(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.
§ 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).