(345 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard insulin syringe, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is an insulin syringe, which is used to administer a drug (insulin) but does not itself provide a therapeutic effect.
No
Explanation: The device is an insulin syringe, which is used for the delivery of medication (insulin) into the body, not for identifying a disease or condition. Its purpose is therapeutic administration rather than diagnosis.
No
The device description clearly outlines a physical medical device (syringe with barrel, plunger, needle, etc.) and discusses hardware-related aspects like materials, sterilization, and physical performance testing. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous injection of U100 insulin." This is a direct medical intervention on a patient, not a test performed on a sample taken from the body.
- Device Description: The description details a syringe, which is a tool for administering substances into the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests outside of the body on samples taken from the body. Insulin syringes are used to deliver medication into the body.
N/A
Intended Use / Indications for Use
Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.
Product codes
FMF
Device Description
Sure-Fine Insulin Syringes are designed for the subcutaneous injection of a dose of U-100 insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color.
Category: U-100
Insulin syringe: 1/2cc and 1cc
Needle Gauge: 28Gauge
Needle Length: 1/2"
Cap color: Needle cap - Orange, Plunger Cap - Orange or white
Insulin syringe: 3/10cc, 1/2cc and 1cc
Needle Gauge: 29Gauge
Needle Length: 1/2"
Cap color: Needle cap - Orange, Plunger Cap - Orange or white
Insulin syringe: 3/10cc, 1/2cc and 1cc
Needle Gauge: 30Gauge
Needle Length: 1/2"
Cap color: Needle cap - Orange, Plunger Cap - Orange or white
Insulin syringe: 3/10cc, 1/2cc and 1cc
Needle Gauge: 30Gauge
Needle Length: 5/16"
Cap color: Needle cap - Orange, Plunger Cap - Orange or white
Insulin syringe: 3/10cc, 1/2cc and 1cc
Needle Gauge: 31Gauge
Needle Length: 5/16"
Cap color: Needle cap - Orange, Plunger Cap - Orange or white
This device operates in the principles of a piston syringe fluid path is sterile (EO gas sterilization), single use disposable.
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)
Non-clinical testing was performed.
Performance Testing: The Sure-Fine Insulin Syringes have been designed and successfully tested to meet the applicable requirements outlined in ISO8537.
Key results: Tests performed per ISO8537:2007 (5 Freedom from extraneous matter, 6.Extraction testing, 7 Lubrication of syringes and needles, 8 Range of sizes, 9 Graduated scale, 10 Barrel, 11 Piston/Plunger assembly, 12 Nozzle, 13 Needles tubing and needles, 14 Performance of assembled syringe).
Biocompatibility Testing: The material of the Sure-Fine Insulin Syringes have successfully passed testing as outlined in ISO10993-1 for devices categorized as External communicating devices, Limited exposure.
Key results: Tests performed per ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (Irritation and Sensitization), ISO 10993-11 (systemic toxicity), ISO 10993-4 (interactions with blood), and The United States Pharmacopeia (Pyrogen test).
Sterilization and Shelf-life Testing: Sterilization of the Sure-Fine Insulin Syringes has been validated using the half-cycle method as outlined in ISO11135.
Key results: Testing demonstrated maximum levels of ethylene oxide and ethylene chlorohydrins do not exceed the limits presented in IS010993-7. Shelf-life testing supports a shelf-life of 5-years after sterilization.
Clinical Data: No prospective clinical trials were conducted in support of this Traditional 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2016
Shina Med Corporation c/o Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E. Chapman Ave., Ste. 110 Irvine, California 92831
Re: K152879
Trade/Device Name: Sure-Fine Insulin Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: August 4, 2016 Received: August 10, 2016
Dear Ms. 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 (QS) 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 and the name "Tina Kiang" in black font. The signature is illegible and consists of a series of loops and curves. There is a faint watermark in the background that is difficult to read.
Tina Kiang, Ph.D. Acting 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) K152879
Device Name
Sure-Fine Insulin Syringes
Indications for Use (Describe)
Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.
Type of Use (Select one or both, as applicable)
| Registration (Part 21 CFR 201.1 Subpart D) | Drug Use Compounding (21 CFR 201.1 Subpart G) |
|---|---|
| --------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) SUMMARY
(K152879)
September 07, 2016
1. Submitted by:
Il-hwan, Jeong / Quality Management Representative SHINA MED CORPORATION 455-30, Bogaewonsam-ro, Bogae-myun, Anseong-si, Gyeonggido, 456-871, Republic of Korea Phone: +82 31 8057 2125 Fax : + 82 31 8057 2150
2. US Agent/Contact Person:
Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92831
Device Name : 3.
- Trade Name : Sure-Fine Insulin Syringes
- Classification : Class II .
- Regulation Name : Piston syringe .
- Product Code . : FMF
- . Regulation Number : 21 CFR 880.5860
- · Review Panel : General Hospital
Predicate Device : 4.
