(34 days)
To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.
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.
This 510(k) summary for the CompuDent STA™ Syringe indicates that it is substantially equivalent to a previously marketed device (CompuDent™ computer controlled syringe). As such, it relies on the predicate device's performance and does not describe a new study with acceptance criteria and device performance. Device performance for substantial equivalence is often established through detailed comparisons to the predicate device's specifications and existing performance data, rather than new, stand-alone clinical trials with explicitly stated acceptance criteria.
Therefore, many of the requested elements (like sample size, number of experts, ground truth, MRMC study, and training set details) are not explicitly present in the provided text because the submission is for substantial equivalence to an existing device rather than a de novo approval requiring extensive new clinical validation.
However, based on the provided text, I can infer what would typically be considered "acceptance criteria" for a device of this nature and the "study" demonstrating performance, which in this case is the substantial equivalence comparison.
Here's an attempt to answer your questions based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the primary "acceptance criterion" is that the new device performs as intended and is substantially equivalent to the predicate device. Performance is demonstrated by showing that the design, materials, principle of operation, and intended use are the same as the predicate. The document doesn't quantify specific performance metrics with numerical acceptance criteria (e.g., "flow rate must be within X% of target").
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (from text) |
|---|---|
| Intended Use: Device performs its intended function effectively and safely. | "To inject local anesthetic agents subcutaneously or intramuscularly for dental applications." (Same as predicate) |
| Principle of Operation: Device operates on the same scientific principles. | "The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes." (Implies same as predicate) |
| Material Equivalence: Materials used are safe and comparable to predicate. | "The materials... are the same as other marketed piston and cartridge syringes." (Implies same as predicate) |
| Safety: Device presents no new safety concerns. | No new safety concerns identified; substantial equivalence implies comparable safety. |
| Performance Features: Device provides similar functionality and user feedback. | "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." (Comparable to predicate functionality) |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable or not specified. Substantial equivalence typically relies on design verification/validation and comparison to the predicate's established performance, rather than a new clinical "test set" in the traditional sense for a novel device.
- Data provenance: Not explicitly stated. The comparison is against the "company's currently marketed CompuDent™ computer controlled syringe," which implies internal company data and existing market performance data for the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As this is not a study requiring medical image interpretation or complex diagnostic outcome assessment, there isn't a "ground truth" established by experts in this context. The "truth" is established by demonstrating that the device functions according to its design and industry standards, and is equivalent to the predicate.
4. Adjudication method for the test set
- Not applicable. There was no "test set" in the clinical trial sense that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is a mechanical syringe, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device, not a software algorithm, and it always functions with human-in-the-loop operation (a dentist or other medical professional).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is based on the established performance and safety of the legally marketed predicate device (CompuDent™ computer controlled syringe), combined with design verification and validation testing to ensure the new device meets its specifications and performs as intended. There isn't a specific "ground truth" from a medical outcome perspective for a substantial equivalence submission of this type of device.
8. The sample size for the training set
- Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
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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
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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.
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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
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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)
§ 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.