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.

AI/ML Overview

This document is a 510(k) summary for the Unifine Insulin Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance as typically seen in AI/ML device submissions. Therefore, many of the requested categories about acceptance criteria, study details, ground truth, and expert involvement are not applicable or cannot be extracted from this specific filing.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The provided document does not contain a table of acceptance criteria or reported device performance in the context of a new study to demonstrate safety and effectiveness. Instead, it asserts substantial equivalence to a predicate device based on manufacturing identity.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No formal test set or corresponding study data is presented in this 510(k) summary to evaluate a new device's performance. The basis for clearance is substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device clearance for an insulin syringe, not an AI/ML product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable.

8. The sample size for the training set

Not applicable.

9. How the ground truth for the training set was established

Not applicable.

Summary of Device and 510(k) Basis:

Device Name: Unifine (Insulin syringes)
Intended Use: Subcutaneous injection of insulin.
Substantial Equivalence Claim: The Unifine syringes are stated to be identical to the Omnican Insulin Syringe manufactured and distributed by B. Braun (K962084). Owen Mumford Inc. sells and distributes these syringes without re-packaging, re-working, or modifications.
Regulatory Conclusion: The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This determination is based on the claim of product identity with a previously cleared device, not on new performance study data.

Summary

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K983994

8 1999 JAN

510(k) SUMMARY

DATE OF APPLICATION:	1ª August 1998
APPLICANTS ADDRESS:	Owen Mumford Inc849 Pickens Industrial DriveSuite 14MariettaGA 30062USA
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 equOmnican Insulin Syringe manufdistributed by B Braun (K96208

rivalent to the factured and distributed by B Braun (K962084).

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

DEVICE DESCRIPTION

STATEMENT OF INTENDED USE

The device is for the subcuraneous injection of insulin.

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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

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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

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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

Regulation Number and Section

§ 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).