(30 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard syringe, with no mention of AI or ML.
No
The device is described as a general-purpose syringe for aspiration and injection of fluids, and its intended use does not specify any therapeutic action.
No
Explanation: The device is described as a syringe intended for general purpose aspiration of fluid or injection of liquid. Its function is to transfer fluids, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components like a barrel, plunger, metal tube, and connectors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin." This describes a device used for administering or withdrawing substances directly from or into the body, not for testing samples in vitro (outside the body).
- Device Description: The description details a syringe with a barrel, plunger, and needle, designed for injection and aspiration. This aligns with a medical device used for direct patient interaction, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
QNQ, QNS, FMI
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 below the skin. The device consists of a calibrated barrel (cylinder) with a 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. 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. The attached needle is covered by the protective cap which is intended to provide physical protection to the needle tube. The attached needle may have a safety guard that protects the user after use. This product is packed by sterile paper and sterilized by EO gas, and is a single-use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
below the surface of the skin.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests for the device's performance were conducted. Bench testing includes the mechanical testing, sterility testing including EO residuals. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. Bench testing was done in accordance with the following standards:
- 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 Requirements and test methods
- ISO 80369-7:2021- Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
Biocompatibility of the PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile 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 (
§ 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).
0
Image /page/0/Picture/0 description: The image shows 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.
May 29, 2024
Poonglim Pharmatech Inc. % Peter Chung, President PlusGlobal 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K241190
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 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: QNQ, QNS, FMI Dated: January 19, 2024 Received: April 29, 2024
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 (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).
1
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 QS 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.
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).
Sincerely,
Gang Peng -S
for
Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K241190
Device Name
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe: PLPT LDV(Low Dead Volume) LL(Luer-Lock) 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image contains a logo for "PLPT POONGLIM Pharmatech Inc.". The logo has the letters "PLPT" in blue, stacked on top of the company name in Korean and English. The font is sans-serif and the overall design is simple and modern.
510(k) Summary K241190
[as required by 807.92(c)]
Date of Preparation: May 23, 2024 1.
2. Applicant
- Company: Poonglim Pharmatech Inc. 1)
-
- Address: 21, Jayumuyeok 1-Gil, Gunsan, 54001, Republic of Korea
-
- Tel: +82-63-451-8141
-
- Fax: +82-63-451-8145
- ર) Contact person: Peter Chung, 412-512-8802
- Contact person address: 300 Atwood Street, Pittsburgh, PA, 15213, USA 6)
-
- Submission date: April 29, 2024
3. Subject Device Information
-
- Trade name: PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
-
- Common name: Piston syringe
- Classification name: Low Dead Space Piston Syringe 3)
-
- Product code: QNQ, QNS, FMI
-
- Regulation number: 21 CFR 880.5860
- Class of device: Class II 6)
-
- Panel: General hospital
4. Predicate Device
- 1.1 Predicate device
-
- Trade name (Predicate Submission Number):
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe (K221860)
-
- Manufacturer: Poonglim Pharmatech Inc.
રા 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 below the skin. The device consists of a calibrated barrel (cylinder) with a 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. 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. The attached needle is covered by the protective cap which is intended to provide physical protection to the needle tube. The attached needle may have a safety guard that protects the user after use. This product is packed by sterile paper and sterilized by EO gas, and is a 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 testing including EO residuals. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. Bench testing was done in accordance with the following standards:
- ISO 7886-1:2017 Sterile hypodermic syringes for single use a.
- ISO 7864:2016 Sterile hypodermic needles for single use b.
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices Requirements C. and test methods
- ISO 80369-7:2021- Small-bore connectors for liquids and gases in healthcare applications Part 7: d.
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Image /page/4/Picture/0 description: The image contains the logo for Poonglim Pharmatech Inc. The logo consists of the letters "pLpT" in blue, stacked on top of the company name in Korean and English. The English version of the name, "POONGLIM Pharmatech Inc.", is in a smaller font size and is located below the Korean version.
