(33 days)
Not Found
No
The summary describes a purely mechanical device (volumetric incentive spirometer) and makes no mention of AI, ML, or any computational processing.
Yes
The device is explicitly stated to be "for use in respiratory therapy" and operates as a "Volumetric Incentive Spirometer," which is a common therapeutic device used to improve lung function.
No
Explanation: The device description states it is a "Volumetric Incentive Spirometer" used for "respiratory therapy," and it operates by inspiration to lift a piston. This indicates it is a therapeutic device for lung exercise, not for diagnosing conditions.
No
The device description explicitly states it is a "Volumetric Incentive Spirometer" which operates by inspiration lifting a piston inside a chamber, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "respiratory therapy" and operates by "inspiration." This is a therapeutic device used to help patients improve lung function, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: It's described as a "Volumetric Incentive Spirometer" that operates by the patient's inspiration. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
In summary, the Spiro-Ball is a therapeutic device used to aid in respiratory recovery, not a diagnostic device used to test samples for medical information.
N/A
Intended Use / 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).
Product codes
BWF
Device Description
SPIRO-BALL is a Volumetric Incentive Spirometer. It is a nonsterile device, which operates by inspiration, that lifts the piston placed inside the chamber.
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
adult people
Intended User / Care Setting
medical center and out of it (homecare therapies)
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
Non-clinical tests have been performed in SPIRO-BALL to confirm that the device 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.
Clinical tests have not been performed in SPIRO-BALL.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).
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DEC 1 3 2005
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.
-
- 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).
- Intended use:
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.
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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.
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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
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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
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