(323 days)
Not Found
No
The description focuses on a computer-controlled syringe with a motor and foot switch for regulating flow rate, and explicitly states the principle of operation is the same as other marketed piston and cartridge syringes. There is no mention of AI, ML, or any learning or adaptive capabilities.
Yes
The device is used for the "injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block," which is a therapeutic intervention.
No
Explanation: The device is used for injecting lidocaine, an anesthetic, for infiltration and nerve block. It is a drug delivery device, not a diagnostic one. Its function is to administer a substance, not to detect or analyze a medical condition.
No
The device description clearly outlines multiple hardware components including a motor housing, metal piston, foot switch, hypodermic needles, carpules, vinyl tubing, handpiece, and holster. It is a physical device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a system for controlled injection of anesthetic. This aligns with a therapeutic or procedural device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is to deliver medication, which is a therapeutic action.
N/A
Intended Use / Indications for Use
For injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block.
Product codes
FMF
Device Description
The Wand™ 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.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
JUN - 6 2000
Summary of Safety and Effectiveness
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™ Syringe Date: May 25, 2000
Description:
The Wand™ 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 is substantially equivalent to the Wand™ (Spintech, K961648); the Shifa syringe (Alshifa Medical; K962614); and the CCS Computer Controlled Syringe (CATCO; K983105).
Indications for use:
For injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block.
1
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which are meant to represent the human form.
JUN - 6 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 NW, Suite 700 Washington, DC 20036
Re : K992404 Trade Name: The Wand Regulatory Class: II Product Code: FMF Dated: May 1, 2000 Received: May 2, 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 aqainst 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 Requlations, 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 requlation may result in requlatory 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Manelli
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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
for Susan Runser
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
510(k) Number (if known): _______K992404
Device Name: The Wand™ Computer Controlled Anesthetic Delivery System
Indications for Use:
For injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Patroca Cucenete
Histon 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)