CARDIOSCOPE

{0}------------------------------------------------ ## 510 (k) Summary K121266 ps 1094 | Date Prepared: | November 28, 2012 | | |------------------------|-----------------------------------------------|-------------| | Sponsor Information: | Pulsecor Limited | DEC 11 2012 | | | Level 2, 135 Morrin Road | | | | Auckland 1072, New Zealand | | | Sponsor Contact: | Andrew Lowe | | | | Telephone: 64 (9) 280 3504 | | | | Fax: 64 (9) 280 3505 | | | Device Name: | CardioScope™ | | | Common/Usual Name: | NIBP | | | Classification Name: | Noninvasive Blood Pressure Measurement System | | | Regulation Number: | 21 CFR 870.1130 | | | Product Code: | DXN | | | Device Classification: | Class II | | | Review Panel: | Division of Cardiovascular Devices | | ## Predicate Devices | | Predicate Devices | | |------------------------------------|--------------------------------------------------------------------------|---------------| | Manufacturer | Brand Name | 510(k) Number | | HealthSTATS International Pte Ltd. | A-PULSE CASPro and A-PULSE CASPal Monitors | K101002 | | AtCor Medical Pty Ltd. | SphygmoCor Px | K012487 | | I.E.M. GmbH | Mobil-O-Graph 24h PWA and Hypertension Management Software Client Server | K110603 | {1}------------------------------------------------ # 510 (k) Sum ### 2. 3. 4. ## Product Description The CardioScope™ is a compact standalone measurement device that incorporates a SP10 compliant conventional oscillometric blood pressure module using a brachial cuff on the upper arm. The CardioScope first measures brachial systolic and diastolic blood pressures and pulse rate using the Oscillometric method. It then inflates the cuff to a pressure about 30 mmHg higher than systolic (Suprasystolic) pressure to acquire a further oscillometric pulse waveform. The suprasystolic pulse waveform is used in combination with the conventional upper-arm blood pressures to derive central systolic, diastolic and mean blood pressures. ## Indications for Use CardioScope™ is a non-invasive, compact standalone measurement device that automatically measures systolic and diastolic pressure, and pulse rate in adult and pediatric patients. CardioScope also provides non-invasive central (aortic) systolic, mean and diastolic blood pressure, and pulse waveform intended for use in adult patients. CardioScope performs measurements using a conventional oscillometric method via a brachial cuff on the upper arm. The device is intended to be used under supervision by qualified healthcare personnel. Caution: Federal (USA) law restricts this device to sale by or on order of a physician. Predicate Product Comparisons Table 12.1 compares the predicate devices with the Pulsecor CardioScope™ as it relates to indications for use, Blood pressure measurements, pulse waveforms, central systolic pressure, blood pressure cuff and operating temperature and humidity, storage requirements, power source and product dimensions. All of the parameters used to compare the various areas of interest were substantially equivalent with one exception: {2}------------------------------------------------ ## 510 (k) Summary | Parameters | Pulsecor<br>CardioScope™ | HealthSTATS<br>A-Pulse CASPro | AtCor<br>SphygmoCor Px | I.E.M GmbH<br>Mobil-O-Graph<br>24h | |-------------------|--------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------| | Pulse<br>Waveform | Brachial pulse<br>waveform using<br>oscillometry | Radial pulse wave<br>form using<br>applanation<br>tonometry | Carotid or radial<br>pulse wave form<br>using<br>applanation<br>tonometry | Brachial pulse<br>waveform using<br>oscillometry | A discussion of the applanation tonometry method versus the oscillometry method was presented with the conclusion that no new issues of safety and effectiveness were found between the two methods. #### Safety and Effectiveness Studies 5. #### Summary Electrical Testing 5.1 | Standard | Results | |------------------------------------------------|----------| | IEC 60601-1 Medical Electrical Equipment - | Pass | | Part 1: General Requirements for Safety, 1988; | | | Amendment 1, 1991-11, Amendment 2, 1995. | | | IEC 60601-1-2: 2007 Medical Electrical | Complies | | Equipment – Part 2: General Requirements for | | | Safety - Collateral Standard: Electromagnetic | | | Compatibility | | #### Summary Biocompatibility Tests - WelchAllyn FlexiPort Cuff 5.2 (K070060) | Standard | Results | |----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | ISO 10993-5 Biological evaluation of medical<br>devices -- Part 5: Tests for In Vitro cytotoxicity | The test article is considered non-cytotoxic<br>and meets the requirements of the Elution | | | Test, ISO 10993. | | ISO 10993-10 Biological evaluation of medical | The Primary Irritation Index is 0.0, and the test | | devices - Part 10: Tests for irritation and skin | article is considered a non-irritant according to | | sensitization | the procedures outlined in the FHSA | | | guidelines, 16 CFR, Section 1500.41. | | ISO 10993-10 Biological evaluation of medical | The skin treated with the test article extract | | devices - Part 10: Tests for irritation and skin | exhibited no reaction to the challenge (0% | | sensitization | sensitization). Therefore, as defined by the | | | scoring system of Kligman, this is a Grade l | | | reaction and the test article extract is | {3}------------------------------------------------ ## 510 (k) Summary K121266 pg. 4 of 4 | classified as having weak allergenic potential.<br>A Grade I sensitization rate is not considered | |---------------------------------------------------------------------------------------------------| | significant. | ### Summary SP10 Tests | Standard | Results | |---------------------|-----------------------------------------------------------------------------------------------------------| | ANSI/AMMI SP10:2002 | The Noninvasive software algorithm meets the<br>ANSI/AAMI SP10:2002 requirements for<br>adults/pediatrics | #### Clinical Validation (Comparison) Study Summary 5.3 Bland-Altman analysis of agreement between tonometric and oscillometric estimation of central systolic, diastolic, and mean pressures showed mean differences of less than 5 mmHg, and standard deviations of the difference of less than 8 mmHg. Similarly, agreement between oscillometric measures and invasive (catheter) measures of central systolic, diastolic, and mean pressures showed mean differences of less than 5 mmHg, and standard deviations of the difference of less than 8 mmHg. ### 6. ### Conclusion The Pulsecor CardioScope™ has demonstrated it is substantially equivalent to the predicate devices listed above. {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 Pulsecor, Ltd. c/o Mr. E.J. Smith President Smith Associates 1468 Harwell Avenue Crofton, MD 21114 Re: K121266 > Trade/Device Name: Cardioscope Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: November 28, 2012 Received: November 28, 2012 #### Dear Mr. Smith: 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. {5}------------------------------------------------ Page 2 - Mr. E.J. Smith 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 or any I 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 Of It Far 60 7), as emage (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.htm for 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/Resourcesfor You/Industry/default.htm. Sincerely vours Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use Form 510(k) Number (if known): K121266 Device Name: CardioScope Indications for Use: CardioScope™ is a non-invasive, compact standalone measurement device that automatically measures systolic and diastolic pressure, and pulse rate in adult and pediatric patients. CardioScope also provides non-invasive central (aortic) systolic, mean and diastolic blood pressure, and pulse waveform intended for use in adult patients. CardioScope performs measurements using a conventional oscillometric method via a brachial cuff on the upper arm. The device is intended to be used under supervision by qualified healthcare personnel. Caution: Federal (USA) law restricts this device to sale by or on order of a physician. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 ision Sign-Off) sion Sign-Only sion of Cardiovascular Devices 510(k) Numb