COVERTIP SAFETY SYRINGE

K971077 · Medisys Technologies, Inc. · MEG · May 15, 1998 · General Hospital

Device Facts

• Record ID: K971077
• Device Name: COVERTIP SAFETY SYRINGE
• Applicant: Medisys Technologies, Inc.
• Product Code: MEG · General Hospital
• Decision Date: May 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

CoverTip Safety Syringe is a standard piston syringe featuring a passive safety mechanism. During injection, a plastic sheath is automatically deployed; the sheath extends beyond the needle tip upon completion of the injection and prior to removal from tissue. This action blunts the needle tip to protect the user and patient from accidental needle sticks. The device is intended for use by healthcare professionals during intramuscular injections. The primary benefit is the reduction of sharps-related injuries through passive, automatic shielding of the needle.

Clinical Evidence

Bench testing only. Performance data demonstrated that the design and manufacture meet or exceed relevant international standards and that the needle blunting capability is equivalent to legally marketed predicate devices.

Technological Characteristics

Piston syringe with integrated passive needle-sheathing mechanism. Plastic sheath deploys automatically to extend beyond the needle tip. Class II device (21 CFR 880.5860).

Indications for Use

Indicated for administration of intramuscular (IM) injections. Aids in prevention of accidental needle sticks by passively and automatically deploying a sheath covering the sharp needle upon completion of injection.

Regulatory Classification

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.

Predicate Devices

• Safety-Lok Syringe (K920321)
• Punctur-Guard (K895024)

Reference Devices

• Standard Syringe (pre-enactment)

Submission Summary (Full Text)

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K 97/077

MAY 15 1998

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: [phone]
Facsimile: [phone]

Consultant:

Joel S. Faden, Ph.D.
Joel S. Faden, Ph.D., Inc.
Telephone: [phone]
Facsimile: 301-881-9249

Dr. Faden is an independent consultant 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)

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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 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.

## 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, as defined in 21 U.S.C. Section 360c(i), to legally 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 Safety Syringe | Standard Syringe | Safety-Lok Syringe | Punctur-Guard |
| --- | --- | --- | --- | --- |
| Manufacturer
510(k) # | Medisys Tech.
current document | Becton Dickinson
pre-enactment | Becton Dickinson
K920321 | Bioplexus
K895024 |
| Indicated for IM injection | yes | yes | yes | no |
| Standard piston syringe | yes | yes | yes | no - blood collection needle |
| Safety feature | sheath over needle
extended beyond tip | none | barrel size tube
extended over needle | tube inside needle
extended beyond tip |
| Aim of safety feature | 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 of relevant international standards. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 15 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
Received: March 23, 1998

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 Regulations, 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 regulations.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 (IM) injection. The CoverTip™ Safety Syringe aids in the prevention of accidental needle sticks by passively and automatically deploying a sheath that covers the sharp needle upon completion of the injection.

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(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)
(Optional Format 1-2-96)

OR Over-The-Counter:
*(Division Sign-Off)*
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number **K971077**

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