The CoverTip™ Safety Syringe is indicated for use in the administration of an intramuscular (IM) injection. The CoverTip™ Safety Syringe aids in the prevention of accidental needle sticks. The CoverTip™ Safety Syringe employs a sheath that covers the sharp needle upon completion of the injection.

Device Description

The CoverTip Safety Syringe is a standard piston syringe which incorporates a passive sharp safety needle covering feature. The syringe automatically deploys a plastic cover (sheath) over the needle as the injection is completed and prior to the needle's removal from the tissue. The sheath protrudes beyond the end of the needle, shielding the user and patient from the sharp after removal. The sheath effectively blunts the end of the needle.

AI/ML Overview

The provided text details a 510(k) summary for the CoverTip Safety Syringe, establishing its substantial equivalence to predicate devices, rather than an acceptance criteria and a study proving device meeting those criteria in the way typically seen for clinical performance studies of AI/diagnostic devices. The document focuses on regulatory approval based on comparison to existing legally marketed devices, not on specific performance metrics with defined acceptance thresholds as one would expect for a new diagnostic or AI-driven medical device. Therefore, many of the requested fields cannot be directly extracted or are not applicable.

However, I can interpret some of the information given the context of a 510(k) submission, particularly regarding "performance data" demonstrating equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of quantitative thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" are implied by the process of demonstrating "substantial equivalence" to predicate devices. The performance data presented focuses on showing that the safety feature functions as intended and is comparable to existing safety syringes.

Acceptance Criterion (Implied by Substantial Equivalence and Performance Testing)	Reported Device Performance (Summary from text)
Functionality as a standard piston syringe for IM injections	"The CoverTip Safety Syringe is a standard piston syringe..." "Indicated for IM injection: yes"
Effectiveness of passive sharp safety needle covering	"The syringe automatically deploys a plastic cover (sheath) over the needle as the injection is completed... shields the user and patient from the sharp."
Needle blunting capability of the deployed sheath	"The sheath effectively blunts the end of the needle." "Performance testing demonstrated that the deployed needle sheath... is substantially equivalent in its needle blunting capability to that found in legally marketed predicate devices."
Conformance to relevant international standards	"Performance testing conducted demonstrated that the design and manufacture of the CoverTip Safety Syringe meets or exceeds the requirements relevant international standards."

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

Sample Size for Test Set: Not explicitly stated. The document refers to "Performance data presented" and "Performance testing conducted," but does not specify the number of units or tests performed.
Data Provenance: Not specified. It's highly likely to be internal laboratory testing performed by the manufacturer (Medisys Technologies, Inc.) or an accredited testing facility, typically done prospectively as part of device development. The country of origin for the testing is not mentioned, but the manufacturer is based in the USA.

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

Number of Experts: Not applicable. This type of device (a safety syringe) does not rely on expert interpretation of data to establish a "ground truth" in the way a diagnostic imaging device would. The "ground truth" for its performance would be objective measurements of its mechanical function (e.g., successful sheath deployment, blunting force, fluid delivery accuracy).
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Since there's no expert interpretation involved in establishing ground truth for this device's performance tests, no adjudication method would be used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No. An MRMC study is relevant for diagnostic devices where human readers interpret medical cases, and the study aims to measure the impact of an AI tool on reader performance. This device is a medical instrument, not a diagnostic tool requiring human interpretation of medical cases.

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

Standalone Study: Yes, in the sense that the "Performance testing" mentioned is inherently a standalone evaluation of the device's mechanical and functional properties. The syringe's safety mechanism operates automatically ("automatically deploys a plastic cover"), so its performance is evaluated independent of a human operator's cognitive input regarding the safety feature's function.

7. The Type of Ground Truth Used

Type of Ground Truth: For the "Performance testing," the ground truth would be established through objective physical measurements and engineering specifications. This includes:
- Verification of proper mechanical deployment of the sheath.
- Measurement of needle blunting effectiveness (e.g., force required to penetrate a test material with and without the sheath).
- Dimensional analysis.
- Fluid delivery accuracy confirmation.
- Conformance to relevant international standards (e.g., ISO standards for syringes).

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a mechanical product, not an AI or machine learning algorithm that requires a "training set" of data. Its design and manufacturing are based on engineering principles and material science.

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

Ground Truth for Training Set: Not applicable, as there is no "training set" in the context of this mechanical device. Design validation and verification are based on engineering specifications and testing, not data-driven machine learning.

Summary

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K 97/077

MAY | 5 |998

510 (k) SUMMARY CoverTip Safety Syringe™ March 21, 1996

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarket notification was in accordance with 21 CFR 807.87 and the SMDA.

