CRANIAL SYMMETRY SYSTEM

K022273 · Beverly Hills Prosthetics Orthotics, Inc. · MVA · Sep 9, 2002 · Neurology

Device Facts

• Record ID: K022273
• Device Name: CRANIAL SYMMETRY SYSTEM
• Applicant: Beverly Hills Prosthetics Orthotics, Inc.
• Product Code: MVA · Neurology
• Decision Date: Sep 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' three to eighteen months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants' with plagiocephalic and brachycephalic shaped heads. The sale and distribution of the device is restricted to prescription use in accordance with 21CFR801.109

Device Story

Cranial orthosis helmet; custom-fabricated via vacuum forming polypropylene shell and Aliplast foam liner over modified plaster cast of infant skull. Provides passive pressure to prominent cranial areas while creating space for growth in flattened areas. Features Velcro chinstrap for suspension and ventilation holes. Used in clinical settings; prescribed by physicians; fitted by orthotists. Improves cranial symmetry in infants with positional plagiocephaly. Benefits include non-invasive correction of skull shape without restricting brain growth.

Clinical Evidence

No clinical data provided for the subject device. Relies on literature references regarding helmet treatment for plagiocephaly and congenital muscular torticollis (Clarren et al., 1979; 1981) to support safety and effectiveness.

Technological Characteristics

Cranial orthosis; custom-fabricated. Materials: 3/16" polypropylene outer shell, 3/16" Aliplast closed-cell copolymer foam liner. Form factor: helmet with ear cutouts and ventilation holes. Suspension: Velcro chinstrap. Fabrication: vacuum-formed over modified plaster cast of infant skull. Non-powered.

Indications for Use

Indicated for infants 3 to 18 months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic and brachycephalic head shapes.

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

• Clarren Helmet (K003035)

Submission Summary (Full Text)

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Beverly Fills Prosthetics Orthotics, Inc.

#### 9 2002 SEP

6300 Wilshire Boulevard, Suite 150 Los Angeles, CA 90048 [phone] Fax [phone]

#### K022273 510(k) Number:

15230 Burbank Boulevard, Suite 103 Van Nuys, CA 91411 [phone] Fax [phone]

# 510(k) SUMMARY (as required by section 807.92(c)) CRANIAL SYMMETRY SYSTEM

## BEVERLY HILLS PROSTHETICS ORTHOTICS, INC.

This 510(k) summary of safety and effectiveness for the Cranial Symmetry System helmet is submitted in accordance with requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

- Applicant: Beverly Hills Prosthetics Orthotic
- 6300 Wilshire Blvd., Suite 150 Address: Los Angeles, CA 90048

Keith E. Vinnecour, President, C.P.O. Contact Person:

Telephone: [phone] (telephone) 323-866-2560 (facsimile)

March 21, 2002 Preparation date:

- Cranial Symmetry System Device Trade Name:
- Common Name: Cranial Orthosis

Classification Name: Cranial Orthosis (see C.F.R. 882.5970)

MVA Product Code:

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Predicate Device: Clarren Helmet, 510(k) number K003035 Beverly Hills Prosthetics Orthotics, Inc. is claiming substantial equivalence with Cranial Symmetry System to the legally marketed device Clarren Helmet (K003035) per 807.92(a)(3).

The Cranial Symmetry System provides passive Device Description: pressure to the prominent areas of the infants' skull while allowing for growth into the flattened areas. There are no exceeding pressures that could put restrictions on brain growth. The cranial orthosis helmet is custom fabricated with lightweight materials. The outer shell consists of a sheet of three-sixteenths inch thick polypropylene. The padded inner liner consists of three-sixteenths inch Aliplast. These materials are vacuumed formed over the modified plaster cast mold of the infants' skull. There is a Velcro chinstrap that is used as a method of suspension. The chinstrap is fastened securely through the Dacron loops at the cut out section for the infants' ears. The chinstrap holds the helmet in place eliminating the risk of slippage. There are air holes drilled into the helmet for ventilation.

Intended Use: The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' three to eighteen months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants' with plagiocephalic and brachycephalic shaped heads.

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Indications For Use:

The sale and distribution of the device is restricted to prescription use in accordance with 21CFR801.109

The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' three to eighteen months of age, with plagiocephalic and brachycephalic shaped heads.

Technological Characteristics

Compared to Predicate Device: The Cranial Symmetry System and the predicate device (The Clarren Helmet) are both classified as cranial orthosis (21CFR882.5970). The Cranial Symmetry System uses a 3/16" thickness polypropylene and the Clarren Helmet uses a 3/8" thickness polypropylene. The padded lining in the Cranial Symmetry System helmet is a 3/16" thickness Aliplast and the Clarren Helmet uses a 1/4" thick Plastizote. Both are closed cell copolymer foams. Both helmets are custom fabricated by vacuum forming the materials over the modified cast mold of the infant's skull. There are cutouts for the ears in bot designs, as well as air holes for ventilation. Helmet therapy was introduced to Beverly Hills Prosthetics Orthotics, Inc. by Sterling Clarren M.D. and therefore the methodology and technique for measurements and casting gleaned is still used in practice today.

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Performance Data: Clarren, Sterling, M.D., "Plagiocephaly and torticollis: Etiology, natural history, and helmet treatment, "Journal of Pediatrics, 98:1 (92-95)(Jan. 1981); Clarren, et al., "Helmet treatment for plagiocephaly and congenital muscular torticollis," Journal of Pediatrics , 94:1 (43-46)(Jan. 1979). Conclusions: Based on the foregoing and all information included in this 510(k) application, Beverly Hills Prosthetics Orthotics, Inc. believes that the performance data provides reasonable assurance of the safety and effectiveness of the Cranial Symmetry System for its proposed indications for use. Further, the Cranial Symmetry System is substantially equivalent to its claimed predicate device under the conditions of intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a cascading manner. The profiles are rendered in black and have a flowing, abstract design. Encircling the profile graphic is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 9 2002

Keith E. Vinnecour, President, C.P.O. Beverly Hills Prosthetics Orthotics, Inc. 6300 Wilshire Blvd., Suite 150 Los Angeles, California 90048

Re: K022273

Trade/Device Name: Cranial Symmetry System Regulation Number: 21 CFR 890.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: July 11, 2002 Received: July 25, 2002

Dear Mr. Vinnecour:

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. Ilsting 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. Keith E. Vinnecour

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 and additionally 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Stipt Rwdrs
Dr. Colin McWee Ph.D., M.P.

a 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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510(k)Number: K022273

## INDICATIONS FOR USE OF THE CRANIAL SYMMETRY SYSTEM HELMET

11.000

The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' 3 to 18 months of age, with plagiocephalic and brachycephalic shaped heads.

The sale and distribution of the device is restricted to prescription use in accordance with 21CFR801.109

Stipt Ruvde

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

510(k) Number_KO22273