ANS1 SOFTWARE

{0}------------------------------------------------ ## MAY 2 2 2014 K140412 Page 1 of 3 ## Special 510(k) Summary ANS 1 Software ## This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92 1. Device Trade Name of the device: ANS 1 Software Device Common name: ANS Data management software Regulation number: 21CFR 8701130: Non Invasive Blood pressure measurement system, Class II 21 CFR 870 2700: Oximeter, Class II 21 CFR 882 1540: Galvanic Skin responses device Class II 21 CFR 870 2770: Analyzer Body Composition Class II 21 CFR 862 2100: Calculator/data processing module for clinical use, Class I Product Codes: DXN, DQA, GZO and MNW Classification: Class II Classification Panel: Cardiology/Neurology #### 2. Submitter's Identification: Manufacturer: L.D TECHNOLOGY LLC CEO of LD Technology: Albert MAAREK Address: L.D Technology 100 N.Biscayne Blvd. Suite 502 Miami, FL, 33132, USA Tel: 305-379-9900 Fax: 305 397 1115 Email: albert.ldteck@gmail.com #### 3. Predicate legally marketed (unmodified) device Trade name: ES Complex Software 510K number K113264 Applicant and Manufacturer: LD TECHNOLOGY LLC (Same as new device) Product codes: DXN, QDA, GZO and MNW #### 3. Intended use ANS 1 Software is an optional software accessory for use with the following models with data management capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer). When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1 software uploads the data of the devices, analyzes the data, and then displays the data in a computer for enhanced data management. The ANS 1 software is intended for use in clinical settings as an aid for health care professionals to review, analyze, and evaluate the historical tests results. The device provides values. It is the physician responsibility to make proper judgment based on these numbers. {1}------------------------------------------------ The ANS 1 software data are stored in back up files located on the PC. The software is intended for use only with adult subjects. Prescription Use: Federal law restricts this device to sale by or on the order of a physician. ## 4. Device Description and Comparison Devices' comparison Table AN1 / ES Complex . | Name device (510k<br>number) | ANS1 Software | ES Complex Software K113264 | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | ANS1 Software is an optional software<br>accessory for use with the following models<br>with data management capabilities: a) TM-Oxi<br>(Oximeter and blood pressure device) and b)<br>SudoPath (Galvanic Skin response) and c) ES-<br>BC (Body Composition Analyzer)<br>When used in combination with TM-Oxi and/or<br>SudoPath, and/or ES-BC devices, the ANS1<br>software uploads the data of the devices,<br>analyzes the data, and then displays the data<br>in a computer for enhanced data management.<br>The ANS1 software is intended for use in<br>clinical settings as an aid for health care<br>professionals to review, analyze, and evaluate<br>the historical tests results. | ES Complex Software is an optional software<br>accessory for use with the following models with<br>data management capabilities: a) Contec 08A,<br>blood pressure device b) ESO, oximeter c) EIS-GS,<br>galvanic skin response device and d) ES-BC.<br>Analyzer body composition<br>When used in combination Contec 08A and ESO,<br>and/or EIS-GS and/or ES-BC, the ES Complex<br>software uploads the data of the devices,<br>analyzes the ESO and Contec08A data and then,<br>displays the data into a computer for enhanced<br>data management.<br>The ES Complex software is intended for use in<br>clinical settings as an aid for health care<br>professionals to review, analyze, and evaluate the<br>historical tests results. | | Results/Performances | | | | Data management | YES | YES | | Historical test results | YES | YES | | Operating system | Windows | Windows | | Results screen | PC | PC | | Displayed data | SpO2%, HRV analysis, photoelectrical<br>Plethysmography analysis, conductance values<br>body composition and Blood pressure. | SpO2%, HRV analysis, photoelectrical<br>Plethysmography analysis, conductance values<br>body composition and Blood pressure. | | Data acquisition | Direct acquisition and/or upload from the device | Direct acquisition and/or upload from the device | | Data analysis | Memory | Memory | | Data analysis | YES | YES | | Indication for use | clinical settings | Clinical settings | ## 5. Type of device ANS 1 is a software for data management ## 6. Software Specifications - Hardware platform: Laptop or PC based workstation (Intel architecture) . {2}------------------------------------------------ #### K140412 Παγε 3 οφ 3 - Operating system: Windows 7/8 . - Use of Off-the-Shelf software: Windows 7/8 and PDF . - . Language: C++ - Microsoft Visual C++ compiler requirements: 2 GB free space . - Program size requirements 27Mb . #### 7. Comparison with the legally marketed (unmodified) device: The submission is complying with the Items required under §807.87 Similarities: The modified device ANS1 Software has the following similarities to ES complex Software which has previously received 510(k) clearance: - Has the same intended use . - . Upload and manage the same data - Do not affect the Fundamental Scientific Technology . - Do not change the prescription for use ● #### Modifications: Trade name: Change of the Trade name of the device Software: Data management come from different cleared devices. Labeling: Label was modified with the new trade name of the device (ANSI to replace ES Complex) Instructions for Use were modified according to the new cleared devices associated with the software. #### 8. Special 510k requirements The modified device ANS 1 software is complying with the Items required under §807.87 for a special 510k submission. #### 9. Performances and Effectiveness - 1. New risk management - 2. Software verification (SRS/SDS/STD/STR) - 3. Summary of Design Control Activities and Declaration of Design control conformity #### 10. General Safety Concerns The fact to use the data from different cleared devices not affects the general safety concerns #### Conclusions The ANS 1Software is equivalent in performance, technology, safety and efficacy to the legally marketed (unmodified) predicate device ES Complex Software. #### Signature: ## Albert MAAREK Here is the JSON requested: {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human figure with outstretched arms, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. **Foo** Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-002 Public Health Service May 22, 2014 LD Technology, LLC c/o Mr. Albert Maarek President 100 Biscayne Blvd Suite 502 Miami, FL 33132 US Re: K140412 > Trade/Device Name: ANS1 Software Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DQA, GZO Dated: April 22, 2014 Received: April 25, 2014 Dear Mr. Albert Maarek: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {4}------------------------------------------------ #### Page 2 - Mr. Albert Maarek 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htmfor the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Image /page/4/Picture/5 description: The image shows a logo with the letters FDA. The letters are stylized and appear to be hand-drawn. The logo is black and white and has a rough, textured appearance. The letters are surrounded by a border of lines and shapes. forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ # K140412 ## Indications for Use 510(k) Number: 140412 Device Name: ANSI Software Indications for Use: ANS I Software is an optional software accessory for use with the following models with data management capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer) When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS I software uploads the data of the devices, analyzes the data, and then displays the data in a computer for enhanced data management. The ANS I software is intended for use in clinical settings as an aid for health care professionals to review, analyze, and evaluate the historical tests results. The device provides values. It is the physician responsibility to make proper judgment based on these numbers. The ANS 1 software data are stored in back up files located on the PC. The software is intended for use only with adult subjects. Prescription Use X RIP/OR (C (21-CFD-001-G-1-C) (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C) Over-The-Counter Use (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED #### Concurrence of CDRH, Office of Device Evaluation (ODE) Image /page/5/Picture/17 description: The image shows a stamp with the text "FDA" and a signature. The date and time "2014.05.22 15:05:09 -04'00" are also present. The stamp appears to be official, possibly indicating approval or verification by the Food and Drug Administration.