(10 days)
Not Found
No
The device description and intended use clearly describe a standard, mechanical insulin syringe with no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is an insulin syringe, which is used to administer insulin, but it does not exert a therapeutic effect itself. The therapeutic effect comes from the insulin, not the device.
No
The device description states that the insulin syringes are used for the injection of U-100 insulin, which is a treatment delivery, not a diagnostic function.
No
The device description clearly outlines a physical, disposable insulin syringe with a needle, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the injection of insulin. This is a direct administration of a substance into the body, not a test performed in vitro (outside the body) on a sample from the body.
- Device Description: The description details a syringe and needle, which are tools for administering substances, not for performing diagnostic tests on biological samples.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro analysis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is for delivering a treatment (insulin) directly into the body.
N/A
Intended Use / Indications for Use
Insulin syringes are intended only for the injection of U-100 insulin.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMI
Device Description
The sureone disposable insulin syringe is used for subcutaneous injection of U-100 insulin. This device is a sterile, single-use, disposable piston syringe with permanently affixed hypodermic single lumen needle. The sureone disposable insulin syringe consists of a syringe barrel, a plunger rod, and a hypodermic single lumen needle permanently bonded to the tip of the syringe with epoxy. The sureone disposable insulin syringes are available in 1.0cc (100 units), 0.5cc (50 units), and 0.3cc (30 units) syringe capacities with the following sizes of hypodermic single lumen needle: 28 GA x ½", 29 GA x ½", and 30 GA x 3/10". In addition, the 1.0cc and 0.5cc syringe capacities are available with a 31 GA x 5/16" needle.
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)
Not Found
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
APR 2 6 2002
510(k) Summary
Submitter
Date Prepared April 5, 2002
Hosuk Company, Ltd. 52-6 Dukjeong-Ri, Samsung-Myun, Umsung-Gun Chungcheong Province, Korea Contact Person: Mr. Y. H. Kim, Manager, Quality Management Section
Telephone: +82-43-883-0411 Fax: +82-43-883-0414
Name of Device
| Common Name: | Insulin Syringe |
|---|---|
| Proprietary Name: | sureone Insulin Syringe |
| Classification Name: | Piston Syringe, Hypodermic Single Lumen Needle |
| Regulation: | 880.5860 and 880.5570 |
| Class: | Class II |
| Product Code: | FMF and FMI |
Predicate Devices
The sureone Insulin Syringe is substantially equivalent in intended use, function and composition to the currently marketed sureone Disposable Insulin Syringes, K002921, and to NovoFine® 31 GA needles, K002403.
Device Description
The sureone disposable insulin syringe is used for subcutaneous injection of U-100 insulin. This device is a sterile, single-use, disposable piston syringe with permanently affixed hypodermic single lumen needle. The sureone disposable insulin syringe consists of a syringe barrel, a plunger rod, and a hypodermic single lumen needle permanently bonded to the tip of the syringe with epoxy. The sureone disposable insulin syringes are available in 1.0cc (100 units), 0.5cc (50 units), and 0.3cc (30 units) syringe capacities with the following sizes of hypodermic single lumen needle: 28 GA x ½", 29 GA x ½", and 30 GA x 3/10". In addition, the 1.0cc and 0.5cc syringe capacities are available with a 31 GA x 5/16" needle.
Intended Use
Insulin syringes are intended only for the injection of U-100 insulin.
Technological Characteristics
The only design change being incorporated into current sureone Insulin Syringes compared to currently marketed sureone Insulin Syringes is the addition of a new needle size - 31 GA x 5/16" length. This needle has a smaller diameter than the currently marketed sureone Insulin Syringes. All other aspects are identical to the currently marketed sureone Insulin Syringes. sureone Insulin Syringes meet the following standards:
ISO 8537, Sterile, Singe-Use Syringes, with or without Needle, for Insulin ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices
Special 510(k) Hosuk Company, Ltd.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters and is arranged to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2002
Hosuk Company Limited C/O Ms. Carole Stamp Regulatory & Clinical Research Institute, Incorporated 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416
Re: K021197
Trade/Device Name: Sureone Insulin Syringe Regulation Number: 880.5860 and 880.5570 Regulation Name: Piston Syringe, Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMF and FMI Dated: April 5, 2002 Received: April 16, 2002
Dear Ms. Stamp:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Ms. Stamp
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); good manufacturing practice and insting (21 es tee restly 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Purner
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use K021197 sureone Insulin Syringe
510(k) Number (if known): Device Name:
Indications for Use:
Insulin syringes are intended only for the injection of U-100 insulin.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Vile Hilliard for Ref. Cincinati.
Special 510(k) Hosuk Company, Ltd. (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 02 119
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