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 synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, 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 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 provided text describes a 510(k) submission for a medical device called "MyCRO Band," a cranial orthosis used for infants with positional plagiocephaly. However, the document does not contain the information necessary to describe acceptance criteria and a study proving device performance as requested in the prompt.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (STARband®) based on similar indications for use, intended use, basic principles of operation, and basic design, along with non-clinical testing. It mentions "Scanner Evaluation utilized a worst-case challenge reference object of known dimensions to assess 3D imaging devices for adequate accuracy, repeatability, and reproducibility" and "Verification testing included dimensional analysis, fit assessment, and mechanical testing of test samples," but it does not provide:

A table of specific acceptance criteria and reported device performance values related to clinical outcomes or direct head shape correction metrics.
Sample sizes for a clinical test set (as the described tests are non-clinical).
Data provenance (country of origin, retrospective/prospective).
Information on experts establishing ground truth or adjudication methods.
Any multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone algorithm performance (as this is a physical orthosis, not an AI/algorithm-based device).
Type of ground truth used related to clinical efficacy.
Training set sample size or ground truth establishment for a training set (again, not an AI/algorithm device).

The "Summary of Testing" section lists:

Biological evaluation per ISO 10993-1:2018
Cytotoxicity testing per ISO 10993-5:2009
Irritation and Sensitization testing per ISO 10993-10:2010
Scanner evaluation, including repeatability/reproducibility study
Verification testing

While these tests "successfully met the predetermined acceptance criteria," the specific criteria and the detailed results demonstrating the device's efficacy in correcting cranial deformities (beyond dimensional accuracy of the scanner or fit of the orthosis) are not provided in this 510(k) summary. These are typically covered in a more detailed study report that is part of the full 510(k) submission but not included in this high-level summary.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and proven device performance based solely on the provided text. The text focuses on the engineering and biocompatibility aspects for demonstrating substantial equivalence rather than a detailed clinical performance study as would be seen for an AI/algorithm device or a device with novel mechanisms of action requiring extensive clinical validation.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

June 9, 2022

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

Re: K213587

Trade/Device Name: MyCRO Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: May 11, 2022 Received: May 13, 2022

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

{1}------------------------------------------------

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 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K213587

Device Name MyCRO Band

Indications for Use (Describe)

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)	☐

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 ConsultantStrategic Quality Solutions, LLCTelephone: (801) 916-8188Email: Adrienne@device2market.com
Date Prepared:	June 9, 2022
Submission Type:	Traditional 510(k)
Proprietary Name:	MyCRO Band
Common Name(s):	Cranial orthosis
Classification:	21 CFR 882.5970, Cranial orthosis
Device Class:	Class II
Device Product Code:	MVA, OAN
Predicate Device:	K180109 - Orthoamerica Products, Inc., STARband®
Reference Device:	K201426 - Otto Bock HealthCare LP, MyCRO Band

Device Description

{4}------------------------------------------------

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	Reference 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	K213587	K201426	K180109
Product Code	MVA, OAN	MVA	OAN, MVA
Intended Use	Redirects head growth by maintaining contact over cranialareas which protrude and by creating voidsover areas of depression or flattening in order to improvesymmetry.		Maintains total contact over areas of bossingor protrusion and creates voids over areas ofdepression or flattening to redirect cranialgrowth toward 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 of patient'shead shape		Patient-matched sizing by scanning animage of patient's head shape or plastermold to makepositive mold of head shape
Software Used forShape	CAD software is used to modify the shape of the scannedimage to improve symmetry and shape of the helmet to bemanufactured		Customized and/or CAD software may beused to modify the shape of the scannedimage to improve symmetry and shape of thehelmet to bemanufactured
DesignComponents	Polymer helmet with side opening closure and paddedlining		Polymer helmet with side openingclosure and padded lining
ApproximateWeight	4 — 6.5 oz		6 — 10 oz
Device Characteristic	Subject Device	Reference Device	Predicate Device
Manufacturing Process	Additively manufacture the orthosis based upon measurements of the infant's head taken by a compatible 3-dimensional imaging device	Additively manufacture the orthosis based upon measurements of the infant's head taken by a compatible 3-dimensional imaging device	- Form orthosis from a positive mold of infant's head- Positive mold is formed based upon measurements of the infant's head taken by an approved 3-dimensional imaging device from which a 3-dimensional image is made or from a traditional plaster cast- The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine
Compatible3-DimensionalImaging Devices	Creaform HCPCreaform Peel1Creaform Peel 3DRodin4D M4D ScanTechMed3D BodyScanOMEGA Scanner 3DArtec EvaArtec Eva LiteiFab EasyScan	Creaform HCPCreaform Peel1Creaform Peel 3DRodin4D M4D ScanTechMed3D BodyScanOMEGA Scanner 3DArtec 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 challenge reference object of known dimensions to assess 3D imaging devices for adequate accuracy, repeatability, and reproducibility. The iFab EasyScan was compared to scanners previously cleared for use as well as internal acceptance criteria.Verification testing demonstrated software performance, interoperability, and ability to meet internal device specifications. Verification testing included dimensional analysis, fit assessment, and mechanical testing of test samples to evaluate the iFab EasyScan as part of the manufacturing process performance, which was compared to the process used for the predicate device.	Scanner Evaluation utilized a worst-case challenge reference object of known dimensions to assess 3D imaging devices for adequate accuracy, repeatability, and reproducibility. Scanners were compared to those previously cleared for use for the predicate device as well as internal acceptance criteria.Software Validation demonstrated software performance, interoperability, and ability to meet internal device specifications. In addition to IQ, OQ, and PQ studies, a Fit Assessment was performed using test samples which were additively manufactured from 3D images of representative simulated cranial shapes using a compatible scanner.Process Validation included dimensional analysis and	Cranial Shape Capture Accuracy Study utilized a representative cranial shape that possesses a predefined shape with known dimensions, which compared proposed device to cast and predicate device. Associated parameters analyzed included coordinate planes (A-P; M-L; P-D) and various radius parameters, squareness, and flatness.
Comparison of the Subject and Predicate Devices
DeviceCharacteristic	Subject Device	Reference Device	Predicate Device
		samples to evaluate theadditive manufacturingprocess performance, whichwas compared to theprocess used for thepredicate device.
Biocompatibility	Biocompatibility Testing• Cytotoxicity• Sensitization• Irritation		Biocompatibility Testing• Cytotoxicity• Sensitization• Irritation

{5}------------------------------------------------

{6}------------------------------------------------

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

Summary of Testing

The following non-clinical tests were conducted and successfully met the predetermined acceptance criteria:

1. Biological evaluation per ISO 10993-1:2018
1. Cytotoxicity testing per ISO 10993-5:2009
1. Irritation and Sensitization testing per ISO 10993-10:2010
1. Scanner evaluation, including repeatability/reproducibility study
1. Verification testing

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 demonstrated 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)).