Nanum Syringe is the plastic syringe for Single use, with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

Device Description

A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:

Device: Nanum Syringe (Piston Syringe)

Summary of Study Type: This documentation describes a bench testing and biocompatibility testing study conducted to demonstrate substantial equivalence of the Nanum Syringe to a legally marketed predicate device (K190002, Shanghai Kohope Medical Devices Co., Ltd. Sterile Hypodermic Syringe for Single use). The study's purpose is to show that the Nanum Syringe performs in a substantially equivalent manner in terms of functionality and biological safety.

1. Table of Acceptance Criteria and Reported Device Performance

Test Item	Acceptance Criteria (Requirement)	Reported Device Performance (Result)	Details / Standard Referenced
Mechanical/Physical
Appearance and Structure	MFDA Notification No. 2018-72, The standards for the medical device	Pass	MFDA Notification No. 2018-72
Nozzle	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use	Pass	ISO 7886-1:2017 (Report: MTK-2019-000829)
Scale	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use	Pass	ISO 7886-1:2017
Piston/Plunger Assembly	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use	Pass	ISO 7886-1:2017
Tightness	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use	Pass	ISO 7886-1:2017
Extraction Test : pH	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use	Pass	ISO 7886-1:2017
Extraction Test : Heavy Metal	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use	Pass	ISO 7886-1:2017
Extraction Test : Potassium Permanganate-Reducible Substances	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use	Pass	ISO 7886-1:2017
Extraction Test : Residue on Evaporation	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use	Pass	ISO 7886-1:2017
Quantity of Silicone Oil	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use	Pass	ISO 7886-1:2017
Shelf Life	ASTM1980-07: 2011 Standard guide for Accelerated Aging of Sterile Barrier System for Medical Device & ISO11607-1:2006 Packaging for terminally sterilized medical devices	Pass	ASTM1980-07: 2011, ISO11607-1:2006 (Reports: NC-SLR-1902, NC-060-F0729, NC-060-F0421)
Biocompatibility
Cytotoxicity	ISO 10993-5(2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Pass	ISO 10993-5(2009)
Acute Systemic Toxicity Test	ISO 10993-11(2009) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity	Pass	ISO 10993-11(2009)
Pyrogen Test	ISO 10993-11 Test for systemic toxicity, pyrogen test	Pass	ISO 10993-11
Sensitization Test	ISO 10993-10 (2010) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Pass	ISO 10993-10 (2010)
Hemolytic Test	ISO 10993-4:2017, ASTM F756-17 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood	Pass	ISO 10993-4:2017, ASTM F756-17
Intracutaneous Reactivity Test	ISO 10993-10 (2010) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Pass	ISO 10993-10 (2010)
LAL Test (Endotoxin)	ISO 10993-11 Test for systemic toxicity, pyrogen test	Pass	ISO 10993-11 (Report: MSK-2020-002259)

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state the sample sizes used for each individual test within the bench and biocompatibility studies. It only states that "Bench test were performed" and lists the tests.

Sample Size (Test Set): Not explicitly stated for each test.
Data Provenance: The tests are described as "Bench test were performed." This implies the data were generated in a laboratory setting, likely by Nanum Company Co., Ltd or a testing facility they contracted. The company is located in Daegu, Korea, suggesting the testing was performed there or outsourced. The studies are prospective in nature, as they involve newly manufactured devices being subjected to specific tests to determine their performance against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: This type of testing (bench and biocompatibility) generally relies on standardized protocols and objective measurements, not on human expert consensus to establish "ground truth" in the diagnostic sense. Therefore, the concept of "experts" establishing a ground truth as one would for image review or clinical outcomes is not applicable here.
Qualifications of Experts: Not applicable. The results are typically interpreted by qualified laboratory personnel following the specified test standards.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. For bench and biocompatibility testing, results are typically objectively measured and compared against predefined pass/fail criteria outlined in the relevant ISO or ASTM standards. There is no mention of a subjective "adjudication" process akin to what would be used for clinical trial endpoints or image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This is a medical device (syringe), not an AI-powered diagnostic or assistive technology. The evaluation focuses on the physical and biological properties of the syringe.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: No, a standalone performance evaluation (as defined for an algorithm) was not done. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on established international and national standards for medical device performance and biocompatibility.

For mechanical/physical tests, the ground truth is defined by the objective pass/fail criteria specified in standards like ISO 7886-1:2017 and MFDA Notification No. 2018-72.
For biocompatibility tests, the ground truth is defined by the objective pass/fail criteria specified in standards like ISO 10993 series and ASTM F756-17, which evaluate the biological response to the device materials.

8. The Sample Size for the Training Set

Sample Size (Training Set): Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical product designed and manufactured to meet specific specifications.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device evaluation.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 17, 2021

Nanum Company Co., Ltd % Peter Chung President Plus Global 300 Atwood St. Pittsburgh, Pennsylvania 15213

Re: K201930

Trade/Device Name: Nanum Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: June 24, 2020 Received: July 10, 2020

Dear Mr. 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.

