RHS HELMET

K012007 · Restorative Health Svs, Inc. · MVA · Sep 19, 2001 · Neurology

Device Facts

• Record ID: K012007
• Device Name: RHS HELMET
• Applicant: Restorative Health Svs, Inc.
• Product Code: MVA · Neurology
• Decision Date: Sep 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The RHS 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

RHS Helmet is a cranial orthosis for infants 3-18 months with moderate to severe nonsynostotic positional plagiocephaly. Device consists of a vacuum-formed polypropylene shell (3/8 inch thick) with a plastizote liner (1/4 inch thick). It is custom-fitted over a plaster model of the infant's head. The helmet applies passive pressure to prominent cranial regions to improve symmetry and shape. Ventilation is provided via small holes in the shell and large ear openings. The device is intended for prescription use.

Clinical Evidence

Bench testing only. Information provided on biocompatibility of materials and general safety/effectiveness of helmet therapy.

Technological Characteristics

Cranial orthosis; polypropylene shell (3/8 inch thick); plastizote liner (1/4 inch thick); vacuum-formed over plaster model; passive pressure application; ventilation holes; non-powered.

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 (K003035)

Submission Summary (Full Text)

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K012007

SEP 1 9 2001

## APPENDIX E

## 510(k) SUMMARY RHS Helmet Restorative Health Services, Inc.

This 510(k) summary of safety and effectiveness for the Cranial Helmet 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:

Restorative Health Services, Inc. DBA Dillard Prosthetics-Orthotics

Cranial Orthosis (see 21 C.F.R. § 882.5970)

ventilation, and large holes for the child's ears.

Clarren Helmet -- 510(k) # 003035

Address:

Contact Person:

Telephone:

311 18th Avenue North Nashville, TN 37203

Aaron J. Sorensen. C.P.O.

President

[phone] (telephone) [phone] (fax)

Product Code: MVA

Preparation Date: June 2001

Device Trade Name: RHS Helmet

Common Name: Cranial Orthosis

Classification Name:

Predicate Device:

Device Description:

Intended Use:

The Cranial Helmet is a cranial orthosis that applies passive pressure to prominent regions of an infant's cranium in order

The RHS 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. It consists of a polypropylene helmet, three-eighths of an inch thick, that is vacuum formed over a plaster model of a baby's head to produce a helmet. A liner for the helmet is made of plastizote, one-fourth of an inch in thickness. Small holes are bored in the helmet for

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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.

Performance Data: Information was provided on the biocompatibility of the materials and the safety and effectiveness of helmet therapy.

CONCLUSIONS:

Based on the foregoing and other information in this application, RHS, Inc. believes that the Cranial Helmet is substantially equivalent to its claimed predicate under conditions of intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

SEP 1 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Restorative Health Services, Inc. c/o Mr. David J. Bloch Reed Smith 1301 K Street, N.W. Suite 1100-East Tower Washington, D.C. 20005

Re: K012007

Trade/Device Name: RHS Helmet Regulation Number: 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: II Product Code: MV A Dated: June 27, 2001 Received: June 27, 2001

Dear Mr. Bloch:

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. David J. Bloch

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,

Susa Walker, MD

Image /page/3/Picture/5 description: The image shows a simple, hand-drawn symbol. It resembles a stylized letter or a combination of shapes. The symbol consists of a curved line that forms a loop at the top and extends downward, ending in a small, curled tail on the right side. The overall impression is abstract and minimalist.

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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KO12007 510(k) Number:

Device Name: RHS Helmet

INDICATIONS FOR USE:

The RHS 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.

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

Prescription Use
(Per 21 C.F.R. 801.109)

OR

Over-the-Counter Use

SR

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

510(k) Number_KO12007