(106 days)
Not Found
No
The description details a standard mechanical syringe and does not mention any computational or learning capabilities.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is used to administer insulin, but the syringe itself is not treating or preventing a disease; it is the delivery mechanism for a therapeutic substance (insulin).
No
This device is a hypodermic insulin syringe used for the subcutaneous injection of insulin, which is a treatment and delivery method, not a diagnostic one.
No
The device description clearly outlines a physical hypodermic insulin syringe with a barrel, plunger rod, and needle/hub assembly, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "subcutaneous injection of insulin." This describes a device used to administer a substance into the body, not to test a sample from the body.
- Device Description: The description details a syringe, which is a tool for injection, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
This device is clearly intended for the delivery of medication, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is a hypodermic insulin syringe for subcutaneous injection of insulin.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
Shina Insulin Syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The Syringes are available in the following sizes:
1/2cc and 1cc 28 gauge x 1/2" 3/10cc, 1/2cc, and 1cc 29 gauge x ½" 3/10cc, 1/2cc, and 1cc 30 gauge x 1/2"
3/10cc, 1/2cc, and 1cc 30 gauge x 5/16" 3/10cc, 1/2cc, and 1cc 31 gauge x 5/16"
These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (EO Gas sterilization), non-toxic, non-pyrogenic, and 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)
Bench tests relating to the performance of the needle length were conducted. The tests performed include needle pull-out (force), hub pull-off (force), needle angularity, needle break-off testing and dose accuracy. The results demonstrate that Shina Insulin Syringes perform equivalent to the predicate devices and are safe and effective when used as intended.
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 shows a simple line drawing of a circle with a small, curved arrow extending from the bottom of the circle and pointing towards the right. A vertical line is present on the left side of the image, positioned close to the circle. The drawing is in black and white.
CORPORATION
OWNER'S TOWER, 16-5, SUNAE-DONG, BUNDANG-GU, SEONGNAM-SI, GYEONGGI-DO, KOREA. TEL : 82-31-711-8180(REP.) FAX : 82-31-711-8190 E-MAIL : shinacor@chollian.net
AUG 0 62009
510K SUMMARY OF SAFETY AND EFFECTIVENESS
Revised 6-22-09
Supplement K091167
1. Submitted by:
Mr. YONG NAM SHIN President
Shina Corporation Establishment Registration No : 8040619 #1005 Owner's Tower 16-5 Sunae- Dong Bundang-GU Seongnam-Si, Gyeonggi-Do Korea Contact person: H. D. Cho. Sales Manager E-Mail : shinacor@shinacor.co.kr Phone: 011-82-31-711-8180 Fax: 011-82-31-711-8190
2. Date Prepared April 1, 2009
3. Device Name:
Trade Name: Insulin Syringes manufactured by Shina Corporation for private label (customer labels) example: Accu-Sure Insulin Syringe Common Name: Insulin Syringe Classification Name: Piston Syringe
4. Predicate Device:
| BD Insulin Syringe: | K941657, K955235, K024112 |
|---|---|
| Manufactured by: | Becton Dickinson Consumer Healthcare |
5. Device Description:
Shina Insulin Syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The Syringes are available in the following sizes:
1/2cc and 1cc 28 gauge x 1/2" 3/10cc, 1/2cc, and 1cc 29 gauge x ½" 3/10cc, 1/2cc, and 1cc 30 gauge x 1/2"
Factory : 691-1, Boheong-Lee, Woosung-Myun, Kongju-City, Choong Nam, Korea. FAX : 82-41-853-0872 E-MAIL : syringes@kornet.net TEL : 82-41-853-0871
SHINA CORPORATION
1
3/10cc, 1/2cc, and 1cc 30 gauge x 5/16" 3/10cc, 1/2cc, and 1cc 31 gauge x 5/16"
These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (EO Gas sterilization), non-toxic, non-pyrogenic, and single use disposable.
6. Intended Use:
This device is a hypodermic insulin syringe for subcutaneous injection of insulin.
7. Technological Characteristics:
Shina insulin syringe and the predicate devices have the identical technological characteristics and perform as piston syringes.
8. Performance:
.
Bench tests relating to the performance of the needle length were conducted. The tests performed include needle pull-out (force), hub pull-off (force), needle angularity, needle break-off testing and dose accuracy. The results demonstrate that Shina Insulin Syringes perform equivalent to the predicate devices and are safe and effective when used as intended.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings and body. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
AUG 0 6 2009
Mr. Yong Nam Shin President Shina Corporation #1005, Owner's Tower, 16-5, Sunae- Dong, Bundang-Gu Seongnam -Si, Gyeonggi-Do Republic of Korea
Re: K091167
Trade/Device Name: Insulin Syringe (Manufactured By Shina Corporation) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 28, 2009 Received: July 28, 2009
Dear Mr. Shin:
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 i requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 vour 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.
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Page 2- Mr. Shin
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
signature
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K091167
Device Name: Insulin Syringe (manufactured by Shina Corporation)
Indications For Use: This device is a hypodermic insulin syringe for subcutaneous injection of insulin.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091167 Page 1 of _