(31 days)
Not Found
No
The description details a standard manual syringe and needle, with no mention of AI or ML capabilities.
No
The device is described as a syringe for preparation, aspiration, and injection of fluids, which are procedures rather than a therapeutic effect from the device itself.
No
Explanation: The device is a syringe intended for the preparation/mixing of substances and the injection or aspiration of fluids. Its function is to administer or withdraw substances, not to provide diagnostic information about a medical condition.
No
The device description clearly describes a physical syringe with a fixed needle, which is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. This examination happens outside of the body (in vitro).
- Terumo Allergy Syringe Intended Use: The intended use of the Terumo Allergy Syringe is for the preparation/mixing of substances, manual aspiration of fluids, and injection of fluids into parts of the body below the surface of the skin. This involves direct interaction with the body (in vivo) for administration or removal of substances, not for the examination of specimens outside the body.
The description clearly indicates the device's function is related to administering or withdrawing substances directly from or into the body, which is not the purpose of an IVD.
N/A
Intended Use / Indications for Use
The Terumo Allergy Syringe is intended for the preparation/mixing of allergenic extracts/prescribed substances, the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The syringe is designed for manual use. These allergy syringes will be sold by prescription only, and the labeling will bear the statement "Caution: Federal law restricts this device to sale by or on the order of a physician."
Product codes
FMF
Device Description
The Terumo Allergy Syringe with fixed hypodermic single lumen needle is a sterile, single use, standard piston syringe, designed for manual use. The syringe is available in Icc volumes with 23G, 26G and 27G, 1/2" and 3/8" fixed hypodermic single lumen needles. These needles have either a regular or intradermal bevel.
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
physician (by prescription only)
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
The following tests were performed demonstrating the substantial equivalence of the Terumo Allergy Syringe submitted in this 510k to the B-D® Allergy Syringe (K941657).
- Volume .
- Cannula/barrel adherence .
- Maximum penetration force .
- Leakage .
- Aspiration initial breakaway force ●
- . Aspiration
- Injection force ●
- Residual volume .
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SECTION II: Summary of Safety and Effectiveness
K980796 APR - 2 1998
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
Proprietary Device Name: Terumo Allergy Syringe or similar proprietary name Syringe, piston with fixed hypodermic single lumen needle Classification Name:
INTENDED USE
The Terumo Allergy Syringe is intended for the preparation/mixing of allergenic extracts/prescribed substances, the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The syringe is designed for manual use. These allergy syringes will be sold by prescription only, and the labeling will bear the Federal law restricts this device to sale by or on the order of a statement "Caution: physician. "
DESCRIPTION
The Terumo Allergy Syringe with fixed hypodermic single lumen needle is a sterile, single use, standard piston syringe, designed for manual use. The syringe is available in Icc volumes with 23G, 26G and 27G, 1/2" and 3/8" fixed hypodermic single lumen needles. These needles have either a regular or intradermal bevel. See following chart:
PROPOSED:
| NEEDLE GAUGE | NEEDLE LENGTH | NEEDLE BEVEL | SYRINGE PACKAGING |
|---|---|---|---|
| 23 | 1/2" | Regular | Trays of 25 |
| 26 | 3/8" | Regular | Trays of 25 |
| 27 | 1/2" | Regular | Individual |
| 27 | 1/2" | Regular | Trays of 25 |
| 27 | 1/2" | Intradermal | Trays of 25 |
| 27 | 3/8" | Intradermal | Trays of 25 |
PREDICATE:
| NEEDLE GAUGE | NEEDLE LENGTH | NEEDLE BEVEL | SYRINGE PACKAGING |
|---|---|---|---|
| 23 | 1" | Regular | Individual |
| 25 | 5/8" | Regular | Individual |
| 26 | 1/2" | Regular | Trays of 25 |
| 26 | 3/8" | Intradermal | Trays of 25 |
| 27 | 1/2" | Regular | Trays of 25 |
| 27 | 3/8" | Intradermal | Trays of 25 |
1
SECTION II: Summary of Safety and Effectiveness
SUBSTANTIAL EQUIVALENCE
The Terumo Allergy syringe submitted in this 510k is substantially equivalent in intended use, design, specifications, technology/principles of operation, materials and performance to the cleared B-D® Allergy syringe which is the subject of K941657.
PRINCIPLE OF OPERATION/TECHNOLOGY
The Terumo Allergy Syringe and the B-D Allergy Syringe are both operated manually or by a manual process.
MATERIALS
| MATERIALS | PROPOSED | PREDICATE |
|---|---|---|
| Barrel | Polypropylene | Polypropylene |
| Plunger | Polystyrene | Polystyrene |
| Gasket | Thermoplastic elastomer | Unknown |
| Needle | Stainless steel | Unknown |
PERFORMANCE
The performance of the Terumo Allergy Syringe is substantially equivalent to the performance of the cleared B-D® Allergy Syringe (K941657).
The following tests were performed demonstrating the substantial equivalence of the Terumo Allergy Syringe submitted in this 510k to the B-D® Allergy Syringe (K941657).
- Volume .
- Cannula/barrel adherence .
- Maximum penetration force .
- Leakage .
- Aspiration initial breakaway force ●
- . Aspiration
- Injection force ●
- Residual volume .
2
ADDITIONAL SAFETY INFORMATION
The sterility of the product is assured using a sterilization method validated and qualified in accordance with the ISO 11137- "Sterilization of Healthcare Products Requirements for Validation and Routine Control - Radiation Sterilization" to a sterility assurance level (SAL) of 10-6.
Additionally each lot is monitored with calibrated Harwell Red Perspex 4034 dosimeters to determine the Gamma radiation dose delivered. Critical parameters, such as exposure time and dose delivery interruption are confirmed to comply with procedure.
Manufacturing control test methods include functional tests.
LAL testing is performed on production samples from every lot number.
Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." [External Communicating Devices, Blood Path Indirect, Limited Duration of Contact (