1.0 Submitter of 510 (k) and Manufacturer

Name: Medisys Technologies, Incorporated 9624 Brookline Avenue Baton Rouge, LA 70809

Attention:	Mr. Kerry Frey
Telephone:	(504) 926-0422
Facsimile:	(504) 926-1586

Consultant:

Joel S. Faden, Ph.D. Joel S. Faden, Ph.D., Inc. Telephone: 301-881-9139 Facsimile: 301-881-9249

Faden is an independent consultant Dr. to Medisys Technologies, Incorporated.

2.0 Name of Device

2.1 Trade/Proprietary Name

CoverTip Safety Syringe

2.2 Common/Usual Name

Piston Syringe

2.3 Classification Name

Piston Syringe (21 C.F.R. 880.5860, class II)

000142

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3.0 Reason for Submitting the 510 (k)

We are submitting this 510(k) to notify you of our desire to commercially distribute for the first time the CoverTip Safety Syringe.

4.0 Device Description

The CoverTip Safety Syringe is a standard piston syringe which incorporates a passive sharp safety needle covering The syringe automatically deploys a plastic feature. cover (sheath) over the needle as the injection is completed and prior to the needle's removal from the The sheath protrudes beyond the end of tissue. the needle, shielding the user and patient from the sharp after removal. The sheath effectively blunts the end of the needle.

5.0 Indications for Use & Intended Use

5.1 Indications For Use

The CoverTip Safety Syringe™ is indicated for use in the administration of an intramuscular (IM) injection.

5.2 Intended Use

The CoverTip Safety Syringe™ is a piston syringe intended for use in the administration of an intramuscular (IM) injection.

6. Substantial Equivalence

The CoverTip Safety Syringe is substantially equivalent, defined in 21 U.S.C. Section 360c(i), to legally as marketed predicate devices.

The CoverTip Safety Syringe has technological characteristics substantially equivalent to those of legally marketed predicate devices. Provides in Table 1 is a tabulated comparison of the essential technological characteristics of the CoverTip Safety Syringe and several legally marketed predicate devices.

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Table 1
Technological Characteristics
CoverTip Safety Syringe vs. Predicate Devices

Device Name	CoverTip SafetySyringe	Standard Syringe	Safety-LokSyringe	Punctur-Guard
Manufacturer	Medisys Tech.	Becton Dickinson	Becton Dickinson	Bioplexus
510(k) #	current document	pre-enactment	K920321	K895024
Indicated for IMinjection	yes	yes	yes	no
Standard pistonsyringe	yes	yes	yes	no - bloodcollection needle
Safety feature	sheath over needleextended beyondtip	none	barrel size tubeextended overneedle	tube inside needleextended beyondtip
Aim of safetyfeature	blunt the needle	not applicable	blunt the needle	blunt the needle

The CoverTip Safety Syringe was shown to have the same Indication for Use and Intended Use as predicate devices. Further, as indicated in the table the technological characteristics of the CoverTip Safety Syringe and predicate devices are substantially equivalent. Performance data presented demonstrated that the CoverTip Safety Syringe is substantially equivalent to legally marketed predicate devices. Performance testing conducted demonstrated that the design and manufacture of the CoverTip Safety Syringe meets or exceeds the requirements relevant international standards. of Next, the performance testing demonstrated that the deployed needle sheath of the CoverTip Safety Syringe is substantially equivalent in its needle blunting capability to that found in legally marketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY | 5 1998

Medisys Technologies, Incorporated ·C/O Joel S. Faden, Ph.D. Consultant Joel S. Faden, Ph.D., Incorporated 11605 Hitching Post Lane Rockville, Maryland 20852

Re : K971077 Trade Name: Covertip Safety Syringe Regulatory Class: II Product Code: MEG Dated: March 20, 1998 March 23, 1998 Received:

Dear Dr. Faden:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Faden

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) 594-4692. 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" (21CFR 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.gov/cdrh/dsma/dsmamain.,html".

Sincerely yours,

Timothy 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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510(k) - CoverTip Safety Syringe Medisys Technologies, Inc.

Indications For Use

Device Name: CoverTip™ Safety Syringe

Indications For Use:

The CoverTip™ Safety Syringe is indicated for use in the administration of an intramuscular The Cover Tip - Barey Syringe aids in the prevention of accidental needle sticks (Int) inforton. The Ocerapy a sheath that covers the sharp needle upon completion of the injection.

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

Prescription Use: (Per 21 CFR 801.109)

Over-The-Counter: OR

(Optional Format 1-2-96)

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

Capital Devices
510(k) Number K9716

(k) Number 4971077

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).