PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe

K221860 · Poonglim Pharmatech, Inc. · QNQ · Sep 15, 2023 · General Hospital

Device Facts

• Record ID: K221860
• Device Name: PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
• Applicant: Poonglim Pharmatech, Inc.
• Product Code: QNQ · General Hospital
• Decision Date: Sep 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile Syringe is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

Device Story

Manual, single-use sterile syringe system; includes calibrated barrel, plunger, piston, and optional needle with hub, protective cap, and safety guard. Available in Luer-Cone or Luer-Lock configurations. Used by healthcare professionals in clinical settings for fluid aspiration and subcutaneous/intramuscular injection. Operates via manual plunger movement to draw and expel fluids. Low dead volume design minimizes medication waste. Safety guard provides sharps injury protection. Device is EO gas sterilized. Benefits include precise fluid delivery and reduced risk of needle-stick injuries.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via ISO 7886-1 (syringes), ISO 7864 (needles), ISO 9626 (tubing), ISO 80369-7 (connectors), and ISO 23908 (sharps protection). Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, hemolysis, intracutaneous reactivity, acute systemic toxicity, pyrogenicity) met all acceptance criteria. Sterilization validated per ISO 11135.

Technological Characteristics

Materials: Polypropylene (barrel, plunger, hub, cap), SUS304 (cannula), Epoxy (adhesive). Manual piston-driven operation. Luer-Cone or Luer-Lock connectors. EO gas sterilization (SAL 10^-6). Complies with ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, and ISO 23908. No software or electronic components.

Indications for Use

Indicated for healthcare professionals to aspirate fluids from vials/ampoules and perform liquid injections below the skin surface.

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

• PLPT LDV (Low Dead Volume) Sterile Syringe (K210443)
• EZ-Injec LDV Sterile Safety Needle (K210444)

Reference Devices

• EZ-Injec Single Use Needle (K192222)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 15, 2023

Poonglim Pharmatech Inc. % Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K221860

Trade/Device Name: PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe Regulation Number: 21 CFR 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QNG, QNG, FMI Dated: September 1, 2023 Received: September 5, 2023

Dear Peter Chung:

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.

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542 of the Act); 21 CFR 1000-1050.

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 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 (QS) 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-

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.

Image /page/1/Picture/5 description: The image shows the name "Courtney Evans-S" in a large, bold, sans-serif font. The name is split into two lines, with "Courtney" on the first line and "Evans-S" on the second line. The background of the image is a light blue color, with a faint pattern of overlapping rectangles.

Digitally signed by Courtney Evans -S Date: 2023.09.15 22:15:47 -04'00'

For 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

Enclosure

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# Indications for Use

510(k) Number (if known) K221860

### Device Name

PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe; PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe

### Indications for Use (Describe)

PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile Syringe is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary K221860

## [as required by 807.92(c)]

#### 1. Date of Preparation: September 12, 2023

#### 2. Applicant

- 1) Company: Poonglim Pharmatech Inc.
- Address: 21, Jayumuyeok 1-Gil, Gunsan, 54001, Republic of Korea 2)
- Tel : [phone])
- Fax : [phone])
- Contact person : Peter Chung, 412-512-8802 ર)
- Contact person address : 300 Atwood Street, Pittsburgh, PA, 15213, USA 6)
- Submission date: September 12, 2023 7)

#### Subject Device Information 3.

- Trade name : PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) 1) LL(Luer-Lock) Sterile Syringe
- 2) Common name : Disposal syringe
- 3) Classification name : Low Dead Space Piston Syringe
- Product code : ONQ 4)
- 5) Regulation number : 21 CFR 880.5860
- Class of device : Class II 6)
- Panel : General hospital 7)

#### Predicate/Reference Device 4.

### 4.1 Predicate device

- 1) Trade name (Predicate Submission Number):
- (1) PLPT LDV (Low Dead Volume) Sterile Syringe (K210443)
- (2) EZ-Injec LDV Sterile Safety Needle (K210444)

2) Manufacturer: Poonglim Pharmatech Inc.

- 4.2 Reference device
- 1) Trade name
- (1) EZ-Injec Single Use Needle (K192222)
- 2) Manufacturer: Poonglim Pharmatech Inc.

