MyCRO Band

K201426 · Otto Bock Healthcare LP · MVA · Mar 26, 2021 · Neurology

Device Facts

• Record ID: K201426
• Device Name: MyCRO Band
• Applicant: Otto Bock Healthcare LP
• Product Code: MVA · Neurology
• Decision Date: Mar 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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-, 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 Story

MyCRO Band is a custom-made, non-sterile cranial orthosis for infants 3-18 months. Input consists of 3D head scans captured by cleared imaging devices; CAD software modifies scan data to design the helmet shape. Device uses contact zones (to limit growth at protrusions) and growth zones (to allow expansion at depressions) to guide cranial development. Manufactured via additive manufacturing; features thermoplastic shell with soft, washable interior lining and adjustable side closure. Used in clinical settings by healthcare providers to treat positional plagiocephaly or post-surgical deformities. Provider uses output to guide head growth toward symmetry; benefits include improved cranial shape and symmetry.

Clinical Evidence

Bench testing only. No clinical data. Evidence includes biocompatibility testing (ISO 10993-5:2009, ISO 10993-10:2010), scanner evaluation for accuracy/repeatability/reproducibility, software workflow validation, simulated cranial fit assessment using additively manufactured test samples, and additive manufacturing process validation.

Technological Characteristics

Thermoplastic polymer helmet with soft, washable interior lining. Features adjustable side-opening closure. Dimensions are patient-matched via 3D scanning. Additive manufacturing process. Biocompatibility per ISO 10993-5 and ISO 10993-10. Non-sterile.

Indications for Use

Indicated for infants 3-18 months with moderate-to-severe non-synostotic positional plagiocephaly (plagiocephalic, brachycephalic, scaphocephalic) to improve cranial symmetry/shape via mild pressure. Also indicated as adjunctive therapy post-surgical correction of synostosis for infants 3-18 months with residual moderate-to-severe cranial deformities. Contraindicated for infants with pre-surgical craniosynostosis or hydrocephalus.

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

• STARband (K180109)

Submission Summary (Full Text)

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

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="font-size:1.2em">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:1.2em">☐</span> 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 Drive<br>Salt Lake City, UT 84120<br>Telephone: [phone] |
| Submitter Contact: | Caleb Beck,<br>Director, Regulatory and Quality Compliance - North America<br>Adrienne von Foller<br>Regulatory Affairs Consultant<br>Telephone: [phone]<br>Email: [e-mail] |
| 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

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.

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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
- 2. Intended use
- 3. Basic principles of operation
- 4. Basic design

| Comparison of the Subject and Predicate Devices | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Characteristic | 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 over<br>cranial areas which protrude and by creating voids<br>over areas of depression or flattening in order to<br>improve symmetry. | Maintains total contact over areas of bossing or<br>protrusion and creates voids over areas of<br>depression or flattening to redirect cranial growth<br>toward greater symmetry. |
| Contraindications | Not for use on infants with pre-surgical<br>craniosynostosis or hydrocephalus | Not for use on infants with synostosis or<br>hydrocephalus |
| Prescription<br>required? | Prescription Use Only | Prescription Use Only |
| Size Options | Patient-matched sizing by scanning an image of<br>patient's head shape | Patient-matched sizing by scanning an image of<br>patient's head shape or plaster mold to make<br>positive mold of head shape |
| Software Used for<br>Shape | CAD software is used to modify the shape of the<br>scanned image to improve symmetry and shape of<br>the helmet to be manufactured | Customized and/or CAD software may be used to<br>modify the shape of the scanned image to improve<br>symmetry and shape of the helmet to be<br>manufactured |
| Design<br>Components | Polymer helmet with side opening closure and<br>padded lining | Polymer helmet with side opening closure and<br>padded lining |
| Approximate<br>Weight | 4 – 6.5 oz | 6 – 10 oz |
| Manufacturing Process | | |
| Additively manufacture the orthosis based<br>upon measurements of the infant's head taken<br>by a previously cleared 3-dimensional imaging<br>device | - Form orthosis from a positive mold of infant's<br>head<br>- Positive mold is formed based upon<br>measurements of the infant's head taken by an<br>approved 3-dimensional imaging device from<br>which a 3-dimensional image is made or from a<br>traditional plaster cast<br>- The 3-dimensional image is used to produce a<br>positive mold using a 5-axis routing machine | |
| Approved 3-<br>Dimensional<br>Imaging Devices | Creaform HCP<br>Creaform Peel1<br>Creaform Peel 3D<br>Rodin4D M4D Scan<br>TechMed3D<br>BodyScan OMEGA<br>Scanner 3D Artec Eva<br>Artec Eva Lite | Spectra 3D Scanner<br>M4DScan/BodyScan System<br>Omega Scanner<br>3dMDhead System<br>3dMDcranial System<br>3dMDflex System<br>scanGogh-II<br>STARscanner I<br>STARscanner II<br>SmartSoc System for Android and iOS devices |
| Testing | Scanner Evaluation utilized a worst-case challenge<br>reference object of known dimensions to assess 3D<br>imaging devices for adequate accuracy,<br>repeatability, and reproducibility. Scanners were<br>compared to those previously cleared for use for<br>the predicate device as well as internal acceptance<br>criteria.<br><br>Software Validation demonstrated software<br>performance, interoperability, and ability to meet<br>internal device specifications. In addition to IQ, OQ,<br>and PQ studies, a Fit Assessment was performed<br>using test samples which were additively<br>manufactured from 3D images of representative<br>simulated cranial shapes using a previously cleared<br>scanner.<br><br>Process Validation included dimensional analysis<br>and mechanical testing of test samples to evaluate<br>the additive manufacturing process performance,<br>which was compared to the process used for the<br>predicate device. | Cranial Shape Capture Accuracy Study utilized a<br>representative cranial shape that possesses a<br>predefined shape with known dimensions, which<br>compared proposed device to cast and predicate<br>device. Associated parameters analyzed included<br>coordinate planes (A-P; M-L; P-D) and various<br>radius parameters, squareness, and flatness. |
| Biocompatibility | Biocompatibility Testing<br>- Cytotoxicity<br>- Sensitization | Biocompatibility Testing<br>- Cytotoxicity<br>- 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)
- 2. Irritation and Sensitization testing per ISO 10993-10:2010 (Recognition Number: 2-174)
- 3. Scanner evaluation, including repeatability/reproducibility study
- 4. Validation of software workflow
- 5. Simulated Cranial Fit Assessment
- 6. 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.