(291 days)
Not Found
No
The device description details a purely mechanical safety mechanism for a syringe and needle. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a syringe for fluid injection, designed for safety and to prevent reuse, not to treat or diagnose a disease or condition.
No
The device is described as a safety syringe intended for the injection of fluids, not for diagnosis. Its mechanism focuses on preventing needle-stick injuries and reuse.
No
The device description clearly details a physical syringe with a mechanical safety mechanism, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for injection of fluids into the body". This describes a device used on or in the body for therapeutic or diagnostic purposes, not a device used to examine specimens from the body in a laboratory setting.
- Device Description: The description details a syringe and needle designed for injecting substances and preventing needle sticks. This aligns with a medical device used for administering treatments or collecting samples from the body, not for testing those samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is for administering substances into the body.
N/A
Intended Use / Indications for Use
Jeesung safety syringe and single use needles is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Product codes (comma separated list FDA assigned to the subject device)
MEG
Device Description
Jeesung Safety Syringe and Single Use Needles is an integrated needle and piston syringe with an anti-needle-stick mechanism. There is a swell on the top of inside barrel, which can be used to fix the hub of needle to the top of inside barrel. Four legs on the bottom of hub are caught on the swell part on the top of inside barrel when the hub is pulled.
After using this syringe (such as injecting medicine into body etc.), the hub of needle is pulled back to the inside of the barrel. Because the four legs of hub is bound to the top of the plunger which has a smaller swell part than the top of inside barrel for being caught. Therefore, by pushing plunger until it makes a binding sound, the hub can follow with the plunger is broken off and the needle cannot be come out of the barrel. This renders the needle unusable and safe from accidental needle sticks.
Jeesung Safety Syringe and Single Use Needles has syringe capacity of 3cc attached with 18-30 gauge and the length of the needle (8mm, 10mm, 13mm, 19mm, 25mm, 32mm, 38mm).
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
Prescription Use
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)
- Cytotoxicity test
- Test method: ISO10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity, Test on extracts method
- Test criteria: Non-cytotoxicity
- Test result: Non-cytotoxicity (Pass)
- Hemolysis test
- Test method: ISO10993-4: 2002(E) Biological evaluation of medical devices - Part 4: Selection for tests for interactions with blood, Evaluation of hemolytic properties of medical and their components; ISO10993-4: 2002/Amd.1 : 2006 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood AMENDMENT 1 Annex C.6 Hemolysis testing General considerations Refer to test report
- Test criteria: Non-hemolytic
- Test result: Non-hemolytic (Pass) There was non-hemolytic.
- Acute systematic toxicity test
- Test method: ISO10993-11: 2006(E) Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity, 5. Acute systemic toxicity
- Test criteria: No dead animals, No strange reaction animals
- Test result: Non-acute systemic toxicity (Pass)
- Skin sensitization test
- Test method: ISO10993-10: 2010(E), Biological evaluation of medical devices Part 10: Teat for Irritation and sensitization. Guinea pig Maximization test (GPMT)
- Test criteria: Non-skin hypersensitivity reaction
- Test result: There was non-skin hypersensitivity reaction. (Pass)
- Pyrogen Test
- Test method: ISO 10993-11 :2006, Biological evaluation of medical devices, Test for systemic, Annex(F) Information on material-mediated pyrogens; USP 38 NF 33 Bacterial Endotoxin test "Gel clot method"
- Test criteria: Non-pyrogenicity; Concentration of the reaction solution is determined as (-)
- Test result: Non-pyrogenicity (Pass); As a result of the reaction, all the concentration of the test solution were determined as (-). Therefore, endotoxin concentration of the test sample is less than 4.0 EU/device.
- Intracutaneous reactivity test
- Test method: ISO 10993-10 :2010(E), Biological evaluation of medical devices, Test for irritation and skin sensitization, Animal Intracutaneous(intradermal) reactivity Test.