#### న్. Device description

PLPT LDV LC Sterile Syringe / PLPT LDV LL Sterile Syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body the surface of the skin. The device consists of a calibrated barrel (cylinder) with plunger, and metal tube that is sharpened at one end and at the other end joined to a female connector (hub). This device is intended for various medical applications and is not dedication administration. At the distal end of the barrel has a Luer-Cone or Luer-lock connector for the attachment to a hypodermic needle or an administration set. Attached needle has covered by the protective cap which is intended to provide physical protection to the needle tube. Attached needle may have safety guard that protect the user after use. This product is packed by sterile paper and sterilized by EO gas, and single-use device.

#### 6. Indications for Use:

PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile Syringe is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

#### 7. Performance data:

- Bench tests for the device's performance were conducted. Bench testing includes the mechanical testing, sterility 1) testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent mamer to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.

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| Test Standard |
|-----------------------------------------------------------------------------------------|
| ISO 7886-1:2017 Sterile hypodermic syringes for single use |
| ISO 7864:2016 Sterile hypodermic needles for single use |
| ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices |
| ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications |

### 2)

Biocompatibility of the STERILE SINGLE USE LDV SYRINGE, CHOICARE STERILE SINGLE USE LDV SYRINGE was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device – Blood path indirect" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity; Skin sensitization; Hemolysis; Intracutaneous reactivity; Acute systemic toxicity; Pyrogenicity. All evaluation acceptance criteria were met.

| Test item | Test method / Test criteria |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity<br>test | When it was tested accordingly to ISO 10993-5, tests for in vitro cytotoxicity-Test<br>on extracts method, it should satisfy the requirements. |
| Hemolysis test | When it was tested accordingly to ISO 10993-4, Selection off tests for interactions<br>with blood-evaluation of hemolytic properties of medical devices and medical<br>device materials, it should satisfy the requirements. |
| Intracutaneous<br>reactivity test | When it was tested accordingly to ISO 10993-10, Tests for irritation and skin<br>sensitization-Animal intracutaneous (Intradermal) reactivity test, it should satisfy<br>the requirements. |
| Skin<br>sensitization<br>test | when it was tested accordingly to ISO 10993-10, Tests for irritation and skin<br>sensitization-Guinea pig maximization test (GPMT), it should satisfy the<br>requirements. |
| Acute<br>systemic<br>toxicity test | When it was tested accordingly to ISO 10993-11, Tests for systemic toxicity-<br>Acute systemic toxicity, it should satisfy the requirements. |
| Pyrogen Test | When it was tested accordingly to ISO 10993-11, Tests for systemic toxicity-<br>Information on material-mediated pyrogens, it should satisfy the requirements. |
| LAL Test | USP39 <85>, Bacterial Endotoxins Test |
| Particulate<br>Matter<br>Injection | USP <788>, Particulate Matter for Injections (Method 1 Light Obscuration<br>Particle Count Test). Test result should satisfy the requirements described in the<br>USP <788>. |

### 3) Sterility and LAL test

The sterilization method has been validated to ISO 11135, which has thereby determined the routine control and monitoring parameters. The testing is performed according to the following standards:

| # | Test item | Test standard |
|---|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | LAL test | USP39 <85>, Bacterial Endotoxins Test (Unit : EU/Device) |
| 2 | E.O sterilization<br>validation | According to ISO 11135:2014<br>E.O 30%, CO2 70%<br>Temperature: 50 ±7°C<br>Exposure time: 5 hours |
| 3 | Sterility test | According to ISO 11737-2 |
| 4 | E.O Residual test | Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilization<br>residuals, the test articles should meet the test requirements. |

#### 4) Needle injury test

| Test standard |
|-----------------------------------------|
| ISO 23908:2011 Sharps injury protection |

#### 8. Substantially Equivalent (SE) Comparison

#### 8.1. Syringe

| | subject device | Predicate device #1 | |
|--------------|--------------------------|--------------------------|--------|
| Manufacturer | Poonglim Pharmatech Inc. | Poonglim Pharmatech Inc. | Remark |

