The UltiCare Safety Insulin Syringe is intended to inject U-100 insulin into the body. The safety mechanism aids in the prevention of needle stick injuries.

Device Description

The UltiCare Safety Insulin Syringe is a standard piston type syringe with permanently attached (uni-body) needle and protective shield. These syringes are sterile, single-use, disposable piston syringes consisting of a syringe barrel calibrated in units of insulin (U-100), plunger rod with gasket, permanently attached single lumen needle, needle cap, and protective shield. The UltiCare Safety Insulin Syringes are non-toxic and non-pyrogenic, and will be available in numerous sizes and combinations between the smallest (0.3 ml x 31G x 5/16 ") and the largest (1 ml x 29G x 1/2 ").

AI/ML Overview

The UltiCare™ Safety Insulin Syringe is a traditional 510(k) premarket notification for a medical device. As such, the submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a rigorous study proving that the device meets specific acceptance criteria in the manner of a clinical trial for a novel drug or a complex diagnostic AI.

Here's an analysis of the provided information based on your requested criteria, highlighting why some information is absent due to the nature of a 510(k) for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (UltiCare™ Safety Insulin Syringe), the "acceptance criteria" are not reported as specific performance metrics in a clinical context (e.g., sensitivity, specificity for a diagnostic AI). Instead, they are compliance with recognized voluntary standards and FDA guidance documents, along with equivalence to predicate devices. The "reported device performance" is the successful testing against these standards and the assertion of substantial equivalence.

Acceptance Criteria (Standards/Guidance)	Reported Device Performance
ISO 7864: Sterile hypodermic needles for single use.	Designed and successfully tested to meet applicable requirements.
ISO 8537: Sterile single-use syringes, with or without needle, for insulin.	Designed and successfully tested to meet applicable requirements.
ISO 9626: Stainless steel needle tubing for the manufacture of medical devices – Requirements and test methods.	Designed and successfully tested to meet applicable requirements.
Voluntary Standards and FDA Guidance Documents applicable to subject and predicate devices.	Results of non-clinical testing support substantial equivalence.
Biocompatibility: (based on material equivalence)	Uses same materials, dyes/inks, manufacturing process, adhesives, and sterilization process/cycle as previously cleared device (K080600), excluding orange colorant of needle cap, thus additional testing not required.
Sterilization: ISO 11135 (Sterilization of health care products – Ethylene oxide)	Validated using the Half Cycle method.
Residue Levels (Ethylene Oxide/Ethylene Chlorohydrin): ISO 10993-7	Maximum levels will not exceed limits in standard.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for specific tests (e.g., how many syringes were tested for each ISO standard). This detail is typically found in the full test reports, not a 510(k) summary. For physical devices like syringes, testing generally involves a representative sample size to ensure statistical validity, as specified by the testing standards themselves.
Data Provenance: The data appears to be pre-market, non-clinical bench testing data conducted by the manufacturer (UltiMed Inc.) or its designated testing facilities in the United States (based on company location and communication with the FDA).
Retrospective or Prospective: This would be considered prospective in the sense that the testing was specifically performed to support this 510(k) submission for the new device configuration. However, it's not a clinical study on human subjects, so "prospective" here refers to the testing being planned and executed for this regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable (N/A) in the context of this 510(k) submission. "Ground truth" established by experts (e.g., radiologists, pathologists) is relevant for diagnostic devices or AI, where human interpretation is the gold standard. For a physical device like a safety syringe, compliance with engineering standards and functionality is often assessed through mechanical and physical testing performed by technicians and engineers, rather than expert clinical consensus as a "ground truth." The "ground truth" here is the performance specifications defined by the ISO standards.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for this type of device and submission. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review processes, particularly for diagnostic devices or endpoint determination. The performance of the syringe against ISO standards is determined by objective measurements and technical assessment, not expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable (N/A). An MRMC study is relevant for diagnostic interpretation, typically involving multiple human readers interpreting cases (e.g., medical images) to assess accuracy and inter-reader variability, often in the context of AI assistance. This device is a physical medical instrument (syringe), not a diagnostic tool, so an MRMC study would not be performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable (N/A). This concept is specific to AI/algorithm performance. The UltiCare Safety Insulin Syringe is a mechanical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is compliance with international voluntary standards (ISO 7864, ISO 8537, ISO 9626) and FDA guidance documents. These standards define the expected performance characteristics, materials, and safety features for syringes. The testing performed verifies that the device meets these pre-defined, objectively measurable criteria.

8. Sample Size for the Training Set

Not applicable (N/A). "Training set" refers to data used to train an AI algorithm. This device does not involve an AI algorithm; its design and manufacturing are based on established engineering principles and material science.

9. How the Ground Truth for the Training Set Was Established

Not applicable (N/A). As there is no AI algorithm, there is no training set and therefore no ground truth establishment for a training set. The design of the syringe and its safety features are based on engineering specifications and the requirements outlined in the relevant ISO standards, which have been established through consensus and research over time by international standards organizations.

In summary: The UltiCare™ Safety Insulin Syringe 510(k) submission effectively demonstrates substantial equivalence by showing that its design, function, and materials are similar to predicate devices, and that it successfully meets the requirements of applicable recognized industry standards for safety and performance through non-clinical testing. The concepts of "acceptance criteria," "ground truth," and various study methodologies like MRMC or standalone performance are applied differently or are not directly relevant when evaluating a physical medical device for 510(k) substantial equivalence.

