O&P BIVALVE CRANIAL MOLDING HELMET

K063395 · Orthotic & Prosthetic Lab, Inc. · MVA · Dec 22, 2006 · Neurology

Device Facts

• Record ID: K063395
• Device Name: O&P BIVALVE CRANIAL MOLDING HELMET
• Applicant: Orthotic & Prosthetic Lab, Inc.
• Product Code: MVA · Neurology
• Decision Date: Dec 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The O&P Bivalve Cranial Molding Helmet 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 sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic and scaphocephalic shaped heads.

Device Story

Custom-made cranial orthosis for infants; fabricated by taking head cast, creating positive plaster mold, and building up flattened areas to create internal voids. Device features rigid plastic exterior and foam-lined interior; bivalve design with overlapping anterior/posterior sections; secured via rivet and elasticized Velcro closure. Used in clinical settings under physician direction. Principle of operation: passive remolding; device fits closely to prominent cranial regions and loosely over flattened areas; infant skull grows into voids to improve symmetry/shape; provides rounded surface for infant head positioning. Benefits include correction of abnormal head shape without relapse.

Clinical Evidence

No new clinical testing performed. Substantial equivalence supported by historical clinical data and literature. Cited literature includes studies on cranial orthosis effectiveness (Clarren et al., 1979, 1981; Kane et al., 1996) and a comprehensive assessment of >750 infants (Littlefield et al., 1988) documenting complete or near-complete correction of asymmetry in various head shapes with follow-ups at 12, 18, and 24 months.

Technological Characteristics

Custom-fabricated bivalve cranial orthosis; rigid plastic exterior; foam-lined interior; secured with rivet and elasticized Velcro. Passive remolding principle; no energy source; non-networked; manual fabrication process.

Indications for Use

Indicated for infants 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, brachycephalic, and scaphocephalic 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

• Precision Prosthetic and Orthotics, Inc., Orthotic Molding Helmet (K013700)

Reference Devices

• DOC Band (K964992)

Submission Summary (Full Text)

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K063395

# 510(K) SUMMARY

The following summary is provided in accordance with C.F.R. section 807.92.

#### A. APPLICANT INFORMATION

- 비 Submitter :
Orthotic & Prosthetic Lab, Inc. 748 Marshall Ave. Webster Groves, MO 63119

Phone [phone] Fax [phone]

- Contact: 피
Thomas L. Malone, Chief Operating Officer Phone [phone] Fax [phone]

- 를 Summary Date: November 1, 2006
# B. DEVICE NAME AND CLASSIFICAITON

- 에 Common Name: Cranial Molding Helmet
- 페 Classification Name: Cranial Orthosis
- 트 Trade Name: O&P Bivalve Cranial Molding Helmet
- Class: 매 Class II, Cranial Orthosis, Code MVA, CFR 882.5970
- 트 Predicate Device: Precision Prosthetic and Orthotics, Inc., Orthotic Molding Helmet (K013700)

# C. DEVICE DESCIPTION

O&P Bivalve Cranial Molding Helmets are custom made at the direction of a physician's prescription. Helmets are made by hand for each infant by taking a cast of the baby's head. The cast is filled with plaster and a positive mold of the infant's head is created. The flattened areas of the positive mold (corresponding to the flattened areas of the infants head) are then built up

DEC 2 2 2006

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and made round creating a void. As the child's head grows, the skull is slowly reshaped and rounded by growing into the open voids created in the helmet for this purpose. The finished helmet has a foam-lined interior and has rigid plastic exterior. The helmet is bivalve with the anterior section overlapping the posterior section. The helmet is secured by means of a rivet on one side and an elasticized Velcro closure on the opposite side.

#### D. INTENDED USE

The O&P Bivalve Cranial Molding Helmet 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 sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic and scaphocephalic shaped heads.

# E. TCHNOLOGICAL CHARACTERISTICS COMPARISON

The O&P Bivalve Cranial Molding Helmet and its predicate device have exactly the same purpose, are made from the same materials and work in exactly the same way. When Precision Prosthetics and Orthotics, Inc. went out of business in October of 2006, O&P Lab hired their orthotist responsible for the design and fitting of their orthotic molding helmet. Both the O&P Bivalve Cranial Molding Helmet and the Precision Orthotic Molding Helmet work by fitting close to the head where the head sticks out, and loosely over the flattened area. The infant's skull will grow into the loose area of the orthosis, allowing the flattened parts of the head to "catch up" with the prominent areas. The second way that both the O&P Bivalve Molding Helmet and the predicate device work is by insuring that the infant is always lying on a rounded surface, removing the worry about proper positioning.

# F. PERFORMANCE DATA

The O&P Bivalve Cranial Molding Helmet is substantially equivalent to Precisions Orthotic Molding Helmet (K013700). As such, the O&P Cranial Molding Helmet meets the same standards of performance as Precision's Orthotic Molding Helmet and the DOC Band (K964992) for which the Orthotic Molding Helmet claimed substantial equivalence.

Prior to cranial orthoses being classified and for the last nine years, Precision Prosthetics treated over 2,340 children with their orthotic molding helmet as an effective and safe means of treating moderate to severe positional plagiocephaly. This same helmet is now being produced by Orthotic & Prosthetic Lab, Inc. using the helmets original designer and fabrication director.

Researchers studying the effects of treatment with cranial orthoses on infants have concluded that the devices are effective in correcting abnormal headshape, with no evidence of relapse following treatment. The use of passive cranial remolding orthosis dates back to the early 1970's and their effectiveness is well documented in:

- 1. Clarren S, Smith D, Hanson J. Helmet treatment for plagiocephaly and congenital muscular toricollis. Journal of Pediatrics 1979;94:443

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- 2. Clarren SK. Plagiocephaly and torticolis: etiology, natural history, and helmet treatment. Journal of Pediatrics 1981;98L92-95
- 3. Clarren SK, Smith DW. Congenital deformities. Pediatr Clin North Am 1977:24(4) : 665-667 Persing J, Nichter L, Jane J, Edgerton M. Extenal cranial vault molding after craniofacial surgery. Ann Plast Surgery 1986; 17:274-283
- 4. Kane A, Mitchel L, Craven K, Marsh J. Observation on a recent increase in plagiocephaly without synostosis. Pedatrics 1996;97:877-885

The most comprehensive assessment of cranial orthoses monitored the treatment of more than 750 infants over a span of nearly ten years. Results were recorded at the end of the treatment period and again at 12, 18, and 24 month follow-ups. The study documented complete or near complete correction of asymmetry for a wide variety of head shapes. The details of this study can be found at:

- 5. Littlefield TR, Beals SP, Manwaring KH, Pomatto JK, Joganic EF, Golden KA, Ripley CE. Treatment of Craniofacial Asymmetry with Dynamic Orthotic Cranioplasty. Journal of Craniofacial Surgery. 1988; 11-17.
# G. SUMMARY

The safety and effectiveness data submitted to the FDA establishes that the O&P Bivalve Cranial Molding Helmet is safe and effective for its intended use and is substantially equivalent to applicable predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2006

Orthotic & Prosthetic Lab, Inc. % Mr. Thomas L. Malone 748 Marshall Avenue Webster Groves, Missouri 63119

Re: K063395

Trade/Device Name: O&P Bivalve Cranial Molding Helmet Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MV A Dated: November 1, 2006 Received: November 9, 2006

Dear Mr. Malone:

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 (OS) 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. Thomas L. Malone

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 Buehrig

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): K063395

Device Name: O&P Bivalve Cranial Molding Helmet

Indications For Use: The O&P Bivalve Cranial Molding Helmet 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.

Prescription Use
(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)

138110

(Division Signet 2) Division and Neurological Devices

**510(k) Number** K063395

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