br>into the body, while<br>reducing the risk of sharps<br>injuries and the potential<br>for insulin syringe reuse. | Same |
| | Needle Cap (PP) | Needle Sheath (PP) | Same |
| Materials | Needle Tube (SUS304) | Needle (Stainless Steel) | Same |
| | Plunger Stopper<br>(Polyisoprene Rubber) | Piston (TPE) | Different<br>(Comment #1) |
| | Barrel (PP) | Barrel (PP) | Same |
| | Safety-shield (PP) | Needle Sheath (PP) | Same |
| | Plunger (PP) | Plunger (PP) | Same |
| | Size | 0.5cc/ml Needle 28G to<br>31G<br>1cc/ml Needle 27G to<br>31G | 1cc/ml Needle 27G to 31G |
| | | Sterile | Yes |
| Single Use | | Yes | Yes |
| Safety feature | | Manual retraction<br>It is achieved by pushing<br>the safety device and<br>then rotating it. | Manual retraction<br>It is achieved by pushing<br>the safety device and then<br>rotating it. |
| | Safety Feature<br>Performance | In-Safe mode force: not<br>be more than 5N | Test value:3.45-4.45N |
| | | Resist force:<br>60s with 20N weights,<br>and the protective device<br>shall not be opened. | Test value: >20N/60s |
| | | Biocompatibility | Conforms to the<br>requirement of ISO<br>10993 series Standards |
| No cytotoxicity | | | No cytotoxicity |
| No irritation to skin | | | No irritation to skin |
| No significant evidence<br>of sterilization | | | No significant evidence of<br>sterilization |
| No systemic toxicity | No systemic toxicity | | Same |
| No hemolysis | No hemolysis | | Same |
| No pyrogen | No pyrogen | | Same |
| Performance<br>Safety &<br>Effectiveness | Conforms with the<br>requirements of ISO<br>7864 and ISO 8537 | | Conforms with the<br>requirements of ISO 7864<br>and ISO 8537 |

### (2) Insulin Syringe with Safety Retractable

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Image /page/9/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square symbol on the left, followed by the text "Micsafe" in a bold, sans-serif font. Below "Micsafe" is the word "med" in a smaller font size.

### Brief Summary

The subject device has identical classification with the predicate device and boasts the same indications for use with the predicate device.

The two devices have similar technological characteristics, such as they are both sterile and for

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Image /page/10/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square design on the left, followed by the text "Micsafe" in bold, black letters. Below "Micsafe" is the word "med" in a smaller, lighter font.

single use. Though they differ slightly in configuration and sizes, such differences have been further verified by FDA recognized standards – ISO 7864 and ISO 8537, which ensures that the subject device is safe and effective for usage. Such facts further support that the two devices are substantially equivalent.

The biocompatibility of both devices has been ensured by relevant ISO 10993 standards, which ensures that the subject device will be as safe for use as the predicate device.

Comment #1

The difference between subject device and predicate device is the materials of plunger stopper. However, the biocompatibility test for the subject device has been tested and the results comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantial equivalence on safety and effectiveness.

Comment #2

The needle gauge and length between the subject device and predicate device is different. However, the difference is just in dimension. These differences were assessed by performance testing, and the difference does not raise new or different questions of safety or effectiveness.

### 7.7 Discussion of Test Performed

### 7.7.1 Clinical Tests

Clinical testing was not performed for the subject device as part of the submission.

### 7.7.2 Non-Clinical Tests

The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:

- (1) Biocompatibility according to
- . ANSI AAMI ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity;
- . ANSI AAMI ISO 10993-10:2010/(R)2014, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization;
- . ISO 10993-11: Third Edition 2017-09, Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity;

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Image /page/11/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top left and top right squares being red, and the bottom left and bottom right squares being blue. To the right of the square is the text "Micsafe" in bold, black letters, with a small "®" symbol in the upper right corner. Below "Micsafe" is the word "med" in a smaller, non-bold font.

- . ISO 10993-4: Third Edition 2017-04. Biological Evaluation Of Medical Devices - Part 4: Selection Of Tests For Interactions With Blood;
- . ASTM F756-17, Standard Practice For Assessment Of Hemolytic Properties Of Materials.
- (2) Performance safety and effectiveness according to ISO 7864 Fourth Edition 2016-08-01,

Sterile Hypodermic Needles For Single Use Requirements And Test Methods:

- . Cleanliness
- . Limits for acidity or alkalinity
- . Limits for extractable metals
- . Needle cap
- . Tolerances on length
- . Freedom from defects
- . Lubricant
- Needle point
- . Bond between hub and needle tube
- . Patency of lumen
- Sharps injury protection
- (3) Performance safety and effectiveness according to ISO 8537 Third Edition 2016-03-15,

Sterile Single-use Syringes, With Or Without Needle, For Insulin:

- Colour coding
- . Limits for acidity or alkalinity
- . Limits for extractable metals
- Lubrication of syringes
- . Lubrication of needle tube
- . Barrel and plunger stopper
- . Finger grips
- Fit of plunger stopper in barrel
- . Position of nozzle on end of barrel
- . Needle tubing for syringe types 5, 6,7, and 8

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Image /page/12/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square symbol on the left, followed by the text "Micsafe" in bold, black font. Below "Micsafe" is the word "med" in a smaller, lighter font. There is a registered trademark symbol to the right of the word "safe".

- Bond between hub and needle tube
- . Dead space
- . Freedom from leakage at needle
- . Freedom from leakage past plunger stopper
- (4) Performance safety and effectiveness according to ISO 9626 Second Edition 2016-08-01, Stainless Steel Needle Tubing for The Manufacture of Medical Devices - Requirements and Test Methods:
- . Dimensions
- Stiffness
- . Resistance to breakage
- . Resistance to corrosion
- (5) Particulate matter testing per USP <788>, Method 1
- (6) ETO residuals ISO 10993-7:2008
- (7) Packaging and Shelf life testing per ASTM D4169-16, ASTM F1929-15:1998 ASTM F88:2009
- (8) Additional performance safety and effectiveness for Insulin Syringe/ Insulin Syringe with

Safety Retractable:

- Risk Management Report
- Sharps Injury Protection Test Report to ISO 23908 First Edition 2011-06-11

### 7.8 Conclusion

Based on the comparison and analysis above and the performance testing conducted, the subject

device is determined to be Substantiality Equivalent (SE) to the predicate device.