The UltiCare Disposable Syringe is used to draw a quantity of pharmaccutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.

Device Description

The UltiCare 3 ml Disposable Syringe is a standard piston type hypodermic syringe, with a black colored protective needle cap. This device is a sterile, single-use, disposable piston svringe with permanently affixed hypodermic single lumen needle. This device is a sterile, single use, disposable piston syringe with permanently affixed hypodermic single lumen needle. The UltiCare 3 ml Disposable Syringe consists of a syringe barrel, a plunger rod, and a hypodermic single lumen needle permanently bonded to the tip of the syringe with epoxy. The UltiCare 3 ml Disposable Syringe is available in a 3.0 cc syringe capacity with a 22 GAUGE x 1½" hypodermic single lumen needle.

AI/ML Overview

This document is a 510(k) summary for a disposable medical device (syringe), not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device performance and testing (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and compliance with established performance standards for syringes.

Here's the information that is extractable and relevant from the provided document, presented as closely as possible to the requested format:

Acceptance Criteria and Device Performance for UltiCare™ Disposable Syringe (3 ml/cc)

This 510(k) submission primarily relies on demonstrating substantial equivalence to two predicate devices and compliance with recognized international standards for syringes. The "acceptance criteria" are implicitly these standards, and the "reported device performance" is the claim of meeting these standards and being substantially equivalent.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance
Design & Function	Substantial Equivalence: - Intended Use - Function - Basic Composition	The UltiCare 3 ml Disposable Syringe is substantially equivalent in intended use, function, and basic composition to the Ulti Med UltiCare 1 ml Disposable Syringe (K994230) and the Becton Dickinson Medsaver Syringe (K941095). The only design change from the 1ml UltiCare syringe is syringe capacity and corresponding dimensional changes, and minimal material component changes. All other aspects are identical.
Material & Sterility	ISO 8537: Sterile, Single-Use Syringes, with or without Needle, for Insulin	UltiCare Disposable Syringes "meet the following standards." (Implies compliance)
Needle Material	ISO 9626: Stainless Steel Needle Tubing for Manufacture of Medical Devices	UltiCare Disposable Syringes "meet the following standards." (Implies compliance)
Intended Use	Draw and administer pharmaceuticals via direct injection or intravenous port/heparin lock/saline lock.	Device is used to draw and administer pharmaceuticals directly to the patient or via an intravenous port, heparin lock, or saline lock.

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

Not Applicable. This submission is for a conventional medical device (syringe), not an AI/ML device. Performance is demonstrated through substantial equivalence to predicate devices and compliance with ISO standards, rather than through a clinical test set with specific sample sizes and data provenance as would be relevant for an AI/ML algorithm. Testing would have typically involved laboratory-based verification and validation of engineering design and manufacturing against the ISO standards. The document does not detail this testing (which is common for 510(k) summaries of such devices).

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. See point 2. Ground truth establishment by experts is not a concept applied to the evaluation of a disposable syringe in this context.

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

Not Applicable. See point 2.

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 non-AI device.

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

Not Applicable. This is a non-AI device.

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

Not Applicable. For this device, "ground truth" equates to the physical and functional characteristics specified in the ISO standards (e.g., sterility, dimensional accuracy, material properties, fluid delivery pressure/flow) and the functionality of predicate devices. These are not established by expert consensus, pathology, or outcomes data in the way an AI algorithm's performance is evaluated.

8. The sample size for the training set

Not Applicable. This is a non-AI device; there is no training set.

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

Not Applicable. This is a non-AI device; there is no training set or associated ground truth establishment process.

Summary

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K033794
Confidential

510(k) Summary

Submitter

Date Prepared 04 December 2003

Ulti Med Inc. 287 East Sixth Street St. Paul, Minnesota Contact Person: Tom Erickson

Telephone: (651) 291-7909 Fax: (651) 291-7074

Name of Device

Common Name: Proprietary Name: Classification Name: Regulation: Class: Product Code:

Disposable Syringe UltiCare™ Disposable Syringe 3 ml/cc Piston Syringe 880.5860 Class II FMF/FMI

Predicate Devices

The UltiCare 3 ml Disposable Syringe is substantially equivalent in intended use, function and basic composition to the currently marketed Ulti Med UltiCare 1 ml Disposable Syringe, K994230, and to the Becton Dickinson Medsaver "Syringe, K941095.

Device Description

The UltiCare 3 ml Disposable Syringe is a standard piston type hypodermic syringe, with a black colored protective needle cap.

This device is a sterile, single-use, disposable piston svringe with permanently affixed hypodermic single lumen needle. This device is a sterile, single use, disposable piston syringe with permanently affixed hypodermic single lumen needle. The UltiCare 3 ml Disposable Syringe consists of a syringe barrel, a plunger rod, and a hypodermic single lumen needle permanently bonded to the tip of the syringe with epoxy.

The UltiCare 3 ml Disposable Syringe is available in a 3.0 cc syringe capacity with a 22 GAUGE x 1½" hypodermic single lumen needle.

Intended Use

The UltiCare Disposable Syringe is used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.

Technological Characteristics

The only design change being incorporated into current UltiCare 3 ml Disposable Syringe compared to currently marketed UltiCare 1 ml Disposable Syringe is the syringe capacity and corresponding dimensional changes, and minimal material component changes. All other aspects are identical to the currently marketed

Special 510(k) Ulti Med Inc.

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UltiCare Disposable Syringe. UltiCare Disposable Syringes meet the following standards:

ISO 8537, Sterile, Singe-Use Syringes, with or without Needle, for Insulin ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices

Special 510(k) Ulti Med Inc.

: 上一篇:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three distinct lines forming its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 3 0 2003

Ulti Med, Incorporated C/O Ms. Ellen G. Redding, MSN Regulatory and Clinical Research Institute, Incorporated Principal Regulatory Advisor 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416-1334

Re: K033794

Trade/Device Name: UltiCare™ Disposable Syringe (3 m!/cc) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: December 4, 2003 Received: December 5, 2003

Dear Ms. Redding:

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 (Spccial 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. Redding

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 (301) 594-4618. Also, please note the regulation cntitled, "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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Pintura Cuantitativa

Chiu Lin, Ph.D. Director Division of Ancsthesiology, General Hospital, 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): 大む33794

Device Name:

UltiCare™ Disposable Syringe (3 ml/cc)

Indications for Use:

Antonie Caccante

Infection Control, D

510(k) Number:

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Special 510(k) Ulti Med Inc.

Page 16 of 21

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).