LERMAN & SON CRANIAL ORTHOSIS HELMET

K012830 · Lerman & Son · MVA · Nov 20, 2001 · Neurology

Device Facts

• Record ID: K012830
• Device Name: LERMAN & SON CRANIAL ORTHOSIS HELMET
• Applicant: Lerman & Son
• Product Code: MVA · Neurology
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Lerman & Son Cranial Orthosis Helmet is intended to be used by or under the direction of a physician for treatment of abnormal head shape in infants from 3-18 months of age (positional/ deformational plagiocephaly).

Device Story

Custom-made cranial orthosis helmet for infants (3-18 months) with positional/deformational plagiocephaly. Device fabricated from a mold by a certified orthotist; utilizes copolymer plastic shell with closed-cell polypropylene foam padding and Velcro straps. Principle of operation involves applying pressure via internal concavities to encourage skull growth into a more normal shape. Used under physician direction; worn 23 hours/day. Effectiveness typically observed within 2-4 months for patients aged 3-7 months. Benefits include correction of abnormal head shape.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparison to the predicate device.

Technological Characteristics

Materials: Copolymer plastic shell, closed-cell polypropylene foam padding, Velcro straps. Form factor: Custom-molded cranial helmet. Dimensions: 4"-5.5" side-to-side, 6"-7.5" front-to-back. Weight: 8-12 ounces. Non-powered, passive orthotic device.

Indications for Use

Indicated for infants 3-18 months of age with positional or deformational plagiocephaly. Contraindicated for patients with craniosynostosis 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

• Orthomerica STARband (K001167)

Submission Summary (Full Text)

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

K012830 PG1 of 3

NOV 2 0 2001

510(k) Summary Lerman & Son Cranial Orthosis Helmet Lerman & Son

# 510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

#### 807.92(a)(1)

#### Submitter Information

Lerman & Son 8710 Wilshire Blvd. Beverly Hills, California 90211 Phone: [phone] Facsimile: [phone]

Contact Persons: Max Lerman, President

Date: August 20, 2001

807.92(a)(2)

Trade Name:

Lerman & Son Cranial Orthosis Helmet

Common Name: Cranial Helmet

Classification Name(s): Orthosis, Cranial

Classification Number: MVA

807.92(a)(3)

#### Predicate Device(s)

Orthomerica

STARband

K001167

Additional substantial equivalence information is provided in the following Substantial Equivalence Comparison Table.

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510(k) Summary Lerman & Son Cranial Orthosis Helmet Lerman & Son

#### 807.92(a)(5)

#### Intended Use(s)

The Lerman & Son Cranial Orthosis Helmet is intended to be used by or under the direction of a physician for treatment of abnormal head shape in infants from 3-18 months of age (positional/ deformational plagiocephaly).

### Device Description

The Lerman & Son Cranial Orthosis Helmet is a custom made orthosis used to treat children between the ages of three and eighteen months for abnormal head shapes. Through the concavity formed during the design of this helmet, the skull is encouraged to grow in a more normal manner.

The Lerman & Son Cranial Orthosis Helmet is intended for use by or under the direction of a physician for treatment of abnormal infant head shape (positional/ deformational plagiocephaly).

The Lerman & Son Helmet is substantially equivalent to Orthomerica's STARband helmet cleared by FDA via K001167. A Substantial Equivalency table has been included within this submission.

| Materials: | Helmet-Copolymer plastic; Padding-Closed cell foam polypropylene |
|--------------|------------------------------------------------------------------|
| Straps: | Velcro |
| Final shape: | Dependant upon infant head shape |
| Size: | Side to side - 4"-5-1/2"<br>Front to back - 6"-7-1/2" |
| Weight: | 8 - 12 ounces |

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)(012830 P&G of 3

# 510(k) Summary
Lerman & Son Cranial Orthosis Helmet
Lerman & Son

| Substantial Equivalence Comparison Table | | |
|----------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| | Orthomerica STARband K001167 | Lerman & Son Cranial Orthosis Helmet This submission |
| Indications for Use | Treatment of abnormal infant head shape (positional/deformational plagiocephaly) | Treatment of abnormal infant head shape (positional/deformational plagiocephaly) |
| Materials | Copolymer plastic/Closed Cell<br>Polyethylene Foam/Velcro strap | Copolymer plastic/Closed Cell<br>Polyethylene Foam/Velcro strap |
| Clinical Population | Infants age 3-18 months | Infants age 3-18 months |
| Daily Wear Time | 23 hrs./day | 23 hrs./day |
| Avg. Time to Effectiveness (patients age 3-7 mos.) | 2 - 4 months | 2 - 4 months |
| Contraindications for Use | Craniosynostosis/ Hydrocephalus | Craniosynostosis/ Hydrocephalus |
| Method of Manufacture | Custom from mold | Custom from mold by Certified Orthotist |

#### 4-1 P ..... . Comparison Tahle Cubet

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2001

Mr. Max Lerman President Lerman & Son 8710 Wilshire Boulevard Beverly Hills, California 90211

Re: K012830

Trade/Device Name: Lerman & Son Cranial Orthosis Helmet Regulation Number: 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: II Product Code: MVA Dated: August 20, 2001 Received: August 23, 2001

Dear Mr. Lerman:

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. Max Lerman

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,

Mark A. Millener

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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## Indications for Use Statement

Applicant: Lerman & Son

NOV 2 0 2001 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Lerman & Son Cranial Orthosis Helmet

Indications For Use:

The Lerman & Son Cranial Orthosis Helmet is intended to be used by or under the direction of a 11te Lennan & Soll Cramar Of abnormal head shape in infants from 3-18 months of age (positional/ deformational plagiocephaly).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over The Counter_ Prescription Use

(Per 21 CFR, 801.109)

(Optional Format 1-2-99)
Mark N Millerson
0 K017830

General, Restorative and Neurological Devices

510(k) Number K012830