PROVIDENCE MOLDING HELMET

K030669 · Northeast Orthotics and Prothetics, Inc. · MVA · Jul 18, 2003 · Neurology

Device Facts

• Record ID: K030669
• Device Name: PROVIDENCE MOLDING HELMET
• Applicant: Northeast Orthotics and Prothetics, Inc.
• Product Code: MVA · Neurology
• Decision Date: Jul 18, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Providence Molding Helmet is used for treatment of children from three (3) to eighteen (18) months with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is prescribed by a physician to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.

Device Story

Custom-fitted cranial orthosis; treats moderate to severe non-synostotic positional plagiocephaly in infants (3-18 months). Device fabricated from plaster mold of infant's head. Principle of operation: applies gentle holding pressure to prominent skull regions while providing voids for growth in flattened areas; facilitates skull reshaping toward symmetry. Used in clinical/home settings; prescribed by physician. Output is physical correction of cranial shape through passive mechanical pressure. Benefits include improved cranial symmetry.

Clinical Evidence

Literature review provided. No clinical trials or bench testing metrics reported.

Technological Characteristics

Cranial orthosis consisting of 5/32 polypropylene outer shell and two layers of 3/16 volara foam inner lining. Posteriorly split design with elastic Velcro strap for securement. Custom-fabricated from plaster mold of patient's head.

Indications for Use

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

• Ballert Molding Helmet (K011433)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

Submitter: D. Barry McCoy C.P.O. Northeast Orthotics and Prosthetics Inc. Rhode Island Hospital, 2 Dudley St, Providence, RI 02903 and Custom Composite Mfg. Inc. 170 Macklin St. Cranston, RI 02920

Contact: D. Barry McCoy C.P.O. Telephone [phone] Fax [phone] Date: June 9, 2003

- Classification: Class II I .
- Common or Usual Name: cranial orthosis, cranial band, helmet, Molding helmet II.
- Classification Name: Cranial Orthosis, Code MVA CFR 882.5970 III.
- Predicate Device: Ballert Molding Helmet (K 011433) IV.
- V. Performance Standards: None, Special Controls required
- VI. Description:
- A. The Providence Molding Helmet is a cranial orthosis used to treat moderate to severe non-synostotic positional plagiocephaly in children from 3 to 18 months of age. This includes infants with plagiocephalic-, brachyecephalic-, and scaphocephalic- shaped heads. This device works by applying gentle holding pressure to the prominent regions of the infant's skull while leaving room for growth in the adjacent flattened regions.
- B. The Providence Molding Helmet consists of a 5/32 polypropylene outer shell and two (2) layers of 3/16 volara foam inner lining. The helmet is split posteriorly and an elastic Velcro strap is attached to the back of the helmet to keep it securely in place. The device allows for growth of the flattened areas of the infant's skull into the voids of the shell/foam lining, thus correcting the plagiocephaly and giving the infant's skull a more symmetrical shape.
- C. The Providence Molding Helmet is custom designed and custom fitted for each patient from a plaster mold of the infants' head.
- Labels and Labeling: Labels and instructions for use are provided including VII. precautions, and materials required by the special controls to which this product is subject.
- Indications for Use: The Providence Molding Helmet is intended for medical VIII. purposes to improve cranial symmetry and/or shape. This device is prescribed by a physician to treat moderate to severe non-synostotic positional plagiocephaly in children from 3 to 18 months of age.
- IX. Substantial Equivalence: The Providence Molding Helmet is substantially equivalent to the Ballert Molding Helmet (K 011433)
- Clinical Review and Discussion: A review of the literature was provided. X.
- Indications for Use: The Providence Molding Helmet is a cranial orthosis used to XI. treat moderate to severe non-synostotic positional plagiocephaly in children from 3 to 18 months of age. This includes infants with plagiocephalic-, brach vecephalic -, and scaphocephalic - shaped heads.
- Contraindications for Use: Infants with synostosis, or hydrocephalus. XII.

(End of Summary)

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2003

D. Barry McCoy, C.P.O. 170 Macklin St. Cranston, Rhode Island 02920

Re: K030669

Trade/Device Name: Providence Molding Helmet Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: June 19, 2003 Received: June 13, 2003

Dear Mr. McCoy:

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. D. Barry McCoy, C.P.O.

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]. 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

Mark A. Millan

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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510(k) Number: K030669

Device Name: Providence Molding Helmet

Indications for Use:

The Providence Molding Helmet is used for treatment of children from three (3) to eighteen (18) months with moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is prescribed by a physician to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape.

Contradictions for Use: Infants with synostosis or hydrocephalus.

Mark N Milkerso

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

510(k) Number -