(34 days)
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No
The description focuses on computer-controlled mechanical aspects (motor, piston, foot switch) and status indicators, with no mention of AI/ML terms or functions typically associated with learning or adaptive algorithms.
No.
The device is described as a computer-controlled syringe for injecting local anesthetic agents, which is a delivery mechanism rather than a therapeutic treatment itself.
No
The device is used to inject anesthetic agents, and while it provides status indicators related to the injection process, its primary function is therapeutic (delivery of a substance), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly outlines hardware components such as a motor housing, metal piston, foot switch, hypodermic needles, carpules, vinyl tubing, handpiece, and holster. While it has computer control and software features (audible/visible indicators), it is not solely software.
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 local anesthetic agents subcutaneously or intramuscularly for dental applications." This describes a device used in vivo (within a living organism) for administering medication.
- Device Description: The description details a syringe system for delivering anesthetic. It does not mention any components or processes related to testing samples in vitro (outside of a living organism) to diagnose diseases or conditions.
- Lack of IVD Indicators: There are no mentions of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the delivery of a therapeutic agent.
N/A
Intended Use / Indications for Use
To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.
Product codes
EJI
Device Description
The CompuDent STA™ Syringe is a computer controlled syringe consisting of a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes. The device provides audible and visible status indicators of injection rate, amount of anesthetic remaining in the carpule, and pressure at the tip of the needle.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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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.
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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
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§ 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
510(k) Summarv
Submitted by:
Daniel J. Manelli Manelli & Fisher, P.L.L.C. 5335 Wisconsin Ave., NW (Suite 440) Washington, DC 20015
Telephone: 202-885-5548
On behalf of Milestone Scientific, Inc. 220 South Orange Avenue Livingston, NJ 07039
510(k) Submission: CompuDent STA™ Syringe Date: July 5, 2006
Description: The CompuDent STA™ Syringe is a computer controlled syringe consisting of a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes. The device provides audible and visible status indicators of injection rate, amount of anesthetic remaining in the carpule, and pressure at the tip of the needle. It is substantially equivalent to the company's currently marketed CompuDent™ computer controlled syringe.
Indications for Use:
To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.
AUG - 8 2006
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the top half of the circle. The bottom half of the circle contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES". In the center of the seal is an abstract image of an eagle.
AUG - 8 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Milestone Scientific, Incorporated C/O Mr. Daniel J. Manelli Attorney Manelli & Fisher, P.L.L.C 5335 Wisconsin Avenue NW, Suite 440 Washington, D.C. 20015
Re: K061904
Trade/Device Name: CompuDent STA™ Regulation Number: 21 CFR 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Code: EJI Dated: July 5, 2006 Received: July 5, 2006
Dear Mr. Manelli:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rown and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device nucesure connects, or to devices that have been reclassified in accordance with the provisions of Amendments, of to arrivand Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 000; Drag, are grand you may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (I Wry, It may of bacycer to easily of Federal Regulations, Title 21. Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Ecderal Register.
2
Page 2 - Mr. Manelli
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syvette y. Michael DMD.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Exhibit 4
510(k) Number (if known):
Device Name:
CompuDent STA™
Indications for Use:
To inject local anesthetic agents subcutaneously or intramuscularly for dental applications
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation
Suger Rurre
Off) lion Sign-ംon of Anesthesiology, General Hospital, otion Control, Dental De
Number: KO(0)904
Prescription Use J (Per 21 CFR 801.1091)
Over-The-Counter Use
(Optional format 1- 2 - 96)