(84 days)
Not Found
No
The description details a mechanical syringe for administering injections and makes no mention of AI or ML.
Yes
The device is described as a syringe used to administer an anesthetic product, which is a therapeutic intervention aimed at relieving pain or inducing numbness.
No
The device is described as a syringe for administering intraligamental injections of anesthetic product, not for diagnostic purposes.
No
The device description clearly describes a physical syringe with a metal barrel, plunger, and needle attachment, indicating it is a 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 "administer intraligamental injections of anaesthetic product." This describes a procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a syringe designed for injecting substances into the body. This is a medical device used for treatment or diagnosis in vivo, not for testing in vitro.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
This product is intended to be used to administer intraligamental injections of anaesthetic product, through a two-ended needle.
Product codes (comma separated list FDA assigned to the subject device)
76 E J I
Device Description
The Miniiect Syringe is a cartridge syringe with a metal syringe barrel to which the metal or plastic hub of the injection needle is threaded. The barrel accommodates a 1.8cc anesthetic cartridge. The syringe has a plunger on one end, which engages the rubber piston of the anesthetic cartridge. These characteristics are the same or similar for the "Intralig", by Miltex, (K823536) and Ligmaject, (K802483).
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
§ 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
AUG 25 1999
Image /page/0/Picture/1 description: The image contains a series of handwritten numbers and letters. The characters include 'K', '99', '88', and what appears to be an 'f'. The handwriting is somewhat stylized and the characters are spaced apart.
510(k) Summary
Submitted By: Spartan Marketing Group 1663 Fenton Business Park Ct. Fenton, MO 63026 USA
Establishment Registration Number - #1926480
Telephone Number - 314.343.8733 FAX Number - 949.203.2122 Email - aeagle311@aol.com
Contact Person: Aldo Eagle Title: Director of International Business Development
Date of Application - May 28, 1999
Device Name:
-
Miniject Syringe Proprietary Name -Cartridge Syringe or Intraligamental Syringe Common Name -Proposed Classification Name - Syringe, Cartridge
Class II ס -
Product Code -76 E J I ם
Predicate Device - Substantial Equivalence
The Miniject Syringe is substantially equivalent in terms of safety and effectiveness to the marketed injection devices of (K823536) Intralig and (K802483) Ligmaject
Device Description
The Miniiect Syringe is a cartridge syringe with a metal syringe barrel to which the metal or plastic hub of the injection needle is threaded. The barrel accommodates a 1.8cc anesthetic cartridge. The syringe has a plunger on one end, which engages the rubber piston of the anesthetic cartridge. These characteristics are the same or similar for the "Intralig", by Miltex, (K823536) and Ligmaject, (K802483).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a symbol of three stylized human profiles facing right, with flowing lines above them that resemble a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 25 1999
Mr. Aldo Eagle Director Spartan Ultrasonics, Incorporated 1663 Fenton Business Park Court Fenton, Missouri 63026
Re : K991888 Trade Name: Miniject Regulatory Class: II Product Code: EJI May 28, 1999 Dated: Received: June 2, 1999
Dear Mr. Eagle
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
2
Page 2 - Mr. Eagle
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA dinding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regarderen endtification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaygov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K 99/888/A'
Image /page/3/Picture/1 description: The image is a logo for Obtura Spartan, a company that specializes in endodontic success. The logo features a stylized image of a tooth with the company name written below it. The slogan "Enhancing Endodontic Success" is written below the company name. The logo is black and white.
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510(k) Number (if known): K991888
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
This product is intended to be used to administer intraligamental injections of anaesthetic product, through a two-ended needle.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER P. NEGOED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Bank
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
| 510(k) Number | K991885 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ (Per 21 CFR 801.109) | OR | Over-The-Counter Us (Optional Form) |
|---|---|---|---|
| ------------------ | ----------------------------------------------------------------- | ---- | ------------------------------------- |
1663 FENTON BUSINESS PARK COURT • FENTON, MISSOURI 63026 USA (314) 343-8300 • (800) 325-9027 • FAX (314) 343-5794