Connectors for intravascular or hypodermic applications
2) Biocompatibility
Biocompatibility of the PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile 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 (, Bacterial Endotoxins Test | Pass |
| Particulate
Matter Injection | USP , Particulate Matter for Injections (Method 1 Light Obscuration
Particle Count Test). Test result should satisfy the requirements described in the
USP . | Pass |
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 | Test result |
|---|---|---|---|
| 1 | LAL test | USP39 , Bacterial Endotoxins Test (Unit : EU/Device) | Pass |
| 2 | E.O sterilization | ||
| validation | According to ISO 11135:2014 | ||
| E.O 30%, CO2 70% | |||
| Temperature: 50 $\pm$ 7°C | |||
| Exposure time: 5 hours | Pass | ||
| 3 | Sterility test | According to ISO 11737-2 | Pass |
| 4 | E.O Residual test | Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilization | |
| residuals, the test articles should meet the test requirements. | Pass |
4) Needle injury test
| # | Test item | Test standard | Test result |
|---|---|---|---|
| 1 | Needle | ||
| penetration force | ISO 23908: 2011 Sharps injury protection | Pass | |
| 2 | Pull-out force | ISO 23908: 2011 Sharps injury protection | Pass |
| 3 | Needle cap | ||
| removal force | ISO 23908: 2011 Sharps injury protection | Pass | |
| 4 | Activation | ||
| (locking) force | ISO 23908: 2011 Sharps injury protection | Pass | |
| 5 | Unlocking force | ISO 23908: 2011 Sharps injury protection | Pass |
8. Substantially Equivalent (SE) Comparison
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Image /page/5/Picture/0 description: The image contains a logo for Poonglim Pharmatech Inc. The logo consists of the letters "pLpT" in blue, stacked above the Korean text "풍림파마텍" which is also in blue. Below the Korean text is the English translation "POONGLIM Pharmatech Inc." in a smaller font size, also in blue.
Syringe 8.1.
| Proposed device | Approved device | Remark | |
|---|---|---|---|
| Manufacturer | POONGLIM Pharmatech Inc. | POONGLIM Pharmatech Inc. | Same |
| 510(K) No. | K241190 | K221860 | N/A |
| Indication 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. | 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. | Same | ||
| Classification name | Syringe, Piston | Syringe, Piston | Same |
| Components | Barrel, Plunger, Plunger rod | Barrel, Plunger, Plunger rod | Same |
| Dead space | |||
| specification | ≤ 0.023mL with 95% confidence/95% | ||
| reliability | ≤ 0.023mL with 95% confidence/95% | ||
| reliability | Same | ||
| Connection type | Luer-lock, Luer-cone | Luer-lock, Luer-cone | Same |
| Raw Materials | |||
| Plunger rod | PP | PP | Same |
| Plunger | Rubber | Rubber | Same |
| Barrel | PP | PP | Same |
| Capacity (Syringe | |||
| volume) | 0.5, 1, 3, 5, 10 mL | 0.5, 1 mL | Difference |
| #1 | |||
| Sterilization method | E.O Gas Sterilization | E.O Gas Sterilization | Same |
| SAL | 10-6 | 10-6 | Same |
| Performances | Complies with ISO 7886-1 : 2017 Sterile | ||
| hypodermic syringes for single use - Part 1 : | |||
| Syringes for manual use | Complies with ISO 7886-1 : 2017 Sterile | ||
| hypodermic syringes for single use - Part 1 : | |||
| Syringes for manual use | Same | ||
| Biocompatibility | Conforms to the | ||
| requirements of ISO 10993 | |||
| series standards. | |||
| Cytotoxicity | |||
| Hemolysis test | |||
| Pyrogen test | |||
| Intracutaneous reactivity test | |||
| Skin sensitization test | |||
| Acute systemic toxicity test | |||
| LAL test (Endotoxin) | |||
| Sterility test | |||
| E.O. Gas Residual | Conforms to the | ||
| requirements of ISO 10993 | |||
| series standards. | |||
| Cytotoxicity | |||
| Hemolysis test | |||
| Pyrogen test | |||
| Intracutaneous reactivity test | |||
| Skin sensitization test | |||
| Acute systemic toxicity test | |||
| LAL test (Endotoxin) | |||
| Sterility test | |||
| E.O. Gas Residual | Same | ||
| Principle of | |||
| 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. For Manual Use | |||
| Only, | |||
| For Single Use Only | 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. For Manual Use | |||
| Only, | |||
| For Single Use Only | Same | ||
Equivalence discussion
Difference 1 - Capacity (Syringe Volume)
Although the configuration of PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe is similar to the configuration of the predicate device, the capacity (syringe volume) of the proposed device is different from the predicate device. However, this change is just in dimension. This difference does not alter the risks or raise potential risks per its intended use. Other aspects (e.g., Biocompatibility) are the same with the predicate device. Performance testing was conducted for this change, and it was confirmed that the differences on configuration do not raise new or different questions of safety and effectiveness when compared to the predicate device.
