CLARREN HELMET (ORTHOMERICA)

K021918 · Orthomerica Products, Inc. · OAN · Jul 25, 2002 · Neurology

Device Facts

• Record ID: K021918
• Device Name: CLARREN HELMET (ORTHOMERICA)
• Applicant: Orthomerica Products, Inc.
• Product Code: OAN · Neurology
• Decision Date: Jul 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Clarren Helmet is a cranial orthosis that applies passive 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.

Device Story

Clarren Helmet is a cranial orthosis for infants with nonsynostotic positional plagiocephaly. Device applies passive pressure to prominent cranial regions to improve symmetry/shape. Construction involves vacuum-forming a polypropylene sheet over a positive model of the infant's head; model obtained via manual casting or 3D scanning (STARscanner). Liner made of Plastizote; helmet includes ventilation holes, ear cutouts, and Velcro chinstrap. Used in clinical settings; fabricated at facility based on patient-specific geometry. Output is a custom-fitted helmet; clinical benefit is improved cranial shape. STARscanner automates mold fabrication, providing higher accuracy than manual methods.

Clinical Evidence

No new clinical trials were conducted for this submission. Evidence relies on literature regarding the efficacy of the Clarren Helmet (Clarren et al., 1979; 1981) and performance data demonstrating that the STARscanner-based fabrication process produces more accurate molds than manual methods.

Technological Characteristics

Polypropylene shell (3/8 inch thick); Plastizote liner (1/4 inch thick); Velcro chinstrap. Fabrication via vacuum forming over a positive model. STARscanner used for 3D surface scanning to generate positive models. Device is a custom-fitted, passive cranial orthosis.

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

• Clarren Helmet (Children's Hospital)

Reference Devices

• STARband cranial remolding orthosis (K011350)

Submission Summary (Full Text)

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

## 510(k) SUMMARY

## Clarren Helmet (Orthomerica) and the STARscanner™

## Orthomerica Products, Inc.

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

| Applicant: | Orthomerica Products, Inc. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 6333 N. Orange Blossom Trail<br>Orlando, FL 32810 |
| Contact Person: | Deanna Fish, MS, CPO<br>Clinical Education Manager<br>[phone] (telephone)<br>[phone] (fax)<br>[e-mail] |
| Preparation Date: | June 2002 |
| Device Trade Name: | Clarren Helmet (Orthomerica) |
| Common Name: | Cranial Orthosis |
| Classification Name: | Cranial Orthosis (see 21 C.F.R. § 882.5970) |
| Product Code: | MVA |
| Device Description: | The Clarren Helmet is a cranial orthosis that applies passive<br>pressure to prominent regions of an infant's cranium in order<br>to improve cranial symmetry and/or shape in infants from 3<br>to 18 months of age with moderate to severe nonsynostotic<br>positional plagiocephaly. It consists of a polypropylene<br>sheet, three-eights of an inch thick, which is vacuum formed<br>over a plaster model of a baby's head to produce a helmet.<br>A liner for the helmet is made of Plastizote, one-fourth of an<br>inch in thickness. Small holes are bored in the helmet for ventilation and large holes for the child's ears A Velero |
| | |
| Intended Use: | The Clarren Helmet is a cranial orthosis that applies passive<br>pressure to prominent regions of an infant's cranium in order<br>to improve cranial symmetry and/or shape in infants from 3<br>to 18 months of age with moderate to severe nonsynostotic<br>positional plagiocephaly, including infants with<br>plagiocephalic, brachycephalic, and scaphocephalic- shaped<br>heads.<br><br>chinstrap is attached to help keep the helmet in place on the<br>baby's head. It is manufactured from a positive model,<br>obtained via traditional manual casting methods or a three-<br>dimensional scan of the infant's head. |
| Performance Data: | The Clarren Helmet (Orthomerica) –<br>Clarren, Sterling, M.D., "Plagiocephaly and torticollis:<br>Etiology, natural history, and helmet treatment," Journal of<br>Pediatrics, 98:1 (92-95) (Jan. 1981); Clarren, et al., "Helmet<br>treatment for plagiocephaly and congenital muscular<br>torticollis," Journal of Pediatrics, 94:1 (43-46) (Jan. 1979).<br><br>The STARscanner –<br>The STARscanner has previously received FDA clearance<br>when used in conjunction with Orthomerica's STARband<br>cranial remolding orthosis (K011350). The performance<br>data demonstrates that the proposed automation of<br>measuring for and carving a positive mold of the patient's<br>head yields more accurate results than the manual process<br>used for the predicate device. Specific information regarding<br>the STARscanner is attached at Appendix D. |
| Conclusions: | The Clarren Helmet (Orthomerica) is safe and effective and<br>identical to the Clarren Helmet (Children's Hospital). FDA<br>has already reviewed and cleared the Clarren Helmet<br>(Children's Hospital) based on performance data. FDA has<br>also approved the use of the STARscanner in the fabrication<br>of other cranial orthoses. Therefore, use of the scanner to<br>fabricate the Clarren Helmet (Orthomerica) at Orthomerica's<br>fabrication facility in Orlando, Florida raises no new issues of<br>safety and effectiveness.<br><br>Based on the foregoing and other information in this<br>application, Orthomerica Products, Inc. believes that the<br>performance data provide reasonable assurance of the<br>safety and effectiveness of the Clarren Helmet (Orthomerica)<br>for its proposed indications for use. Further, the Clarren<br>Helmet (Orthomerica) is substantially equivalent to its |

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

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

Clarren Helmet and STARscanner™

claimed predicate, the Clarren Helmet (Children's Hospital) under conditions of intended use.

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear as a single, flowing shape. Encircling the profile image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

APR 2 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Deanna Fish Orthomerica Products, Inc. 6333 North Orange Blossom Trail Orlando, FL 32810

Re: K021918

Trade/Device Name: Clarren Helmet (Orthomerica) Regulation Number: 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN Dated: June 7, 2002 Received: June 11, 2002

Dear Ms. Fish:

This letter corrects our substantially equivalent letter of July 25, 2002.

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 (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 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

{4}------------------------------------------------

This letter will allow you to continue 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] {see http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). 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/dsma/dsmamain.html.

Sincerely yours,

Cabare Buchers

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known): ب

Page

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Indications for Use: The Clarren Helmet is a cranial orthosis that applies passive 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.

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

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

(Optional Format 3-10-98)

for Mark N. Millman

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

510(k) Number K021918