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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K201930

Device Name Nanum Syringe

Indications for Use (Describe)

Nanum Syringe is the plastic syringe for Single use, with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

1. Applicant

Company : NANUM COMPANY Co., Ltd 1)
Address : 4th floor, 40, Siji-ro, Suseong-gu, Daegu, Korea 2)
Tel : 82-53-795-7076 3)
1. Fax : 82-53-795-7078
1. Prepared date : June 24, 2020
୧) Contact person : Peter Chung, 412-512-8802
1. Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
1. Submission date : Nov. 20, 2020

2. Device Information

1. Trade name : Nanum Syringe
1. Common name : Piston Syringe
Regulation name : Syringe, Piston 2)
1. Product code : FMF
1. Regulation number : 880.5860
Class of device : Class II 5)
1. Panel : General Hospital

3. The legally marketed device to which we are claiming equivalence

K190002, Shanghai Kohope Medical Devices Co., Ltd. / Sterile Hypodermic Syringe for Single use, with/without needle

4. Device description

5. Intended Use

Nanum Syringe is the plastic syringe for Single use, with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

6. Performance data:

1. Bench test were performed. Bench testing included biocompatibility and mechanical testing. 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.

Test item	Requirements	Results
Appearance and Structure	MFDA Notification No. 2018-72, The standards for the medical device
Nozzle	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringesfor manual use	Pass — MTK-2019-000829
Scale	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringesfor manual use
Piston/Plunger Assembly	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringesfor manual use

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Tightness	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Extraction test : pH	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Extraction test : Heavy metal	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Extraction test : Potassiumpermanganate-reduciblesubstances	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Extraction test : Residue onevaporation	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Quantity of silicone oil	ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
	ASTM1980-07: 2011 Standard guide for Accelerated Aging of SterileBarrier System for Medical DeviceISO11607-1:2006 Packaging for terminally sterilized medical devices	NC-SLR-1902
Shelf life test	Performance test of Real time and accelerated aged devices	NC-060-F0729NC-060-F0421

2) Biocompatibility

#	Test item	Test method / Test criteria	Test result
1	Cytotoxicity	ISO 10993-5(2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Pass
2	Acute systemic toxicity test	ISO 10993-11(2009) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity	Pass
3	Pyrogen test	ISO 10993-11 Test for systemic toxicity, pyrogen test	Pass
4	Sensitization test	ISO 10993-10 (2010)	Pass
5	Hemolytic test	ISO 10993-4:2017, ASTM F756-17	Pass
6	Intracutaneous reactivity test	ISO 10993-10 (2010)	Pass
7	LAL Test	ISO 10993-11 Test for systemic toxicity, pyrogen test	PassMSK-2020-002259

The performance tests demonstrated that the subject device performs in a substantially equivalent manner to the predicate device.

7. Predicate device comparison table

Manufacturer	NANUM COMPANY Co., Ltd	Shanghai Kohope Medical Devices Co., Ltd.	Remark
510(k) No.	N/A	K190002	N/A
Indication for use	Nanum Syringe is the plastic syringe forSingle use, with/without needle is intendedto be used for medical purposes to injectfluid into or withdraw fluid from body.	The sterile Hypodermic Syringe for Singleuse, with/without needle is intended to beused for medical purposes to inject fluid intoor withdraw fluid from body.	Similar
Classificationname	Syringe, Piston	Syringe, Piston	Same

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Manufacturer	NANUM COMPANY Co., Ltd	Shanghai Kohope Medical Devices Co., Ltd.	Remark
Trade name	Nanum Syringe	Sterile Hypodermic Syringe for Single use,with/without needle, Sterile Insulin Syringefor Single use, with needle, SterileHypodermic needle for Single use	N/A
Model/type	NS-10, NS-20, NS-50	N/A	N/A
Components	Cylinder, Plunger, Gasket, Clip	Barrel, Plunger, Piston	Similar
Nozzle type	Lock type, Lock clip type	Lock and Slip type	Similar
MaterialsBarrelPlungerPiston	PPPPRubber	PPPPRubber	Same
Capacity	10mL, 20mL, 50mL	1mL, 2mL, 3mL, 5mL, 10mL, 20mL, 30mL,35mL, 50mL, 60mL	Similar
Principle ofoperation	Manual	Manual	Same
Performances	Complies with ISO 7886-1 : 2017 Sterilehypodermic syringes for single use – Part 1 :Syringes for manual use	Complies with ISO 7886-1 : 2017 Sterilehypodermic syringes for single use - Part 1 :Syringes for manual use	Same
Biocompatibility	CytotoxicityAcute systemic toxicityPyrogenicitySensitizationHemolysisIntracutaneous testEndotoxin (LAL) test	CytotoxicityAcute systemic toxicityPyrogenicitySensitizationIrritationSubacute toxicity	Similar
Principle ofOperation	The plunger of syringe can be pulled andpushed along inside the barrel, allowing thesyringe to take in and expel the fluidsthrough the connector to the patient.	The plunger of syringe can be pulled andpushed along inside the barrel, allowing thesyringe to take in and expel the fluidsthrough the connector to the patient.	Same

8. Conclusion

The device is investigated for function to compare the operation of function between Nanum Syringe and predicate devices.

Comparison results demonstrate that the specifications and performance of the device are substantially equivalent to the legally marketed predicate device.

Therefore, it is concluded that Nanum Syringe are substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 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).