CARE-E-VAC 3

{0}------------------------------------------------ K062610 # 510(k) Summary of Safety and Effectiveness | Date: | June 5, 2006 | SEP 2 8 2006 | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Submitter: | Ohio Medical Corporation<br>1111 Lakeside Drive<br>Gurnee, IL 60031 | | | Contact Person: | Hoby Chae<br>Director of Engineering & Quality<br>Ohio Medical Corporation<br>847-855-6272<br>847-855-6304 (fax) | | | Device: | Trade Name: | care-e-vac 3 | | Common/Usual Name: | Portable medical suction device | | | Classification Names: | | | | CFR Reference: | 21CFR878.4780 | | | Classification Name: | Pump, Portable, Aspiration | | | Product Code: | BTA | | | Predicate Device: | K926566 - Care-E-Vac II | | | Device Description: | The device uses conventional technology to provide medical suction.<br>The mechanical portion of the aspirator consists of an electrically driven<br>pump to provide suction, a gauge to indicate the suction level and a<br>regulator to control the suction level. | | | Intended Use: | The device is a portable aspirator which uses suction as a means to<br>withdraw fluids or foreign bodies from a patient. The primary intended<br>use of the care-e-vac 3 is as an aspirator to be used to help evacuate<br>saliva, mucous, vomitous or other aspirant from the mouth and or<br>airway to allow adequate respiration or ventilation of the patient. | | | Technology: | The care-e-vac 3 employs the same functional technology as the<br>predicate device. | | | Test Summary: | The care-e-vac 3 complies with the voluntary standards as detailed in<br>Section 9 of this submission. | | | Conclusion: | The results of these measurements demonstrated that the care-e-vac 3<br>is as safe, as effective, and performs as well as the predicate device. | | {1}------------------------------------------------ ## Section 3 Proposed Labeling ## 3.1 Intended Use The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the care-e-vac 3 is as an aspirator to be used to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient. The intended use has not changed as a result of changes to the care-e-vac 3. ## 3.2 Proposed Operating Instructions Refer to Appendix A for a copy of changes made to the care-e-vac 3 Operator's Manual due to the device modifications contained in this release. ## 3.3 Promotional Material / Specification Sheet A draft promotional brochure / specification sheet for the care-e-vac 3 can be found in Appendix B. ## 3.4 Device and Package Labeling Draft device and package labeling for the care-e-vac 3 can be found in Appendix E. #### Reference the following documents: | | Appendix | |--------------------------------------------|----------| | Operating Instructions | A | | Promotional Brochure / Specification Sheet | B | | Label - Example | E | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 8 2006 Mr. Hoby Chae Director of Engineering and Quality Ohio Medical Corporation 1111 Lakeside Drive Gurnee, Illinois 60031 Re: K062610 Trade/Device Name: CARE-E-VAC 3 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II · Product Code: BTA Dated: August 30, 2006 Received: September 5, 2006 Dear Mr. Chae: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register. {3}------------------------------------------------ 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 (QS) 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) 276-0120. 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, Syndie Y. Michael Davis 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): TBD Device Name: care-e-vac 3 Indications For Use: The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the caree-vac 3 is as an aspirator to be used to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ...sion Sign-Off) sion of Anesthesiology, General Hospital, Distol Devices ion of Anesthoundains of Devices Page 1 of 21