STATIC CRANIOPLASTY ORTHOSIS

K063098 · Boston Brace Intl., Inc. · OAN · Apr 11, 2007 · Neurology

Device Facts

• Record ID: K063098
• Device Name: STATIC CRANIOPLASTY ORTHOSIS
• Applicant: Boston Brace Intl., Inc.
• Product Code: OAN · Neurology
• Decision Date: Apr 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Static Cranioplasty Orthosis is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes.

Device Story

Custom-fabricated cranial orthosis for infants 3-18 months with positional plagiocephaly. Input: physical cast of infant head or 3D scan via STARscanner. Processing: practitioner performs mathematical analysis and plaster/foam model modification to design orthosis. Output: static orthosis consisting of thermoformable plastic outer shell and hypoallergenic polyethylene foam liner. Used in clinical setting; fitted and monitored by practitioner. Device applies passive pressure to prominent cranial regions to guide skull growth into created voids. Benefits: improves cranial symmetry/shape; may reduce need for surgical intervention. Caregiver monitors skin and wear schedule.

Clinical Evidence

Clinical effectiveness supported by literature (Jeff Larson, CO:JPO 2004, Vol 16, Num 4s). Studies indicate cranial orthoses are significantly effective in correcting abnormal head shape without relapse and may improve outcomes for surgical candidates. Safety established via biocompatibility assessments of materials (polyethylene foam, copolymer shell).

Technological Characteristics

Custom-molded cranial orthosis. Materials: thermoformable plastic outer shell, 5-6 layers of hypoallergenic polyethylene foam liner. Energy source: none (passive). Connectivity: none. Sterilization: N/A. Fabrication: manual modification of cast/scan based on practitioner analysis.

Indications for Use

Indicated for infants 3-18 months of age with abnormally shaped craniums (plagiocephalic, brachycephalic, or scaphocephalic) and no outstanding cranial abnormalities. Requires physician prescription following assessment to rule out craniosynostosis. Contraindicated for infants with 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 Cranial Remolding Orthosis (K011350)

Submission Summary (Full Text)

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Ka63098

APR 1 1 2007

## 510 K Summary of Effectiveness and Safety

The following summary is provided in pursuant to Section 513 (1)(3)(A) of the Federal Food, Drug and Cosmetic Act.

#### 1) Applicant Information

i) Submitter: Boston Brace International, Inc., 20 Ledin Drive, Avon, MA 02322

ii) Contact: James Wynne, CPO, Director of Education, Boston Brace International.

Telephone [phone] ext. 244

- iii) Summary Date .- Feb 16, 2006 V B.
## 2) Device Name and Classification:

- i) Proprietary Name: Boston Band Cranial remolding Orthosis
- ii) Common Name: Cranial Orthosis
- iii) Classification Name: Cranial Orthosis, laser scan. OAN
- iv) Predicate Device: STARband Cranial Remolding Orthosis, (K011350), classified under 21 CFR £ 882.5970

#### 3) Device Description

The Static Cranioplasty Orthosis is a cranial orthosis used to treat abnormally shaped craniums in infants three to 18 months of age. This condition is clinically known as positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattenedareas of the skull into the created spaces. The Static Cranioplasty Orthosis is only available if prescribed by a physician.

The orthosis is custom designed for each patient from a cast of the infant's head or a scan using the STARscanner from Orthomerica . The mold, either plaster from the cast, or foam from the scan, is modified and prepared for fabrication by the treating practitioner using mathematical analyses and plaster modification techniques. The orthosis is then fabricated under the direction of the same practitioner. Each orthosis is composed of an outer shell of thermoformable plastic, 5-6 layers of hypoallergenic polyethylene foam and a strap for securing the orthosis. Optimum fit and alignment is insured and monitored by the same clinical practitioner.

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## 4) Intended Use

The Static Cranioplasty Orthosis is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes.

## 5) Comparison to Predicate Device

The Static Cranioplasty Orthosis and the predicate device are very similar with respect to production, instructions for use, materials, safety and effectiveness and special controls. The main difference is the use of Velcro hook strap attached to a self adhesive loop, versus a chafe loop system, and the thickness and layers of the polyethylene foam. The thin layers of foam allow selective voids to aid in the ability to guide growth.

