Intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

Device Description

The Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head shape caused by positioning in infants three (3) to eighteen (18) months of age. As such, this device is manufactured to match patient anatomy and may only be used on the patient for which the cranial orthosis was designed. The orthosis uses contact and growth zones to guide the growth of the head. The contact zones define gentle limits for growth, while the growth zones leave space in areas required for forming the natural head shape. An adaptable closure allows for adjustability as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on the interior.

AI/ML Overview

The MyCRO Band is a cranial orthosis intended for infants aged 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including plagiocephalic, brachycephalic, and scaphocephalic-shaped heads. It works by applying mild pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. It is also indicated for adjunctive use in infants with surgically corrected synostosis who still have moderate-to-severe cranial deformities.

Because the MyCRO Band functions similarly to the predicate device (Orthomerica Products, Inc., STARband® K180109), the acceptance criteria are based on comparative testing rather than specific performance metrics. The summary provided outlines the types of non-clinical tests conducted and their successful completion, rather than specific numerical acceptance criteria.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Passed Cytotoxicity testing per ISO 10993-5:2009.
	Passed Irritation and Sensitization testing per ISO 10993-10:2010.
Scanner Evaluation	Utilized a worst-case challenge reference object of known dimensions to assess 3D imaging devices for adequate accuracy, repeatability, and reproducibility. Scanners compared to previously cleared devices and internal acceptance criteria.
Software Validation	Demonstrated software performance, interoperability, and ability to meet internal device specifications (IQ, OQ, PQ studies).
Simulated Cranial Fit	Fit Assessment performed using test samples additively manufactured from 3D images of representative simulated cranial shapes (using a previously cleared scanner).
Manufacturing Process	Included dimensional analysis and mechanical testing of test samples to evaluate additive manufacturing process performance, compared to the predicate device's process.
Indications for Use	Identical to the predicate device (K180109).
Technological Characteristics	Basic principles of operation and basic design are the same as the predicate device.

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 does not explicitly state the specific sample sizes for each test set (e.g., number of test samples for fit assessment, number of scans for scanner evaluation). It refers to "test samples" and "representative simulated cranial shapes."

The data provenance (country of origin, retrospective/prospective) is not provided in the document.

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 in the document. The testing described appears to be primarily technical and comparative against established standards or predicate device characteristics, rather than requiring expert adjudication for ground truth.

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

An adjudication method is not mentioned, likely because the tests are technical and objective (e.g., passing a specific ISO standard, dimensional analysis, repeatability metrics).

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical cranial orthosis, not an AI or imaging diagnostic tool that would involve human readers.

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

This concept is not applicable as the device is a physical cranial orthosis, not an algorithm or AI system.

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

The "ground truth" for the tests appears to be:

Biocompatibility: Established ISO standards (ISO 10993-5:2009, ISO 10993-10:2010).
Scanner Evaluation: Known dimensions of a "worst-case challenge reference object" and the performance of previously cleared devices.
Software Validation: Internal device specifications and criteria for interoperability.
Simulated Cranial Fit Assessment: The fit of manufactured samples to "representative simulated cranial shapes" derived from 3D images.
Manufacturing Process Validation: Dimensional analysis and mechanical testing, compared to the process used for the predicate device.

8. The sample size for the training set

This information is not applicable and not provided. The development and testing of this physical orthosis does not involve a "training set" in the context of machine learning.

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

This information is not applicable and not provided.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 26, 2021

Otto Bock Healthcare LP % Adrienne Von Foller Consultant Strategic Quality Solutions, LLC 1594 E Monaco Ave Salt Lake City, Utah 84121

Re: K201426

Trade/Device Name: MyCRO Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MV A Dated: February 25, 2021 Received: February 26, 2021

Dear Adrienne Von Foller:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K201426

Device Name MyCRO Band

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

Name of 510(k) Owner:	Otto Bock HealthCare LP
Address of Submitter:	3820 West Great Lakes DriveSalt Lake City, UT 84120Telephone: (801) 956-2400
Submitter Contact:	Caleb Beck,Director, Regulatory and Quality Compliance - North AmericaAdrienne von FollerRegulatory Affairs ConsultantTelephone: (801) 916-8188Email: Adrienne.SQS@gmail.com
Date Prepared:	March 26, 2021
Submission Number:	K201426
Proprietary Name:	MyCRO Band
Common Name(s):	Cranial orthosis, cranial helmet
Classification:	21 CFR 882.5970, Cranial orthosis
Device Class:	Class II
Device Product Code:	MVA
Predicate Device:	K180109 – Orthomerica Products, Inc., STARband®

Device Description

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Indications for Use

Intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, and scaphocephalicshaped heads.

