(33 days)
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).
SPIRO-BALL is a Volumetric Incentive Spirometer. It is a nonsterile device, which operates by inspiration, that lifts the piston placed inside the chamber.
The provided text is a 510(k) summary for the SPIRO-BALL Incentive Spirometer. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a study detailing device performance against such criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. I also cannot describe the sample sizes, data provenance, expert ground truth details, adjudication methods, MRMC study results, or training set information because these details are not present in the provided text.
Here's what I can extract and what is explicitly stated:
1. A table of acceptance criteria and the reported device performance:
- Not provided in the document. The document states: "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." However, the specific established specifications (acceptance criteria) and the results of these tests (reported device performance) are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the document. The document mentions "non-clinical tests" but does not specify sample sizes or data provenance.
- Clinical tests: The document explicitly states: "Clinical tests have not been performed in SPIRO-BALL."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No clinical tests were performed, and no external ground truth establishment is described for the non-clinical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical tests or expert review processes are described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is an incentive spirometer, not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" would be the "established specifications." The document doesn't detail how these specifications were derived or what specific metrics were used.
8. The sample size for the training set:
- Not applicable. No machine learning model or "training set" is relevant to this device's regulatory submission.
9. How the ground truth for the training set was established:
- Not applicable. No machine learning model or "training set" is relevant to this device's regulatory submission.
Summary of available information regarding compliance:
The device's "acceptance criteria" appear to be its "established specifications" as assessed by "Non-clinical tests." The document states: "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." This is the general conclusion, but specific performance metrics are not provided. The basis for clearance is substantial equivalence to a predicate device (DHD EMERALD PRODUCT (COACH 2) K970596), suggesting that its performance is expected to be similar to that legally marketed device.
{0}------------------------------------------------
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.
{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
§ 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).