The material is handled in an identical manner to the polymer used in the predicate device, incorporating all of the safety and standards of practice. The proposed indications of use are analogous to those presented by the predicate device, and biocompatibility, function and effectiveness further parallel those of the predicate device.

See table next page.

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| Labeling | Predicate Device | Proposed device | | | |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Indications | Infants, 3 -18 months of age, with abnormally<br>shaped craniums with no outstanding cranial<br>abnormalities that have a RX from a physician who<br>has assessed the child to rule out Craniosynostosis | Same | | | |
| | Contraindications | Infants with Craniosynostosis or hydrocephalus | Same | | |
| | Warnings | Evaluate head circumference measurements and<br>neurological status at intervals appropriate to the<br>infant's age and rate of growth. Describe to caregiver<br>steps that should be taken to reduce the potential<br>restrictions of cranial growth and possible<br>impairments to brain growth and development. A<br>clinician or caregiver must evaluate the patient's skin<br>at frequent intervals. | Same | | |
| | | Precautions | If the positional plagiocephaly is associated with<br>torticollis, the torticollis must also be treated.<br>Evaluate the device's structural integrity and fit it<br>according to fitting instructions. Wear and care guide<br>to be reviewed and provided to caregiver.(copy<br>attached) | Same | |
| Adverse Effects | | | This device may cause skin irritations or breakdown | Same | |
| Intended use | | | Intended for medical purposes to passively hold<br>prominent cranial regions of an infant's skull in<br>order to improve cranial symmetry and or shape in<br>infants with plagiocephaly, including infants with<br>plagiocephalic, brachycephalic, and scaphocephalic<br>patterned head shapes | Same | |
| | | | Instructions for Use | Wear and care guide provided to caregiver | Same |
| | | | Expiration date | When the infant outgrows the cranial helmet or the<br>orthosis is discontinued for any reason, the referring<br>physician is contacted. If an other helmet is<br>requested by the family to try to further correction,<br>refer back to their physician for reevaluation and a<br>new prescription. | Same |
| | | | | | |

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## 6) New Performance Data

- 1) The effectiveness of the Static Cranioplasty Orthosis has been established through clinical trials. (Ottoto: Treatment Protocols for Plagiocephaly, Jeff Larson, CO:JPO 2004, Vol 16, Num 4s). The effects of treatment with cranial orthoses on infants have concluded that the devices are significantly effective in correcting abnormal head shape, without evidence of relapse following treatment. Treatment with cranial orthoses is reported to improve the results of surgical correction of severe cases, often eliminating the need for further surgical intervention. The predicate device is fabricated using th same techniques and materials ( From Biocompatability: The predicate device designed by Orthomerica( K011350) incorporates an outer 3/16 Copolymer shell lined on its interior with a medium durometer crosslinked Polyethylene Foam, Volara(Ali-plast) lining (Per web site www.orthomerica.com/products/cranial/starband.htm) Description of Orthosis
The safety of the cranial orthoses is established under standard biocompatibility assessments for each material used. These assessments reveal that the device and the materials

- · Side-opening band
- · Proximal Opening
- · 3/16" copolymer shell
- 1/2" polyethylene foam liner
- · 1 1/2" Velcro@ strap and chafe closure

used are not expected to adversely affect the infants under the intended conditions of wear.(Polyethylene foam is commonly used to line orthoses) The materials are not reported to cause skin irritation or any toxic effects. Further, the product is designed to avoid improper migration or harmful levels of pressure. The interior of the device is smooth and poses no significant threat to the child during application within the normal scope of its intended use.

#### 7) Summary

The safety and effectiveness information submitted to the FDA establishes that the Boston Band Cranial Remolding Orthosis is safe and effective for its intended use and is substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1 2007

Boston Brace International % Mr. James Wynne, CPO Director of Education/Training 20 Ledin Drive Avon, Massachusetts 02322

Re: K063098

Trade/Device Name: Boston Band Cranial Remolding Orthosis Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: OAN Dated: February 16, 2007 Received: February 22, 2007

Dear Mr. Wynne:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. James Wynne, CPO

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Bush

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K063098

Boston Band Cranial Remolding Orthosis Device Name:

Indications For Use:

Infants. 3 - 18 months of age, with abnormally shaped craniums with no outstanding cranial abnormalities that have a RX from a physician who has assessed the child to rule out craniosynostosis.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buehrn

Division of General, Restorative, and Neurological Devices

**510(k) Number** K063098

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