RESPIFIT S, MODEL RS-LR1001004

K080299 · Eumedics Medizintechnik Und Marketing GmbH · BWF · Jan 13, 2009 · Anesthesiology

Device Facts

• Record ID: K080299
• Device Name: RESPIFIT S, MODEL RS-LR1001004
• Applicant: Eumedics Medizintechnik Und Marketing GmbH
• Product Code: BWF · Anesthesiology
• Decision Date: Jan 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 disease and cystic fibrosis in the hospital, clinic and home.

Device Story

Portable inspiratory muscle trainer; used in hospital, clinic, or home settings by patients. Device consists of patient module with aperture; user inhales against resistance to train respiratory muscles. Device electronically measures breathing parameters; provides visual feedback to user. Output includes measurements of endurance and tidal volume. Healthcare providers use output to monitor training progress; device facilitates muscle strengthening and endurance improvement for patients with neuromuscular disease or cystic fibrosis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Portable inspiratory muscle trainer; patient module with aperture for resistance-based breathing. Features electronic storage of breathing measurements and visual feedback display. Class II device (Product Code BWF).

Indications for Use

Indicated for adults and patients with neuromuscular disease and cystic fibrosis to improve inspiratory muscle strength and endurance via strength and endurance training.

Regulatory Classification

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.

Predicate Devices

• PFLEX RESPIRATORY MUSCLE EXERCISER (K842634)
• EXPIRATORY BREATHING EXERCISER (K945118)
• THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER (K870514)
• MICROLAB SPIROMETER (K031102)

Submission Summary (Full Text)

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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 [phone] [phone] January 30, 2008

David Levine, President, R1 Technologies LLC 1341 W. Fullerton, 103 Chicago, IL 60614 [phone] [phone] 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 RESPIRATORY<br>MUSCLE EXERCISER | Healthscan | K842634 |
| EXPIRATORY<br>BREATHING EXERCISER | DHD Diemolding<br>Healthcare | K945118 |
| THRESHOLD(TM)<br>INSPIRATORY MUSCLE<br>TRAINER | 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 [phone]. 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 [phone] or [phone] 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: