(225 days)
Not Found
No
The summary describes a custom-designed cranial orthosis manufactured using 3D scanning and CAD software. There is no mention of AI or ML being used in the design process, analysis of the scan data, or determination of the orthosis shape. The process relies on established CAD/CAM technology and a physician's prescription.
Yes
The device is a cranial orthosis explicitly stated to "treat abnormally shaped craniums in infants" and addresses "abnormal cranial configurations classified as nonsynostotic positional plagiocephaly and post-operative nonsynostotic plagiocephaly," which are medical conditions.
No
The KidCap™ is a cranial orthosis used to treat abnormally shaped craniums in infants, not to diagnose them. While a 3D scan is used to custom design the orthosis, this scan is for manufacturing purposes, not for diagnosing a condition.
No
The device description clearly states that the KidCap™ is a physical cranial orthosis made of a rigid polymer shell, foam padding, a hinge, and lateral guides. While it utilizes software for design and manufacturing, the device itself is a physical product.
Based on the provided information, the KidCap™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The KidCap™ is a physical orthosis applied externally to the infant's head. It does not analyze blood, tissue, or any other bodily fluid or substance.
- IVDs are used to provide information for diagnosis, monitoring, or treatment. While the KidCap™ is used for treatment (correcting head shape), it does not provide diagnostic information itself. The diagnosis of plagiocephaly is made by a physician.
- The device description clearly states it's a cranial orthosis. This is a type of medical device used to support or correct the shape of the skull.
The KidCap™ is a therapeutic device, not a diagnostic one.
N/A
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.
Product codes
MVA
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium, frontal bone, occiput, temporozygomatic arch, openings for eye fissures, and auditory canals
Indicated Patient Age Range
three (3) months to eighteen (18) months of age
Intended User / Care Setting
Prescribed by a physician.
Home and through daily activities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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)).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue box, and the full name of the agency, "U.S. Food & Drug Administration," is in blue text.
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
1
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)
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
10523 Main St.
Fairfax, Virginia 22030
Registration Number: 3005021665
Owner/Operator Number: 9049723 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph Terpenning
Tel: (703) 807-5899
Fax: (703) 807-1183
jterpenning@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
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.
5
| Characteristic
of Equivalence | Predicate Device:
Static Cranioplasty Orthosis
K020448 | Equivalent Device:
KidCapTM |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | Reshaping of an infant's head with
nonsynostotic plagiocephalic,
brachycephalic and scaphocephalic
head shapes | Reshaping of an infant's head with
nonsynostotic plagiocephalic,
brachycephalic and scaphocephalic
head shapes |
| Target
Population | Infants 3-18 months of age | Infants 3-18 months of age |
| Design | Bivalved 2-piece polymer shell
with padded interface | Bivalved 2-piece polymer shell
with padded interface |
| Biocompatibility | Materials are not reported to cause
skin irritation or any toxic harms | Materials are not reported to cause
skin irritation or any toxic harms |
| Mechanical
safety | Device is non-mechanical,
containing no active parts. Device
is inherently safe, but not a
protective device. | Device is non-mechanical,
containing no active parts. Device
is inherently safe, but not a
protective device. |
| Chemical safety | Orthosis is non-reactive with
patients skin | Orthosis is non-reactive with
patients skin |
| Anatomical sites | Cranium, frontal bone, occiput,
temporozygomatic arch, openings
for eye fissures, and auditory canals | Cranium, frontal bone, occiput,
temporozygomatic arch, openings
for eye fissures, and auditory canals |
| Energy
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
Orthosis | A Negative impression filled with
liquid plaster forms the positive
mold | 3-dimensional scan of the cranium
is obtained using the OMEGA
Tracer Software and Scanner which
is then used to create the positive
mold |
| Sterility | Device is not required to be
sterilized for use | Device is not required to be
sterilized for use |
| Performance | Effectiveness has been proven
statistically significant by Paired T-
tests of clinical data | Software Validation, Process
Validation, and Dimensional
Equivalency Comparison for mold
acquisition method |
| Materials Used | Durr Plex™, Hypoallergenic
Suspension Padding | Durr Plex™, Hypoallergenic
Suspension Padding |
Basis for Substantial Equivalence Table
6
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.