PENETREASE

K980078 · P.T. Panca Pusaka Deli · FMF · Oct 16, 1998 · General Hospital

Device Facts

• Record ID: K980078
• Device Name: PENETREASE
• Applicant: P.T. Panca Pusaka Deli
• Product Code: FMF · General Hospital
• Decision Date: Oct 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

A device intended for medical purposes used to inject fluids into , or withdraw fluids from, the body that consists of a calibrated hollow bernel and a movable pinner. At only of barrel there body that consists of a calibrated hollow befrei and a movaole planet. noedle.

Device Story

PenetrEase (Monomedisjes) consists of a calibrated hollow barrel, movable plunger, and needle. Used for fluid injection or withdrawal from the body. Operated by clinicians or patients (for insulin). Simple mechanical device; no electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical syringe with calibrated hollow barrel, movable plunger, and needle. No electronic components, software, or energy source.

Indications for Use

Indicated for medical purposes to inject fluids into or withdraw fluids from the body. Over-the-counter use restricted to insulin syringes only; otherwise prescription use per 21 CFR 801.109.

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)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its head turned to the right. The eagle is composed of three curved lines that suggest the shape of the bird's head, neck, and wing. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 16 1998

Panca Pusaka Deli P.T. C/O Ms. Jane B. Campbell J & D Campbell Associates, Incorporated 485 LaRoe Road Chester, New York 10918

K980078 Re : PenetrEase Trade Name: Requlatory Class: II Product Code: FMF Auqust 27, 1998 Dated: August 27, 1998 Received:

Dear Ms. Campbell:

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 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. ರ್ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Please note: this response to your the Federal Reqister. premarket notification submission does 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 regulations.

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Page 2 - Ms. Campbell

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 [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

Time A. 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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Thu, BQ Jon 50 11 -20

510K # : K980078 Monomedi-jech

## ATTACHMENT &

## Page of

510(k) Number (If known): K980078
Trade Name!
Device Name : Monomodisjes Penty Ease Syringes Needles

## Indications for Use :

A device intended for medical purposes used to inject fluids into , or withdraw fluids from, the body that consists of a calibrated hollow bernel and a movable pinner. At only of barrel there body that consists of a calibrated hollow befrei and a movaole planet. noedle.

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

on

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

Prescription Use-(Per 21 CFR 801.109)

Over The Counter Use Insulin Syringes Only

( Optional format 1-2-96 )

Patricia Cucente
(Division Sign-Off)
Division of Dentual, Infection Control,
and General Hospital Devices
510(k) Number K980078