Accu-Sure Insulin syringe (K091167) manufactured by SHINA CORPORATION
5. Device Description:
Sure-Fine Insulin Syringes are designed for the subcutaneous injection of a dose of U-100 insulin. The syringe has a graduated barrel, a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy. The syringes are available in the following sizes and cap color.
| Category | Insulin syringe | Needle
Gauge | Needle
Length | Cap color | |
|----------|-----------------------|-----------------|------------------|------------|-----------------|
| | | | | Needle cap | Plunger Cap |
| U-100 | 1/2cc and 1cc | 28Gauge | 1/2" | Orange | Orange or white |
| U-100 | 3/10cc, 1/2cc and 1cc | 29Gauge | 1/2" | Orange | Orange or white |
| U-100 | 3/10cc, 1/2cc and 1cc | 30Gauge | 1/2" | Orange | Orange or white |
| U-100 | 3/10cc, 1/2cc and 1cc | 30Gauge | 5/16" | Orange | Orange or white |
| U-100 | 3/10cc, 1/2cc and 1cc | 31Gauge | 5/16" | Orange | Orange or white |
This device operates in the principles of a piston syringe fluid path is sterile (EO gas sterilization), single use disposable.
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6. Indications for Use :
Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.
7. Technological Characteristics :
The Sure-Fine Insulin Syringes are substantially equivalent to previously marketed device, Accu-Sure Insulin Syringe (K091167) manufactured by Shina Corporation. The device design, materials of construction, manufacturing method, release specifications and performance specifications are the same as the predicate device.
| Device Name | Subject Device | Predicate Device | |
|---|---|---|---|
| Manufacturer | SHINA MED CORPORATION | SHINA CORPORATION | |
| 510(k) Number | K152879 | K091167 | |
| Product Code | FMF | FMF | |
| Intended Use | Sure-Fine Insulin Syringes are | ||
| hypodermic insulin syringes for | |||
| subcutaneous injection of insulin. | Accu-Sure Insulin Syringe is a | ||
| hypodermic insulin syringe for | |||
| subcutaneous injection of insulin | |||
| Design (Syringe) | Design | Needle / Barrel / Gasket / | |
| Plunger / Needle Cap / | |||
| Protective end cap | Needle / Barrel / Gasket / | ||
| Plunger / Needle Cap / | |||
| Protective end cap | |||
| Volume | 0.3cc, 0.5cc, 1.0cc | 0.3cc, 0.5cc, 1.0cc | |
| Gauge | 28, 29, 30,31Gauge | 28, 29, 30,31Gauge | |
| Length | 1/2", 5/16" | 1/2", 5/16" | |
| Materials | Needle | STS304 | STS304 |
| Barrel | Polypropylene | Polypropylene | |
| Plunger | Polypropylene | Polypropylene | |
| Piston | Isoprene Rubber | Isoprene Rubber | |
| Needle Cap | Polyethylene | Polyethylene | |
| Protective end cap | Polyethylene | Polyethylene | |
| Silicone | Polydimethylsiloxane | Polydimethylsiloxane | |
| Biocompatibility | Conform ISO10993-1 | Conform ISO10993-1 | |
| Sterilization method | |||
| and S.A,L | Sterilized by ethylene | ||
| oxide gas SAL = 10-6 | Sterilized by ethylene | ||
| oxide gas SAL = 10-6 |
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8. Non-clinical testing
The Sure-Fine Insulin Syringes have been designed and tested to meet the requirements of voluntary standards (listed below) and FDA Guidance documents (Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes) applicable to the subject and predicate devices. The results of the non-clinical testing supported the conclusion of substantial equivalence.
Performance Testing
The Sure-Fine Insulin Syringes have been designed and successfully tested to meet the applicable requirements outlined in ISO8537.
- Test performed per ISO8537:2007
- · ISO 8537-2007 Clause 5 Freedom from extraneous matter
- · ISO 8537-2007 Clause 6.Extraction testing
- · ISO 8537-2007 Clause 7 Lubrication of syringes and needles
- · ISO 8537-2007 Clause 8 Range of sizes
- ISO 8537-2007 Clause 9 Graduated scale
- ISO 8537-2007 Clause 10 Barrel
- · ISO 8537-2007 Clause 11 Piston/Plunger assembly
- · ISO 8537-2007 Clause 12 Nozzle
- · ISO 8537-2007 Clause 13 Needles tubing and needles
- · ISO 8537-2007 Clause 14 Performance of assembled syringe
Biocompatibility Testing
The material of the Sure-Fine Insulin Syringes have successfully passed testing as outlined in ISO10993-1 for devices categorized as External communicating devices, Limited exposure.
- · ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- · ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Test for Irritation and Sensitization 5.4 Intracutaneous reactivity test
- · ISO 10993-10 2010 Biological evaluation of medical devices Part 10: Teat for Irritation and Sensitization 6.2 Maximization sensitization test
- · ISO 10993-11 2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity 6.5 Acute systemic toxicity
- ISO 10993-4:2002 Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood.
- · The United States Pharmacopeia (Pyrogen test)
Sterilization and Shelf-life Testing
Sterilization of the Sure-Fine Insulin Syringes has been validated using the half-cycle method as outlined in ISO11135. Testing demonstrated maximum levels of ethylene oxide and ethylene chlorohydrins do not exceed the limits presented in IS010993-7. Shelf-life testing supports a shelf-life of 5-years after sterilization.
Clinical Data
No prospective clinical trials were conducted in support of this Traditional 510(k)
9. Discussion
Sure-Fine Insulin Syringes have the same intended use, technological characteristics, materials of construction and performance specifications as the predicate device, Accu-Sure Insulin Syringe (K091167), and thus it performs in a substantial equivalent manner to the predicate device.
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10. Conclusion
Based on the information provided in this premarket notification, SHINA MED CORPORATION concludes that the Sure-Fine Insulin Syringes are substantially equivalent to predicate device.