DOC BAND-POSTOP

K042385 · Cranial Technologies, Inc. · MVA · Dec 17, 2004 · Neurology

Device Facts

• Record ID: K042385
• Device Name: DOC BAND-POSTOP
• Applicant: Cranial Technologies, Inc.
• Product Code: MVA · Neurology
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

This DOC Band-PostOp is intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device is contraindicated for use on infants with craniosynostosis or hydrocephalus.

Device Story

Cranial orthosis for post-operative infants; applies pressure to prominent cranial regions to improve symmetry/shape. Device consists of semi-rigid plastic band with foam lining, fasteners, and optional strut. Used in clinical setting; prescribed by physicians. Provider monitors cranial shape; device provides passive mechanical pressure to guide skull growth. Benefits include improved aesthetic outcomes for infants with residual deformities following synostosis surgery.

Clinical Evidence

Clinical data provided to demonstrate safety and effectiveness for post-operative use in the absence of active craniosynostosis. No specific study metrics (e.g., p-values, CIs) reported in summary.

Technological Characteristics

Cranial orthosis; USP Class VI semi-rigid polypropylene-polyethylene copolymer outer surface; medium density polyethylene (Pelite) foam inner lining; plastic/steel fasteners with Velcro; optional strut (Bi-Cal design). Non-sterile. Complies with FDA special controls for cranial orthosis.

Indications for Use

Indicated for adjunctive use in infants 3-18 months old with surgically corrected synostosis and residual moderate to severe cranial deformities (plagiocephalic, brachycephalic, or scaphocephalic). Contraindicated for infants with active 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

• DOC Band (K964992)

Submission Summary (Full Text)

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KD42385

DEC 17 2004

## 510(k) SUMMARY

## Cranial Technologies, Inc.'s DOC Band Post-Op™

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Cranial Technologies, Inc. 1395 West Auto Drive Tempe, AZ 85284 Phone: [phone] Facsimile: [phone]

Timothy R. Littlefield Contact Person:

August 5, 2004 Date Prepared:

# Name of Device and Name/Address of Sponsor

DOC Band-PostOp™

Cranial Technologies, Inc. 1395 West Auto Drive Tempe, AZ 85284 Phone: [phone] Facsimile: [phone]

# Common or Usual Name

Cranial Remodeling Band, Cranial Helmet, Molding Helmet

#### Classification Name

Cranial Orthosis, 21 C.F.R. § 882.5970

## Predicate Devices

Cranial Technologies, Inc.'s DOC Band (K964992)

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## Intended Use / Indications for Use

This DOC Band-PostOp is intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

The device is contraindicated for use on infants with craniosynostosis or hydrocephalus.

### Technological Characteristics

The DOC Band-PostOp consists of a plastic band, a fastener with Velcro strap, and, in some models, a strut to hold height at the top of the head.

#### Substantial Equivalence

The DOC Band-PostOp has the same intended uses, technological characteristics, and principles of operation as its predicate device, the cleared DOC Band, and very similar indications. The new indication for use does not raise any new questions of safety or effectiveness. Furthermore, clinical data demonstrate that the DOC Band-PostOp, as indicated for use post-operatively, in the absence of craniosynostosis, is as safe and effective as the DOC Band. Thus, the DOC Band-PostOp is substantially equivalent. A summary of substantial equivalence between the devices is provided in the following Substantial Equivalence Chart.

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#### CRANIAL TECHNOLOGIES, INC.'S DOC BAND-POSTOP SUBSTANTIAL EQUIVALENCE CHART

| | DOC Band-PostOp™ | DOC Band®<br>(K964992) |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The device is intended for medical<br>purposes to apply pressure to<br>prominent regions of an infant's<br>cranium to improve cranial<br>symmetry or shape. | The device is intended for medical<br>purposes to apply pressure to<br>prominent regions of an infant's<br>cranium to improve cranial symmetry<br>or shape. |
| Indications for Use | Indicated "for adjunctive use in<br>infants from three to eighteen<br>months of age whose synostosis<br>has been surgically corrected, but<br>who still have moderate to severe<br>cranial deformities including<br>plagiocephalic-, brachycephalic-,<br>or scaphocephalic-shaped heads." | Indicated "to treat infants from three<br>to eighteen months of age with<br>moderate to severe non-synostotic<br>positional plagiocephaly, including<br>plagiocephalic-, brachycephalic-,<br>scaphocephalic-shaped heads." |
| Contraindications | Infants with craniosynostosis or<br>hydrocephalus. | Infants with craniosynostosis or<br>hydrocephalus. |
| Technological<br>Characteristics | