SPIRO-BALL

{0}------------------------------------------------ DEC 1 3 2005 K053149 # 510 (k) Summary of Safety and Effectiveness for Incentive Spirometer SPIRO-BALL - LEVENTON S.A. Submitter's name: 1. c/Newton 18-24, Poligono Industrial Sesrovires Address: 08635 Sant Esteve Sesrovires Barcelona (Spain) +34 93 817 63 00 Phone number: +34 93 817 63 01 Fax number: Mr. Joaquim Soriano (General Manager) Contact person: 12.09.05 Date: SPIRO-BALL Trade name: 2. Volumetric Incentive Spirometer, Volumetric Common names: Exerciser Incentive Spirometer (per 21 CFR 868.5690) Classification name: - Legally marketed device: DHD EMERALD PRODUCT (COACH 2) 3. K970596 510 (K) number: #### Description: 4. SPIRO-BALL is a Volumetric Incentive Spirometer. It is a nonsterile device, which operates by inspiration, that lifts the piston placed inside the chamber. - 5. Intended use: The SPIRO-BALL is a product for use in respiratory therapy and for adult people. It is intended for a single patient use, and it can be used both in the medical center and out of it (homecare therapies). {1}------------------------------------------------ ### Technological characteristics versus predicate device: 6. Both SPIRO-BALL and the legally marketed device have the same technological characteristics: - Equivalent product configuration (a cylindrical chamber which . Equivalorit production, the indicator element of the air flowrate and the inspiration tube). - the inopiration mechanism: the piston goes up when inspiring . Same operation moonanism a more accurate indication of the through the table rate. #### Non clinical tests: 7. Non-clinical tests have been performed in SPIRO-BALL to Non oliniour tooter complies the established specifications. These tests have been done on products in normal conditions of use, but also in products subjected to extreme conditions of use. #### 8. Clinical tests: Clinical tests have not been performed in SPIRO-BALL. #### Tests conclusions: 9. All the tests performed in SPIRO-BALL (bench tests and physical and biological assays) demonstrate this device operates correctly, is safe for the user and is effective according its intended use. {2}------------------------------------------------ Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services. Public Health Service DEC 1 3 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Leventon, S.A. C/O Mr. Stefan Preiss Responsible Third Party Official TÜV America, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112 Re: K053149 Trade/Device Name: SPIRO-BALL Regulation Number: 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: II Product Code: BWF Dated: November 28, 2005 Received: December 7, 2005 Dear Mr. Preiss: 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 releveloca doove and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to act result Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the rion ation , 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 (1 MA), it may be subject to back as a federal Regulations, Title 21, Parts 800 to 898. In your device our of fourther announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 -Mr. Preiss 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 moun mat 1 Dr may made statutes and regulations administered by other Federal agencies. or the Act of any I each s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and libiling (21 certh 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) I mis letter with use in 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), 11 you dontact 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 maj oveans of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, 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): K053149 SPIRO-BALL Device Name: Indications For Use: The Spiro-Ball is a product for use in respiratory therapy and for adult people. It is intended for a single patient use, and it can be used both in the medical center and out of it (homecare therapies). × 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) Cum mbtm (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device 510(k) Number Page 1 of __ 1 5.2