(110 days)
Not Found
No
The summary describes a standard lung function measurement system with software for data acquisition and analysis, including quality checks and reanalysis capabilities. There is no mention of AI, ML, or related concepts.
No.
The document describes a diagnostic device used to measure lung function (airway resistance, lung volume, breathing patterns) rather than to treat a condition.
Yes
The device measures physiological parameters (airway resistance, absolute lung volume, and tidal breathing patterns) to assess lung function in infants, which falls under the definition of a diagnostic device used to identify medical conditions or provide information for diagnosis.
No
The device description explicitly states it is a "neonatal lung function measurement system that utilizes a bodyplethysmograph" and is a "local moveable device". It also mentions being "equipped with a computer and the Baby-Bodyplethysmography program". This indicates the device includes hardware components (the bodyplethysmograph and a computer) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- Device Function: The MS PAED - BABY BODY is a lung function measurement system. It directly measures physiological parameters (airway resistance, lung volume, breathing patterns) from the patient's body using a bodyplethysmograph. It does not analyze biological specimens.
- Intended Use: The intended use is to measure lung function in babies and premature infants, providing information about their respiratory status. This is a direct physiological measurement, not an in vitro analysis of a sample.
Therefore, the MS PAED - BABY BODY falls under the category of a medical device used for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MS PAED – BABY BODY is a neonatal lung function measurement system that utilizes a bodyplethysmograph. It is intended to be used under the direction of a physician. MS PAED - BABY BODY may be used in the clinic, doctors office, or hospital. Patient population that may benefit from the use of this device include only babies and premature infants.
The MS PAED - BABY BODY, or any of the accessories supplied with it, is not to be used, alone or in combination, as a life support device, a life support system, or as a critical component in a life support device or life support system.
Product codes
CCM
Device Description
The MS PAED - BABY BODY is a local moveable device for the determination of airway resistance, absolute lung volume at FRC and tidal breathing patterns of babies and infants. Equipped with a computer and the Baby-Bodyplethysmography program the software is extremely easy to use, allows you to very quickly make several measurements and tolerates less experienced operators. The operator is to be guided through the program.
The built in quality checks of the program prompt the user about a bad performed manoeuvre or an unacceptably low quality of the measurement.
The body plethysmography measurement is provided with a reanalysis mode, which means that the physician can modify all data whenever required thereby eliminating the need for patients to return for additional measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
babies and premature infants
Intended User / Care Setting
under the direction of a physician. MS PAED - BABY BODY may be used in the clinic, doctors office, or hospital.
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
Performance testing was conducted in the laboratory to confirm compliance to device specifications; all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies.
Testing to internationally accepted standards for electrical safety and electromagnetic compatibility were performed; the MS PAED - BABY BODY complied with the requirements of these standards.
Key Metrics
Not Found
Predicate Device(s)
INFANT BODY TEST (K853390)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1750 Pressure plethysmograph.
(a)
Identification. A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.(b)
Classification. Class II (performance standards).
0
02 37096
Summary of Safety and Effectiveness
MAR 0 3 2003
Date of Preparation: October 29, 2002
- Erich Jaeger GmbH Submitter: Leibnizstasse 7 D-97204 Hoecherg Germany
- Earl Draper Contact: SensorMedics Corp. Phone: (714) 283 2228 extension 8461 Fax: (714) 283 8426
Alternate (Germany) Elmar Niedermeyer Erich Jaeger GmbH Phone: 01149 931 4972-361 Fax: 01149 931 4972-62361
Device Trade Name: MS PAED – BABY BODY
Device Common/Classification Name: The MS PAED – BABY BODY is an Erich Jaeger GmbH device classified under 73 CCM, "Plethysmograph, Pressure", per Regulation No. 868.1750.
Predicate Device: INFANT BODY TEST (K853390)
Intended Use:
The MS PAED – BABY BODY is a neonatal lung function measurement system that utilizes a bodyplethysmograph. It is intended to be used under the direction of a physician. MS PAED - BABY BODY may be used in the clinic, doctors office, or hospital. Patient population that may benefit from the use of this device include only babies and premature infants.
The MS PAED - BABY BODY, or any of the accessories supplied with it, is not to be used, alone or in combination, as a life support device, a life support system, or as a critical component in a life support device or life support system.
Devise Description:
The MS PAED - BABY BODY is a local moveable device for the determination of airway resistance, absolute lung volume at FRC and tidal breathing patterns of babies and infants. Equipped with a computer and the Baby-Bodyplethysmography program the software is extremely easy to use, allows you to very quickly make several measurements and tolerates less experienced operators. The operator is to be guided through the program.
The built in quality checks of the program prompt the user about a bad performed manoeuvre or an unacceptably low quality of the measurement.
1
The body plethysmography measurement is provided with a reanalysis mode, which means that the physician can modify all data whenever required thereby eliminating the need for patients to return for additional measurements.
Comparison to Predicate Device:
The MS PAED - BABY BODY is similar to the Jaeger INFANT BODY TEST as follows: it transduces physiological signals into electrical signals. Also, the recorded data is analyzed and presented graphically and numerically. Both devices record the same physiological parameters relevant to pulmonary disease.
Summary of Performance Testing:
Performance testing was conducted in the laboratory to confirm compliance to device specifications; all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies.
Testing to internationally accepted standards for electrical safety and electromagnetic compatibility were performed; the MS PAED - BABY BODY complied with the requirements of these standards.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 3 2003
Erich Jaeger GmbH C/O Mr. Earl Draper SensorMedics, Incorporated 22705 Savi Ranch Parkway Yorba Linda, California 92887-4645
Re: K023796
Trade/Device Name: MS PAED-Baby Body Regulation Number: 868.1750 Regulation Name: Pressure Plethysmograph Regulatory Class: II Product Code: CCM Dated: February 18, 2003 Received: February 21, 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.
3
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 vours.
Susan Punnen
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
4
K02379K 510(k) Number:
MS PAED - BABY BODY Device Name:
Indications For Use:
The MS PAED - BABY BODY is a neonatal lung function measurement system that utilizes a bodyplethysmograph. It is intended to be used under the direction of a physician. MS PAED - BABY BODY may be used in the clinic, doctors office, or hospital. Patient population that may benefit from the use of this device include only babies and premature infants.
The MS PAED – BABY BODY, or any of the accessories supplied with it, is not to be used, alone or in combination, as a life support device, a life support system, or as a critical component in a life support device or life support system.
(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,
Infestion Control, Dental DevicesInfection Control, Dental Devices
510(k) Number ._______________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)