(208 days)
Not Found
No
The device description details a purely mechanical safety mechanism for a syringe, with no mention of software, data processing, or any AI/ML related terms.
No
The device is a syringe used for administering medication, which is a delivery method, not a therapeutic agent itself. Its primary function is to aid in the prevention of needlestick injuries.
No
Explanation: The device is described as a hypodermic syringe for injection of medication, and its primary function is to aid in the prevention of needlestick injuries. It does not perform any diagnostic functions.
No
The device description clearly details a physical syringe with mechanical components for needle retraction and reuse prevention, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intramuscular and subcutaneous injection of medication to patients." This describes a device used on a patient for administering substances, not a device used on biological samples in vitro (outside the body) to diagnose conditions.
- Device Description: The description details a syringe with a needle and a mechanism for preventing reuse and needlestick injuries. This is consistent with a device used for administering injections directly into a patient's body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not fit that definition.
N/A
Intended Use / Indications for Use
The Manual Safety Syringe is a single-use safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
Product codes (comma separated list FDA assigned to the subject device)
MEG
Device Description
The Manual Safety Syringe is a single-use safety hypodermic syringe, which is very similar to a traditional syringe, with the exception that it possesses an integral needle retracting mechanism. The device comes in two variations:
- 3. Manual Safety Syringe (2-parts) 5ml
-
- Manual Safety Syringe (3-parts) 5ml
The Manual Safety Syringe (2-parts) consists of a conventional syringe barrel equipped with a mechanism that shall prevent re-use of an already used syringe. When the plunger is pressed in its bottom position the injection is completed. When retracting the plunger the snare will drag the needle into the barrel, and thus prevent reuse of the syringe. The cone prevents the needle from going back into the barrel during the injection. The nozzle holds the needle, snare and cone and is attached to the barrel prior to injection. The needle cap protects the needle when handled. Also, when pulled back, the plunger is unable to be detached from the barrel. As an additional safety feature the operator is encouraged to break off the plunger when the plunger has been pulled back.
The Manual Safety Syringe (3-parts) is identical to the 2-parts version with respect to the operation of the device. The design differs only with respect to the plunger and the lubrication. The 3-parts version is equipped with an extra sealing and the inside of the barrel is lubricated with silicon. The 2-parts version is not lubricated.
The Manual Safety Syringe is only available in one size (5ml).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5860 Piston syringe.
(a)
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.(b)
Classification. Class II (performance standards).
0
OCT 16 2006
H 510(k) Summary – Traditional Submission
510(k) Owner
| Establishment: | MedSafe ASA |
|---|---|
| Address: | Forskningsveien 2A, N-0373 Oslo, Norway |
| Phone: | +47 23 22 36 14 |
| Fax: | +47 22 14 02 55 |
Contact Person
| Name: | Nils Gunnarsson |
|---|---|
| Establishment: | MedSafe ASA |
| Address: | Forskningsveien 2A, N-0373 Oslo, Norway |
| Phone: | +47 23 22 36 14 |
| Fax: | +47 22 14 02 55 |
Date of Preparation
March 9, 2006
ldentification of the Device
| 1. Proprietary Name: | Manual Safety Syringe (2-parts),
Manual Safety Syringe (3-parts) |
|-------------------------|-----------------------------------------------------------------------------------------|
| 2. Common Name: | Sharps Injury Prevention Piston Syringe |
| 3. Classification Name: | Antistick Syringe |
| 4. Class II, Procodes: | FMF - Piston Syringe
MEG – Antistick Syringe
FMI – Hypodermic Single Lumen Needle |
Equivalent Legally Marketed Device
Claim of Substantial Equivalence is made to BIOTOP DJT-A Safety Syringe (K032747).
Intended Use
The Manual Safety Syringe is a single-use safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
1
Description of the Device
The Manual Safety Syringe is a single-use safety hypodermic syringe, which is very similar to a traditional syringe, with the exception that it possesses an integral needle retracting mechanism. The device comes in two variations:
-
- Manual Safety Syringe (2-parts) 5ml
-
- Manual Safety Syringe (3-parts) 5ml
The Manual Safety Syringe (2-parts) consists of a conventional syringe barrel equipped with a mechanism that shall prevent re-use of an already used syringe. When the plunger is pressed in its bottom position the injection is completed. When retracting the plunger the snare will drag the needle into the barrel, and thus prevent reuse of the syringe. The cone prevents the needle from going back into the barrel during the injection. The nozzle holds the needle, snare and cone and is attached to the barrel prior to injection. The needle cap protects the needle when handled. Also, when pulled back, the plunger is unable to be detached from the barrel. As an additional safety feature the operator is encouraged to break off the plunger when the plunger has been pulled back.
The Manual Safety Syringe (3-parts) is identical to the 2-parts version with respect to the operation of the device. The design differs only with respect to the plunger and the lubrication. The 3-parts version is equipped with an extra sealing and the inside of the barrel is lubricated with silicon. The 2-parts version is not lubricated.
The Manual Safety Syringe is only available in one size (5ml).
| The Manual Safety Syringe | BIOTOP DJT-A Safety Syringe | |
|---|---|---|
| Syringe type | Antistick syringe | Antistick syringe |
| Intended use | The Manual Safety Syringe is a single-use safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. | Similar |
| Principle of operation | Activation of safety feature consists of three steps: |
- Press the plunger to the bottom position to complete injection.
- Retract the plunger to full stop to drag the needle into the barrel.
- Brake plunger off. | Identical |
| Volume (ml/cc) | 5ml | 1ml/3ml/5ml |
| Nozzle type | Luer | Luer Lock Tip |
| Barrel | | Identical |
Safety and Effectiveness, Comparison to Predicate Device
2
| marking | ||
|---|---|---|
| Reuse | Non-reusable | Identical |
| Materials | 1. Barrel: | |
| Polypropylene | Polypropylene | |
| 2. Plunger: | ||
| Polyethylene | Polypropylene | |
| 3. Snare | ||
| Polypropylene | N/A | |
| 4. Needle: | ||
| Stainless steel | Stainless steel | |
| 5. Cone: | ||
| Polycarbonate | N/A | |
| 6. Nozzle: | ||
| Polycarbonate | Polypropylene | |
| 7. Sealing | ||
| Thermoplastic Elastomer Compound | Unknown | |
| 8. Lubrication | ||
| Silicon lubrication | Unknown | |
| 9. Needle cap | ||
| Polypropylene | Unknown | |
| 10. Primary container: | ||
| Peel-packs made of plastic | Unknown | |
| 11. Secondary container: | ||
| Cardboard box | Unknown | |
| 12. Transport container: | ||
| Corrugated cardboard | Unknown | |
| Sterility | Sterilized by ethylene oxide gas | Sterilized by ethylene oxide gas |
| SAL |