(58 days)
The Henke-Sass Wolf, Disposable Hypodermic Single Lumen Needle is 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.
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
Below is the information regarding the acceptance criteria and the study for the submitted device, a Hypodermic Single Lumen Needle.
Device Name: Hypodermic Single Lumen Needle (Proprietary Name: FINE-JECT®)
Classification Name: Hypodermic Needle
Product Code: FMI
Regulation Number: 880.5570
Classification: Class II
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission for the Hypodermic Single Lumen Needle (FINE-JECT®) relies on demonstrating substantial equivalence to already marketed predicate devices rather than presenting specific quantitative performance data against predefined acceptance criteria for novel safety/efficacy endpoints. The "acceptance criteria" here are therefore generally understood as compliance with established manufacturing and quality standards, and the "reported device performance" is its adherence to these standards and functional equivalency to predicate devices.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Manufacturing Standards | Compliance with cGMP (current Good Manufacturing Practices) | Devices are manufactured according to cGMP's. |
| Compliance with Harmonized Standards | Applicable Harmonized Standards ISO 9001/EN 46001. | |
| Compliance with AAMI and ASTM Standards | Applicable AAMI and ASTM Standards are followed. | |
| Material Composition | Needle: Medical grade stainless steel standards | Needle: Survical grade Stainless Steel (AISI SUS 304) certified according to ISO 5832/1 and ASTM 899. This is identical to predicate devices. |
| Hub: Compatible plastics | Needle Hub: Polypropylene/Novollen 1100N - From BASF. This is identical to predicate devices. | |
| Protective Cap: Compatible plastics | Needle Protective Cap: HDPE Mobil HMA 018 - From Mobil International, KL. | |
| Sterilization | Sterilization validation according to recognized standards | Sterilized in a microprocessor-controlled ethylene oxide sterilizer at an ISO Approved Facility. 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". Complies with European Norm - EN 550. |
| Sterility maintenance in packaging | Sealed within a unit package to preserve sterility. | |
| Single-use design | Intended for single use only. | |
| Intended Use | Consistent with predicate devices | Intended to be used for injecting fluids into, or withdrawing fluids from parts of the body below the surface of the skin. This is the same intended use as predicate devices. |
| Technological Equivalence | Similar design and operating principles to predicate devices | Comparison shows the same operating principles and intended uses as competitive devices. The Stainless Steel Material and plastic hub material are identical to predicate devices. The range of sizes available is similar. In function, the needles are the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This submission is a 510(k) Premarket Notification for a Class II medical device (Hypodermic Single Lumen Needle). For such submissions, especially for devices like hypodermic needles that rely on well-established technology, the primary evidence of "safety and efficacy" (or substantial equivalence) often comes from bench testing, material conformity, and adherence to recognized standards, rather than clinical trials with patient test sets.
- Sample Size for Test Set: Not explicitly stated in terms of a "test set" from a patient population. The safety and efficacy information presented is based on material composition, manufacturing processes, sterilization validation, and comparison to predicate devices. Performance is assessed against industry standards and the characteristics of existing devices.
- Data Provenance: The data provenance is primarily from bench testing, material certifications, and regulatory standards compliance documents. This type of data is generated during the manufacturing and quality assurance processes, not typically from a clinical patient population. The country of origin for manufacturing is Germany (HENKE-SASS, WOLF GmbH, D-78532 Tuttlingen Germany). The data is retrospective in the sense that it refers to established manufacturing practices, material specifications, and standardized testing procedures, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Given the nature of a 510(k) for a hypodermic needle, "ground truth" is established through:
- Material Science Experts: To certify the quality and properties of the stainless steel (ISO 5832/1 and ASTM 899) and plastics.
- Sterilization Experts: To validate the ethylene oxide sterilization process against ISO 11135-1194 and EN 550.
- Quality Management/Regulatory Experts: To ensure compliance with cGMP, ISO 9001/EN 46001, AAMI, and ASTM standards.
The specific "number of experts" and their detailed qualifications (e.g., "radiologist with 10 years of experience") are not provided nor typically required for this type of 510(k) submission. Instead, the submission relies on the certification of the manufacturing facility (ISO Approved Facility) and adherence to international standards, which implicitly involve expert-validated methodologies and practices.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typical for studies involving human interpretation (e.g., medical imaging) to resolve discrepancies in expert opinions. For this device, which relies on physical characteristics and performance against objective standards:
- Adjudication Method: None in the context of expert review of subjective data.
- Instead, performance is determined by objective measurements, material specifications, and validation reports (e.g., sterilization cycle reports, material certificates of conformity) that meet predefined quantitative and qualitative standards. Deviations from these standards would constitute a failure to meet acceptance criteria, not a matter for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is designed for evaluating diagnostic devices where human readers interpret medical data, often with and without AI assistance. This type of study is not applicable to a basic medical device like a hypodermic needle.
- The device's effectiveness is established by its functional equivalence to predicate devices and compliance with safety and performance standards relevant to its physical properties and intended use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: Not applicable in the context of an algorithm.
- For a hypodermic needle, the "standalone performance" refers to the device's ability to function as intended (injecting/withdrawing fluids) and its associated safety aspects (sterility, material integrity, sharpness, break resistance, etc.). These performances are assessed through bench testing and compliance with specific ASTM/ISO standards relevant to needles, ensuring that the device itself performs its mechanical and biological functions without requiring human "interpretation" of data generated by the device itself.
7. The Type of Ground Truth Used
The "ground truth" for a device like a hypodermic needle is based on:
- Objective Standards and Specifications: Adherence to defined material compositions (e.g., AISI SUS 304, ISO 5832/1, ASTM 899 for stainless steel), manufacturing tolerances, and physical properties (e.g., needle sharpness, hub attachment strength).
- Validated Processes: Successful validation of sterilization processes according to ISO 11135-1194 and EN 550.
- Functional Equivalence: Confirmation that the device's operating principles and intended uses are the same as legally marketed predicate devices, implying comparable safety and efficacy profiles that have been historically accepted.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not involve an AI algorithm or machine learning components that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable. As there is no AI/ML component, there's no training set or associated ground truth for a training set.
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| 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.
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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 (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)
§ 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).