8.2. Needle
| Proposed device | Approved device | Remark | |
|---|---|---|---|
| Manufacturer | POONGLIM Pharmatech Inc. | POONGLIM Pharmatech Inc. | Same |
| 510(K) No. | K241190 | K221860 | N/A |
| Indication for use | PLPT LDV (Low Dead Volume) LC(Luer- | ||
| Cone) Sterile Syringe / PLPT LDV (Low | PLPT LDV (Low Dead Volume) LC(Luer- | ||
| Cone) Sterile Syringe / PLPT LDV (Low | Same |
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Image /page/6/Picture/0 description: The image contains a logo for POONGLIM Pharmatech Inc. The logo consists of the letters "pLpT" in blue, stacked on top of each other. Below the letters, there is Korean text, followed by the English text "POONGLIM Pharmatech Inc."
| Dead Volume) LL(Luer-Lock) Sterile | Dead Volume) LL(Luer-Lock) Sterile | ||
|---|---|---|---|
| Syringe is intended for use by health care | Syringe is intended for use by health care | ||
| professionals for general purpose aspiration | professionals for general purpose aspiration | ||
| of fluid from vials, ampoules and liquid | of fluid from vials, ampoules and liquid | ||
| injection below the surface of the skin. | injection below the surface of the skin. | ||
| Raw Material | |||
| Hub of needle | Polypropylene (PP) | Polypropylene (PP) | |
| Protect cap | Polypropylene (PP) | Polypropylene (PP) | Same |
| Cannula | SUS304 | SUS304 | |
| Adhesive | Epoxy | Epoxy | |
| Length | 4, 6, 8, 13, 16, 25, 30, 40mm | 4, 6, 8, 13, 16, 25, 30, 40mm | |
| Gauge | 18, 21, 22, 23, 25, 26, 27, 29, 30, 31, 32, | 21, 22, 23, 25, 26, 27, 29, 30, 31, 32, 33, | Difference |
| #2 | |||
| 33, 34G | 34G | ||
| Dead space | |||
| specification | ≤0.0054ml | ≤0.0054ml | Same |
| Tip configuration | Bevel | Bevel | Same |
| Wall type | TW | TW | Same |
| ISO 7864: 2016 Sterile hypodermic needles | ISO 7864: 2016 Sterile hypodermic needles | ||
| for single use - Requirements and test | for single use - Requirements and test | ||
| Needle | methods | methods | |
| Performance | Same | ||
| Requirements | ISO 9626: 2016 Stainless steel needle | ISO 9626: 2016 Stainless steel needle | |
| tubing for the manufacture of medical | tubing for the manufacture of medical | ||
| devices - Requirements and test methods | devices - Requirements and test methods | ||
| Safety feature | |||
| performance | |||
| specification | ISO 23908: 2011 Sharps Injury Protection - | ISO 23908: 2011 Sharps Injury Protection - | Same |
| Requirements And Test Methods - Sharps | Requirements And Test Methods - Sharps | ||
| Protection Features For Single-Use | Protection Features For Single-Use | ||
| Hypodermic Needles, Introducers For | Hypodermic Needles, Introducers For | ||
| Catheters And Needles Used For Blood | Catheters And Needles Used For Blood | ||
| Sampling | Sampling | ||
| Conforms to the | Conforms to the | Same | |
| requirements of ISO 10993 | requirements of ISO 10993 | ||
| series standards. | series standards. | ||
| Cytotoxicity | Cytotoxicity | ||
| Cytotoxicity (Hub) | Cytotoxicity (Hub) | ||
| Hemolysis test | Hemolysis test | ||
| Biocompatibility | Pyrogen test | Pyrogen test | |
| Intracutaneous reactivity test | Intracutaneous reactivity test | ||
| Skin sensitization test | Skin sensitization test | ||
| Acute systemic toxicity test | Acute systemic toxicity test | ||
| LAL test (Endotoxin) | LAL test (Endotoxin) | ||
| Sterility test | Sterility test | ||
| E.O. Gas Residual | E.O. Gas Residual | ||
| Sterilization 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 |
Equivalence discussion
Difference #2 – Needle gauge
The overall configuration of PLPT LDV LL/LC Sterile Syringe's needle component is similar as the configuration of the predicate device; the difference is that the subject device has more variable needle configurations. However, the needle configuration is widely used clinically. Performance testing for the needle component was conducted in accordance to internationally recognized standard (ISO 7864, and the testing shows that the needle configuration of the subject device conforms with the relevant standards. Therefore, the differences in the configuration do not raise new or different questions of safety and/or effectiveness when compared to the predicate device.
9. Sterility, Shipping and Shelf-Life
Sterilization validation was performed in accordance with ISO 11135:2014 to show that the E.O Gas sterilization process has been suitable for the continuous production, sterilization process was deemed acceptable.
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Image /page/7/Picture/0 description: The image contains a logo for a company called "POONGLIM Pharmatech Inc." The logo consists of the letters "pLpT" in blue, stacked on top of each other. Below the letters, the company name is written in Korean and English. The Korean text is larger and bolder than the English text.
Also, the device's Shelf life of 5 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 when compared to the predicate device. A comparison to the predicate device has been conducted and demonstrated that the specifications and performance of the device are substantially equivalent as the legally marketed predicate device.