CAMLAB CRANIAL ORTHOSIS HELMET

K081787 · Biosculptor Corporation · OAN · Jan 27, 2009 · Neurology

Device Facts

• Record ID: K081787
• Device Name: CAMLAB CRANIAL ORTHOSIS HELMET
• Applicant: Biosculptor Corporation
• Product Code: OAN · Neurology
• Decision Date: Jan 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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. This orthosis is only available if prescribed by a physician.

Device Story

Custom cranial orthosis for infants; treats nonsynostotic positional plagiocephaly. Input: 3D head geometry acquired via handheld laser scanner (BioScanner) or traditional casting. Processing: BioSculptor CAD/CAM system generates 3D model from scan data; creates positive mold for orthosis fabrication. Output: Custom-fitted helmet consisting of plastic outer shell, foam inner shell, and fasteners. Usage: Prescribed by physician; practitioner modifies fit and monitors progress. Benefit: Applies pressure to prominent cranial regions to improve symmetry/shape.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Custom-molded cranial orthosis. Materials: Copolymer plastic outer shell, closed-cell polyethylene foam inner liner, Velcro strap. Manufacturing: Laser scanning, CAD/CAM system, 5-axis router. Connectivity: Digital order/data transfer via email or secure internet application. Non-sterile.

Indications for Use

Indicated for infants 3-18 months with moderate to severe nonsynostotic positional plagiocephaly (plagiocephalic, brachycephalic, scaphocephalic). Contraindicated for craniosynostosis and 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

• STARband Orthomerica (K011350)

Submission Summary (Full Text)

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

510(k) Summary CAMLab Cranial Orthosis Helmet BioSculptor Corporation

K081787. '/2

# JAN 2 7 2009

# 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

BioSculptor Corporation 2480 West 82nd Street, #8 Bay 1A Hialeah, Florida 33016

[phone] Phone: Fax: [phone] Contact: Mark Mazloff

Date: June 18, 2008

807.92(a)(2)

Proprietary Name: Common or Usual Name: Regulation Number: Classification Name(s):

Classification Code: OAN Secondary Classification Code: MVA

807.92(a)(3)

#### Predicated Device(s)

Cranial Orthosis Helmet

Orthosis, Cranial Laser Scan

21 CFR 882.5970

Cranial Orthosis

CAMLab Cranial Orthosis Helmet

STARband Orthomerica

K011350

Classified under 21 CFR 882.570

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

807.92(a)(4)

#### Device Description

The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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. This orthosis is only available if prescribed by a physician.

The initial geometry of the patient is acquired from either laser scanned measurements using the BioScanner (a.k.a. Polhemus Fastscan handheld laser scanner) or via traditional casting methods. If a cast is taken, the cast will be scanned with the BioScanner as well.

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

K081787. 2/2

510(k) Summary CAMLab Cranial Orthosis Helmet BioSculptor Corporation

The resulting three dimensional model along with a digital order form and any other pertinent information is then sent to BioSculptor Corporation via email or secured internet application. Utilizing this information, the BioSculptor CAD/CAM system will then create a positive mold representative of the patient scan. This positive model will then be used to create the orthosis.

Each orthosis consist of a plastic outer shell, a foam inner shell, a strap and fastener to secure the orthosis. The practitioner modifies the orthosis to achieve an accurate fit and monitors the progress to ensure that no adverse effects occur.

## 807.92(a)(5)

### Intended Use(s)

The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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.

#### 807.92(a)(6)

| | Orthomerica STARband<br>Cranial Orthosis<br>K011350 | CAMLab Cranial<br>Orthosis Helmet<br>(This submission) |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Indications for Use | Treatment of abnormal<br>infant head shape<br>(positional/deformational<br>plagiocephaly) | Treatment of abnormal<br>infant head shape<br>(positional/deformational<br>plagiocephaly) |
| Materials | Copolymer plastic/closed<br>cell polyethylene<br>foam/Velcro strap | Copolymer plastic/closed<br>cell polyethylene<br>foam/Velcro strap |
| Clinical Population | Infants age 3-18 months | Infants age 3-18 months |
| Daily Wear Time | 23 hrs./day | 23 hrs./day |
| Average Time to Effectiveness<br>(patients age 3-7 months) | 2-4 months | 2-4 months |
| Contradictions for Use | Craniosynostosis/Hydrocephalus | Craniosynostosis/Hydrocephalus |
| Method of Manufacture | Custom from mold using<br>a laser scanner,<br>CAD/CAM system and<br>5-axis router machine | Custom from mold using<br>a laser scanner,<br>CAD/CAM system and<br>5-axis router machine |

# Substantial Equivalence Comparison Table

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2-7 2009

BioSculptor Corporation % Mr. Mark Mazloff 2480 West 82nd Street, #8 Hialeah, Florida 33016

Re: K081787

Trade/Device Name: CAMLab Cranial Orthosis Helmet Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: II Product Code: OAN, MVA Dated: January 6, 2009 Received: January 7, 2009

### Dear Mr. Mazloff:

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.

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

# Page 2 - Mr. Mark Mazloff

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Mulkerson

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

Enclosure

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

# INDICATIONS FOR USE STATEMENT

Applicant:

BioSculptor Corporation

(08)78 510(k) Number (if known):

Device Name:

CAMLab Cranial Orthosis Helmet

Indications for Use:

The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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.

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

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

Prescription Use _ V Over the Counter

(Per 21 CFR,801.109)

(Optional Format 1-2-96)

N

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

510(k) Number

Confidential Information BioSculptor Corporation

Page 4 v. 6188.