Hanger Cranial Band 3D

K203134 · Symbion Logistics, LLC · MVA · Jul 1, 2022 · Neurology

Device Facts

• Record ID: K203134
• Device Name: Hanger Cranial Band 3D
• Applicant: Symbion Logistics, LLC
• Product Code: MVA · Neurology
• Decision Date: Jul 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

Device Story

Custom-fabricated cranial remolding orthosis; treats positional plagiocephaly in infants. Input: 3D laser scan of infant cranium. Process: CAD/CAM software modifies scan to create positive mold via routing machine; additive-manufactured thermoplastic resin (nylon polyamide) outer shell attached to polyethylene foam liner. Output: Helmet applying gentle pressure to prominent skull regions while allowing growth in depressed areas. Used in clinical settings by orthotists; worn by infants up to 23 hours/day. Output guides clinical fit and cranial reshaping; benefits patient by correcting skull symmetry.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including biocompatibility, tensile strength, drop testing, and chemical testing of the outer shell material, alongside validation of manufacturing geometry and dimensional tolerances.

Technological Characteristics

Cranial orthosis; outer shell of 2mm thermoplastic resin (nylon polyamide); inner liner of 1/2" polyethylene foam. Custom-fabricated via 3D laser scanning and CAD/CAM routing. Fastened with Velcro straps, chafe/loop, and rivets. Biocompatible materials.

Indications for Use

Indicated for infants 3-18 months old with moderate to severe non-synostotic positional plagiocephaly (plagiocephalic, brachycephalic, or scaphocephalic shapes). Contraindicated for infants with synostosis 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

• Hanger Cranial Band (K072566)

Submission Summary (Full Text)

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July 1, 2022

Symbion Logistics, LLC Roselle Abad Quality Engineer 1119 W Geneva Dr Tempe, Arizona 85281

Re: K203134

Trade/Device Name: Hanger Cranial Band 3D Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: September 30, 2021 Received: October 4, 2021

Dear Roselle Abad:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (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 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) K203134

Device Name HANGER CRANIAL BAND 3D

### Indications for Use (Describe)

Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

Contraindications for use: Infants with synostosis or hydrocephalus.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary K203134

- l. Application Information
- A. Applicant Name and Address

Symbiont Logistics, LLC (dba Hanger Fabrication Network) 302 E University Dr, Suite 301 Phoenix, AZ 85042 T: 480-894-1755 F: 480-921-9686

FDA Establishment Registration Number: 2032381

- B. Submission Correspondent
Roselle Abad Quality Engineer, Hanger Fabrication Network (Symbiont Logistics, LLC) T: 480-894-1755, [e-mail]

- C. Contact Person
Antonio Dias Engineering Director, Hanger Fabrication Network (Symbiont Logistics, LLC) T: 480-894-1755, [e-mail]

- D. Summary Date June 27, 2022
#### II. Submission Information

- A. Trade or Proprietary Name:
- B. Common Name:
- C. Regulation Classification:
- D. Regulation Number:
- E. Product Code:
- F. Panel:
- G. Device Class:
- H. Predicate Device 510(k):

Hanger Cranial Band 3D Cranial Orthosis, Helmet Orthosis, Cranial, Laser Scan 882.5970 MVA, OAN Neurology = Hanger Cranial Band, K072566

- lll. Device Description
The Hanger Cranial Band 3D is a cranial remolding orthosis comprised of an additivemanufactured outer shell with a polyethylene foam inner lining.

The device is custom fabricated for individual patients by obtaining measurements via a handheld 3D laser scanner. Clinical measurements of the infant's cranium are taken from the digital file. The scan is then modified utilizing a CAD/CAM technology package—to add or remove material, increase or decrease the circumference of model to aid in fit and

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functionality of the cranial orthosis. The 3D image is used to produce a positive mold using a routing machine, to which the foam liner is pulled onto. The 3D file is also used manufacture the outer shell, which is then attached to the foam-lined positive model.

The completed device applies gentle pressure to the elevated areas of the skull while leaving space for cranial growth in the depressed regions. It is open at one side and closed with a fastener to provide the selected fit and proper stability.

