BALLERT CRANIAL MOLDING HELMET

K011433 · Gema, Inc. · MVA · Jun 12, 2001 · Neurology

Device Facts

• Record ID: K011433
• Device Name: BALLERT CRANIAL MOLDING HELMET
• Applicant: Gema, Inc.
• Product Code: MVA · Neurology
• Decision Date: Jun 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Ballert Cranial Molding Helmet is intended for use by or under the direction of a physician 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-and brachycephalic-shaped heads.

Device Story

Ballert Cranial Molding Helmet is a custom-fitted orthosis used to treat nonsynostotic positional plagiocephaly in infants. Device applies controlled pressure to prominent cranial regions to guide skull growth toward a more symmetrical shape. Used under physician direction; typically worn by infant. Benefits include correction of cranial deformities. No electronic components, software, or automated processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Custom-molded cranial orthosis. Passive mechanical device. No energy source, software, or connectivity. Materials and construction consistent with standard orthotic practices for cranial molding.

Indications for Use

Indicated for infants 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic and brachycephalic head shapes, to improve cranial symmetry and/or shape.

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.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

JUN 1 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GEMA, Inc. Mr. Gene Bernardoni President c/o Ballert Orthopedic 2434 West Peterson Avenue Chicago, Illinois 60659

Re: K011433

Trade Name: Ballert Cranial Molding Helmet Regulation Number: 882.5970 Regulatory Class: II Product Code: MV A Dated: May 4, 2001 Received: May 10, 2001

Dear Mr. Bernardoni:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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## Page 2 - Mr. Gene Bernardoni

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

DSmtchell RUA tos

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

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# Indications for Use Statement

Applicant: Ballert Orthopedic

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ballert Cranial Molding Helmet

Indications For Use:

The Ballert Cranial Molding Helmet is intended for use by or under the direction of a physician 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-and brachycephalic-shaped heads.

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

OR Over The Counter Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Per 21 CFR, 801.109)

(Optional Format 1-2-96)

Armnkeeeeno por cur

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K011432