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.

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 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.

AI/ML Overview

The Mercy babyTAPE device is intended for health care professionals to estimate the body weight of infants (0-90 days old) using head and chest circumference measurements. The device is a flexible strip of tape with numbered bins, printed on both sides (yellow for head, blue for chest), and the measurements are used with a validated algorithm to estimate weight.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Correlation between actual weight and predicted weight	Regression slope of 0.96 (95% CI 0.94, 0.98), intercept of 0.08 (95% CI 0.03, 0.12)
Mean error	-69 ± 257 grams
Mean percentage error	-1.3 ± 6.9%
Percentage of infants predicted within 10% of actual weight	0.86 (86%)
Percentage of infants predicted within 15% of actual weight	0.99 (99%)
Concordance Correlation Coefficient (CCC)	0.98

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions a "predictive performance study" that evaluated the babyTAPE device's predicted weights against measured weights. It also refers to "Study TAP02" which was used to derive the algorithm. The validation data subset from Study TAP02 appears to be the most relevant "test set" for the final performance evaluation.

Test Set Sample Size: 416 infants (listed as the validation group in TAP02).
Data Provenance: The algorithm was developed using data from "2097 US infants at 8 sites" (Study NICHD-2014-TAP02). The predictive performance study described seems to be a validation of this algorithm. The study was likely prospective as it involved obtaining anthropometric data for the purpose of algorithm development and validation. The country of origin is the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The ground truth for the test set was established using "weight measured on a calibrated scale." This implies direct measurement rather than expert interpretation. Therefore, experts were not involved in establishing the ground truth measurements themselves, but rather in conducting these measurements accurately. The document does not specify the qualifications of the individuals performing the weight measurements.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. The ground truth was direct weight measurement on a calibrated scale, which typically does not involve adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. This device is a manual measurement tool with an integrated algorithm, not an AI system designed to assist human readers in image interpretation or diagnosis. The study focused on the accuracy of the device's predicted weight compared to actual weight.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance study evaluated the "baby TAPE device predicted weights with weight measured on a calibrated scale." The device itself incorporates the measurement (human-in-the-loop for taking circumference measurements) and then uses the algorithm to provide the predicted weight. Therefore, it's not purely "algorithm-only" in the sense of a fully automated system without any human interaction. However, the reported performance metrics (regression slope, mean error, percentage accuracy) directly assess the output of the device's algorithm given the anthropometric inputs. The comparison to the "reference measuring tape estimated weight" suggests a direct comparison of the Mercy babyTAPE algorithm's performance against another established method.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was actual measured body weights obtained using a calibrated scale.

8. The sample size for the training set

The algorithm was developed using demographic and anthropometric data from Study TAP02.

Training Set Sample Size: 1681 infants (for model development).

9. How the ground truth for the training set was established

For the training set (Study NICHD-2014-TAP02), the ground truth for weight was established via direct measurement of infant weight and various circumferential and segmental anthropometric measures. These measurements were used to derive the algorithm. This would involve using calibrated measuring tools by trained personnel. The study explicitly states, "Data [was] derived from 2097 US infants (n = 1681 for model development, n = 416 for validation)." It further details the types of measurements taken.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K191174

Device Name Mercy babyTAPE

Indications for Use (Describe)

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)

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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

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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

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.

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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 DeviceMercy TAPE (2D and 3D Models)(K142469)Product Code PIR
	The Mercy babyTAPE device is intended for use byhealth care professionals to estimate the body weightof infants between the ages of 0 days (birth) and 90days, using circumferential measurements fromspecific anatomical landmarks made with the MercybabyTAPE device for head and chest circumference.	The Mercy TAPE device is intended to estimate the body weight ofpediatric patients using linear measurements from specific anatomicallandmarks made with the Mercy TAPE device for humeral length (HL,for the 2D model) or half-humeral length (HHL, for the 3D model) andthe mid-upper arm circumference (MUAC).
Indication for Use	Head: place the Mercy babyTAPE across the frontalbones, slightly above eyebrows and ears, over theoccipital prominence, perpendicular to the long axisof the face.
	Chest: place the Mercy babyTAPE around the uppertorso, passing under the axilla and by the xyphoidprocess at the level of the nipple. Measure at end-exhalation.
Use for General Use	Yes	Yes
Device Class	1	1
Technological Characteristics	Paper, coated paper, fabric, or plastic tape - coated,flexible, and printed with numbered bins	Paper, coated paper, fabric, or plastic tape - coated, flexible, and printedwith numbered bins
Anthropometric Measurementson Body Surface	Yes, converted to weight	Yes, converted to weight
Weight Determination	Yes, based upon measured circumferences of bodyparts	Yes, based upon measured lengths on body parts
	Mercy babyTAPE	Predicate DeviceMercy TAPE (2D and 3D Models)(K142469)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

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K191174 September 25, 2019

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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.

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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.

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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).

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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.

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.