(60 days)
Not Found
No
The device description and intended use clearly describe a standard insulin syringe, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is an insulin syringe, which is used for drug delivery (insulin injection) and not for treating or curing a disease itself.
No
Explanation: The device is described as a syringe for the injection of insulin, which is a treatment delivery device, not a diagnostic one.
No
The device description clearly states it is a range of syringes, which are physical hardware devices used for injecting insulin. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "subcutaneous injection of insulin." This is a direct administration of a substance into the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a syringe, which is a tool for administering substances, not for performing diagnostic tests on samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers in samples
- Providing information for diagnosis, monitoring, or screening of diseases
Therefore, this device is a medical device for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is for the subcuraneous injection of insulin.
The Unifine range of Syringes is designed for the subcutaneous injection of insulin.
Product codes (comma separated list FDA assigned to the subject device)
80 HO, FMF
Device Description
The Unifica range if syringes are ldentical to that of the Orientan range of syringss manufactured by B Braun. The syringes are manufactured, packed and mentised by B Braun and supplied to Owen Mumford for sale or distribution. No re-packaging roworking or modifications are made to the systems or packaging by Owen Mumford, The are supplied in three sizes (0.3ml, 0.5ml) in boxes of 100. The individual syringes are supplied in peel pouches and are sterilised using Ethylone Oxide.
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
8 1999 JAN
510(k) SUMMARY
| DATE OF APPLICATION: | 1ª August 1998 |
|---|---|
| APPLICANTS ADDRESS: | Owen Mumford Inc |
| 849 Pickens Industrial Drive | |
| Suite 14 | |
| Marietta | |
| GA 30062 | |
| USA | |
| CONTACT: | Mr Robert Shaw |
| POSITION: | Director |
| TEL: | 770 425 5138 |
| FAX: | 770 426 5365 |
| REGISTRATION No: | 1058602 |
| TRADE NAME | Unifine |
| COMMON NAME: | Insulin syringes |
| CLASSIFICATION NAME: | Piston Syringe |
| CLASS: | 2 |
| CLASSIFICTION PANEL: | General Hospital |
| PANEL CODE: | 80 HO |
| CFR NUMBER: | 880.5860 |
| SUBSTANTIAL EQUIVALENCE | The product is substantially equ |
| Omnican Insulin Syringe manuf | |
| distributed by B Braun (K96208 |
rivalent to the factured and distributed by B Braun (K962084).
:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DEVICE DESCRIPTION
The Unifica range if syringes are ldentical to that of the Orientan range of syringss manufactured by B Braun. The syringes are manufactured, packed and mentised by B Braun and supplied to Owen Mumford for sale or distribution. No re-packaging roworking or modifications are made to the systems or packaging by Owen Mumford, The are supplied in three sizes (0.3ml, 0.5ml) in boxes of 100. The individual syringes are supplied in peel pouches and are sterilised using Ethylone Oxide.
STATEMENT OF INTENDED USE
The device is for the subcuraneous injection of insulin.
1
Image /page/1/Picture/1 description: The image contains the words "Public Health Service". The text is in a bold, sans-serif font. The words are stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 JAN
Mr. Robert E. Shaw Owen Mumford, Incorporated 849 Pickens Industrial Drive Suite 14 30062-3165 Marletta, Georgia
Re : K983994 Trade Name: Unifine Requlatory Class: II Product Code: FMF November 6, 1998 Dated: November 9, 1998 Received:
Dear Mr. Shaw:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Mr. Shaw
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
UNIFINE SYRINGES 510(k) SUBMISSION
510(k) Number: Not Known
Device Name: Unifine
Indications for Use:
The Unifine range of Syringes is designed for the subcutaneous injection of insulin.
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ Qver-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21CFR 801.109) ivision Sign-Off ivision 1 Theat Informon Control, and General 14.0 period Devices 6 510(k) Number _ Page 8 of 9