The KidCap™ is a cranial orthosis used to treat abnormally shaped craniums in infants between the ages of three (3) months to eighteen (18) months of age. It is designed to address abnormal cranial configurations classified as nonsynostotic positional plagiocephaly and post-operative nonsynostotic plagiocephaly. It includes infants with plagiocephalic, brachycephalic and scaphocephalic patterned head shapes, and post-operative craniosynostosis management. The KidCap™ utilizes the principles of static equilibrium to influence the cranial plates while utilizing an anatomical kinetic chain to influence the bones comprising the orbits, cheek structure, and lower mandible. The orthosis is designed to intimately contact the prominences of the expanding cranium, but will not initiate a force upon the cranium. The KidCap™ is only available if prescribed by a physician.

Device Description

The KidCap" is a cranial orthosis used to treat abnormally shaped craniums in infants three (3) to eighteen (18) months of age. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened areas of the skull into the created spaces.

The orthosis is custom designed for each patient by obtaining a three-dimensional scan of the patient cranium using the Omega Scanner. The scan of the cranium is translated into a digital image of the shape in the Computer Aided Design (CAD) software. From the digital image a positive model is generated by Ohio Willow Wood using a CAD carver. The positive model is then used to manufacture the KidCap". The orthosis is composed of a rigid polymer shell, Durr Plex™ with biocompatible foam padding. The orthosis is held together with a polyethylene hinge, and two lateral guides composed of Polypropylene. The external pieces are adhered to the orthosis with polymer rivets that are countersunk into the interior for a smooth, unobtrusive transition with the orthosis.

The anterior and posterior sections of the orthosis are held secure with a 3/4" Velcro™ strap that encircles the posterior hemisphere of the orthosis has ventilation apertures to promote convectionary cooling as the patient perspires

AI/ML Overview

The provided text describes the KidCap™ cranial orthosis and its substantial equivalence to a predicate device (Static Cranioplasty Orthosis K020448). However, it does not include detailed acceptance criteria or a study dedicated to proving the device meets specific performance criteria in terms of efficacy for treating cranial deformities.

Instead, the submission focuses on demonstrating substantial equivalence primarily through:

Identical Indications for Use and Target Population: The device treats the same conditions in the same age range as the predicate.
Similar Design and Materials: Both devices are bivalved polymer shells with padded interfaces and use similar materials.
Similar Safety Characteristics: This includes biocompatibility, mechanical safety (non-mechanical), chemical safety (non-reactive with skin), anatomical sites, and electrical safety.
Performance Claim: The predicate device "Effectiveness has been proven statistically significant by Paired T-tests of clinical data." For the KidCap™, performance is supported by "Software Validation, Process Validation, and Dimensional Equivalency Comparison for mold acquisition method."

The "studies" mentioned for the KidCap™ are primarily focused on validating the manufacturing process and the new mold acquisition method, not clinical efficacy or direct performance against acceptance criteria for treating cranial deformities.

Therefore, many of the requested sections about specific acceptance criteria and detailed study data for device performance in relation to those criteria cannot be fully extracted from the provided text for the KidCap™ itself, as the submission relies on substantial equivalence to the predicate's proven clinical effectiveness, and non-clinical testing for the manufacturing process.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical efficacy (e.g., specific reduction in cranial asymmetry indices). Instead, the "performance" for the KidCap™ is demonstrated through non-clinical validation of its manufacturing process and dimensional equivalency. The predicate device's performance is stated as "Effectiveness has been proven statistically significant by Paired T-tests of clinical data," implying the predicate met clinical acceptance criteria, which the KidCap™ is deemed equivalent to.

Acceptance Criteria (Implied / For Predicate)	Reported Device Performance (KidCap™ / Supporting Data)
Clinical Effectiveness: Reduction in abnormal cranial configurations (nonsynostotic positional plagiocephaly, brachycephaly, scaphocephaly, post-operative craniosynostosis management). (Criteria not explicitly defined for KidCap™ but implied by equivalence to predicate)	For KidCap™: No direct clinical performance data provided. The device is deemed substantially equivalent to the predicate, which has proven effectiveness. Supporting Data: Software Validation, Process Validation, and Dimensional Equivalency Comparison for mold acquisition method.
Manufacturing Accuracy: Molds created by new method are dimensionally equivalent to previous method.	Measured Performance: Dimensional Equivalency Comparison Report (details not provided, but report supports equivalence).
Software Functionality: Omega Tracer Software (risk assessment, system requirement, installation, operational, performance qualified).	Measured Performance: Software Validation documents executed (risk assessment, system requirement specification, installation qualification, operational qualification, and performance qualification).
Process Control: Manufacturing process for KidCap™ is validated.	Measured Performance: Summary of process validation provided.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not specified in the document.
Data Provenance: Not specified for any clinical data. For the KidCap™ non-clinical testing (software, process, dimensional equivalency), the data is from internal validation studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided. The non-clinical testing described does not involve expert-established ground truth in the context of clinical assessment.

4. Adjudication Method for the Test Set

Not applicable as the described "studies" are non-clinical validations (software, process, dimensional equivalency) and not clinical trials with expert 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 MRMC comparative effectiveness study was done for the KidCap™. The device is a cranial orthosis, not an AI-assisted diagnostic tool.

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

Not applicable as the device is a physical orthosis, not an algorithm. The software (Omega Tracer Software) is for scanning and mold design, but its "performance" is about accurate measurement and model creation, not autonomous clinical decision-making.

7. The Type of Ground Truth Used

For Dimensional Equivalency Comparison: The "ground truth" would likely be the measurements obtained from the original method of plaster impressions, against which the 3D scan and CAD model measurements were compared. However, specifics are not provided.
For Clinical Efficacy (for predicate, by inference): The predicate device's clinical data would have used clinical measures of cranial shape improvement as ground truth, likely assessed by medical professionals.

