KidCap

K180568 · Eastern Cranial Affiliates, LLC · MVA · Oct 16, 2018 · Neurology

Device Facts

• Record ID: K180568
• Device Name: KidCap
• Applicant: Eastern Cranial Affiliates, LLC
• Product Code: MVA · Neurology
• Decision Date: Oct 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

Cranial orthosis for infants 3-18 months; treats abnormal cranial configurations via static equilibrium. Input: 3D cranial scan via Omega Scanner; digital image processed via CAD software to generate positive model. Output: Custom-fitted rigid polymer shell (Durr Plex) with biocompatible foam padding, polyethylene hinge, and polypropylene lateral guides. Used in home/daily activities; prescribed by physician. Device contacts cranial prominences to guide growth into flattened areas without applying active force. Benefits: non-invasive cranial reshaping.

Clinical Evidence

Bench testing only. Evidence includes software validation (risk assessment, system requirements, IQ/OQ/PQ) for the Omega Tracer system, process validation, and a dimensional equivalency comparison report demonstrating that 3D scanning for mold acquisition is equivalent to traditional plaster impression methods.

Technological Characteristics

Bivalved 2-piece rigid polymer shell (Durr Plex) with biocompatible foam padding; polyethylene hinge; polypropylene lateral guides; Velcro strap. Non-mechanical; no active parts; non-conductive. Custom-fabricated via 3D laser scanning (Omega Scanner) and CAD software. Non-sterile.

Indications for Use

Indicated for infants 3-18 months of age with nonsynostotic positional plagiocephaly, post-operative nonsynostotic plagiocephaly, plagiocephalic, brachycephalic, or scaphocephalic head shapes, and post-operative craniosynostosis management.

Regulatory Classification

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.

Special Controls

*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)).

In addition to the general controls of the act, the Dynamic Orthotic Cranioplasty - DOC™ Band is subject to the following special controls in order to provide reasonable assurance of the safety and effectiveness: (1) The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109. (2) The labeling must include (a) contraindications for the use of the device on infants with synostosis or with hydrocephalus; (b) warnings indicating the need: (i) to evaluate head circumference measurements and neurological status at intervals appropriate to the infant’s age and rate of head growth, and to describe steps that should be taken in order to reduce the potential for restriction of cranial growth and possible impairment of brain growth and development; (ii) to evaluate the skin at frequent intervals, e.g., every three to four hours, and to describe steps that should be taken if skin irritation or breakdown occurs; (c) precautions indicating the need: (i) to additionally treat torticollis, if the positional plagiocephaly is associated with torticollis; (ii) to evaluate device fit and to describe the steps that should be taken in order to reduce the potential for restriction of cranial growth, possible impairment of brain growth and development and skin irritation and/or breakdown; (iii) to evaluate the structural integrity of the device and to describe the steps that should be taken to reduce the potential for the device to slip out of place and cause asphyxiation or trauma to the eyes or skin; (d) adverse events, i.e., skin irritation and breakdown that have occurred with the use of this device; (e) clinician’s instructions for casting the infant, for fitting the device, and for care and use of the device; and (f) parents’ instructions for care and use of the device. (3) The materials must be assessed for biocompatibility with testing appropriate for long term direct skin contact.

Predicate Devices

• Static Cranioplasty Orthosis (K020448)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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 Affiliates<br>10523 Main St.<br>Fairfax, Virginia 22030<br>Registration Number: 3005021665<br>Owner/Operator Number: 9049723 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph Terpenning<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |

# 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

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

### 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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| Characteristic<br>of Equivalence | Predicate Device:<br>Static Cranioplasty Orthosis<br>K020448 | Equivalent Device:<br>KidCapTM |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | Reshaping of an infant's head with<br>nonsynostotic plagiocephalic,<br>brachycephalic and scaphocephalic<br>head shapes | Reshaping of an infant's head with<br>nonsynostotic plagiocephalic,<br>brachycephalic and scaphocephalic<br>head shapes |
| Target<br>Population | Infants 3-18 months of age | Infants 3-18 months of age |
| Design | Bivalved 2-piece polymer shell<br>with padded interface | Bivalved 2-piece polymer shell<br>with padded interface |
| Biocompatibility | Materials are not reported to cause<br>skin irritation or any toxic harms | Materials are not reported to cause<br>skin irritation or any toxic harms |
| Mechanical<br>safety | Device is non-mechanical,<br>containing no active parts. Device<br>is inherently safe, but not a<br>protective device. | Device is non-mechanical,<br>containing no active parts. Device<br>is inherently safe, but not a<br>protective device. |
| Chemical safety | Orthosis is non-reactive with<br>patients skin | Orthosis is non-reactive with<br>patients skin |
| Anatomical sites | Cranium, frontal bone, occiput,<br>temporozygomatic arch, openings<br>for eye fissures, and auditory canals | Cranium, frontal bone, occiput,<br>temporozygomatic arch, openings<br>for eye fissures, and auditory canals |
| Energy<br>used/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 the<br>Orthosis | A Negative impression filled with<br>liquid plaster forms the positive<br>mold | 3-dimensional scan of the cranium<br>is obtained using the OMEGA<br>Tracer Software and Scanner which<br>is then used to create the positive<br>mold |
| Sterility | Device is not required to be<br>sterilized for use | Device is not required to be<br>sterilized for use |
| Performance | Effectiveness has been proven<br>statistically significant by Paired T-<br>tests of clinical data | Software Validation, Process<br>Validation, and Dimensional<br>Equivalency Comparison for mold<br>acquisition method |
| Materials Used | Durr Plex™, Hypoallergenic<br>Suspension Padding | Durr Plex™, Hypoallergenic<br>Suspension 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.