(85 days)
Not Found
No
The description focuses on the mechanical features of the syringe for needle retraction and safety, with no mention of AI or ML.
No.
A therapeutic device is one that treats or heals a disease or condition. This device is a syringe designed for the safe administration of medication, not for treating a condition itself. Its primary function is a delivery mechanism, not a therapeutic intervention.
No
Explanation: The device is a syringe designed for administering medication and preventing needle stick injuries, not for diagnosing medical conditions.
No
The device description clearly outlines a physical syringe with various hardware components (plunger, needle, luer-lock, etc.) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
- Saf-T-Syringe Intended Use: The Saf-T-Syringe's intended use is clearly stated as "to provide a safe, accurate and reliable method of injecting medication into a patient" and "to administer safe and accurate subcutaneous and intramuscular injections." This involves introducing substances into the body (in vivo).
- No Specimen Testing: The description does not mention any testing of specimens or analysis of biological samples.
The Saf-T-Syringe is a medical device used for administering medication, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Saf-T-Syringe's primary intended use is to provide a safe, accurate and reliable method of injecting medication into a patient. The syringe is available in a 3cc, 5cc and 10cc with various needle sizes. The needle automatically withdraws and prevents accidental needle sticks.
Product codes (comma separated list FDA assigned to the subject device)
MEG, FMF
Device Description
The Saf-T-Syringe is a 3cc, 5cc, and 10cc, sterile, non-toxic, non-pyrogenic, disposable, one-hand operated, passively activated, automatic retraction, plunger type, Anti-Stick syringe with a unique, dedicated luer-lock hypodermic needle, as detailed within this submission and in relevant patents. The syringe includes an interchangeable needle; 18 gauge to 25 gauge and lengths of 5/8", 1" and 1-1/2".
The primary intended use of the device is to administer safe and accurate subcutaneous and intramuscular injections. Its secondary intended use is to retract and contain the contaminated needle after injection which renders the syringe inoperable for reuse, while not introducing any additional steps to the one-handed operating method, for the purpose of aiding in the prevention of accidental needle stick injuries.
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
SECTION 5: 510(k) RELEASABLE SUMMARY
510(k) Summary
(As Required by 21 section 807.92 (c))
-
- Submitter Name: Safety Medical International, Incorporated
-
- Address: 2055 Sprint Blvd Apopka, FL 32703
-
- Phone: (407) 880-2301
-
- Fax: (407) 880-3357
-
- Contact Person: David L. Zarrilli, Chief Executive Officer
-
- Date Summary Prepared: June 29, 2005
-
- Device Trade or Proprietary Name: Saf-T-Syringe
-
- Device Common or usual name: Retractable Needle Safety Syringe
-
- Device Classification Name: Piston Syringe, AntiStick, with Hypodermic Needle
-
- Substantial Equivalency is claimed against the following devices:
POP-N-LOCK SYRINGE ( currently marketed as the VANISHPOINT™ SYRINGE) from RETRACTABLE TECHNOLOGIES, INC., 510k #K946219, BD INTEGRA™ Syringe, from BECTON DICKINSON MEDICAL SURGICAL, 510(k) #K011103.
11. Description of the Device:
The Saf-T-Syringe is a 3cc, 5cc, and 10cc, sterile, non-toxic, non-pyrogenic, disposable, one-hand operated, passively activated, automatic retraction, plunger type, Anti-Stick syringe with a unique, dedicated luer-lock hypodermic needle, as detailed within this submission and in relevant patents. The syringe includes an interchangeable needle; 18 gauge to 25 gauge and lengths of 5/8", 1" and 1-1/2".
The primary intended use of the device is to administer safe and accurate subcutaneous and intramuscular injections. Its secondary intended use is to retract and contain the contaminated needle after injection which renders the syringe inoperable for reuse, while not introducing any additional steps to the one-handed operating method, for the purpose of aiding in the prevention of accidental needle stick injuries.
12. Intended Use of the Device:
The Saf-T-Syringe's primary intended use is to provide a safe, accurate and reliable method of injecting medication into a patient. The syringe is available in a 3cc, 5cc and 10cc with various needle sizes. Because the contaminated needle automatically withdraws into the needle plunger the syringe is protected from accidental needle sticks
1
13. Safety and Effectiveness of the Device:
This device is safe and effective as the predicated devices cited above
The Saf-T-Syringe is sterilized using the Ethylene Oxide Sterilization method. The Sal-1 -Oyninge is assured using this sterilization method, which is The stenlity of the dones to assistance with ANSI/AAMI/ISO 11135-1994, "Medical Devices validation and Routine Control of Ethylene Oxide Sterilization" and BS EN 1174; Validation and Nouthe Souther of Ecripes – Part 1: Estimation of the Parts 1-3(1950-1991) Stoninzation of Microorganisms Part 2. Guidance; and Fopulation of Mioroorganisms on Falidation of Microbiological Techniques." The r art of Surate to the ilized to provide a Sterility Assurance Level (SAL) of 108
The Saf-T-Syringe is classified as an Externally Communicating Device, Blood The Our T Oynings to Use (