BECKER BAND CRANIAL REMOLDING ORTHOSIS

K013719 · Becker Orthopedic Appliance Co. · MVA · Feb 5, 2002 · Neurology

Device Facts

• Record ID: K013719
• Device Name: BECKER BAND CRANIAL REMOLDING ORTHOSIS
• Applicant: Becker Orthopedic Appliance Co.
• Product Code: MVA · Neurology
• Decision Date: Feb 5, 2002
• 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 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

BeckerBand™ is a custom-fabricated cranial remolding orthosis (helmet) used to treat positional plagiocephaly in infants. Fabrication involves taking a plaster-of-paris impression of the infant's head to create a positive mold. The mold is modified by building up areas to create space for growth while the orthosis applies gentle pressure to prominent cranial regions. The device is worn by the infant; it is managed by clinicians. It functions as a passive mechanical corrective device to guide cranial growth toward a more symmetrical shape. No electronic or software components are involved.

Clinical Evidence

No clinical trials were conducted for this submission. The manufacturer provided a comprehensive review of existing literature to support the safety and effectiveness of cranial remolding orthoses for the treatment of positional plagiocephaly.

Technological Characteristics

Thermoplastic helmet; outer shell of polypropylene or polypropylene-polyethylene copolymer; inner lining of medium density polyethylene foam. USP Class VI materials. Passive mechanical device; no energy source. Custom-fabricated via plaster-of-paris impression and positive mold modification.

Indications for Use

Indicated for infants 3-18 months old with moderate to severe non-synostotic positional plagiocephaly (plagiocephalic, brachycephalic, or scaphocephalic head 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

• Doc Band (K964499)
• OPI Band (K001167)
• Craniocap (K000861)
• Cranial Molding Orthosis (K010273)

Submission Summary (Full Text)

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

### FEB 0 5 2002 510(k) SUMMARY OF SAFETY AND EFFECTIVENISS

I. Submitter; Dr. James H. Campbell, Becker Orthopedic, Troy, Michigan, Ph. 248-588-6961

II. Classification: Class II.

III. Common or usual name: Cranial orthosis

IV, Proprictary Name: BeckerBand™ Cranial Remolding Orthosis

IV. Registration No.: 1824252

V. Classification Name: Cranial Orthosis, Code MVA, CFR 882.5970

VI. Performance standards: None, Special Controls required.

VII, Description: The BeckerBand™ is a thermoplastic helmet prepared with USP Class VI materials, consisting of a polypropylene or polypropylene-polyethylenc copolymer outer sholl. To this shell is thermobonded a modium density polychylone form inner lining. The device is fabricated by talany a plaster-of-paris impression of the infants head. This immession is filled with a plaster shorize a positive mold of the skull. The deformity is corrected to the desired configuration by building the inold up in selected areas with molding material. This corrected model serves as a template for pregaration of the Bocker Band orthosis, The completed device applies gentle pressure to the clovated arcus of the skull while leaving space for cranial growth in the depressed regions.

VIII. Labels and Labels and Instructions for Use are provided including precautions, and materials required by the special controls to which this product is subject.

IX. Instructions for Use: For treatment of positional plagiocephaly.

X. Substantial Equivalence: The BockerBand 146 is substantially equivalent to the classified device (Cranial Orthosis), to the Doc Band device of Cranial Technology, cleared under K-9644992, the OPI Band cleared by Orthouserica Products, Inc. in K-001167, the Craniocap cleared by Gilette Childrens, in K-000861, and the Cranial Molding Orthosis cleared by Orthotic Solutions in K-010273. The devices are made of similar if not identical materials widely used in the orthotic industry, by well-known technology, under carefully controlled conditions, The BeckerBand" complies with the Class II special controls cstablished for this device in the classification process to provide assurance of safety and effectiveness.

The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed.

Xf. Clinical Discussion and Literature: A comprehensive review of the Sierature was provided.

XII. Indications for Use

Intended for medical purposes to apply pressure to prominant regions of an inforts crazing to inprove cranial symmetry or shape. To treat inflants from the of are with moderate to severe non-synostonal playiocuphaly, including plagiocophalic- brachycephalic- scaphocophalic-shaped heads.

Contraindications for use: Infants with synostosis or hydrocephalus.

(End of Summary)

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized image. The stylized image resembles a bird or abstract human figure, composed of three curved lines. The logo is printed in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2002

James H. Campbell, Ph.D. Director, Product Development Engineering & Tech Services Becker Orthopedic Appliance Company 635 Executive Dr. Troy, Michigan 48083

Re: K013719

Trade/Device Name: BeckerBand™ Cranial Remolding Orthosis Regulation Number: 21 CFR 890.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: November 3, 2001 Received: November 8, 2001

Dear Dr. Campbell:

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.

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

Page 2 - Dr. James H. Campbell

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wif anow you to ough finding of substantial equivalence of your device to a legally prematics notification. The 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 and If you desire spoonly at not 10- 75- 10-2 in vitro diagnostic devices), please contact the Office of additionally 21 Of ICT Car 3659. Additionally, for questions on the promotion and advertising of Compliance at (201) 27 Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oinsion 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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark N Melkersen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

KOLIZ 719 510(k) Number: NA

# Device Name: BeckerBand™

## Indications for Use:

Intended for medical purposes to apply 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.

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

ದ

# Concurrence of CDRH, Office of Device, Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

Or

Over-The-Counter Use (Optional Format 1-2-96)

I CFR 801.109)

(Division Sign-Off)

:

Division of General, Restorative

013719

and Neurological Devices

510(k) Number