The UltraSafe® Model C200 Injector with Needle Guard is designed to hold a sterile medication cartridge with needle 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 C200 Injector is used with a standard Sanofi-Winthrop Carpuject® 2.0ml medication cartridge 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 a wide range of clinical conditions.

Device Description

The UltraSafe® Model C200 Injector with Needle Guard is a product which is intended to be used with a sterile medication cartridge with needle 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 consists of a safety guard that 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. The guard requires a two-handed action in order to cover the needle point after use. The Model C200 Injector is made of K-Resin KR01, KR03, and ABS Resin.

AI/ML Overview

The provided text describes the K972877 Premarket Notification for the UltraSafe® Injection System Model C200 Injector with Needle Guard. This document focuses on the substantial equivalence of the new device to existing predicate devices, rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics in the way a clinical trial for a novel drug or a complex AI diagnostic device would.

Here's an analysis based on the provided text, addressing your points as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicit quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as this is a 510(k) for a medical device seeking substantial equivalence, not a clinical effectiveness trial for a new therapeutic or diagnostic.

However, we can infer some implied criteria and reported performance based on the comparison to predicate devices:

Acceptance Criterion (Implied)	Reported Device Performance (UltraSafe® Model C200 Injector with Needle Guard)
Ability to deliver medication from a cartridge	Intended to be used with a sterile medication cartridge with needle to deliver medication.
Protection against accidental needle stick injuries	Equipped with a needle shield that can be snapped into place after use, protecting the caregiver by eliminating the need to recap and minimizing accidental needle stick injuries.
Ease of assembly and use (compared to predicate)	"As easy to assemble and use as the Sanofi-Winthrop Injector."
Usable needle length (compared to unguarded needles)	"Provides the same useable needle length as an unquarded needle."
Ability to perform typical hypodermic procedures	User can perform typical hypodermic procedures equivalently to standard, unguarded needles.
Needle guard strength (compared to predicate)	"Found to have considerably greater strength than the predicate device."
Biocompatibility of materials	Uses the same materials as the Safety Syringes predicate device, which "have passed biocompatibility tests."
Requires two-handed action to cover needle	"Requires a two-handed action in order to cover the needle point after use."

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

The provided text does not specify a "test set" in the context of performance metrics or a study. The information presented is descriptive and comparative based on the device's design, materials, and intended function. There is no mention of a particular sample size for testing users or assessing effectiveness in a clinical setting in this document. The data provenance is primarily from the manufacturer's internal assessments and comparisons to predicate devices.

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

This information is not available in the provided text. The document is a regulatory submission for substantial equivalence based on device design and comparison, not a study requiring a ground truth established by experts for performance evaluation.

4. Adjudication Method for the Test Set

This information is not available in the provided text. As there is no explicitly defined "test set" with performance metrics requiring adjudication, this concept does not apply to the provided document.

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

An MRMC study is not applicable to this device. This device is a manual medical instrument (injector with a needle guard) and does not involve AI or "human readers" in a diagnostic or interpretive sense.

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

This information is not applicable as the device is a mechanical injector, not an algorithm.

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

This information is not available or applicable in the context of a "ground truth" for performance evaluation in the way it would be for a diagnostic or AI device. The "ground truth" for this device revolves around its physical properties (e.g., strength of the guard, ease of use with standard procedures) and safety features (prevention of needle sticks), which are presumably assessed through engineering tests, usability studies, and adherence to established biocompatibility standards.

8. The sample size for the training set

This information is not applicable as the device is a mechanical medical instrument, not an AI model requiring a training set.

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

This information is not applicable as the device is a mechanical medical instrument, not an AI model.

Summary of the Study (as described in the document):

The document describes a comparison study (or more accurately, a descriptive comparison for the purpose of a 510(k) submission) to demonstrate substantial equivalence of the UltraSafe® Injection System Model C200 Injector with Needle Guard to its predicate devices.

The "study" or justification for equivalence is based on the following:

Design and Functionality Comparison: The C200 is intended for the same use (delivering medication from a cartridge) as the predicate Sanofi-Winthrop Injector. Its needle guard is designed to prevent needle stick injuries, similar to the concept of the UltraSafe Aspirating Syringe.
Performance Comparison:
- The C200's needle guard reportedly has "considerably greater strength than the predicate device." However, the standard or test method for this strength comparison is not detailed.
- It's stated to be "as easy to assemble and use" as the Sanofi-Winthrop Injector. This is a qualitative assessment.
- It provides the "same useable needle length" as an unguarded needle, ensuring equivalent performance of hypodermic procedures.
Material Equivalence and Biocompatibility: The C200 uses the "same materials" (K-Resin KR01, KR03, and ABS Resin) as the Safety Syringes predicate device, and these materials have "passed biocompatibility tests."
Safety Features: The primary safety feature is the needle shield that can be snapped into place after use, eliminating recapping and minimizing accidental needle sticks. A key operational safety aspect highlighted is the "two-handed action" required to cover the needle.

In essence, the "study" presented here isn't a traditional scientific study with detailed experimental protocols, control groups, and statistical analysis of performance metrics. Instead, it's a submission for regulatory clearance asserting that the new device is fundamentally similar in design, materials, and intended use, and performs equivalently to legally marketed devices, with an improvement in needle guard strength.

Summary

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K972877

FEB 26 1998

510(k) Premarket Notification UltraSafe® Injection System Model C200 Injector with Needle Guard

9.0 Summary of Safety and Effectiveness

Safety Syringes Contact Person .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 C200 Injector with Needle Guard

9.3 Predicate Devices

Safety Syringes UltraSafe® Aspirating Syringe - K944425 Sanofi-Winthrop Injector - Pre-amendment

Product Description and Function 9.4

9.5 Comparison to Predicate Devices/Equivalence

Descriptive Comparison to Legally Marketed Devices Model C200 Injectors with Needle Guard are intended to be used to deliver medication from a cartridge. The guard

Safety Syringes, Inc. UltraSafe C200 Injector 510(k) Submission

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

The Model ( 200 needle guard has been tested and found to have considerably greater strength than the predicate device. The C200 Injector is as easy to assemble and use as the Sanofi-Winthrop Injector.

With the Mode! C200 needle guard in the "ready-to-use" position, it provides the same useable needle length as an unquarded needle. The user can perform typical hypodermic procedures equivalently to standard, unguarded needles.

9.6 Comparison of Materials

The UltraSate® Injection System, Model C200 Injector 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 C200 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 C200 Injector 510(k) Submission

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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 with three lines representing its body and wings. The eagle's head is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 1998

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

K972877 Re : UltraSafe® Injection System Model C200 Trade Name: Injector with Needle Guard Regulatory 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 qeneral 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 against 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. And ----------substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq 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 requlation (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 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.gov/cdrh/dsmamain.html".

Sincerely yours,

K. Whitworth

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

Enclosure

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1 Page 1 of

510(k) Number (if known): K972877

UltraSafe® Injection System Model C200 Injector With Needle Guard Device Name:

Indications For Use:

Patricio Cucumita

(Division Sign-Off) (Division of Dinal, Infection Control, and General Trospital Devices 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
(Per 21 CFR 801.109)

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).