(343 days)
The Respifit S is indicated for use as a training device used for conducting strength and endurance training by breathing into a patient module that contains an aperture. The purpose of this training is to improve inspiratory muscle strength and endurance. Training with the Respifit S can be performed in adults and patients with neuromuscular disease and cystic fibrosis in the hospital, clinic and home.
The Respifit S is a portable device for training the respiratory muscles for strength and endurance.
The provided text is a 510(k) summary for a medical device called "Respifit S," an inspiratory muscle trainer. It does not contain a study section describing acceptance criteria or performance data as one would typically find in a detailed study report. The document is primarily focused on establishing substantial equivalence to predicate devices for regulatory approval.
Therefore, for aspects of your request such as "acceptance criteria," "reported device performance," "sample size," "ground truth," "MRMC study," or "standalone study," the information is not available in the provided text. The document only states: "All tests were verified to meet the required acceptance criteria." Without further detail, it's impossible to elaborate on those points.
Here's a breakdown of what can be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The document states "All tests were verified to meet the required acceptance criteria" but does not specify what those criteria were or detail the performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document mentions "tests" but provides no details about sample sizes, data provenance, or study design.
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)
This information is not available in the provided text. There is no mention of an "expert" review or ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. There is no mention of adjudication methods.
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
This information is not available in the provided text. The Respifit S is described as an "Inspiratory Muscle Trainer" and a "Spirometer," not an AI-assisted diagnostic tool involving human "readers." The document does not describe any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available in the provided text. The device is a physical inspiratory muscle trainer, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not available in the provided text. There is no mention of ground truth types for any testing.
8. The sample size for the training set
This information is not available in the provided text. There is no mention of a "training set" as this device is not an AI/machine learning model.
9. How the ground truth for the training set was established
This information is not available in the provided text. As there is no training set mentioned, there is no explanation of how ground truth was established for it.
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510(k) Summary
[As required by 21 CFR 807.87(h)]
JAN 1 3 2009
Identification of Submitter
Submitter
. .
Telephone No: Fax Date of Preparation
Official Contact Person,
Eumedics Medizintechnik und Marketing GmbH Linzer Strasse 45, Purkersdorf, Austria A3002 +43 2231 643 10 0 +43 2231 643 10 33 January 30, 2008
David Levine, President, R1 Technologies LLC 1341 W. Fullerton, 103 Chicago, IL 60614 +1 773 517 9386 +1 773 913 2448 dave(@r1technologies.com
Telephone No: Fax No: . Email:
Identification of the Product
Device Proprietary Name: Common Name: Classification Name:
Respifit S Inspiratory Muscle Trainer Spirometer, Therapeutic (incentive)
Marketed Devices to Which Equivalence is Claimed
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| PFLEX RESPIRATORYMUSCLE EXERCISER | Healthscan | K842634 |
| EXPIRATORYBREATHING EXERCISER | DHD DiemoldingHealthcare | K945118 |
| THRESHOLD(TM)INSPIRATORY MUSCLETRAINER | Health Products, Inc. | K870514 |
| MICROLAB SPIROMETER | Micro-Direct, Inc | K031102 |
The Respifit S is a portable device for training the respiratory muscles for strength and endurance.
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Indications for Use
- The Respifit S is indicated for use as a training device and is used for a. conducting strength and endurance training by inhaling into a patient module. The purpose of this training is to improve inspiratory muscle strength and endurance.
- The training can be performed in adults and patients with neuromuscular b. disease and cystic fibrosis in the hospital, clinic and home.
Comparison with Predicate Devices
The Respifit S device is a device that is equivalent to the other inspiratory muscle training devices(K842634, K945118, K870514) in that the patient breathes into a mouthpiece against a resistance. The Respifit S also can store electronically breathing measurements and provide visual feedback in a manner similar to the Microlab Spirometer(K031102) from Micro-Direct. The Respifit S device also provides a measurement of endurance depicted as a form of tidal volume. The Microlab Spirometer (K031102) provides a measurement for tidal volume and endurance training is conducted with the other inspiratory muscle training devices(K842634, K945118, K870514) devices, however these devices do not provide measurable outputs. All tests were verified to meet the required acceptance criteria. In summary, the device described in this submission is substantially equivalent to the predicate devices for the reasons mentioned in this section and the submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized eagle emblem, with its wings forming three distinct segments. The eagle faces to the left.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eumedics Medizintechnik und Marketing GmbH C/O Mr. Dave Levine President R1 Technologies L.L.C. 1341 West Fullerton, Suite 103 Chicago, Illinois 60614
JAN 1 3 2009
Re: K080299
Trade/Device Name: Respifit S Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: II Product Code: BWF Dated: January 8, 2009 Received: January 9, 2009
Dear Mr. Levine:
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 Federal Register.
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Page 2 - Mr. Levine
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Andover, 29, 1906
Ginette Y. Michaud, M.D. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K080299
Device Name: Respifit S
Indications for Use: ·
The Respifit S is indicated for use as a training device used for conducting strength and endurance training by breathing into a patient module that contains an aperture. The purpose of this training is to improve inspiratory muscle strength and endurance. Training with the Respifit S can be performed in adults and patients with neuromuscular disease and cystic fibrosis in the hospital, clinic and home.
Division Sign-Off
510(k) Number:
Prescription Use X AND/OR
Over-The Counter Use
(per 21 CFR 801 : 109 Subpart C)
(per 21 CFR 801.109 Subpart D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antun Vimin Mar An93
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K4802999 510(k) Number:
§ 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).