- IV. Indication for Use Statement
Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

Contraindications for use: Infants with synostosis or hydrocephalus.

#### V. Substantial Equivalence Discussion

The comparison chart below provides evidence to facilitate the substantial equivalence determination between Hanger Cranial Band 3D to the predicate device, Hanger Cranial Band (K0272566) with respect to intended use, technological characteristics and principles of operation.

| Features | Predicate Device<br>Hanger Cranial Band, K072566 | Proposed Device<br>Hanger Cranial Band 3D |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/<br>Indications for Use | Intended for medical purposes to apply<br>static or gentle pressure to prominent<br>regions of an infant's cranium to improve<br>cranial symmetry or shape. To treat<br>infants from three to eighteen months of<br>age with moderate to severe non-<br>synostotic positional plagiocephaly,<br>including plagiocephalic-, brachycephalic-,<br>scaphocephalic-shaped heads. | Intended for medical purposes to apply<br>static or gentle pressure to prominent<br>regions of an infant's cranium to improve<br>cranial symmetry or shape. To treat infants<br>from three to eighteen months of age with<br>moderate to severe non-synostotic<br>positional plagiocephaly, including<br>plagiocephalic-, brachycephalic-,<br>scaphocephalic-shaped heads. |
| | Contraindications for use: Infants with<br>synostosis or hydrocephalus. | Contraindications for use: Infants with<br>synostosis or hydrocephalus. |
| OTC and/or Rx | Rx | Rx |
| Clinical Population | Infants age 3-18 months | Infants age 3-18 months |
| Daily Wear Time | Up to 23 hrs/day | Up to 23 hrs/day |
| Materials | Outer shell of 5/32" copolymer plastic Inner liner of 1/2" polyethylene foam | Outer shell of 2mm thermoplastic resin, nylon polyamide Inner liner of 1/2" polyethylene foam |

## Table 1 – Comparison of Characteristics

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| | Velcro strap, 1 ½" Chafe and loop, 1 ½" Speedy rivet, 91X | Velcro strap, 1 ½" Chafe and loop, 1 ½" Speedy rivet, 91X |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Production | Measurement of infant's head taken by a 3D scanner from which a 3D image is made. The 3D image is used to produce a positive mold using a routing machine. Form orthosis from the positive mold of infant's head. | Measurement of infant's head taken by a 3D scanner from which a 3D image is made. The 3D image is used to produce a positive mold using a routing machine. Form orthosis from the positive mold of infant's head. |

#### VI. Technological Characteristics

The polyethylene foam liner used in both proposed and predicate devices remains identical-- this is the device component that maintains skin contact during treatment.

Hanger Cranial Band 3D differs from the predicate device through the material used for the outer shell. The material used comprises of a thermoplastic resin, nylon polyamide, with fusing and detailing agents, and has passed biocompatibility and non-clinical bench tests. Further discussion of the material can be found in Section 12 (Substantial Equivalence Discussion).

#### VII. Non-Clinical Performance Data

There are no performance standards applicable to the subject device as established by FDA under section 514. Non-clinical test were performed based on typical handling of cranial orthoses.

- . Both outer shell and inner foam lining were tested and found to be biocompatible (reference Section 15).
- Tensile stress testing was conducted on the outer shell material of the subject device, in comparison to typical tensile strength values of the predicate device's outer shell. Average tensile strength value of the Hanger Cranial Band 3D was found to be higher than the copoly plastic values.
- Drop and chemical tests were performed on the outer shell and had passed the attribute acceptance criteria.
- Validation activities were performed and demonstrated that the device can be reliably manufactured with the intended geometry and dimensional tolerances based upon patient-specific scan information.

#### VIII. Clinical Performance Data

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There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The predicate device has been on the market for years with a proven safety and efficacy for the use of the device.

#### IX. Conclusion/Statement of Substantial Equivalence

Hanger Cranial Band 3D has the same intended use as the predicate device, Hanger Cranial Band (K072566). The technological difference do not raise any questions regarding Hanger Cranial Band 3D's safety and effectiveness.

The information provided in this submission supports the substantial equivalence to the predicate device.