(58 days)
Not Found
Not Found
No
The 510(k) summary describes a standard hypodermic needle and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is a needle used for injecting or withdrawing fluids, which is a tool for a medical procedure rather than a therapeutic device that directly treats a condition or disease.
No
The device is described as a hypodermic needle intended for injecting or withdrawing fluids, which are procedures for treatment or sample collection, not for diagnosis.
No
The device description clearly states it is a sterile hypodermic single lumen needle, which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "injecting fluids into, or withdrawing fluids from parts of the body below the surface of the skin." This describes a direct interaction with the body for therapeutic or diagnostic purposes in vivo (within a living organism).
- IVD Definition: In vitro diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used in vitro (outside of a living organism).
The description of the device and its intended use clearly falls under the category of a general medical device used for procedures on the body, not for testing samples outside the body.
N/A
Intended Use / Indications for 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.
Product codes
FMI
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Becton Dickinson and Company "BD PrecisionGlide® Needle", TSK STERJEKT Premium Disposable Hypodermic Needle, B. Braun STERICAN® Needles.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
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.(b)
Classification. Class II (performance standards).
0
| 510(K) Summary / Statement | |
|---|---|
| Submitters Name: | HENKE-SASS, WOLF GmbH |
| Kronenstrasse 16 | |
| D-78532 Tuttlingen Germany | |
| Ph: (011) 49-7461-189-118 Fax: (011) 49-7461-189-182 | |
| 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.
2
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)