FETALGARD LITE-NIBP, MODEL FGL-NIBP

{0}------------------------------------------------ DEC 2 7 2005 K05.1903 page 1 of 4 ## 510(k) Summary For Analogic Corporation # FETALGARD Lite-NIBP ### Date this Summary was Prepared: 1. July 12, 2005 #### Submitter's Name and Address: 2. Analogic Corporation Submitter's Name: 8 Centennial Drive Address: Peabody, MA 01960 City, State, and Zip: Registration Number: 1219601 #### 3. Contact Person: | Name: | Janet R. Kwiatkowski | |------------|---------------------------| | Title: | Regulatory Affairs | | Telephone: | (978) 326-4186 | | Facsimile: | (978) 977-6808 | | E-mail: | Jkwiatkowski@analogic.com | #### Device Name: 4. | Proprietary or Trade Name: | FETALGARD Lite-NIBP | |------------------------------|---------------------------------------| | Common Name: | Fetal Monitor | | Model Name: | FGL-NIBP | | Classification Name: | Perinatal Monitoring System | | Classification Panel: | Obstetrical and Gynecological Devices | | Product Codes: | HGM, DXN | | Code of Federal Regulations: | 884.2740, 870.1130 | ### APPENI)IX D {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "K.051903", and the text below reads "page 2 of 4". The text appears to be part of a document or report, possibly indicating a page number or document identifier. Regulatory Classification of FETALGARD Lite-NIBP | Device Panel | CFR<br>Section | Product<br>Code | Device<br>Class | Description | |---------------------------------------------|----------------|-----------------|-----------------|-------------------------------------------------------| | Obstetrical and<br>Gynecological<br>Devices | 870.1025 | HGM | II | System, monitoring, perinatal | | Cardiovascular<br>Devices | 870.1130 | DXN | II | System, measurement, blood-<br>pressure, non-invasive | #### Predicate Devices: 5. The legally marketed devices to which equivalence is being claimed are: The FETALGARD Lite cleared under Premarket Notification K002503. This predicate device was chosen specifically for the fetal heart rate and uterine pressure indications. The C3 Patient Monitor cleared under Premarket Notification K030931. The applicable part of this predicate device is the non-invasive blood pressure module and heart rate (derived from NIBP) indications. #### Description of FETALGARD Lite-NIBP 6. The FETALGARD Lite-NIBP is a compact, lightweight device for measuring, processing, displaying, and printing information derived from four physiological measurements: - Fetal Heart Rate. Two types of ultrasound transducers can be used to monitor single or . twins fetal heart rate and display real-time on the LCD screen or permanently recorded on the optional printer. - Uterine Activity. Uterine pressure changes via a tocotonometer are used to monitor . uterine contractions. The waveforms are displayed real-time on the LCD screen or permanently recorded on the optional printer. - Maternal non-invasive blood pressure. Blood pressure is measured non-invasively (NIBP) . by the oscillometric method. - Maternal heart rate. The algorithm used to derive maternal heart rate is identical to the . derived heart rate parameter used in the C3 Patient Monitor when the NIBP module is the measurement source. A printer records fetal heart rate and tocotonometer waveforms, maternal non-invasive blood pressure value, and maternal heart rate value. The FETALGARD Lite-NIBP is powered by internal sealed lead-acid batteries or from the mains supply via an external battery eliminator. A fully charged battery will power the monitor for two hours minimum. {2}------------------------------------------------ K051903 page 3 of 4 #### Intended Use: 7. The FETALGARD Lite-NIBP is a Perinatal Monitoring System for non-invasively measuring THE LETALOTHED ERS THEF 10 a Lontractions, fetal heart rate, maternal non-invasive blood aller showing graphically means of display on a non-permanent graphical display pressure, and maternal near. This data is to aid in assessing the well-being of the fetus and mother during the final trimester of pregnancy (non-stress test). This device is for use only by trained medical personnel located in hospitals, clinics, doctors' offices, and patient's home. #### Comparison of Technological Characteristics: 8. The technological characteristics of the FETALGARD Lite-NIBP are the same as the legally marketed predicate devices. ### Non-clinical Tests to be used in Determination of Substantial Equivalence: 9. Prior to marketing the FETALGARD Lite-NIBP, verification testing activities will be r not to internetition the compliance, performance, and reliability characteristics of the FETALGARD Lite-NIBP. This is to include the following non-clinical tests: IEC 60601-1 (including Amendments 1 & 2), Medical Electrical Equipment - General Requirements for Safety IEC 60601-1-2: 2001 Medical electrical equipment - Electromagnetic compatibility emission limits meet Group 1 Class B IEC 60601-1-4: Medical electrical equipment – Part 1: General requirements for safety – 4. Collateral standard: Programmable electrical medical systems IEC 60601-1-8 Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical system IEC 60601-2-30 Medical electrical equipment – Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment IEC 60601-2-49 Medical electrical equipment – Particular requirements for the safety of multifunction patient monitoring equipment ANSI/AAMI SP10 Manual, Electronic, or Automated Sphygmomanometers Mechanical shock and vibration tests will be performed in accordance with IEC 60068 series of standards to ensure the device withstands shocks and vibrations in environment of intended usc. Shipping container transportation tests will be performed in accordance with ISTA; Project 2A to ensure packaging of equipment is not adversely affected during shipping. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text "K0519.03. page 4 of 4" in a handwritten style. The text appears to be a page number or document identifier. The handwriting is clear and legible, with a simple and straightforward style. Altitude tests will be performed to ensure that operation at higher altitudes does not adversely affect electrical safety or performance. Tests will be performed to verify enclosure material robustness and resistance to cleaning materials commonly used in hospitals. #### Conclusions from Non-clinical Testing: 10. The test schedule of the FETALGARD Lite-NIBP combined with "Information for The lest schedule of the PDFIL Of Clearance of Diagnostic Ultrasound Systems and Manufacturers," September 1997, Track 1 tests already performed demonstrate that the squirel Transducers, "September 1997, Track I tests and its is substantially equivalent to the performance of the PLTADSARD Lets Monitor predicate devices cited in Section 5 of this FETALOAND Lite and the CS Fatten Associety safety and effectiveness. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows a circular seal with an eagle in the center. The eagle is depicted in a stylized manner with three curved lines representing its body and wings. The seal is surrounded by text, which appears to be the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 7 2005 Ms. Janet R. Kwiatkowski Regulatory Affairs Specialist Analogic Corporation 8 Centennial Drive PEABODY MA 01960 K051903 Re: Trade/Device Name: FETALGARD Lite-NIBP Fetal Monitor Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Regulation Number: 21 CFR §870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II Product Code: DXN Dated: November 21, 2005 Received: December 5, 2005 Dear Ms. Kwiatkowski: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your events is substantially equivalent (for the indications for use stated in above and nave docemi... rarketed predicate devices marketed in interstate commerce prior to me cholosure) to regary maatdware of the Medical Device Amendments, or to devices that have been May 20, 1770, all cliavaniet 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 do not require upproval or a visions 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 (Premarket it your are to re reserved in ( to such additional controls. Existing major regulations affecting your Apploval), it the you be of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA device our of to read announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease or advisou that 127 rion 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 I cacal statues and regulation but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good nanufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Scetion 510(k) The status and the support of all and startial squivalence of your device to Jeg This letter will allow you to oegn mancellig your and all of your device to a legally premarket notification. The FDA thing of sacstination of 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), pleased If you desire specific advice for your device on our leaseling of the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation chilited, "finistian on your responsibilities under the Act from the 807.97). You may obtain other general monnance 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, Nancy C. Brigdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "ANALOGIC" in bold, black letters. The letters are sans-serif and appear to be a custom font. To the right of the word is a registered trademark symbol and a black square. ### Device Name: FETALGARD Lite-NIBP # Indications for Use Statement The FETALGARD Lite-NIBP is a Perinatal Monitoring System for non-invasively measuring and showing graphically abdominal contractions, fetal heart rate, maternal non-invasive blood and showing graptivally deachedly means of display on a non-permanent graphical display and pressure, and material neare is to aid in assessing the well-being of the fetus and mother optionally on a primester of pregnancy (non-stress test). This device is for use only by trained medical personnel located in hospitals, clinics, doctors' offices, and patient's home. Prescription Use X (Per 21 CFR 801 Subpart D) ND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) ----------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Ingram (Division Sign-Off) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number