The UltraSafe® Model T200 Injector with Needle Guard is designed to hold a TUBEX® Sterlie Cartridge-Needle Unit 2.5 ml. in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit.

The UltraSafe® Model T200 Injector is used with a Tubex® Sterile Cartinge-Needle Unit 2.5 ml. to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for parenteral methods of administration.

Device Description

The UltraSafe® Model T200 Injector with Needle Guard is a product which is intended to be used with a TUBEX® Sterile Cartridge-Needle Units 2.5 ml to deliver medication from the cartridge into the tissues of the patient. The device is totally disposable and is equipped with a needle shield which can be snapped into place after use of a syringe, thus protecting the caregiver by eliminating the need to recap the needle, and minimizing accidental needle stick injuries during disposal of the syringe/needle.

AI/ML Overview

This device is a medical injector system and the documentation provided is a 510(k) premarket notification to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone performance metrics.

Therefore, many of the requested specific details regarding acceptance criteria, study design, and performance metrics (like sensitivity, specificity, F1 score, effect size in MRMC studies, sample sizes for test and training sets with ground truth specifics) are not available in the provided text. The document is primarily a descriptive comparison and regulatory submission.

However, based on the input, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Protection from accidental needle stick injuries	Needle shield can be snapped into place after use, eliminating need to recap and minimizing accidental needle sticks.
Functionality: Deliver medication from cartridge	Intended to be used to deliver medication from a cartridge.
Ease of Assembly and Use	As easy to assemble and use as the Wyeth Injector (predicate device).
Material Biocompatibility	Materials have passed biocompatibility tests.
Strength (Mechanical)	Considerably greater strength than the predicate device.
Usable Needle Length (when ready-to-use)	Provides the same usable needle length as an unguarded needle.
Equivalent Hypodermic Procedures	User can perform typical hypodermic procedures equivalently to standard, unguarded needles.
Disposability	Totally disposable.
Compatibility with TUBEX® Sterile Cartridge-Needle Units	Designed to hold a TUBEX® Sterile Cartridge-Needle Unit 2.5 ml.
User Protection during Disposal	Guard is intended to protect the user from needle sticks after injection and during disposal.
Material Equivalence to Predicate Device	Made of K-Resin KR01, KR03, and ABS Resin, same as Safety Syringes predicate device.
Labeled Warning Statements	"Hands must remain behind the needle at all times during use and disposal."

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

Sample Size: Not specified. The document mentions "The Model T200 Injector with Needle Guard has been tested," but does not provide details on the number of devices or subjects tested.
Data Provenance: Not specified. It's implied to be internal testing by Safety Syringes, Inc. The document does not mention country of origin explicitly or whether it was retrospective or prospective.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Not specified. The document describes a statement of substantial equivalence rather than a detailed clinical or performance study with adjudication.

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

No, an MRMC study was not done. This device is a mechanical injection system, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable.

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

No, this is not applicable. The device is a physical injection system, not an algorithm. The "standalone performance" refers to the device's inherent mechanical safety and functionality, which is implicitly what the "testing" mentioned in the document aimed to assess.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be derived from specific measurable engineering and functional tests (e.g., force required to activate safety mechanism, needle exposure length, material strength tests) and perhaps user performance assessments (e.g., ease of use, ability to perform typical hypodermic procedures). The document states the device "has been tested" and "found to have considerably greater strength," indicating these types of tests were performed.
For biocompatibility, the ground truth would be established through standardized biocompatibility tests as per medical device regulations.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical medical device, not an AI/machine learning model, so there is no concept of a "training set."

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

Not applicable. As above, there is no training set for this type of device.

Summary

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FEB 2 6 1998

UltraSafe® Injection System Model T200 Injector with Needle Guard 510(k) Premarket Notification

K 97290 0

9.0 Summary of Safety and Effectiveness

Safety Syringes Contact Person 9.1

David Mitchell Safety Syringes, Inc. 250 West Colorado Blvd. Suite # 101 Arcadia, CA 91007 (626) 821.1121 Phone (626) 821.1009 Fax

9.2 Device Name

UltraSafe® Injection System, Model T200 Injector with Needle Guard

9.3 Predicate Devices

Safety Syringes UltraSafe® Aspirating Syringe - K944425 Wyeth TUBEX® Injector - Pre-amendment

9.4 Product Description and Function

Comparison to Predicate Devices/Equivalence વે.ર

Descriptive Comparison to Legally Marketed Devices

Model T200 Injector with Needle Guard is intended to be used to deliver medication from a cartridge. The guard

Safety Syringes, Inc. UltraSafe T200 Injector 510(k) Submission

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requires a two-handed action in order to cover the needle point after use.

The Model T200 Injector with Needle Guard has been tested and found to have considerably greater strength than the predicate device. The T200 Injector is as easy to assemble and use as the Wyeth Injector.

With the Model T200 in the "ready-to-use" position, it provides the same useable needle length as an unguarded needle. The user can perform typical hypodermic procedures equivalently to standard, unguarded needles.

9.6 Comparison of Materials

The UltraSafe® Injection System, Model T200 Injector with Needle Guard is made of K-Resin KR01, KR03, and ABS Resin which are the same materials as the Safety Syringes predicate device.

Safety and Efficacy Information 9.7

Biocompatibility:

The UltraSafe® Injection System, Model T200 Injector uses the same materials as the Safety Syringes predicate device. The materials have passed biocompatibility tests.

Labeled Warning Statements: Hands must remain behind the needle at all times during use and disposal.

Safety Syringes, Inc. UltraSafe T200 Injector 510(k) Submission

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 1998

Mr. Anthony R. Perez CEO & President Safety Syringes, Incorporated 250 West Colorado Boulevard, Suite 101 Arcadia, California 91007

Re : K972900 UltraSafe® Injection System Model T200 Trade Name: Injector with Needle Guard Requlatory Class: II Product Code: FMF Dated: January 6, 1998 Received: January 7, 1998

Dear Mr. Perez:

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 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 controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal - Requlations, Title 21, Parts 800 to 895 - A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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

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Page 2 - Mr. Perez

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general 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.qov/cdrh/dsmamain.html".

Sincerely yours

Timo thy A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K972900

UltraSafe® Injection System Model T200 Injector With Needle Guard Device Name:

Indications For Use:

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

Patricia Encente

Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972900
Prescription Use
(Per.21 CFR 801.109)
OR

Over-The-Counter Use

(Optional Format 1-2-96)

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).