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### 510(k) Summary

| Item | Subject device | Predicate device | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 510(K) No. | K221860 | K210443 | |
| Indication for use | PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile<br>Syringe is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules, and liquid injection below the surface of the skin. | PLPT LDV (Low Dead Volume) Sterile Syringe is intended to be used for medical purpose to inject fluid into or withdraw fluid from body. | Different #1 |
| Components | Barrel, Plunger, Needle (Cannula), Needle hub, Piston, Needle cap, Safety guard | Barrel, Plunger, Piston | Same |
| Materials | Piston<br>Plunger<br>Barrel | Rubber<br>PP<br>PP | Same |
| Nozzle type | Luer-lock | Luer-lock, Luer-slip | Different #2 |
| Capacity<br>(Syringe volume) | 0.5, 1 mL | 1 mL | Different #3 |
| Dead space<br>specification | ≤ 0.023mL | ≤ 0.023mL | Same |
| Principle of<br>operation | For Manual Use Only<br>For Single Use Only | For Manual Use Only<br>For Single Use Only | Same |
| Syringe<br>Performance<br>Requirements | Complies with<br>ISO 7886-1 : 2017 Sterile hypodermic syringes for single use - Part 1 : Syringes for manual use<br>ISO 80369-7 : 2016 Small-bore connector for liquids and gases in healthcare applications - Part 7 : Connectors for intravascular or hypodermic applications | Complies with<br>ISO 7886-1 : 2017 Sterile hypodermic syringes for single use - Part 1 : Syringes for manual use<br>ISO 80369-7 : 2016 Small-bore connector for liquids and gases in healthcare applications - Part 7 : Connectors for intravascular or hypodermic applications | Same |
| Biocompatibility | Conforms to the<br>requirements of ISO 10993<br>series standards.<br>Cytotoxicity<br>Acute systemic toxicity<br>Pyrogenicity<br>Sensitization<br>Irritation<br>Hemolysis<br>Intracutaneous reactivity<br>Bacterial Endotoxins<br>Particulate Matter Injection | Conforms to the<br>requirements of ISO 10993<br>series standards.<br>Cytotoxicity<br>Acute systemic toxicity<br>Pyrogenicity<br>Sensitization<br>Irritation<br>Hemolysis<br>Intracutaneous reactivity<br>Bacterial Endotoxins<br>Particulate Matter Injection | Same |
| Sterilization | E.O Gas Sterilized | E.O Gas Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| Principle of<br>operation | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. | The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient. | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| | Subject device | Predicate device #2 | Remark |
| Manufacturer | POONGLIM Pharmatech Inc. | POONGLIM Pharmatech Inc. | Same |
| 510(K) No. | K221860 | K210444 | N/A |
| Indication for<br>use | PLPT LDV (Low Dead Volume)<br>LC(Luer-Cone) Sterile Syringe / PLPT<br>LDV (Low Dead Volume) LL(Luer-Lock)<br>Sterile Syringe is intended for use by<br>health care professionals for general<br>purpose aspiration of fluid from vials,<br>ampoules, and liquid injection below the<br>surface of the skin. | This device is intended for use to inject<br>fluids into or withdraw from parts of the<br>body below the surface of the skin | Different #4 |
| | Raw Material | | |
| Hub of needle | Polypropylene (PP) | Polypropylene (PP) | Same |
| Protect cap | Polypropylene (PP) | Polypropylene (PP) | |
| Cannula | SUS304 | SUS304 | |
| Adhesive | Epoxy | Epoxy | |
| Length | 4, 6, 8, 13, 16, 25, 30, 40mm | 25 mm | |
| Gauge | 21, 22, 23, 25, 26, 27, 29, 30, 31, 32, 33,<br>34G | 25G | Different #5 |
| Dead space<br>specification | <0.0054ml | <0.0054ml | Same |
| Tip<br>configuration | Bevel | Bevel | Same |
| Wall type | TW | TW | Same |
| Needle<br>Performance<br>Requirements | ISO 7864 : 2016 Sterile hypodermic needles<br>for single use - Requirements<br>and test methods<br><br>ISO 9626 : 2016 Stainless steel needle<br>tubing for the manufacture of medical<br>devices - Requirements and test methods | ISO 7864 : 2016 Sterile hypodermic needles<br>for single use - Requirements and test<br>methods<br><br>ISO 9626 : 2016 Stainless steel needle<br>tubing for the manufacture of medical<br>devices - Requirements and test methods | Same |
| Safety feature<br>performance<br>Requirements | ISO 23908 : 2011 Sharps Injury<br>Protection - Requirements And Test<br>Methods - Sharps Protection Features For<br>Single-Use Hypodermic Needles,<br>Introducers For Catheters And Needles<br>Used For Blood Sampling | ISO 23908 : 2011 Sharps Injury Protection -<br>Requirements And Test Methods - Sharps<br>Protection Features For Single-Use<br>Hypodermic Needles, Introducers For<br>Catheters And Needles Used For Blood<br>Sampling | Different #6 |
| Biocompatibility | Conforms to the<br>requirements of ISO 10993<br>series standards.<br><br>Cytotoxicity<br>Cytotoxicity (Hub)<br>Hemolysis test<br>Pyrogen test | Conforms to the<br>requirements of ISO 10993<br>series standards.<br><br>Cytotoxicity<br>Cytotoxicity (Hub)<br>Hemolysis test<br>Pyrogen test | Same |

