(105 days)
The SpiroSoft is a portable device and can be used by physicians in the office or hospital and in occupational medicine. The SpiroSoft measures inspiratory and expiratory lung function parameter in adults and children from 4 years on according to the ATS recommendations for diagnostic devices. Results are output graphicaly and numericaly on a screen and on an external printer. SpiroSoft saves all data in the internal memory for later retrieval or printout.
The SpiroSoft is a portable device and can be used by physicians in the office or hospital and in occupational medicine. The SpiroSoft measures inspiratory and expiratory lung function parameter in adults and children from 4 years on according to the ATS recommendations for diagnostic devices. Results are output graphicaly and numericaly on a screen and on an external printer. SpiroSoft saves all data in the internal memory for later retrieval or printout.
This document is a 510(k) premarket notification decision letter from the FDA for the SpiroSoft device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
Therefore, I cannot provide the requested information based on the text provided. Questions 1 through 9 cannot be answered.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2003
VIASYS Healthcare GmbH C/O Mr. Earl Draper Director Ouality Systems & Regulatory Affairs SensorMedics, Incorporated 22705 Savi Ranch Parkway Yorba Linda, California 92887-4645
Re: K031194
Trade/Device Name: SpiroSoft Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: BTY Dated: June 25, 2003 Received: June 30, 2003
Dear Mr. Draper:
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. Draper
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 Office of Compliance at (301) 594-4646. 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 Division 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/dsma/dsmamain.html
Sincerely yours,
Susan Runner, DDS, MA Interim 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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6031194 510(k) Number:
SPIROSOFT Device Name:
Indications For Use:
The SpiroSoft is a portable device and can be used by physicians in the office or hospital and in occupational medicine.
The SpiroSoft measures inspiratory and expiratory lung function parameter in adults and children from 4 years on according to the ATS recommendations for diagnostic devices.
Results are output graphicaly and numericaly on a screen and on an external printer. SpiroSoft saves all data in the internal memory for later retrieval or printout.
The following caution label appears on page 2 of the SpiroSoft Instruction Manual: "Federal U.S. law restricts this device to sale by or on the order of a physician."
April-03-2003 Dr. Jürgen Reinstädtler (Product Manager)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K031194 |
|---|---|
| ---------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).