- Test criteria: Non-intracutaneous reactivity
- Test result: There was non-intracutaneous reactivity. (Pass)
- Particulate matters
- Test method: USP Particulate Matter in Injections
- Test criteria: Particles does not greater than 10um and greater than 25um
- Test result: Particles greater than 10um - 0 particle; Particles greater than 25um - 0 particle
- Syringe (ISO7886-1 : 1993)
- Test items: Inner/outside and structure
- Result summary: Surface is smooth / no particle and foreign substance
- Test items: Graduated scale
- Result summary: Dead space (0.06ml), capacity (2.19ml), Graduation lines were evenly spaces, overall length of scale (32.0mm)
- Test items: Barrel
- Result summary: The length of the barrel is such that the syringe has a maximum usable capacity of at least 10% more than the nominal capacity
- Test items: Piston(gasket)/plunger assembly
- Result summary: Design, fit of piston in barrel, fiducial line are suitable
- Test items: Liquid leakage
- Result summary: Pressure test – no leaked water / aspirate test – no leaked air
- Test items: Lubricant
- Result summary: The quantity of lubricant :0.18mg/cm³
- Needle (ISO7864 : 1993)
- Test items: Inner/outside and structure
- Result summary: No scratch, no crack, smooth, no foreign materials, sharped needle edge
- Test items: Measurement
- Result summary: Outside diameter of needle : 0.645mm for 0.6000-0.673 criteria / length of needle : 24.7mm for 25(+1.5/-2.5) criteria
- Test items: Elasticity test
- Result summary: Needle returned after remove weight.
- Test items: Flexural rigidity
- Result summary: Needle was not broken.
- Test items: Draw test
- Result summary: The union of the hub and needle tube was not broken.
- Stimulated Clinical Use Testing report
- Result summary: As a result of a simulated clinical use study using 500 subject devices, the number of failure of the subject devices safety feature is not founded and resulted to zero failure of the protective feature.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized design featuring a series of overlapping human profiles, creating a sense of unity and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 28, 2016
JeeSung Medical Co., Ltd. % Mr. Peter Chung Plus Global 300 Atwood Street, Pittsburgh, Pennsylvania 15213
Re: K152606
Trade/Device Name: Jeesung Safety Syringe and Single Use Needles Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: May 9, 2016 Received: May 18, 2016
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. 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
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows a signature followed by the name "Tina Kiang". Below the signature and name is the letter "S" preceded by a hyphen. The signature is illegible and appears to be a stylized scribble. The text is in a simple, sans-serif font.
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152606
Device Name
Jeesung Safety Syringe and Single Use Needles
Indications for Use (Describe)
Jeesung safety syringe and single use needles is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K152606
510(k) Summary
[as required by 807.92]
1. Applicant
-
- Company: JeeSung Medical Co.,Ltd.
-
- Address: 54, Mujini 1-gil, Daedeok-gu, Daejeon, Korea
-
- Tel: 82-42-932-6061
-
- Fax: 82-42-932-6063
-
- Contact Person: Peter Chung,
-
- Tel: 412-687-3976
-
- Email: peterchung210@gmail.com
-
- Date of Preparation: June 22, 2016
2. Device Information
-
- Trade Name: Jeesung Safety Syringe and Single Use Needles
-
- Common Name: Syringe, Antistick Piston Syringe
-
- Classification Name: Piston Syringe
-
- Product Code: MEG
-
- Regulation Number: 880.5860
-
- Class of device: Class II
-
- Panel: General Hospital
3. Predicate Device
K142435 3S Safety Syringe with/without Needle
4. Device Description
Jeesung Safety Syringe and Single Use Needles is an integrated needle and piston syringe with an anti-needle-stick mechanism. There is a swell on the top of inside barrel, which can be used to fix the hub of needle to the top of inside barrel. Four legs on the bottom of hub are caught on the swell part on the top of inside barrel when the hub is pulled.
After using this syringe (such as injecting medicine into body etc.), the hub of needle is pulled back to the inside of the barrel. Because the four legs of hub is bound to the top of the plunger which has a smaller swell part than the top of inside barrel for being caught. Therefore, by pushing plunger until it makes a binding sound, the hub can follow with the plunger is broken off and the needle cannot be come out of the barrel. This renders the needle unusable and safe from accidental needle sticks.
Jeesung Safety Syringe and Single Use Needles has syringe capacity of 3cc attached with 18-30 gauge and the length of the needle (8mm, 10mm, 13mm, 19mm, 25mm, 32mm, 38mm).
4
5. Indication for Use
Jeesung safety syringe and single use needles is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
| Comparison table | |||
|---|---|---|---|
| Category | JeeSung Medical Co.,Ltd | Sincere Medical Device Co., Ltd. | |
| Element of | |||
| Comparison | Submission Device | ||
| (K152606) | Predicate Device | ||
| K142435 | |||
| Regulation no. | 880.5860 | 880.5860 | |
| Product code | MEG | MEG | |
| Common name | Syringe, Antistick Piston Syringe | Syringe, Antistick Piston Syringe | |
| Class | Class II | Class II | |
| Indication for use | Jeesung safety syringe and single use | ||
| needles is a sterile, single-use, | |||
| disposable and non-reusable, manual | |||
| retractable safety syringe intended for | |||
| injection of fluids into the body, while | |||
| reducing the risk of sharps injuries and | |||
| the potential for syringe reuse. | The 3S Safety Syringe with/without | ||
| Needle is a sterile, single-use, | |||
| disposable and non-reusable, manual | |||
| retractable safety syringe intended | |||
| for injection of fluids into the body, | |||
| while reducing the risk of sharps | |||
| injuries and the potential for syringe | |||
| reuse. | |||
| Principle of Operation | There is a swell on the top of inside | ||
| barrel, which can be used to fix the hub | |||
| of needle to the top of inside barrel. | |||
| Four legs on the bottom of hub are | |||
| caught on the swell part on the top of | |||
| inside barrel when the hub is pulled. | |||
| After using this syringe (such as | |||
| injecting medicine into body etc.), the | |||
| hub of needle is pulled back to the | |||
| inside of the barrel. Because the four | |||
| legs of hub is bound to the top of the | |||
| plunger which has a smaller swell part | |||
| than the top of inside barrel for being | |||
| caught. Therefore, by pushing plunger | |||
| until it makes a binding sound, the hub | |||
| can follow with the plunger. Then the | |||
| plunger is broken off and the needle | |||
| cannot be come out of the barrel. This | |||
| renders the needle unusable and safe | |||
| from accidental needle sticks. | The needle is contained within the | ||
| syringe barrel. After standard | |||
| techniques for injection, the plunger | |||
| is withdrawn completely into the | |||
| barrel and snapped off and the | |||
| needle is contained within the | |||
| puncture-resistant barrel. This | |||
| renders the needle unusable and safe | |||
| from accidental needle sticks. | |||
| Syringe capacity | 3cc | Various Sizes | |
| (smallest 0.5cc, largest 10cc) | |||
| Lubricant for Barrel | Silicone Oil | Silicone Oil | |
| Barrel transparency | Transparent and Clear | Transparent and Clear | |
| Gradation Legibility | Legible | Legible | |
| Product configuration | Barrel | ||
| Plunger | |||
| Gasket | |||
| Needle Hub | Barrel | ||
| Plunger | |||
| Piston | |||
| Needle Hub | |||
| Material | Needle Protect cap | Needle Sheath | |
| Barrel | Polypropylene | Polypropylene | |
| Plunger | Polypropylene | Polypropylene | |
| Piston(Gasket) | Elastomer | Elastomer | |
| Needle hub | Polycarbonate | Polypropylene | |
| Needle | Stainless steel | Stainless Steel | |
| Needle sheath | |||
| (protect cap) | Polypropylene | Polypropylene | |
| Needle Gauge and | |||
| Length | Needle gauge (18, 19, 20, 21, 22, 23, | ||
| 24, 25, 26, 27, 28, 29, 30G) | |||
| Needle length (8, 10, 13, 16, 19, 25, 32, | |||
| 38mm) | Needle gauge (18, 19, 20, 21, 22, 23, | ||
| 24, 25, 27, 28, 29, 30, 31G) | |||
| Needle length (8, 9, 11, 13, 16, 25, | |||
| 32, 38mm) | |||
| Lubricant for Needle | Silicone Oil | Silicone Oil | |
| Sharp Injury | |||
| Prevention Features | Manual Retractable | Manual Retractable | |
| Performances | Conforms to ISO7864 ISO7886 | Conforms to ISO7864 ISO7886 | |
| Biocompatibility test | Conforms to ISO10993 | ||
| (ISO10993-4, ISO10993-5, ISO10993-10, | |||
| ISO10993-11) | Conforms to ISO10993 | ||
| Labeling | Meet the requirements of 21 CFR Part | ||
| 801 | Meet the requirements of 21 CFR | ||
| Part 801 | |||
| Sterilization information | E.O gas sterilization | ||
| Assurance level : 10-6 | E.O gas sterilization | ||
| Assurance level : 10-6 |
6. Predicate Device Comparison Table
5
The proposed and predicate devices are the same indications for use, principle of operation, Lubricant for Barrel, product configuration, lubricant for needle, sharp injury prevention feature. The proposed device syringe capacity includes 3cc which are within the range of the predicate syringe 0.5cc to 10cc. The subject device needle sizes are 18-30G and needle length 8, 10, 13, 16, 19, 25, 32, 38mm which are within the range of predicate needle gauge 18-31G and needle length 8-38mm. Therefore, these differences do not affect substantially equivalency between the proposed devices and predicate device.
7. Performance Data
| No | Test item | Test method | |
|---|---|---|---|
| Test criteria | Test result (pass / failure) | ||
| 1 | Cytotoxicity test | ISO10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro | |
| cytotoxicity, Test on extracts method | |||
| Non-cytotoxicity | Non- cytotoxicity (Pass) | ||
| 2 | Hemolysis test | ISO10993-4: 2002(E) Biological evaluation of medical devices - Part 4: Selection for tests | |
| for interactions with blood, Evaluation of hemolytic properties of medical and their | |||
| components | |||
| Non-hemolytic | |||
| ISO10993-4: 2002/Amd.1 : 2006 Biological evaluation of medical devices – Part 4: | |||
| Selection of tests for interactions with blood AMENDMENT 1 Annex C.6 Hemolysis | |||
| testing General considerations | |||
| Refer to test report | Non-hemolytic (Pass) | ||
| There was non-hemolytic. | |||
| 3 | Acute | ||
| systematic | |||
| toxicity | |||
| test | ISO10993-11: 2006(E) Biological evaluation of medical devices -- Part 11: Tests for | ||
| systemic toxicity, 5. Acute systemic toxicity | |||
| No dead animals | |||
| No strange reaction animals | Non-acute systemic toxicity (Pass) |
6
| 4 | Skin
sensitization
test | ISO10993-10: 2010(E), Biological evaluation of medical devices Part 10: Teat for Irritation
and sensitization. Guinea pig Maximization test (GPMT) | |
|---|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Non-skin hypersensitivity
reaction | There was non-skin hypersensitivity reaction. (Pass) |
| 5 | Pyrogen Test | ISO 10993-11 :2006, Biological evaluation of medical devices, Test for systemic, Annex(F)
Information on material-mediated pyrogens | |
| | | Non-pyrogenicity | Non-pyrogenicity (Pass) |
| | | USP 38 NF 33 Bacterial Endotoxin test "Gel clot method" | |
| | | Concentration of the reaction
solution is determined as (-) | As a result of the reaction, all the concentration of
the test solution were determined as (-). Therefore,
endotoxin concentration of the test sample is less
than 4.0 EU/device. |
| 6 | Intracutaneous
reactivity test | ISO 10993-10 :2010(E), Biological evaluation of medical devices, Test for irritation and
skin sensitization, Animal Intracutaneous(intradermal) reactivity Test. | |
| | | Non-intracutaneous reactivity | There was non-intracutaneous reactivity. (Pass) |
| 7 | Particulate
matters | USP Particulate Matter in Injections | |
| | | Particles does not greater than
10μm and greater than 25μm | Particles greater than 10μm - 0 particle
Particles greater than 25μm - 0 particle |
Based on the above testing results, the subject devices are biocompatible.
| Test items | Result summary | ||
|---|---|---|---|
| 1 | Syringe | ||
| (ISO7886- | |||
| 1 : 1993) | Inner/outside and structure | Surface is smooth / no particle and foreign substance | |
| Graduated scale | Dead space (0.06ml), capacity (2.19ml), Graduation lines were evenly spaces, overall length of scale (32.0mm) | ||
| Barrel | The length of the barrel is such that the syringe has a maximum usable capacity of at least 10% more than the nominal capacity | ||
| Piston(gasket)/plunger assembly | Design, fit of piston in barrel, fiducial line are suitable | ||
| Liquid leakage | Pressure test – no leaked water / aspirate test – no leaked air | ||
| Lubricant | The quantity of lubricant :0.18mg/cm³ | ||
| 2 | Needle | ||
| (ISO7864 : |
-
| Inner/outside and structure | No scratch, no crack, smooth, no foreign materials, sharped needle edge |
| | | Measurement | Outside diameter of needle : 0.645mm for 0.6000-0.673 criteria / length of needle : 24.7mm for 25(+1.5/-2.5) criteria |
| | | Elasticity test | Needle returned after remove weight. |
| | | Flexural rigidity | Needle was not broken. |
| | | Draw test | The union of the hub and needle tube was not broken. |
| 3 | Stimulated Clinical Use Testing report | | As a result of a simulated clinical use study using 500 subject devices, the number of failure of the subject devices safety feature is not founded and resulted to zero failure of the protective feature. |
Based on the result of the above syringe, needle testing and stimulated clinical use testing, the proposed devices are satisfied with all the acceptance criteria.
7
8. Conclusion
Both subject and predicate devices have the same Indications for Use. Based on the result of the device comparison and performance data, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.