(445 days)
No
The device description and performance studies focus on the mechanical and material properties of a standard syringe and needle, with no mention of AI or ML capabilities.
No
The device is described as a general-purpose syringe for aspiration and injection of fluids, and there is no indication that it provides a specific therapeutic effect in itself. Its function is to deliver or withdraw substances, not to treat a condition.
No
Explanation: The device is a syringe intended for general purpose aspiration and injection of fluids, which are therapeutic or interventional actions, not diagnostic. Its description and intended use do not mention any diagnostic functions such as detection, monitoring, or diagnosis of a disease or condition.
No
The device description clearly outlines physical components like a barrel, plunger, metal tube, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin." This describes a device used for direct interaction with the body (injection and aspiration), not for testing samples in vitro (outside the body).
- Device Description: The description details a syringe and needle, designed for injecting and withdrawing fluids from the body. This aligns with the intended use and not with the function of an IVD, which would typically involve reagents, analyzers, or test kits for analyzing biological samples.
- Anatomical Site: The anatomical site is "parts of the body below the surface of the skin," indicating direct interaction with the patient's body. IVDs analyze samples taken from the body, but the analysis itself happens in vitro.
- Performance Studies: The performance studies focus on the mechanical properties, sterility, biocompatibility, and sharps injury protection of the syringe and needle. These are relevant to a device used for injection and aspiration, not for the analytical performance of an IVD.
- Lack of IVD-specific information: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on the analysis of samples.
In summary, the PLPT LDV Sterile Syringe is a medical device used for administering or withdrawing fluids from the body, which falls under the category of general medical devices, not In Vitro Diagnostics.
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)
QNG, QNG, 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 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.
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 residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent:
- 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
Biocompatibility evaluation was conducted in accordance with ISO 10993-1:2018 for "External communication device – Blood path indirect" with contact duration of "Limited (, Bacterial Endotoxins Test
- ISO 11135:2014 for EO sterilization
- ISO 11737-2 for sterility test
- ISO 10993-7:2008 for EO Residuals
Needle injury test in accordance with ISO 23908:2011 Sharps injury protection.
The differences in indication for use, nozzle configuration, syringe capacity, needle gauge and length, and safety features between the subject device and predicates were evaluated and performance testing was conducted to confirm that these differences do not alter the intended use or affect safety and effectiveness, and do not raise new questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary K221860
[as required by 807.92(c)]
1. Date of Preparation: September 12, 2023
2. Applicant
-
- Company: Poonglim Pharmatech Inc.
- Address: 21, Jayumuyeok 1-Gil, Gunsan, 54001, Republic of Korea 2)
- Tel : +82-63-451-8141 3)
- Fax : +82-63-451-8145 4)
- 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
-
- Common name : Disposal syringe
-
- Classification name : Low Dead Space Piston Syringe
- Product code : ONQ 4)
-
- Regulation number : 21 CFR 880.5860
- Class of device : Class II 6)
- Panel : General hospital 7)
Predicate/Reference Device 4.
4.1 Predicate device
-
- Trade name (Predicate Submission Number):
- Manufacturer: Poonglim Pharmatech Inc.
- 4.2 Reference device
-
- Trade name
- (1) EZ-Injec Single Use Needle (K192222)
-
- 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.
4
| 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 (, Bacterial Endotoxins Test |
| 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 . |
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 , Bacterial Endotoxins Test (Unit : EU/Device) |
| 2 | E.O sterilization | |
| validation | According to ISO 11135:2014 | |
| E.O 30%, CO2 70% | ||
| Temperature: 50 ±7°C | ||
| 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 |
| 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 |
5
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 | ||
| 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 | ||
| Plunger | |||
| Barrel | Rubber | ||
| PP | |||
| PP | Same | ||
| Nozzle type | Luer-lock | Luer-lock, Luer-slip | Different #2 |
| Capacity | |||
| (Syringe volume) | 0.5, 1 mL | 1 mL | Different #3 |
| Dead space | |||
| specification | ≤ 0.023mL | ≤ 0.023mL | Same |
| Principle of | |||
| operation | For Manual Use Only | ||
| For Single Use Only | For Manual Use Only | ||
| For Single Use Only | Same | ||
| Syringe | |||
| Performance | |||
| Requirements | Complies with | ||
| ISO 7886-1 : 2017 Sterile hypodermic syringes for single use - Part 1 : Syringes for manual use | |||
| ISO 80369-7 : 2016 Small-bore connector for liquids and gases in healthcare applications - Part 7 : Connectors for intravascular or hypodermic applications | Complies with | ||
| ISO 7886-1 : 2017 Sterile hypodermic syringes for single use - Part 1 : Syringes for manual use | |||
| 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 | ||
| requirements of ISO 10993 | |||
| series standards. | |||
| Cytotoxicity | |||
| Acute systemic toxicity | |||
| Pyrogenicity | |||
| Sensitization | |||
| Irritation | |||
| Hemolysis | |||
| Intracutaneous reactivity | |||
| Bacterial Endotoxins | |||
| Particulate Matter Injection | Conforms to the | ||
| requirements of ISO 10993 | |||
| series standards. | |||
| Cytotoxicity | |||
| Acute systemic toxicity | |||
| Pyrogenicity | |||
| Sensitization | |||
| Irritation | |||
| Hemolysis | |||
| Intracutaneous reactivity | |||
| Bacterial Endotoxins | |||
| 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 | |||
| 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 | |||
| 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. | This device is intended for use to inject | ||
| fluids into or withdraw from parts of the | |||
| 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, | ||
| 34G | 25G | Different #5 | |
| Dead space | |||
| specification |