The UltiCare™ Safety Syringe is intended to inject fluid into, or withdraw fluid from the body. The safety mechanism aids in the prevention of needle stick injuries.

Device Description

The UltiCare™ 3 mL Luer Lock Safety Syringes with Needle is a standard piston type syringe with a removable needle and protective shield. This sterile, single-use, disposable 3 ml piston syringes consist of a syringe barrel, plunger rod with gasket, removable single lumen needle, needle cap, and protective shield. The UltiCare Safety Syringes are non-toxic and non-pyrogenic, and will be available in a range of needle gauges and lengths between the smallest (27G x 5/16") and the largest (21G x 1 1/2").

AI/ML Overview

This document is difficult to parse completely and does not contain all the information requested. This looks like a 510(k) summary for a medical device (UltiCare™ 3mL Luer Lock Safety Syringes with Needle), which demonstrates substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria based on algorithm performance.

However, I can extract information related to the device's performance testing as described in the summary, which is analogous to acceptance criteria for a physical device.

Here's what can be extracted:

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

For a physical medical device like a syringe, "acceptance criteria" often refer to compliance with recognized standards. The document states the device was "designed and successfully tested to meet the applicable requirements" of several ISO standards. Specific, quantitative acceptance criteria and their corresponding performance reported are not explicitly detailed in a table format in the provided text. Instead, the document provides a list of standards the device met.

Acceptance Criteria (Standards Met)	Reported Device Performance
ISO 594	Successfully met
ISO 6009	Successfully met
ISO 7864	Successfully met
ISO 7886-1	Successfully met
ISO 8537	Successfully met
ISO 9626	Successfully met
ISO 11135 (Sterilization)	Successfully met (Half Cycle method)
ISO 10993 (Biocompatibility)	Successfully met (for removable needles)
ISO 10993-7 (ETO Residues)	Will not exceed limits
USP <151> (Pyrogenicity)	Successfully passed

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

The document does not specify the sample sizes used for the performance tests (e.g., how many syringes were tested for compliance with ISO standards). It also does not mention data provenance in terms of country of origin or retrospective/prospective for these engineering and material performance tests.

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)

This is a physical device, not an AI algorithm involving interpretation. Therefore, the concept of "experts establishing ground truth" in the context of radiologists or similar interpretative tasks is not applicable. Compliance with standards would typically be verified by qualified testing laboratories and personnel, but no specific details are provided.

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

Not applicable for physical device testing against engineering standards.

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, as this is not an AI algorithm but a physical medical device. The document explicitly states: "No prospective clinical trials were conducted in support of this Traditional 510(k)."

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

Not applicable, as this is not an AI algorithm.

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

For the performance testing, the "ground truth" or reference is defined by the specifications and methodologies outlined in the referenced ISO and USP standards. For example, for biocompatibility, the ground truth is "meeting the biocompatibility requirements of ISO 10993" including specific tests like "cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity testing, and hemocompatibility." For pyrogenicity, it's "successfully passed pyrogenicity testing (USP <151> Rabbit Method)."

8. The sample size for the training set

Not applicable, as this is not an AI algorithm.

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

Not applicable, as this is not an AI algorithm.

Summary

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

February 9, 2015

UltiMed Incorporated c/o Mary Beth Henderson, Ph.D. Regulatory & Clinical Research Institute, Incorporated. VP Regulatory Affairs and Quality Systems 5353 Wayzata Boulevard, Suite 505 Minneapolis, MN 55416

Re: K140949

Trade/Device Name: UltiCare™ 3mL Luer Lock Safety Syringes with Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMF, FMI Dated: January 30, 2015 Received: February 2, 2015

Dear Dr. 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 - Mary Beth Henderson, Ph.D.

