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

Device Description

The UltiMed UltiCare Safety Syringe is a standard piston type syringe with permanently attached (uni-body) needle and protective shield. They are sterile, single-use, disposable piston syringes consisting of a syringe barrel, plunger rod with gasket, permanently attached hypodermic single lumen needle, needle cap, and protective shield. The UltiMed UltiCare Safety Syringes are non-toxic and nonpyrogenic, and will be available in a variety of combinations of syringe sizes (0.5 to 3.0 ml (cc)), needle sizes (27 to 21 gauge), and needle lengths (5/16" to 1½''). The protective shield 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, medication 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the UltiMed UltiCare Safety Syringe, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the UltiMed UltiCare Safety Syringe and states its substantial equivalence to a predicate device. Instead of specific performance metrics with numerical targets, the acceptance criteria are defined by compliance with a set of international ISO standards. The "reported device performance" is the statement of this compliance.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
ISO 7864 (1993): Sterile Hypodermic Needles for Single Use	Device complies with this standard.
ISO 7886-1 (1993): Sterile Hypodermic Syringes for Single Use	Device complies with this standard.
ISO 8537 (1991): Sterile single-use syringes, with or without needle, for insulin	Device complies with this standard.
ISO 9626 (1991): Stainless Steel Needle Tubing for Manufacture of Medical Devices	Device complies with this standard.
ISO 10993-1 (2003): Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing	Device complies with this standard.
ISO 10993-4 (2002): Biological Evaluation of Medical Devices: Part 4: Selections of tests for interactions with blood	Device complies with this standard.
ISO 10993-5 (1999): Biological Evaluation of Medical Devices: Part 5: Tests for in vitro cytotoxicity	Device complies with this standard.
ISO 10993-7 (1995): Biological Evaluation of Medical Devices: Part 7: Ethylene oxide sterilization residuals	Device complies with this standard.
ISO 10993-10 (2002): Biological Evaluation of Medical Devices: Part 10: Tests for irritation and delayed-type hypersensitivity	Device complies with this standard.
ISO 10993-11 (2006): Biological Evaluation of Medical Devices: Part 11: Tests for systemic toxicity	Device complies with this standard.
ISO 11607-1 (2006): Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems	Device complies with this standard.
Substantial equivalence in intended use, function, and basic composition to predicate device (Sherwood Medical Co. Monoject Safety Syringe 1cc, 3cc and 12 cc size, K922522)	The device is described as "substantially equivalent based on the descriptive data, compliance with standards, simulated clinical use study, and indications for use."

Study Information

The provided text describes the submission for a 510(k) premarket notification, which focuses on demonstrating "substantial equivalence" rather than a traditional clinical study with a test set and ground truth in the context of diagnostic AI.

Here's the information regarding the "study" (or rather, the evidence presented for substantial equivalence):

Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a "test set" in the sense of a dataset for evaluating an AI algorithm.
- It mentions a "simulated clinical use study," but no details regarding its sample size, design, or data provenance (e.g., country of origin, retrospective/prospective) are provided. It's likely this refers to a benchtop or usability study for the physical device.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This concept is not applicable to the information provided. There is no "ground truth" establishment by experts for a test set in the context of an AI or diagnostic device being evaluated. The evaluation is primarily against engineering standards and comparison to a predicate device.
Adjudication Method for the Test Set:
- Not applicable, as there is no "test set" in the context of an AI algorithm with expert adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as this is a physical medical device (syringe) and not an AI or diagnostic imaging system that would typically undergo such a study.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
The Type of Ground Truth Used:
- The primary "ground truth" here is compliance with established international standards (ISO standards) for mechanical performance, sterility, biocompatibility, and packaging of hypodermic syringes and needles. The other aspect of "ground truth" is that the predicate device (Sherwood Medical Co. Monoject Safety Syringe) is legally marketed and accepted as safe and effective.
The Sample Size for the Training Set:
- Not applicable. This is a physical device, not an AI algorithm requiring a training set.
How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set.

Summary

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510(k) Summary

Submitter

JUN 2 5 2008 Date Prepared 2/29/2008

UltiMed Inc. 287 East Sixth Street Executive Suite 380 St. Paul, MN 55101 Contact Person: Thomas E. Erickson Telephone: (651) 291-7909 Fax: (651) 291-7074

Name of Device

Common Name:	Syringe, Piston
Proprietary Name:	UltiMed UltiCare Safety Syringe (numerous sizes and combinations varying between the smallest 0.5ml x 27G x 5/16" and the largest 3.0ml x 21G x 1½")
Classification Name:	Piston Syringe, Hypodermic Single Lumen Needle, with Sharps Injury Prevention feature
Regulation:	880.5570, 880.5860
Class:	Class II
Product Code:	FMI / FMF / MEG

Predicate Devices

The UltiMed UltiCare Safety Syringe is substantially equivalent in intended use, function and basic composition to the currently marketed Sherwood Medical Co. Monoject Safety Syringe 1cc, 3cc and 12 cc size (K922522).

Device Description

Intended Use

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

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Technological Characteristics

The UltiMed UltiCare Safety Syringe has similar technological characteristics to the currently marketed predicate device listed above. The UltiMed UltiCare Safety Syringe meets the following device specific standards:

ISO 7864	(1993)	Sterile Hypodermic Needles for Single Use
ISO 7886-1	(1993)	Sterile Hypodermic Syringes for Single Use
ISO 8537	(1991)	Sterile single-use syringes, with or without needle, for insulin
ISO 9626	(1991)	Stainless Steel Needle Tubing for Manufacture of Medical Devices
ISO 10993-1	(2003)	Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing
ISO 10993-4	(2002)	Biological Evaluation of Medical Devices: Part 4: Selections of tests for interactions with blood
ISO 10993-5	(1999)	Biological Evaluation of Medical Devices: Part 5: Tests for in vitro cytotoxicity
ISO 10993-7	(1995)	Biological Evaluation of Medical Devices: Part 7: Ethylene oxide sterilization residuals
ISO 10993-10	(2002)	Biological Evaluation of Medical Devices: Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-11	(2006)	Biological Evaluation of Medical Devices: Part 11: Tests for systemic toxicity
ISO 11607-1	(2006)	Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

Performance Data (non-clinical or clinical)

The UltiMed UltiCare Safety Syringe is substantially equivalent to the predicate device based on the descriptive data, compliance with standards, simulated clinical use study, and indications for use.

Conclusion

The technological characteristics and performance data for the UltiMed UltiCare Safety Syringe demonstrates it is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2008

UltiMed, Incorporated C/O Ms. Carole Stamp Senior Principal Regulatory and Quality Advisor Regulatory and Clinical Research Institute, Incorporated 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416-1334

Re: K080600

Trade/Device Name: UltiMed UltiCare Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: June 11, 2008 Received: June 17, 2008

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.

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Page 2 - Ms. Stamp

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); 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.

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Chure
Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number:	Not yet assigned
Device Name:	UltiMed UltiCare Safety Syringe
Indications For Use:	UltiMed UltiCare Safety Syringe is intended to inject fluidinto, or withdraw fluid from the body. The safety shieldaids in the prevention of needle stick injuries.

X Prescription Use AND/OR (21 CFR 801.Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Cem Virm

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080600

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).