(72 days)
Not Found
No
The 510(k) summary describes a standard manual syringe and does not mention any AI or ML capabilities. The performance studies focus on equivalence to a predicate device and compliance with standards, not on algorithmic performance.
No
The device is used for injecting or withdrawing fluids, which are procedures, but it does not in itself treat or cure a disease or condition. While essential in medical procedures, the syringe is a delivery/collection tool, not a therapeutic agent.
No
The device is a hypodermic syringe used for injecting or withdrawing fluids, not for diagnosing medical conditions. Its purpose is therapeutic or procedural rather than diagnostic.
No
The device description clearly indicates a physical, hardware-based medical device (syringe and needle) used for injecting or withdrawing fluids. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for injecting fluids into or withdrawing fluids from the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details a standard syringe for manual use, designed for injecting or withdrawing fluids. This aligns with a general medical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Performing tests or assays
- Providing information for diagnosis based on in vitro analysis
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. A syringe, in this context, is a tool for collecting or delivering substances, not for performing the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Terumo Disposable Hypodermic Syringe, with or without hypodermic single lumen needle, is used for injecting fluids into or withdrawing fluids from the body. The syringe is designed for manual use.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Terumo Disposable Hypodermic Syringe, with or without a hypodermic single lumen needle, is a sterile, single use, standard piston syringe, designed for manual use. The syringe is available in 3, 5, 10, 20, 30 and 60 cc/ml volumes, with luer slip, luer lock, eccentric slip tip, or catheter tip configurations.
The Terumo Disposable Hypodermic Syringe will be sold by prescription only and labeling will bear the statement "Caution: Federal law restricts this device to sale by or on the order of a physician."
Minor design changes have been implemented to produce The Terumo Disposable Hypodermic Syringe. These minor design changes are as follows:
- The outer diameter of the barrel has decreased .
- The overall length of the barrel has decreased .
- The wall of the barrel is slightly thinner ●
- The flange height is slightly less .
- The plunger rib cross section has been very slightly reduced .
- The gasket height has been lessened .
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
APR = 2 1998
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
Terumo Disposable Hypodermic Syringe or similar proprietary Proprietary Device Name: name
Classification Name: Syringe, piston
INTENDED USE
The Terumo Disposable Hypodermic Syringe, with or without hypodermic single lumen needle, is used for injecting fluids into or withdrawing fluids from the body. The syringe is designed for manual use.
- Note: This is the same intended use as the Terumo Hypodermic Syringe cleared under K771205.
DESCRIPTION
The Terumo Disposable Hypodermic Syringe, with or without a hypodermic single lumen needle, is a sterile, single use, standard piston syringe, designed for manual use. The syringe is available in 3, 5, 10, 20, 30 and 60 cc/ml volumes, with luer slip, luer lock, eccentric slip tip, or catheter tip configurations.
The Terumo Disposable Hypodermic Syringe will be sold by prescription only and labeling will bear the statement "Caution: Federal law restricts this device to sale by or on the order of a physician."
SUBSTANTIAL EQUIVALENCE
The Terumo Disposable Hypodermic Syringe submitted in this 510k is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Terumo Hypodermic Syringe (K771205).
1
PRINCIPLE OF OPERATION/TECHNOLOGY
The Terumo Disposable Hypodermic Syringe and the cleared Terumo Hypodermic Syringe (K771205) are both operated manually.
DESIGN/MATERIALS
The materials used to construct the Terumo Disposable Hypodermic Syringe are the same materials used for the cleared Terumo Hypodermic Syringe (K771205). The Terumo Disposable Hypodermic is substantially equivalent in design to the cleared Terumo Hypodermic Syringe (K771205).
SPECIFICATIONS
The Terumo Disposable Hypodermic Syringe, with or without hypodermic single lumen needle, is available in 3, 5, 10, 20, 30 and 60 cc/ml volumes, with luer slip, luer lock, eccentric slip tip or catheter tip configurations.
Minor design changes have been implemented to produce The Terumo Disposable Hypodermic Syringe. These minor design changes are as follows:
- The outer diameter of the barrel has decreased .
- The overall length of the barrel has decreased .
- The wall of the barrel is slightly thinner ●
- The flange height is slightly less .
- The plunger rib cross section has been very slightly reduced .
- The gasket height has been lessened .
NOTE: The inner diameter of the Terumo Disposable Hypodermic Syringe barrel has not changed from the cleared predicate device barrel inner diameter (Terumo Hypodermic Syringe K771205).
PERFORMANCE
The performance of the Terumo Disposable Hypodermic Syringe is substantially equivalent to the performance of the cleared Terumo Hypodermic Syringe (K771205), and will meet the same range of performance acceptance criteria.
2
SECTION II: Summary of Safety and Effectiveness
The Terumo Disposable Hypodermic Syringe complies with ISO 594-1:1986. Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment--Part 1: General requirements and Part 2: Lock fittings.
The Terumo Disposable Hypodermic Syringe complies with Section II, Item #3 (barrel volume) of the Standard for Disposable Hypodermic Syringes, Notification No. 442 of the Japan Ministry of Health and Welfare: December 28, 1970.
The Terumo Disposable Hypodermic Syringe also complies with specific sections of ISO 7886-1 Guidance for Sterile Hypodermic Syringes for Single Use, Part 1: Syringes for manual use, as indicated in the table below.
| APPLICABLE STANDARD | |
|---|---|
| Leakage | |
| Aspiration | |
| Injection | ISO 7886-1 |
| Plunger Mobility/Gasket Slide | ISO 7886-1 |
| Dead Space | ISO 7886-1 |
| Silicone Quantity | ISO 7886-1 |
| Graduation Location | ISO 7886-1 |
| Conical Fitting/Luer Taper | ISO 594-1, ISO 594-2 |
| Barrel Volume | Japan Ministry of Health & Welfare, No. 442: 12/28/70 |
ADDITIONAL SAFETY INFORMATION
Sterilization conditions have been validated according to the European Standard, EN 556: Sterilization of Medical Devices - Requirements for Medical Devices to Be Labeled Sterile, to provide a Sterility Assurance Level (SAL) of 10-6.
Manufacturing control test methods include: functional and sterility tests.
LAL testing is performed on production samples from of every lot number.
3
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 ( | | |
| | (Sign-Off) | | |
| | Dental Infection Control | | |
| | and General Hospital Devices | | |
| 510(k) Number | K980181 | | |
| Prescription Use | | OR | Over-The-Counter Use |
(Optional Format 1-2-96)