8. The Sample Size for the Training Set

Not applicable as the device is a physical orthosis. The software (Omega Tracer) does not describe a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable as there is no mention of a training set or ground truth in the context of machine learning for this device.

Summary

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October 16, 2018

Eastern Cranial Affiliates, LLC Joseph Terpenning Director Of Orthotics 10523 Main Street Fairfax, Virginia 22030

Re: K180568

Trade/Device Name: KidCap Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: October 17, 2016 Received: March 5, 2018

Dear Joseph Terpenning:

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Matthew C. Krueger -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180568

Device Name

KidCap™

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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1.5. 510(k) Summary

510(k) Number:

Date Prepared: October 17, 2016

Submitter Information

Submitter:	Eastern Cranial Affiliates10523 Main St.Fairfax, Virginia 22030Registration Number: 3005021665Owner/Operator Number: 9049723
Contact Person:	Joseph TerpenningTel: (703) 807-5899Fax: (703) 807-1183jterpenning@infinitetech.org

Device Information

Trade Name	KidCapTM
Common/Usual Name	Cranial Orthosis
Classification Name	Cranial Orthosis
Regulation/Product Code	882.5970/MVA
Regulatory Classification	Class II
Device Panel	Neurology

Predicate Device(s): KidCap" is substantially equivalent to the previously-cleared, K020448.

510(k) Number	Device Name/Submitter
K020448	Static Cranioplasty Orthosis/Eastern Cranial Affiliates

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Device Description

Intended Use/Indications for Use

The KidCap" is a cranial orthosis used to treat abnormally shaped craniums in infants between the ages of three (3) months to eighteen (18) months of age. It is designed to address abnormal cranial configurations classified as nonsynostotic positional plagiocephaly and post-operative nonsynostotic plagiocephaly. It includes infants with plagiocephalic, brachycephalic and scaphocephalic patterned head shapes, and post-operative craniosynostosis management. The KidCap" utilizes the principles of static equilibrium to influence the cranial plates while utilizing an anatomical kinetic chain to influence the bones comprising the orbits, cheek structure, and lower mandible. The orthosis is designed to intimately contact the prominences of the expanding cranium, but will not initiate a force upon the cranium. The KidCap" is only available if prescribed by a physician.

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Characteristicof Equivalence	Predicate Device:Static Cranioplasty OrthosisK020448	Equivalent Device:KidCapTM
Indications foruse	Reshaping of an infant's head withnonsynostotic plagiocephalic,brachycephalic and scaphocephalichead shapes	Reshaping of an infant's head withnonsynostotic plagiocephalic,brachycephalic and scaphocephalichead shapes
TargetPopulation	Infants 3-18 months of age	Infants 3-18 months of age
Design	Bivalved 2-piece polymer shellwith padded interface	Bivalved 2-piece polymer shellwith padded interface
Biocompatibility	Materials are not reported to causeskin irritation or any toxic harms	Materials are not reported to causeskin irritation or any toxic harms
Mechanicalsafety	Device is non-mechanical,containing no active parts. Deviceis inherently safe, but not aprotective device.	Device is non-mechanical,containing no active parts. Deviceis inherently safe, but not aprotective device.
Chemical safety	Orthosis is non-reactive withpatients skin	Orthosis is non-reactive withpatients skin
Anatomical sites	Cranium, frontal bone, occiput,temporozygomatic arch, openingsfor eye fissures, and auditory canals	Cranium, frontal bone, occiput,temporozygomatic arch, openingsfor eye fissures, and auditory canals
Energyused/delivered	N/A	N/A
Location of use	Home and through daily activities	Home and through daily activities
Electrical safety	Polymer is nonconductive	Polymer is nonconductive
Fabrication of theOrthosis	A Negative impression filled withliquid plaster forms the positivemold	3-dimensional scan of the craniumis obtained using the OMEGATracer Software and Scanner whichis then used to create the positivemold
Sterility	Device is not required to besterilized for use	Device is not required to besterilized for use
Performance	Effectiveness has been provenstatistically significant by Paired T-tests of clinical data	Software Validation, ProcessValidation, and DimensionalEquivalency Comparison for moldacquisition method
Materials Used	Durr Plex™, HypoallergenicSuspension Padding	Durr Plex™, HypoallergenicSuspension Padding

Basis for Substantial Equivalence Table

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Summary of Testing

Non-Clinical testing being submitted in this 510(k) includes software validation documents, process validation documents and a summary report detailing the dimensional equivalency comparison between the mold acquisition methods. The software validation documents executed for the Omega Tracer Software and Class I Omega Scanner Laser Device include the risk assessment, system requirement specification, installation qualification, operational qualification, and performance qualification. Additionally being submitted is the summary of the process validation which employed the use of the Omega Tracer Software and Scanner used in the manufacturing of the KidCap" and the Dimensional Equivalency Comparison Report. The comparison report in combination with the protocol execution and testing supports a determination of substantial equivalence by showing that the use of the Omega Tracer Software and Scanner for the purpose of mold acquisition, patient assessment, and measurement analysis when fabricating a cranial molding helmet is equivalent to the previous method of obtaining a plaster impression of the patient's skull.

Conclusions

The KidCap™ has identical indications for use as the predicate device, the Static Cranioplasty Orthosis, and identical technological characteristics. Minor feature differences do not raise any new questions regarding safety or effectiveness of the KidCap™ performs as intended, and presents no unacceptable risks to the intended patient population or end user. The KidCap™ is substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.5970 Cranial orthosis.

(a)
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).