(191 days)
Not Found
No
The device description and intended use are for a standard plastic syringe, and there is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies are standard bench tests for mechanical and biocompatibility properties.
No
The device is a syringe used for injecting or withdrawing fluids, which is a delivery mechanism, not a therapeutic treatment itself.
No
The device description states it is a "plastic syringe for Single use" intended "to inject fluid into or withdraw fluid from body." This describes an instrument for administration, not for diagnosis.
No
The device description explicitly states it is a physical, sterile device made of plastic and silicone materials, intended for injecting/withdrawing fluids. It is a hardware device.
Based on the provided information, the Nanum Syringe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "inject fluid into or withdraw fluid from body." This describes a direct interaction with the human body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details a device for injecting/withdrawing fluids/gas to/from a medical device or the body. This aligns with the intended use and does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Nanum Syringe's function is purely mechanical for fluid transfer to or from the body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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: Appearance and Structure, Requirements: MFDA Notification No. 2018-72, The standards for the medical device
Test item: Nozzle, Requirements: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use, Results: Pass — MTK-2019-000829
Test item: Scale, Requirements: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Test item: Piston/Plunger Assembly, Requirements: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Test item: Tightness, Requirements: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Test item: Extraction test : pH, Requirements: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Test item: Extraction test : Heavy metal, Requirements: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Test item: Extraction test : Potassium permanganate-reducible substances, Requirements: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Test item: Extraction test : Residue on evaporation, Requirements: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Test item: Quantity of silicone oil, Requirements: ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
Test item: Shelf life test, Requirements: ASTM1980-07: 2011 Standard guide for Accelerated Aging of Sterile Barrier System for Medical Device ISO11607-1:2006 Packaging for terminally sterilized medical devices, Results: NC-SLR-1902
Test item: Performance test of Real time and accelerated aged devices, Results: NC-060-F0729 NC-060-F0421
Biocompatibility tests:
Test item: Cytotoxicity, Test method / Test criteria: ISO 10993-5(2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, Test result: Pass
Test item: Acute systemic toxicity test, Test method / Test criteria: ISO 10993-11(2009) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity, Test result: Pass
Test item: Pyrogen test, Test method / Test criteria: ISO 10993-11 Test for systemic toxicity, pyrogen test, Test result: Pass
Test item: Sensitization test, Test method / Test criteria: ISO 10993-10 (2010), Test result: Pass
Test item: Hemolytic test, Test method / Test criteria: ISO 10993-4:2017, ASTM F756-17, Test result: Pass
Test item: Intracutaneous reactivity test, Test method / Test criteria: ISO 10993-10 (2010), Test result: Pass
Test item: LAL Test, Test method / Test criteria: ISO 10993-11 Test for systemic toxicity, pyrogen test, Test result: Pass MSK-2020-002259
The performance tests demonstrated that the subject device performs in a substantially equivalent manner to the predicate device.
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.
Not Found
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 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
1
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
2
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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3
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)
-
- Fax : 82-53-795-7078
-
- Prepared date : June 24, 2020
- ୧) Contact person : Peter Chung, 412-512-8802
-
- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
-
- Submission date : Nov. 20, 2020
2. Device Information
-
- Trade name : Nanum Syringe
-
- Common name : Piston Syringe
- Regulation name : Syringe, Piston 2)
-
- Product code : FMF
-
- Regulation number : 880.5860
- Class of device : Class II 5)
-
- 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
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.
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:
-
- 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: Syringes | |
| for manual use | Pass — MTK- | |
| 2019- | ||
| 000829 | ||
| Scale | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes | |
| for manual use | ||
| Piston/Plunger Assembly | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes | |
| for manual use |
4
| 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 : Potassium | ||
| permanganate-reducible | ||
| substances | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | |
| Extraction test : Residue on | ||
| evaporation | 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 Sterile | ||
| Barrier System for Medical Device | ||
| ISO11607-1:2006 Packaging for terminally sterilized medical devices | NC-SLR- | |
| 1902 | ||
| Shelf life test | Performance test of Real time and accelerated aged devices | NC-060- |
| F0729 | ||
| NC-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 | Pass |
| MSK-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 for | ||
| Single use, with/without needle is intended | |||
| to be used for medical purposes to inject | |||
| fluid into or withdraw fluid from body. | The sterile Hypodermic Syringe for Single | ||
| use, with/without needle is intended to be | |||
| used for medical purposes to inject fluid into | |||
| or withdraw fluid from body. | Similar | ||
| Classification | |||
| name | Syringe, Piston | Syringe, Piston | Same |
5
| 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 Syringe | |||
| for Single use, with needle, Sterile | |||
| Hypodermic 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 |
| Materials | |||
| Barrel | |||
| Plunger | |||
| Piston | PP | ||
| PP | |||
| Rubber | PP | ||
| PP | |||
| Rubber | Same | ||
| Capacity | 10mL, 20mL, 50mL | 1mL, 2mL, 3mL, 5mL, 10mL, 20mL, 30mL, | |
| 35mL, 50mL, 60mL | Similar | ||
| Principle of | |||
| operation | Manual | Manual | 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 | Cytotoxicity | ||
| Acute systemic toxicity | |||
| Pyrogenicity | |||
| Sensitization | |||
| Hemolysis | |||
| Intracutaneous test | |||
| Endotoxin (LAL) test | Cytotoxicity | ||
| Acute systemic toxicity | |||
| Pyrogenicity | |||
| Sensitization | |||
| Irritation | |||
| Subacute toxicity | Similar | ||
| 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 |
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.