(173 days)
K85-1903
No
The device description details a mechanical syringe with a protective cover, and there is no mention of AI, ML, or any computational processing.
No
The device is a syringe designed for the safe administration of injections and prevention of needlestick injuries, which falls under the category of a surgical/general hospital device, not a therapeutic device.
No
The device description mentions "aspiration of fluid during the injection to determine if the needle has entered a blood vessel," which is an action taken during a procedure and not a standalone diagnostic function. The primary function described is a safety injection system, not a device for diagnosing medical conditions.
No
The device description clearly details a physical syringe with a protective cover, made of materials like plated brass and polycarbonate. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a strong indicator that the device's purpose is not related to in vitro diagnostics.
- Device Description: The description details a syringe system for administering anesthetic, focusing on features for safe injection and needle handling. This is a medical device used in vivo (within the body), not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
The device is clearly described as an injection system used for administering anesthetic, with a focus on safety features for the user and patient during the injection process. This falls under the category of a medical device used for therapeutic or procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The IntegriTech Safety Injection System is a plated brass syringe with a threaded male on the end of the syringe barrel to which the metal or plastic hub of the injection needle is threaded. The barrel accommodates a 1.8 cc anesthetic carpule. The syringe has a plunger with a harpoon on one end which engages the rubber piston of the anesthetic carpule to allow aspiration of fluid during the injection to determine if the needle has entered a blood vessel. These characteristics are the same for the "Astra" syringe (K85-1903) to which we are claiming equivalence. In addition, the Safety Injection System includes a polycarbonate protective cover which in the extended position locks and completely covers the uncapped needle. This allows the syringe to be set aside during the procedure with the contaminated needle covered thereby protecting the operator, auxiliary and patient from a needlestick injury. The protective cover in the extended locked position also allows for the safe placement of the needle cap into the end of the cover which can then be retracted. This action simultaneously recaps the needle thus preventing a needlestick injury during the recapping process. The protective cover is equivalent to the polycarbonate cover on the disposable UltraSafe Aspirating Syringe by Safety Syringes, Inc. (510K #K944425, January 26, 1995). The difference is that the protective cover on the Safety Injection System (IntegriTech) is a solid autoclavable polycarbonate tube attached to an autoclavable chrome plated brass syringe barrel. This cover can be replaced as needed.
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)
K85-1903
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
SUMMARY
JAN 2 2 1997
IntegriTech, Inc. 6020 Bayou Road Mobile, Alabama 36605 Phone: (334) 443-7268 Fax: (334) 460-2911
Jerry A. Smith Phone: (334) 443-7268
Joseph M. Gerlecz, D.D.S. Phone: (904) 765-3334
June 24, 1996
Date of Preparation:
Submitter's Name:
Contact Persons:
Device Name:
Proprietary Name: Common Name: Classification Name:
Equivalent Device:
Safety Injection System Dental Aspirating Antistick Syringe Cartridge Syringe
Astra Aspirating Syringe 510K Number - K85-1903 Astra Pharmaceutical Products, Inc. 50 Otis Street Westborough, MA 01581 Phone: (508) 366-1100 UltraSafe Aspirating Syringe
Device Description: The IntegriTech Safety Injection System is a plated brass syringe with a threaded male on the end of the syringe barrel to which the metal or plastic hub of the injection needle is threaded. The barrel accommodates a 1.8 cc anesthetic carpule. The syringe has a plunger with a harpoon on one end which engages the rubber piston of the anesthetic carpule to allow aspiration of fluid during the injection to determine if the needle has entered a blood vessel. These characteristics are the same for the "Astra" syringe (K85-1903) to which we are In addition, the Safety Injection System includes a polycarbonate claiming equivalence. protective cover which in the extended position locks and completely covers the uncapped needle. This allows the syringe to be set aside during the procedure with the contaminated needle covered thereby protecting the operator, auxiliary and patient from a needlestick injury. The protective cover in the extended locked position also allows for the safe placement of the needle cap into the end of the cover which can then be retracted. This action simultaneously recaps the needle thus preventing a needlestick injury during the recapping process. The protective cover is equivalent to the polycarbonate cover on the disposable UltraSafe Aspirating Syringe by Safety Syringes, Inc. (510K #K944425, January 26, 1995). The difference is that the protective cover on the Safety Injection System (IntegriTech) is a solid autoclavable polycarbonate tube attached to an autoclavable chrome plated brass syringe barrel. This cover can be replaced as needed.