CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01

K983105 · Dentsply Midwest · EJI · Mar 8, 1999 · Dental

Device Facts

• Record ID: K983105
• Device Name: CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01
• Applicant: Dentsply Midwest
• Product Code: EJI · Dental
• Decision Date: Mar 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for the injection of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with, dental procedures.

Device Story

CCS Computer Controlled Syringe (Model CCS-100) is a programmable electronic device for delivering local anesthetics packaged in cartridges. System comprises a programmable control unit and a handpiece with integrated switches for actuation. Single-use cartridge holders (Model CCS-100-01) facilitate universal injection techniques. Used in dental clinical settings by dental professionals to administer anesthesia. Device provides controlled delivery of anesthetic agents, potentially improving injection precision and patient comfort during dental procedures.

Clinical Evidence

No clinical data provided; performance data referenced in the 510(k) submission.

Technological Characteristics

Programmable electronic control unit; handpiece with manual switches; single-use cartridge holders. Non-sterile. Class II device (21 CFR 872.6770).

Indications for Use

Indicated for patients requiring local anesthesia via infiltration or nerve block for dental procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• The Wand (K961648)

Submission Summary (Full Text)

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K98 3105

## 9.0 Summary of Safety and Effectiveness

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA, 1990.

| Submitted by: | CCS Inc.<br>5 Oxford Street West, London, Ontario, Canada. N6H 1R1<br>Phone [phone] Fax [phone] | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Prepared by: | CATCO:Competitive Advantage Tools Company<br>2288 Yorktown Circle, Mississauga, Ontario, Canada. L5M 5Y2<br>Phone [phone] Fax [phone]<br>Steve Long, President | |
| Date: | August 31, 1998 | |
| Trade Name: | CCS Computer Controlled Syringe<br>CCS Cartridge Holder | (Model CCS-100)<br>(Model CCS-100-01) |
| Classification: | Class II. 21 CFR 872.6770 | |
| Predicate Device: | The Wand (K961648) | |
| Device Description: | The CCS computer controlled syringe is a programmable electronic<br>device that allows the injection of local anesthetics commercially<br>available and packaged in cartridge form. The device consists of a<br>programmable control unit, and a handpiece with switches that actuate<br>the function of the device as programmed. Single use, replacement<br>cartridge holders are available to facilitate universal injection technique. | |
| Intended Use: | Indicated for the injection of local anesthetics for infiltration and nerve<br>block anesthesia administered prior to, or in conjunction with, dental<br>procedures. | |
| Sterility: | The described devices are non-sterile. | |
| Performance Data: | Performance data is presented in the 510(k) submission. | |

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings and a human profile in the negative space below the wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 1999

Computer Controlled Syringe, Incorporated C/O Mr. Steve Long President CATCO:Competitive Advantage Tools Company 2288 Yorktown Circle Mississauga, Ontario, CANADA L5M5Y2

Re : K983105 CCS; Computer Controlled Syringe, Model Trade Name: #CCS-100, CCS; Cartridge Holder, Model #CCS-100-01 Regulatory Class: II Product Code: EJI February 18, 1999 Dated: February 22, 1999 Received:

Dear Mr. Long:

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. ਸ 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Long

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.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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510(k) Number (if known): K983105
Device Name: CCS

Indications For Use:

The CCS Computer Controlled Syringe is an electronic programmable device indicated The OCS Computer Controller of the infiltration and nerve block anesthesia for the injocular of lead an conjunction with, dental procedures

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runser

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number . 3100

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)