2D Mercy TAPE & 3D Mercy TAPE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 1, 2015 Children's Mercy Hospital c/o Mr. Jan S. Peterson The EMMES Corporation 401 N Washington Street, Suite 700 Rockville, MD 20850 Re: K142469 Trade/Device Name: Mercy TAPE Device (2D and 3D Models) Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: I Product Code: PIR Dated: March 31, 2015 Received: April 1, 2015 Dear Mr. Peterson: 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. {1}------------------------------------------------ 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K142469 Device Name Mercy TAPE device (2D and 3D models) #### Indications for Use (Describe) The Mercy TAPE device (2D and 3D models) is intended to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the Mercy TAPE device for humeral length (HL, for the 2D model) or half-humeral length (HHL, for the 3D model) and the midupper arm circumference (MUAC). The Mercy TAPE device may be less reliable for use in children with known or apparent limb deformities, or abnormal body proportions caused by conditions such as edema or severe malnutrition. #### Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 6. 510(k) Summary This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.87(h). ## A. Submitter's Information | Name: | Susan Abdel-Rahman, PharmD | |------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | Professor of Pediatrics<br>Division of Clinical Pharmacology and Medical Toxicology<br>Children's Mercy Hospital<br>2401 Gilham Road, RB 3730.06<br>Kansas City, MO 64108-4619 | | Phone: | 816-234-3059 | | Fax: | 816-855-1958 | | E-mail: | srahman@cmh.edu | | Correspondent: | Jan S. Peterson, MS, CCRA, RAC<br>The Emmes Corporation<br>401 N. Washington Street, Suite 700<br>Rockville, MD 20850-1785<br>301-251-1161<br>jpeterson@emmes.com | | Date of Summary: | April 30, 2015 | ## B. Device Information | Device Name: | Mercy TAPE Device (2D and 3D Models) | |--------------------|----------------------------------------------------------| | Regulation Number: | 21 CFR 878.4800 | | Regulation Name: | Manual surgical instrument for general use, Tape Measure | | Regulatory Class: | I | | Product Code: | PIR | | Panel: | General Hospital | ## C. Predicate Device Information | Manufacturer: | Pfizer, Inc. | |--------------------|--------------| | Product Name: | Tape Measure | | 510(k) Number: | K790089 | | Product code: | FTY | | Regulation Number: | 878.4800 | {4}------------------------------------------------ #### D. Reference Devices #### a) Scale, Stand-on, Patient | Manufacturer: | SR Instruments Inc. | |--------------------|---------------------| | Product Name: | Daily-weight | | 510(k) Number: | K770848 | | Product code: | FRI | | Regulation Number: | 880.2700 | #### b) Scale, Patient | Manufacturer: | U.S. Medical Corp | |--------------------|--------------------------------------| | Product Name: | U.S. Medical PS-2000 Pediatric Scale | | 510(k) Number: | K910582 | | Product code: | FRW | | Regulation Number: | 880.2720 | #### E. Device Description The Mercy TAPE Device (2D and 3D Models) consists of semi-durable or disposable flexible strips of coated paper, fabric or plastic tape printed with numbered bins proportional to fractional body weight of pediatric patients. The markings correspond to the validated Mercy Method (calculation algorithm) for determining pediatric body weight using humeral length and mid-upper arm circumference. The Mercy TAPE Device 2D Model consists of a single strip of tape that is used in two (2) stages to measure humeral length and mid-upper arm circumference. For the Mercy TAPE Device 3D Model, two (2) perpendicular strips of tape are designed to be joined into a sliding "T" shape so that humeral length and mid-upper arm circumference can be measured. ## F. Intended Use The Mercy TAPE Device (2D and 3D Models) is intended to estimate the body weight of pediatric patients between the ages of 2 months and 16 years, using linear measurements from specific anatomical landmarks made with the Mercy TAPE Device for humeral length (HL, for the 2D Model) or half-humeral length (HHL, for the 3D Model) and the mid-upper arm circumference (MUAC). The Mercy TAPE Device may be less reliable for use in children with known or apparent limb deformities, or abnormal body proportions caused by conditions such as edema or severe malnutrition. Rx only. {5}------------------------------------------------ | | G. Summary of comparison with predicate device and reference devices | | |--|----------------------------------------------------------------------|--| |--|----------------------------------------------------------------------|--| | Attribute | Mercy TAPE<br>Device (2D and 3D<br>Models) | Predicate device:<br>Tape Measure<br>(K790089)<br>Product Code<br>FTY | Reference device:<br>Stand-on Patient<br>Scale (K770848)<br>Product Code FRI | Reference device:<br>Patient Scale<br>(K910582)<br>Product Code<br>FRW | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The Mercy TAPE<br>Device (2D and 3D<br>Models) are<br>intended to be used<br>for estimating the<br>weight of a<br>pediatric patient by<br>measuring the<br>length of specific<br>body parts | A tape measure is a<br>device intended to<br>be used in various<br>general surgical<br>procedures for<br>measuring length of<br>parts of the body | A stand-on patient<br>scale is a device<br>intended for<br>medical purposes<br>that is used to<br>weigh a patient<br>who is able to stand<br>on the scale<br>platform | A patient scale is a<br>device intended for<br>medical purposes<br>that is used to<br>measure the weight<br>of a patient who<br>cannot stand on a<br>scale. | | Use for general<br>use | Yes | Yes | Yes (when patient<br>can stand) | Yes | | Anthropometric<br>measurement | Yes | Yes | Yes | Yes | | Length<br>measurement of<br>body part | Yes, converted to<br>weight | Yes | No | No | | Weight<br>Determination | Yes, based upon<br>measured length of<br>body parts | No | Yes | Yes | | Weight<br>determination<br>method | Indirect | No | Direct | Direct | | Output Display | View markings on<br>device and add<br>indicated values | View markings on<br>device | View display<br>indicator on device | View display<br>indicator on device | | Requires<br>Electrical<br>Power | No | No | Optional | Optional | | Hand-<br>manipulated<br>device | Yes | Yes | Optional | Optional | | Reusable | Labeled for Single<br>Patient Use | Yes | Yes | Yes | {6}------------------------------------------------ ## H. Performance Evaluation - Clinical Testing Clinical studies were conducted to evaluate the predictive performance of the Mercy TAPE Device (2D and 3D Models) and their equivalence to the underlying Mercy Tape method algorithm. Non-clinical studies were not performed. In the clinical studies, the device shows acceptably small variability from true weight with minimal bias. The Mercy Tape method algorithm was developed using demographic and anthropometric data on 17,328 individual children 2 months to 16 years of age from the National Health and Nutrition Examination Survey (NHANES) database. In addition, 1,938 datasets were used for method validation. A separate human factors/usability study was also conducted utilizing the Mercy TAPE Device (2D and 3D Models) to examine the speed, accuracy and precision with which "front-line" health care providers could apply the Mercy TAPE Device (2D and 3D Models). The study included emergency department (ED) nurses and first responders who conducted 1,412 assessments comparing the Mercy TAPE Device (2D and 3D Models) to all five of the most common weight estimation strategies, including visual estimation, Advanced Pediatric Life Support (APLS) calculation, Broselow Tape, Devised Weight Estimation Method, and the Luscombe and Owens formula. Our human factors/usability analyses reveal no significant differences in subjective determinations for ease of use between the Mercy TAPE Device (2D and 3D Models) and existing weight estimation strategies. In addition, the critical task errors observed with the Mercy TAPE Device (2D and 3D Models) occur with a frequency similar to or lower than the error rates observed with standard medical equipment (e.g., scales, stadiometers, and tape measures). Importantly, even when factoring in errors and close-calls, the estimated weights generated by the Mercy TAPE Device (2D and 3D Models) are more accurate than the weights returned with existing weight estimation strategies. #### I. Comparison to the Predicate Device and Conclusion The Mercy TAPE Device (2D and 3D Models) shares certain common features with the predicate comparator device, namely the simple tape measure, in that it assesses simple anthropometric measurements. The Mercy TAPE Device (2D and 3D Models), however, provides an estimation of body weight based on an algorithm that is unique to the device. The Mercy TAPE Device (2D and 3D Models) uses linear anthropometric body measurements to derive estimated body weight, and this has been validated against scales that use mechanical strain or balance methods to obtain an estimate of body weight. The clinical testing indicates that the Mercy TAPE Device (2D and 3D Models) is substantially equivalent to the predicate comparator device and was validated against a mechanical scale to demonstrate equivalent performance.