FINE-JECT

K983067 · Henke Sass Wolf of America, Inc. · FMI · Oct 30, 1998 · General Hospital

Device Facts

• Record ID: K983067
• Device Name: FINE-JECT
• Applicant: Henke Sass Wolf of America, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Oct 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

They are intended to be used for the purpose of injecting fluids into, or withdrawing fluids from parts of the body below the surface of the skin.

Device Story

FINE-JECT® disposable hypodermic single lumen needle; used for injecting or withdrawing fluids from body below skin surface. Device consists of stainless steel needle, polypropylene hub, and HDPE protective cap. Distributed sterile for single-patient use. Operated by clinicians or patients for fluid delivery/aspiration. No complex electronics or software; mechanical device function relies on physical penetration of skin. Benefits include sterile, single-use fluid access.

Clinical Evidence

No clinical data. Bench testing only; device performance validated through adherence to manufacturing standards (ISO 9001/EN 46001) and sterilization validation per ISO 11135 and EN 550.

Technological Characteristics

Needle: Surgical grade stainless steel (AISI SUS 304) per ISO 5832/1 and ASTM 899. Hub: Polypropylene (Novollen 1100N). Cap: HDPE (Mobil HMA 018). Single lumen design. Sterilization: Ethylene oxide per ISO 11135 and EN 550. Standalone mechanical device.

Indications for Use

Indicated for the injection of fluids into or withdrawal of fluids from parts of the body below the skin surface. No specific patient population, age, or gender restrictions are defined.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• BD PrecisionGlide® Needle
• TSK STERJEKT Premium Disposable Hypodermic Needle
• B. Braun STERICAN® Needles

Submission Summary (Full Text)

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K983067

| 510(K) Summary / Statement | |
|-------------------------------------|---------------------------------------------------------------|
| Submitters Name: | HENKE-SASS, WOLF GmbH |
| | Kronenstrasse 16 |
| | D-78532 Tuttlingen Germany |
| | Ph: (011) 49-7461-189-118 Fax: [phone] |
| Contact Name: | Ellen Henke, Official Correspondent for Submission |
| | Wayne Knupp, Jr., Director Sales & Marketing-HENKE SASS WOLF |
| | Stefan Knefel;Sales Manager Disposables HENKE SASS WOLF, GmbH |
| Name of Device: | Hypodermic Single Lumen Needle |
| SAFETY & EFFECTIVENESS DATA SUMMARY | |

Hypodermic Single Lumen Needle Classification Name: Common/Usual Name: Hypodermic Needle Proprietary Name: FINE-JECT® Classification: Class II Hypodermic Single Lumen Needle # 80 FMI Reg. # 880.5570

Performance Standards: Devices are manufactured according to cGMP's, Applicable Harmonized Standards ISO 9001/EN 46001, applicable AAMI and ASTM Standards.

Material Composition: Needle: Survical grade Stainless Steel (AISI SUS 304) certified according to ISO 5832/1 and ASTM 899, Needle Hub: Polypropylene/Novollen 1100N - From BASF; Needle Protective Cap: HDPE Mobil HMA 018 - From Mobil International, KL.

Intended Use: They are intended to be used for the purpose of injecting fluids into, or withdrawing fluids from parts of the body below the surface of the skin.

Sterilization Information : The HENKE-SASS , WOLF Hypodermic Needles shall be distributed Sterile and are intended for single use only. Each Device, whether provided individually or contained in a set, will be sealed within a unit package to preserve sterility. The proposed device will be sterilized in a microprocessor - controlled ethylene oxide sterilizer at an ISO Approved Facility. Management review of sterilization results shall be conducted. Release of each lot will be contingent upon management approval of the related data and upon successful completion verification results. All product shall be validated according to the current approved and published AAMI/ISO Standard: ISO 11135-1194 -"Medical Devices - Validation and routine control of ethylene oxide sterilization - Requirements". The product also complies with the European Norm - EN 550.

Device Description: The HENKE -SASS , WOLF FINE-JECT® Disposable Needles are sterile hypodermic Single Lumen Needles, packaged individually for single patient use. The HENKE SASS WOLF Needles have the same operating principals and intended uses as the predicate devices already in commercial distribution

Predicate Devices: Becton Dickinson and Company "BD PrecisionGlide® Needle", TSK STERJEKT Premium Disposable Hypodermic Needle, B. Braun STERICAN® Needles.

Comparison of Technological Characteristics: The Stainless Steel Material to the predicate devices. The plastic hub material is identical to the predicate devices. The range of sizes available is similar to the predicate devices. In function, the needles are the predicate devices with the same intended use.

Safety and Efficacy Information: The HENKE SASS WOLF Hypodermic Disposable Needles have the same operating principals and intended uses as those of the competitive devices already in commercial distribution.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 1998

Ms. Ellen J. Henke Official Correspondent for 510(k) Submission of Hypodermic Single Lumen Needle HENKE SASS WOLF of AMERICA, Incorporated Soroco Industrial Park, Route 131 529 Ashland Avenue Southbridge, Massachusetts 01550

K983067 Re : FINE-JECT® Trade Name: Requlatory Class: II Product Code: FMI Dated: Auqust 31, 1998 September 2, 1998 Received:

Dear Ms. Henke:

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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 regulations.

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Page 2 - Ms. Henke

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 yitro 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 one regaration cretion" (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

Timothy A. Ulatows 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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Page 1 1

510(k) Number (if known):

Hypodermic Single Lumen Needle Device Name:

Indications For Use:

The Henke-Sass Wolf,Disposable Hypodermic Single Lumen Needle inc nenke babb we used for the purpose of injecting fluids is Intended to be used for eno parts of the body below the surface of the skin.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cucenito

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 98304

Prescription Use
(Per 21 CFR 801.109)

OR

il

Over-The-Counter Use

(Optional Format 1-2-96)