Summary

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UltiCare™ Safety Insulin Syringe
Traditional 510(k) Premarket Notification

FEB - 2 201

K10301

Page 5-1 of 3

TRADITIONAL 510(K) SUMMARY 5.0

Submitted by:	UltiMed Inc.287 East Sixth Street, Ste 380St. Paul, MN 55101
Contact Person:	Mary Henderson, Ph.D.Principal AdvisorRegulatory & Clinical Research Institute, Inc.5353 Wayzata Boulevard, Suite 505Minneapolis, Minnesota 55416952-227-3380mbhenderson@rcri-inc.com
Date of Summary:	December 9, 2010
Device Trade Name:	UltiCare ™ Safety Insulin Syringe[Numerous sizes and combinations varying between the smallest(0.3 ml x 31G x 5 / 16 ") and the largest (1 ml x 29G x 1 / 2 ")]
Common or Usual Name:	Syringe with Sharps Injury Prevention Feature
Classification:	Anti-stick Syringe § 880.5860 MEG Class IIPiston Syringe § 880.5860 FMF Class IIHypodermic Single Lumen Needle § 880.5570 FMI Class II
Predicate Device(s):	K080600: UltiMed UltiCare ™ Safety SyringeK922522: Sherwood (Tyco) Monoject ® Safety Syringe (ModelMonoject Insulin Safety Syringe)
Device Description:	The UltiCare Safety Insulin Syringe is a standard piston type syringewith permanently attached (uni-body) needle and protective shield.These syringes are sterile, single-use, disposable piston syringesconsisting of a syringe barrel calibrated in units of insulin (U-100),plunger rod with gasket, permanently attached single lumen needle,needle cap, and protective shield. The UltiCare Safety InsulinSyringes are non-toxic and non-pyrogenic, and will be available innumerous sizes and combinations between the smallest (0.3 ml x31G x 5 / 16 ") and the largest (1 ml x 29G x 1 / 2 ").
Intended Use:	The UltiCare Safety Insulin Syringe is intended to inject U-100insulin into the body. The safety mechanism aids in the preventionof needle stick injuries.

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Technological Characteristics:

The UltiCare Safety Insulin Syringe is substantially equivalent in device description, function, principle of operation, and basic composition to the predicate devices. The subject device and the predicate devices consist of a syringe barrel, plunger rod with gasket, permanently attached single lumen needle, needle cap, and protective shield.

The protective shield is identical to the currently marketed UltiCare Safety Syringe (K080600). It is made of clear plastic and is furnished in a retracted position with the needle cap over the needle. When the needle cap is removed, insulin can be drawn and injected in the conventional manner. After the injection, the protective shield is engaged by sliding it away from the finger grip to an extended position over the needle and then applying a turning or rotating motion to lock the shield in place.

The UltiCare Safety Insulin Syringes will be available in a range of needle gauges and lengths encompassed by the predicate devices.

The UltiCare Safety Insulin Syringes have been designed and tested to meet the requirements of voluntary standards and FDA guidance documents applicable to the subject and predicate devices. Results of the non-clinical testing support the conclusion of substantial equivalence to the UltiCare Safety Insulin Syringes to the predicate devices.

Performance Testing:

The UltiCare Safety Insulin Syringes have been designed and successfully tested to meet the applicable requirements outlined in ISO 7864, ISO 8537, and ISO 9626.

Biocompatibility Testing:

The new UltiCare Safety Insulin Syringe devices use the exact same materials, dyes/inks, manufacturing process, adhesives, and sterilization process/cycle as the previously cleared UltiCare Safety Syringes (K080600), with the exception of the orange colorant of the needle cap, and therefore additional biocompatibility testing to ISO 10993 standards is not required.

Sterilization and Shelf-life Testing:

Sterilization of the UltiCare Safety Insulin Syringes is validated using the Half Cycle method as outlined in ISO 11135. The maximum levels of residues of ethylene oxide and ethylene chlorohydrin will not exceed the limits presented in ISO 10993-7.

Clinical Data:

No prospective clinical trials were conducted in support of this Traditional 510(k).

Testing:

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Substantial Equivalence:

The vast similarities of the UltiCare Safety Insulin Syringes to the predicate devices support the substantial equivalence in intended use, function and basic composition. The non-clinical testing to voluntary standards and applicable FDA guidances provide additional evidence the UltiCare Insulin Syringes are substantially equivalent to the predicate devices in terms of safety, efficacy, and performance.

The minor differences between the UltiCare Safety Insulin Syringes and the predicate devices do not raise new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ulti- Med International, Incorporated C/O Ms. Mary Beth Henderson Regulatory & Clinical Research Institute. Incorporated 5353 Wayzata Boulevard, Suite 505 Minneapolis. Minnesota 55416

FEB - 2 2011

Re: K103011

Trade/Device Name: UltiMed UltiCare™ Safety Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMF, FMI Dated: January 20, 2011 Received: January 21, 2011

Dear Ms. Henderson:

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.

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Page 2- Ms. Henderson

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.goy/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jum T. Rosado
Fos

Anthony D. Watson, B.S., M.S., M.B.A. 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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UltiCare™ Safety Insulin Syringe Traditional 510(k) Premarket Notification

INDICATIONS FOR USE STATEMENT 4.0

510(k) Number:	To be determined.	(K103011)
Device Name:	UltiMed UltiCare™ Safety Insulin Syringe
Intended Use:	The UltiCare Safety Insulin Syringe is intended to inject U-100 insulin into the body. The safety mechanism aids in the prevention of needle stick injuries.

Prescription Use: NO

AND/OR

Over-the-Counter Use: YES

(Part 21 CFR 801 Subpart D)

(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)

Ril C. Chaym 2/2/11

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology. General Hospital
Division of Anesthesiology. General Devices Division of Antool, Dental Devices

510(k) Number: K103011

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).