CORELIFE

K964230 · Core Healthcare , Ltd. · FMF · Jul 24, 1997 · General Hospital

Device Facts

• Record ID: K964230
• Device Name: CORELIFE
• Applicant: Core Healthcare , Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Jul 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is used to inject fluids into or withdraw fluids from the body.

Device Story

Corelife is a piston syringe used for fluid injection or withdrawal. Operated by clinicians or healthcare professionals in clinical settings. Device functions via manual piston displacement to create pressure differentials for fluid transfer. Benefits include standard fluid delivery or aspiration. No automated processing or electronic components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual piston syringe. Materials and design consistent with standard medical syringe specifications for fluid injection/withdrawal. No electronic components, software, or energy sources.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from the body in patients requiring such procedures.

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.

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Core Healthcare Limited
C/O Kumar Kulkarni
46 Lock Haven Lane
Battle Creek, Michigan 49015

Re: K964230
Trade Name: Corelife
Regulatory Class: II
Product Code: FMF
Dated: May 2, 1997
Received: May 5, 1997

JUL 24 1997

Dear Mr. Kulkarni:

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 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 requirement, 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

{1}

Page 2 - Mr. Kulkarni

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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/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

{2}

K964230/52
Page 1 of 1

510(k) Number (if known): K964230

Device Name: CORELIFE (PISTON SYRINGE)

Indications For Use:

This device is used to inject fluids into or withdraw fluids from the body.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Patricia Cucinetti
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K964230

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)