PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE

K993017 · Shinchang Medical Co., Ltd. · FMF · Feb 25, 2000 · General Hospital

Device Facts

• Record ID: K993017
• Device Name: PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE
• Applicant: Shinchang Medical Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Feb 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hypodermic single lumen needle: Device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Piston Syringe: Device is used to inject fluids into, or withdraw fluids from the body. Diabetic Insulin Syringe: Device intended to inject insulin below the surface of the skin.

Device Story

Profi Disposable Syringe, Needle, and DM Ject Insulin Syringe are manual medical devices used for fluid injection or aspiration. Operated by clinicians or patients (for insulin). Devices consist of standard piston syringe and single lumen needle components. Used in clinical or home settings to deliver medication or withdraw bodily fluids. Simple mechanical operation; no electronic or automated components. Benefits include sterile, single-use delivery of fluids and insulin.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual piston syringe and single lumen needle. Sterile, single-use, disposable. No energy source, software, or complex electronics. Materials and dimensions consistent with standard hypodermic syringe/needle specifications.

Indications for Use

Indicated for patients requiring subcutaneous insulin injection (Diabetic Insulin Syringe) or general fluid injection/aspiration (Hypodermic needle/Piston syringe). No specific age or gender restrictions noted.

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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FEB 2 5 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shin Chang Medical Company, Ltd. c/o Ms. Jan J. Frank Shin Chang Medical Company, Ltd. VP Customer Relations Delta Hi-Tech, Incorporated 3762 South 150 East Salt Lake City, Utah 84115

Re : K993017 Profi Disposable Syringe, Profi Disposable Trade Name: Needle, DM Ject Regulatory Class: II Product Code: FMF December 9, 1999 Dated: Received: December 10, 1999

Dear Ms. Frank:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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

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Paqe 2 - Ms. Frank

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 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 [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,

[signature]

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) Number (If known): K993017

Device Name: Profi Disposable Syringe & Needle, DM Ject Insulin Syringe

Indications For Use:

Hypodermic single lumen needle: Device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Device is used to inject fluids into, or Piston Syringe: withdraw fluids from the body.

Diabetic Insulin Syringe: Device intended to inject insulin below the surface of the skin.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Standard Piston Syringes/Needles) (Per 21 CFR 801.109)

OR

Over-The-Counter Use_I (Insulin Syringes W/Noodle)

(Optional Format 1-2-96)

Daltacio Cuenite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number