Basis for Substantial Equivalence

The Ottobock MyCRO Band has the following technological characteristics which are the same as the predicate device. These include:

1. Indications for use
1. Intended use
1. Basic principles of operation
1. Basic design

Comparison of the Subject and Predicate Devices
DeviceCharacteristic	Subject Device	Predicate Device
Trade Name	MyCRO Band	STARband
Common Name	Cranial Helmet, Cranial Orthosis	Cranial Helmet, Cranial Orthosis
Manufacturer	Otto Bock HealthCare LP	Orthomerica Products, Inc.
510(k) Number	K201426	K180109
Product Code	MVA	OAN, MVA
Intended Use	Redirects head growth by maintaining contact overcranial areas which protrude and by creating voidsover areas of depression or flattening in order toimprove symmetry.	Maintains total contact over areas of bossing orprotrusion and creates voids over areas ofdepression or flattening to redirect cranial growthtoward greater symmetry.
Contraindications	Not for use on infants with pre-surgicalcraniosynostosis or hydrocephalus	Not for use on infants with synostosis orhydrocephalus
Prescriptionrequired?	Prescription Use Only	Prescription Use Only
Size Options	Patient-matched sizing by scanning an image ofpatient's head shape	Patient-matched sizing by scanning an image ofpatient's head shape or plaster mold to makepositive mold of head shape
Software Used forShape	CAD software is used to modify the shape of thescanned image to improve symmetry and shape ofthe helmet to be manufactured	Customized and/or CAD software may be used tomodify the shape of the scanned image to improvesymmetry and shape of the helmet to bemanufactured
DesignComponents	Polymer helmet with side opening closure andpadded lining	Polymer helmet with side opening closure andpadded lining
ApproximateWeight	4 – 6.5 oz	6 – 10 oz
Manufacturing Process
Additively manufacture the orthosis basedupon measurements of the infant's head takenby a previously cleared 3-dimensional imagingdevice	- Form orthosis from a positive mold of infant'shead- Positive mold is formed based uponmeasurements of the infant's head taken by anapproved 3-dimensional imaging device fromwhich a 3-dimensional image is made or from atraditional plaster cast- The 3-dimensional image is used to produce apositive mold using a 5-axis routing machine
Approved 3-DimensionalImaging Devices	Creaform HCPCreaform Peel1Creaform Peel 3DRodin4D M4D ScanTechMed3DBodyScan OMEGAScanner 3D Artec EvaArtec Eva Lite	Spectra 3D ScannerM4DScan/BodyScan SystemOmega Scanner3dMDhead System3dMDcranial System3dMDflex SystemscanGogh-IISTARscanner ISTARscanner IISmartSoc System for Android and iOS devices
Testing	Scanner Evaluation utilized a worst-case challengereference object of known dimensions to assess 3Dimaging devices for adequate accuracy,repeatability, and reproducibility. Scanners werecompared to those previously cleared for use forthe predicate device as well as internal acceptancecriteria.Software Validation demonstrated softwareperformance, interoperability, and ability to meetinternal device specifications. In addition to IQ, OQ,and PQ studies, a Fit Assessment was performedusing test samples which were additivelymanufactured from 3D images of representativesimulated cranial shapes using a previously clearedscanner.Process Validation included dimensional analysisand mechanical testing of test samples to evaluatethe additive manufacturing process performance,which was compared to the process used for thepredicate device.	Cranial Shape Capture Accuracy Study utilized arepresentative cranial shape that possesses apredefined shape with known dimensions, whichcompared proposed device to cast and predicatedevice. Associated parameters analyzed includedcoordinate planes (A-P; M-L; P-D) and variousradius parameters, squareness, and flatness.
Biocompatibility	Biocompatibility Testing- Cytotoxicity- Sensitization	Biocompatibility Testing- Cytotoxicity- Sensitization

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In addition, the subject device complies with the special controls for cranial orthoses under 21 CFR 882.5970 for the FDA product classification, including labeling and biocompatibility test requirements.

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Summary of Testing

The following non-clinical tests were conducted and successfully met the pre-determined acceptance criteria (where testing was performed according to a recognized consensus standard, the designation number of the standard is referenced):

1. Cytotoxicity testing per ISO 10993-5:2009 (Recognition Number: 2-245)
1. Irritation and Sensitization testing per ISO 10993-10:2010 (Recognition Number: 2-174)
1. Scanner evaluation, including repeatability/reproducibility study
1. Validation of software workflow
1. Simulated Cranial Fit Assessment
1. Validation of additive manufacturing process

Conclusion

The MyCRO Band has identical indications for use as the predicate device in K180109. The fundamental technological characteristics of the MyCRO Band are the previously cleared predicate device. All testing passed acceptance criteria and demonstrate that the subject device is substantially equivalent to the predicate device.

Based on similarities in indications for use, basic design, and the principle of operation, the Ottobock MyCRO Band is substantially equivalent to the previously cleared 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)).