Mercy babyTAPE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 10, 2019 Susan Abdel-Rahman, PharmD. Professor of Pediatrics Division of Clinical Pharmacology, Toxicology, and Therapeutic Innovation Children's Mercy Hospital 2401 Gilham Road PO Box 2M02.47 Kansas City, MO 64108-4619 Re: K191174 Trade/Device Name: Mercy babyTAPE Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument For General Use Regulatory Class: Class I Product Code: PIR Dated: September 8, 2019 Received: September 11, 2019 Dear Susan Abdel-Rahman, PharmD.: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K191174 Device Name Mercy babyTAPE #### Indications for Use (Describe) The Mercy babyTAPE device is intended for use by health care professionals to estimate the body weight of infants between the ages of 0 days (birth) and 90 days, using circumferential measurements from specific anatomical landmarks made with the Mercy babyTAPE device for head and chest circumference. Head: place the Mercy babyTAPE across the frontal bones, slightly above eyebrows and ears, over the occipital prominence, perpendicular to the long axis of the face. Chest: place the Mercy babyTAPE around the upper torso, passing under the xyphoid process at the level of the nipple. Measure at end-exhalation. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------|---------------------------------------------| | × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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}------------------------------------------------ # 510(k) Summary K191174 This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92. ## 1.0 Submitter's Information | Name: | Susan Abdel-Rahman, PharmD | |------------------|----------------------------------------------------------------| | Address: | Professor of Pediatrics | | | Division of Clinical Pharmacology, Toxicology, and Therapeutic | | | Innovation | | | Children's Mercy Hospital | | | 2401 Gilham Road, POB 2M02.47 | | | Kansas City, MO 64108-4619 | | Phone: | 816-302-3003 | | Fax: | 816-302-9720 | | E-mail: | srahman@cmh.edu | | Date of Summary: | September 25, 2019 | #### 2.0 Device Information | Device Name: | Mercy babyTAPE device | |-------------------|--------------------------------------------------------------------------| | Classification: | Class 1 (General Controls) | | Regulatory Class: | ー | | Product Code: | PIR | | | Regulation Number: 878.4800 (Manual surgical instrument for general use) | | Panel: | General Hospital | #### 3.0 Predicate Device Information | Manufacturer: | Children's Mercy Hospital | |--------------------|--------------------------------------| | Product Name: | Mercy TAPE Device (2D and 3D Models) | | 510(k) Number: | K142469 | | Product Code: | PIR | | Regulatory Class: | 1 | | Regulation Number: | 878.4800 | | Review Panel: | General Hospital | # 4.0 Device Description The Mercy babyTAPE device consists of a semi-durable or disposable flexible strip of paper, coated paper, fabric or plastic tape printed on both sides such that one side uses yellow color to indicate its use for the head circumference measurement, while the other side is printed with blue color to indicate its use for the chest circumference measurement. The start end of the device is indicated with color contrasting arrowheads that span the width of the device. Numbered bins are {4}------------------------------------------------ marked on each side proportional to the fractional body weight of newborn and infant patients. The markings correspond to a validated Mercy babyTAPE Method (calculation algorithm) for determining estimated infant body weight. ## 5.0 Indications for Use The Mercy babyTAPE device is intended for use by health care professionals to estimate the body weight of infants between the ages of 0 days (birth) and 90 days, using circumferential measurements from specific anatomical landmarks made with the Mercy babyTAPE device for head and chest circumference. Head: place the Mercy babyTAPE across the frontal bones, slightly above eyebrows and ears, over the occipital prominence, perpendicular to the long axis of the face. Chest: place the Mercy babyTAPE around the upper torso, passing under the axilla and by the xyphoid process at the level of the nipple. Measure at end-exhalation. {5}------------------------------------------------ K191174 September 25, 2019 # 6.0 Summary of Technological Characteristics and Comparison with the Predicate Device #### Table 1: Comparisons with the predicate device | | Mercy babyTAPE | Predicate Device<br>Mercy TAPE (2D and 3D Models)<br>(K142469)<br>Product Code PIR | |------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The Mercy babyTAPE device is intended for use by<br>health care professionals to estimate the body weight<br>of infants between the ages of 0 days (birth) and 90<br>days, using circumferential measurements from<br>specific anatomical landmarks made with the Mercy<br>babyTAPE device for head and chest circumference. | The Mercy TAPE device is intended to estimate the body weight of<br>pediatric patients using linear measurements from specific anatomical<br>landmarks made with the Mercy TAPE device for humeral length (HL,<br>for the 2D model) or half-humeral length (HHL, for the 3D model) and<br>the mid-upper arm circumference (MUAC). | | Indication for Use | Head: place the Mercy babyTAPE across the frontal<br>bones, slightly above eyebrows and ears, over the<br>occipital prominence, perpendicular to the long axis<br>of the face. | | | | Chest: place the Mercy babyTAPE around the upper<br>torso, passing under the axilla and by the xyphoid<br>process at the level of the nipple. Measure at end-<br>exhalation. | | | Use for General Use | Yes | Yes | | Device Class | 1 | 1 | | Technological Characteristics | Paper, coated paper, fabric, or plastic tape - coated,<br>flexible, and printed with numbered bins | Paper, coated paper, fabric, or plastic tape - coated, flexible, and printed<br>with numbered bins | | Anthropometric Measurements<br>on Body Surface | Yes, converted to weight | Yes, converted to weight | | Weight Determination | Yes, based upon measured circumferences of body<br>parts | Yes, based upon measured lengths on body parts | | | Mercy babyTAPE | Predicate Device<br>Mercy TAPE (2D and 3D Models)<br>(K142469)<br>Product Code PIR | | Weight Determination Method | Indirect | Indirect | | Output Display | View markings on device and add indicated values | View markings on device and add indicated values | | Requires Electrical Power | No | No | | Hand-manipulated Device | Yes | Yes | | Disposable | Yes | Yes | | Labeled for Single Patient Use | Yes | Yes | {6}------------------------------------------------ K191174 September 25, 2019 {7}------------------------------------------------ ## 7.0 Performance Evaluation - Clinical Testing #### 7.1 Introduction A predictive performance study was performed to compare the baby TAPE device predicted weights with weight measured on a calibrated scale. This clinical study evaluated the predictive performance of the Mercy babyTAPE device relative to the underlying Mercy babyTAPE method algorithm and to actual measured body weights. The Mercy babyTAPE method algorithm was developed using demographic and anthropometric data from study TAP02.Weight estimation is performed using an algorithm that is unique to the Mercy babyTAPE device but similar to the algorithm1 used for the predicate Mercy TAPE device (2D and 3D Models). Both devices estimate weight using anthropometric surface measurements. #### 7.2 Deriving the algorithm used to develop the babyTAPE - Study TAP02 Study NICHD-2014-TAP02 obtained anthropometric data to allow the Mercy TAPE 2D and 3D to be modified for weight estimation in newborns and young infants. Circumferential and segmental anthropometric measures were evaluated for their relationship to infant weight and length. This study enrolled 2097 infants at 8 sites. Population growth curves were generated for humeral, ulnar, femoral, tibial, and fibular lengths; mid upper arm, mid-thigh, chest, abdominal, and neck circumferences. The final anthropometric variables selected were the combination of head circumference and chest circumference as described below (Abdel-Rahman'): 'Data [was] derived from 2097 US infants (n = 1681 for model development, n = 416 for validation). Statistical and practical considerations informed final measurement selection. Head circumference and chest circumference demonstrated the best correlations with weight (r = 0.89) and length (r = 0.94 and 0.93), and were among the most reproducible as reflected by intraclass correlation coefficients (>0.98). The head circumference and chest circumference combination offered better goodness-of-fit and smaller limits of agreement than did either measure alone. The final model predicted weight within 10% and 15% of actual for 84% and 94% of infants, respectively, with no bias for postnatal age (P = . 76), gestational age (P = . 10), and sex (P = . 25)' ¹ Abdel-Rahman SM, Ahlers N, Holmes A, et al. Validation of an improved pediatric weight estimation strategy. J Pediatr Pharmacol Ther. 2013;18(2):112-21 ² Abdel-Rahman SM, Paul IM, Delmore P, James L, Fearn L, Atz A et al. A Weight Estimation Strategy for Preterm and Full-Term Infants. Global Pediatric Health. 2017;4: 1-9 2017 Dec 21:4:2333794X17748775. Available from: https://doi.org/10.1177/2333794X17748775 eCollection 2017. PMID: 29308426 Free PMC Article. {8}------------------------------------------------ The 2097 infants represented those that were small, appropriate, and large for gestational age. As illustrated below, both preterm and full-term infants represented a broad range of length, weight, and head circumference values with z-scores spanning more than 8 standard deviations (i.e. <-4 to >+4). Image /page/8/Figure/3 description: The image shows three histograms comparing the frequency of length, weight, and head circumference to the z-score. The histograms are all unimodal and centered around -1. The y-axis of each histogram is labeled "Frequency" and ranges from 0 to 120. The x-axis of each histogram is labeled "z-score" and ranges from -5 to 5. {9}------------------------------------------------ Image /page/9/Figure/3 description: The image shows the title of a section, "7.3 Predictive performance study conclusions". The title is written in a bold, sans-serif font. The number 7.3 is on the left side of the title. The title is centered on the page. There was substantial correlation between the infants' actual weight and the babyTAPE device predicted weight. The regression slope was 0.96 (95% CI 0.94, 0.98) with an intercept of 0.08 (95% CI 0.03, 0.12). Exploring the magnitude of this deviation reveals a mean error of -69 ± 257 grams corresponding to a mean percentage error of -1.3 ± 6.9%. There was also a strong correlation between the infants' actual weight and the reference measuring tape estimated weight using the method from which the babyTAPE device was developed. For this regression the slope was 0.95 (95% CI 0.93, 0.96), the intercept 0.11 (95%CI 0.07, 0.16), the mean error -66 ± 249 grams, and the mean percentage error -1.1 ± 7.1%. The fraction of infants in whom the babyTAPE device predicted weight within 10% and 15% of actual weight was 0.86 and 0.99, respectively (CCC of 0.98). {10}------------------------------------------------ # 8.0 Comparison to the Predicate Device and Conclusion Through a performance usability study, the subject device has demonstrated substantial equivalence to the predicate device.