(265 days)
To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.
The Wand Plus™ 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 status indicators, including optional voice announcement, of injection rate, and volume of anesthetic dispensed.
This document describes a 510(k) submission for "The Wand Plus™ Syringe". The 510(k) summary (K992819) states that the device is "substantially equivalent" to the company's currently marketed "Wand™ computer controlled syringe." Generally, a 510(k) summary provides evidence of substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove they are met.
Given the information provided, a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth information are not applicable or not present in the provided 510(k) summary document. This document primarily focuses on establishing substantial equivalence to a predicate device, which often relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device.
Therefore, I cannot extract the requested information from the provided text.
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MAY 1 1 2000
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510(k) Summary
Daniel J. Manelli Submitted by: Farkas & Manelli, P.L.L.C. 2000 M Street NW (Suite 700) Washington, DC 20036
On behalf of Spintech, Inc. 220 South Orange Avenue Livingston, NJ 07039
510(k) Submission: The Wand Plus™ Syringe Date: December 10th, 1999
The Wand Plus™ is a computer controlled syringe consisting of Description: 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 status indicators, including optional voice announcement, of injection rate, and volume of anesthetic dispensed. It is substantially equivalent to the company's currently marketed Wand™ computer controlled syringe.
Indications for use:
To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
MAY 11 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spintech, Incorporated C/O Mr. Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M street, N.W., Suite 700 Washington, DC 20036
Re : K992819 Trade Name: Wand Plus Regulatory Class: II Product Code: EJI April 4, 2000 Dated: Received: April 4, 2000
Dear Mr. Manelli
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 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 (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: a 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 seations 531 through 542 of
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Page 2 - Mr. Manelli
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 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 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 premarket notification" (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.fde.gov/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
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Page
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
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 (ODE)
Suon Runoe
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
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.