(274 days)
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No
The description focuses on mechanical features (needle retraction) and standard syringe function, with no mention of AI/ML terms or data processing that would suggest AI/ML is involved.
No.
The device is described as "to inject fluids into, or withdraw fluids from, the body below the sufface of the skin for medical purposes," which indicates it is an instrument used for medical procedures, but not a device that directly provides a therapeutic effect. It facilitates therapy by delivering substances or withdrawing fluids, but it is not itself a therapeutic modality.
No
Explanation: The device is described as a syringe used for injecting or withdrawing fluids from the body, and its performance studies relate to its function as a syringe and a needle retraction feature. There is no mention of it being used to diagnose a medical condition or abnormality.
No
The device description clearly states it is a syringe with a needle retraction feature, indicating it is a physical 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 to "inject fluids into, or withdraw fluids from, the body below the surface of the skin for medical purposes." This describes a device used for direct interaction with the body for therapeutic or diagnostic procedures, not for testing samples in vitro (outside the body).
- Device Description: The description focuses on the physical characteristics and function of a syringe, which is a tool for administering or collecting substances from the body.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or any other activities typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of the Terumo Medical Corporation (Terumo) RN Syringe is to inject fluids into, or withdraw fluids from, the body below the sufface of the skin for medical purposes.
Product codes
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Device Description
The Terumo RN Syringe is a sterile, single use device designed to be similar to present single use products. A needle retraction feature allows the user to withdraw the needle into the barrel of the syringe immediately after use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Discussion of Non-Clinical Tests: The non-clinical tests performed on the Terumo RN Syringe are the same protocols and standards used for the evaluation of our standard syringe products. In addition the needle retraction feature was tested with a lock - out and drop test to assure that the needle would remain retracted within the barrel of the device.
Discussion of Clinical Tests: An analysis of the similarities in design, materials, use and function of the Terumo RN Syringe with the predicate products, establishes that the need for simulated clinical use and actual clinical use testing is unnecessary.
Conclusions Drawn from Testing: Since the device is similar to current single use syringes and the needle retraction function is essentially equivalent to the predicate product, there are no new issues of safety or effectiveness involved in the use of the Terumo RN Syringe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
TERUMO MEDIC CORPORATION
MAN 2 1 1996
EGULATORY AFFAIRS DEPARTMENT 25 BLUF BALL ROAD ELKTON, MARYLAND 2192 TELEPHONE: (410) 392-723 FAX: (410) 398-6079
510(k) SUMMARY
Name of the Device:
Terumo Retractable Needle (RN) Syringe
Predicate Product:(s):
There are two products referenced as predicates for the Terumo RN Syringe:
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Terumo Hypodermic Syringes with Needles, K771205 and K771203.
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U.S. Medical Instruments SafeSnap™ syringe, K925039.
Description of the Subject Device:
The Terumo RN Syringe is a sterile, single use device designed to be similar to present single use products. A needle retraction feature allows the user to withdraw the needle into the barrel of the syringe immediately after use.
Intended Use of the Device:
The intended use of the Terumo Medical Corporation (Terumo) RN Syringe is to inject fluids into, or withdraw fluids from, the body below the sufface of the skin for medical purposes.
Comparison of Subject Device to Predicate Device(s):
The Terumo RN Syringe is similar in design, feel and function to a standard Terumo hypodermic syringe with needle. This syringe provides the user with a product similar to a standard disposable syringe that will require little, or no change in the technique that is presently used.
The materials in the subject device are the same as Terumo's standard hypodermic syringe and needle with the exception of the addition of an "O" ring made of silicone. These materials have been tested and as a part of the whole product biocompatibility testing in accordance with the current CDRH guidance.
The needle retraction mechanism of the "crumo RN Syringe locks the needle hub with an adapter on the distal end of the plunger after injection, and allows the needle to be withdrawn into the barrel of the syringe. The predicate syringe requires the user to ensure that the plunger rod has locked into the needle carrier and then to disengage an external locking ring after the completion of the injection. The withdrawal of the plunger rod retracts the needle within the barrel of the syringe. The user then snaps off the plunger rod and inserts the broken segment of the rod into the open end of the barrel and, disposes of the unit in an appropriate sharps container. The needle retraction mechanism of the Terumo RN Syringe is similar to that of the predicate product, except there is no need to disengage a locking ring. The retraction feature of both devices prevents the accidental reuse of the device.
1
Safety Information:
· The Terumo RN Syringe is sterilized by gamma radiation to provide a Sterility Assurance Level (SAL) of 10-6.
· Blood or fluid contacting materials were tested as the whole device for biocompatibility using the FDA's modification of the ISO 10993 Standard as a external communicating device; blood path, indirect; short term exposure and found to be biocompatible.
· The product was found pyrogen free when tested in accordance with U.S.P. XXIII.
· Shelf life for the RN Syringe is based on our experience with Terumo's standard syringes. An additional accelerated test program will be intended that will confirm the full dating period.
Performance Data:
Discussion of Non-Clinical Tests
The non-clinical tests performed on the Terumo RN Syringe are the same protocols and standards used for the evaluation of our standard syringe products. In addition the needle retraction feature was tested with a lock - out and drop test to assure that the needle would remain retracted within the barrel of the device.
Discussion of Clinical Tests
An analysis of the similarities in design, materials, use and function of the Terumo RN Syringe with the predicate products, establishes that the need for simulated clinical use and actual clinical use testing is unnecessary.
Conclusions Drawn from Testing
Since the device is similar to current single use syringes and the needle retraction function is essentially equivalent to the predicate product, there are no new issues of safety or effectiveness involved in the use of the Terumo RN Syringe.
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TMC's statement that these devices are substantially equivalent to any other device is done solely to comply with the requirements of the Federal Food, Drug, and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.
Submitter's Information:
Alan B. Hershman, R.A.C. Manager of Regulatory Affairs Terumo Medical Corporation Regulatory Affairs Department 125 Blue Ball Road Elkton, MD 21921
Phone 410/392-7231 410/398-7069 Fax
Date of Summary: 08/14/95