#### A Equivalence discussion

### Different #1 – Indication for Use

The Indications for Use statement for the subject device is not identical to the predicate device; however, the differences do not alter the intended use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the aspiration of fluid from vials, ampoules and liquid injection. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

### Different #2 - Nozzle Configuration

The configuration of PLPT LDV LC Sterile Syringe is similar as the configuration of predicate device, the

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difference is that propose device has luer-cone nozzle type. However, the syringe with luer-cone type is widely used in the clinical. Whether the nozzle type is a luer-cone or luer-lock type, this will not affect the indication for use of the equipment itself. To validate this claim, performance testing was conducted. In accordance to internationally recognized standard(ISO 7886-1). it is proved that nozzle configuration of subject device conforms with relevant standard. Also, requirements per ISO 80369-7 was validated with subject device. Therefore, the differences on configuration do not raise new questions about its safety and/or effectiveness.

## Different #3 - Capacity (Syringe Volume)

Although the configuration of PLPT LDV LC/LL Sterile Syringe is similar to the configuration of predicate devices, the capacity of the subject device is different per predicates. However, this change is just in dimension. This difference does not alter the any rise potential risks per its intended use. Other aspects (e.g., Biocompatibility) are same with the predicates. Performance testing was conducted for this change, and it was confirmed that the differences on configuration do not raise new questions about its safety and effectiveness.

#### 8.2. Needle

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| | Intracutaneous reactivity test<br>Skin sensitization test<br>Acute systemic toxicity test<br>LAL test (Endotoxin)<br>Sterility test<br>E.O. Gas Residual | Intracutaneous reactivity test<br>Skin sensitization test<br>Acute systemic toxicity test<br>LAL test (Endotoxin)<br>Sterility test<br>E.O. Gas Residual | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Sterilization<br>method | E.O Gas Sterilization | E.O Gas Sterilization | Same |
| SAL | 10-6 | 10-6 | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |

#### A Equivalence discussion

## Different #4 - Indication for Use

The Indications for Use statement for the subject device is not identical to the predicate device; however, the differences do not alter the intended use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the injecting fluids into or withdraw from parts of the body below the surface of the skin. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

## Different #5 - Needle gauge and length

The overall configuration of PLPT LDV LL/LC Sterile Syringe's needle component is similar as the configuration of predicate device; the difference is that propose device has more variable needle configurations. However, the needle configuration is widely used in the clinical. Whether the different needle configurations are present, this will not affect the indication for use of the equipment itself. To validate this claim, performance testing for the needle component was conducted. In accordance to internationally recognized standard (ISO 7864, it is proved that needle configuration of proposed device conforms with the relevant standard. Therefore, the differences on configuration do not raise new questions about its safety and/or effectiveness.

### Different #6 – Safety features

The safety features for each device are identical with each other. Although the configuration of the needle size (cannula's length, gauge) is more variable compared to the predicate device (K210444), See Different #5), the safety guard's mechanism is not affected by its configurations. The design of the safety feature shows that the safety feature performance is dominated by the linkage between the holding component. For this reason, if the structure of the holding component is identical each device will show exact same performance. Referring to the attached product design, this component's structure is identical, and predicate device's safety feature was tested with ISO 23908 and confirmed that it complies with the standards. Therefore, the subject and predicate device's safety features have performance, which is concluded that the difference per the configuration of the needle dimensions does not affect its substantial equivalence on safety and effectiveness.

#### 9. Sterility, Shipping and Shelf-Life

Sterilization validation was performed in accordance with ISO 11135:2014 to prove that the EO Gas sterilization process has been suitable for the continuous production. Through validation, sterilization process was deemed acceptable.

Also, the device's Shelf life of 3 years is validated in accordance with ISO 11607-1:2006 and ISO 11607-2:2006.

### 10. Substantially Equivalent (SE) Conclusion

The differences between the subject and predicate devices do not raise any new or different questions of safety and effectiveness. As this device is comprised of two predicates, each comparison has been conducted and demonstrated that the specifications and performance of the device are substantially equivalent as the legally marketed predicate devices.