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140949

Device Name

UltiCare™ 3mL Luer Lock Safety Syringe with Needle

Indications for Use (Describe)

The UltiCare Safety Syringe is intended to inject fluid into, or withdraw fluid from the body. The safety mechanism aids in the prevention of needle stick injuries.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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TRADITIONAL 510(K) SUMMARY 5.0

Submitted by:	UltiMed Inc.350 Hwy 7, Suite 100Excelsior, MN 55331
Contact Person:	Thomas SauroTelephone: 651-291-7909 x 206
Date of Summary:	December 05, 2014
Device Trade Name:	UltiMed UltiCare™ 3 mL Luer Lock Safety Syringes with Needle
Common or Usual Name:	Syringe with Sharps Injury Prevention Feature
Classification:	Piston SyringeAnti-stick SyringeHypodermic Single Lumen Needle	§ 880.5860§ 880.5860§ 880.5570	FMFMEGFMI	Class IIClass IIClass II
Predicate Device:	UltiCare Safety Syringe (K080600)Sherwood (Tyco) Monoject® Safety Syringe (K922522)
Device Description:	The UltiCare™ 3 mL Luer Lock Safety Syringes with Needle is astandard piston type syringe with a removable needle and protectiveshield.This sterile, single-use, disposable 3 ml piston syringes consist of asyringe barrel, plunger rod with gasket, removable single lumen needle,needle cap, and protective shield. The UltiCare Safety Syringes arenon-toxic and non-pyrogenic, and will be available in a range of needlegauges and lengths between the smallest (27G x 5/16") and the largest(21G x 1 1/2").
Intended Use:	The UltiCare™ Safety Syringe is intended to inject fluid into, orwithdraw fluid from the body. The safety mechanism aids in theprevention of needle stick injuries.
TechnologicalCharacteristics:	The UltiCare™ 3 mL Luer Lock Safety Syringes with Needle is anextension of the UltiCare Safety Syringe product line and issubstantially equivalent in device description, function, principle ofoperation, and basic composition to the predicate device. The subjectand predicate devices consist of a syringe barrel, plunger rod withgasket, removable single lumen needle, needle cap, and protectiveshield.The UltiCare Safety Syringe product line safety shield is made of clearplastic and is furnished in a retracted position (with the needle cap overthe needle). After use of the syringe, the protective shield is engagedby sliding it away from the finger grip to an extended position over theneedle and rotated to lock in place.
Testing:	The subject UltiCare 3 mL Luer Lock Safety Syringes with Needle havebeen designed and tested to meet the requirements of voluntarystandards and FDA guidance documents applicable to the subject andpredicate devices. Results of the non-clinical testing support theconclusion of substantial equivalence to the UltiCare Safety Syringes tothe predicate devices.

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Performance Testing:

The subject UltiCare 3 mL Luer Lock Safety Syringes with Needle have been designed and successfully tested to meet the applicable requirements outlined in ISO 594, ISO 6009, ISO 7864, ISO 7886-1, ISO 8537, and ISO 9626.

Biocompatibility Testing:

The subject UltiCare Safety Syringe body is produced using the same manufacturing processes and uses the same materials, dyes/inks, manufacturing process, adhesives, and sterilization process/cycle as the previously cleared UltiCare Safety Syringes (K080600); therefore additional biocompatibility testing to ISO 10993 standards is not required.

The removable needles are considered externally communicating devices with limited duration contact with circulating blood, and have been tested to meet the biocompatibility requirements of ISO 10993 to include cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity testing, and hemocompatibility.

Sterilization and Shelf-life Testing:

Sterilization of the UltiCare Safety 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.

Pyrogenicity Testing:

The UltiCare 3 mL Luer Lock Safety Syringes with Needle have successfully passed pyrogenicity testing (USP <151> Rabbit Method).

Clinical Data:

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

Substantial Equivalence: The major similarities of the UltiCare Safety Syringe with Removable Needle to the predicate devices support the substantial equivalence in intended use, principles of operation, function and basic composition. The non-clinical testing to voluntary standards and applicable FDA guidances provide additional evidence the subject UltiCare Safety Syringe is substantially equivalent to the predicate devices in terms of safety, efficacy, and performance.

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

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).