CHROMA, MODEL: RZ153C

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for ScottCare. The logo consists of a stylized letter "S" with a heart shape incorporated into it, followed by the word "ScottCare" in a bold, sans-serif font. The logo is black and white. 510(K) SUMMARY K083382 ScottCare Corporation 4791 West 150th Street Cleveland, Ohio 44135 P 800.243.9412 F 216.267.6129 www.scottcare.com # AUG 1 8 2009 This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92 The assigned 510(k) number is _ | Date: | November 12, 2008 | |------------------------------------------|----------------------------------------------------------------------------------------------------------| | Submitted by: | ScottCare Corporation<br>Registration No: 1527715<br>4791 West 150th Street<br>Cleveland, OH 44135 | | Contact Person: | Mr. Timothy J. Leyva<br>216-362-0550 # 113<br>216-264-6129 Fax<br>tleyva@scottcare.com | | Manufacturing Site: | ScottCare Corporation<br>Registration No: 1063268<br>4897 W. Waters Ave, Suite J<br>Tampa, Florida 33634 | | Trade Name: | Chroma | | Common Name: | Digital Holter Recorder | | Classification: | 870.2800<br>Medical Magnetic Tape Recorder | | Product Code: | DSH | | Legally Marketed<br>Predicate Device(s): | DXP1000 Holter Recorder<br>K993618, November 24, 1999 | જુ 001 A Scott Fetzer, Berkshire Hathaway Company {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for ScottCare. The logo consists of a stylized letter 'S' with a heart incorporated into its design, followed by the word 'ScottCare' in a bold, sans-serif font. The overall design is clean and professional, suggesting a healthcare-related organization. ScottCare Corporation 4791 West 150th Street Cleveland, Ohio 44135 P 800.243.9412 F 216.267.6129 www.scottcare.com ## Device Description: The basic operation of the Chroma Holter Recorder RZ153C is to collect and store multiple channels of ECG data. The Holter scanner software reads this data and it can be printed out in tabular form or graphical form. This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. It can only display and store the data. The Holter for Windows software reads this data and provides ability to the user to review, edit and print the data collected. ### Indications for Use: The intended use of the Chroma Holter Recorder RZ153C is to perform ambulatory ECG on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording. Page 2 of 4 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for ScottCare. The logo consists of a stylized letter "S" on the left, followed by the word "ScottCare" in a bold, sans-serif font. The letter "S" is enclosed in a rectangular shape with a textured background. . : 1 ScottCare Corporation 4791 West 150th Street Cleveland, Ohio 44135 : P 800.243.9412 F 216.267.6129 www.scottcare.com ## Substantial Equivalence: | Features | ScottCare Chroma | Predicate Device<br>DXP1000 Holter Recorder | |-----------------------------------------|-------------------------------------|---------------------------------------------| | 510(k) Number | TBD | K993618 | | Date Cleared | TBD | November 24, 1999 | | Number of ECG Channels | 3 | 2 or 3 | | Sample Rate & Resolution | 128-1024Hz / 8,10 or 12 bit | 128-1024Hz / 8 or 10 bit | | Input Voltage Range | +/- 5mV | +/- 5mV | | Analog Bandwidth | 0.05 to 40 Hz | 0.05 to 60 Hz | | Pacemaker Detection &<br>Reporting | Yes | Yes | | Open-Lead Detection &<br>Reporting | Yes | Yes | | Recording Time | Unlimited, based on memory capacity | Up to 72 hours | | Memory Type | Removable flash memory (SD card) | Removable flash memory (CF card) | | Memory Capacity | Up to 2.0GB | Up to 2.0GB | | Data Transfer Method | Removable memory card or USB | Removable memory card | | Memory Card Data Format | Standard FAT format | Standard FAT format | | Display | 262k color OLED | Monochrome LCD | | Keypad | Protected membrane switch keys | Protected membrane switch keys | | Number of keys | 5 | 5 | | Battery | 1 - 1.5V AAA | 1 – 1.5V AA | | Features | ScottCare Chroma | Predicate Device<br>DXP1000 Holter Recorder | | Battery Check Prior to<br>Recording | Yes | Yes | | Internal Clock with Battery | Yes | Yes | | Clock Setting Functionality | Yes | Yes | | External Patient Cable | Yes | Yes | | Record identification procedure | Yes | Yes | | ECG channel preview | Yes | Yes | | Signal quality check prior<br>recording | Yes | Yes | | Multi-language support | Yes | Yes | | Autostart when ready | Yes | Yes | : Page 3 of 4 . . : : {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for ScottCare. The logo consists of a stylized letter "S" with a heart shape incorporated into it, followed by the word "ScottCare" in a bold, sans-serif font. The "S" is intricate and appears to be made of interwoven lines, while the text is clean and modern. ScottCare Corporation 4791 West 150th Street Cleveland, Ohio 44135 P 800.243.9412 F 216.267.6129 www.scottcare.com ## Testing Results Summary: Appropriate testing was conducted in accordance with established design control procedures. The Chroma Holter recorder RZ153C was tested alongside the DXP1000 Holter recorder in a number of situations, including simulated normal ECG signals, simulated paced ECG signals, and on-person ECG signals in laboratory tests. Data recorded by both devices were loaded analyzed in the Holter for Windows scanner software. In all tests, the Chroma Holter recorder produced results very similar to the DXP1000 Holter recorder. ## Conclusion: The Chroma Holter recorder RZ153C and the DXP1000 Holter recorder are both used in clinical applications to collect ambulatory electrocardiographic recordings that can be downloaded to the Holter for Windows® scanner software. The RZ153C conforms to Good Manufacturing Procedures outlined by the FDA cGMP. This recorder is safe and effective for the application for which it is intended and has been tested to confirm the safety and efficacy of the recorder. The RZ153C is found to be substantially equivalent to the DXP1000. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ### NOV 2 4 1999 Mr. David Norberg Regulatory Affairs Representative Braemar, Inc. 11481 Rupp Drive 55337 Burnsville, Minnesota K993618 Re: DXF1000 Holter Recorder Regulatory Class: II (two) Product Code: MWJ Dated: October 25, 1999 October 26, 1999 Received: Dear Mr. Norberg: We have reviewed your Section 510{k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in chousers, as legger 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {5}------------------------------------------------ #### Page 2 - Mr. David Norberg This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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, Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## DXP1000 Holter Recorder # 510(k) Number: K99 3618 Indications for Use: (No change from predicate device) The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently, the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment. Ambufatory (Holter) ECG intended use: The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below. 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3. Evaluation of patients for ST segment changes. 4. Evaluation of a patient's response after resuming occupational activities (e.g., after M.J. or cardiac surgery.) 5. Clinical and epidemiological research studies. 6. Evaluation of patients with pacemakers - 7. Reporting of time and frequency domain heart rate variability 8. Reporting of QT Interval V. Dealla Miller (Division Sign-Off) Division of Cardiovascular, Respirato and Neurological Devices Prescription Use (Per 21 CFR 801.109) {7}------------------------------------------------ Nov 2 4 1999 Section 2: 510(k) SUMMARY Substantially Equivalent (SE) To: � Biosensor Model #1005 510(k) # K950944 K993618 ### Modification Background The essence of this modification is a change of the digital Holter recorder hardware to a smaller configuration with reduced power consumption and the removal of ECG analysis capabilities from the device. In connection with this modification, the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein. As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956). The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device, as is demonstrated on the following pages. | Attribute | DXP1000 | Model #1005 | |---------------------------------|----------------------|-----------------------------| | Storage capacity | Up to 48 hours | 24 hours | | Memory type | Flash (non-volatile) | Flash (non-volatile) | | Memory portability | Non-removable | Non-removable | | On-board ECG analysis | No | Yes | | Liquid Crystal Display (LCD) | Yes | No | | Data transfer method | USB port | Bi-directional parallel I/O | | Pacemaker detection & reporting | Yes | Yes | | Belt clip | Yes | No | | Battery | One AA | Four AA | | Size | 11 x 7 x 2cm | 15 x 6 x 2 cm | | Weight | 135g | 140 g | #### Comparison To The SE Device: NOTE: Together with this Special 510(k), another Special 510(k) has been filed on a similar device (DigiTrakPlus) utilizing alternative hardware which is slightly smaller in size. Both devices incorporate the same fundamental scientific technology, and indeed a substantially identical electro-mechanical design. For clarity, the submitter wishes to note to the reviewer that these two devices are essentially the same other than the size and weight characteristics noted. {8}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002 AUG 13 2009 ScottCare Corporation c/o Mr. Timothy J. Leyva Regulatory/Quality Manager 4791 West 150th Street Cleveland, OH 44135 Re: K083382 Trade/Device Name: Chroma Holter Recorder RZ153C Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (Two). Product Code: MWJ Dated: August 3, 2009 Received: August 5, 2009 Dear Mr. Levva: 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. {9}------------------------------------------------ Page 2 - Mr. Timothy J. Leyva 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 (OS) 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: ScottCare Chroma (RZ153C) Indications for Use: The intended use of the Chroma Holter Recorder RZ153C is to perform ambulatory ECG on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording. Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|--| |--------------------------------------------------------|--| A. Philip B. Zuckerman (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Page 1 of 1 1-0.05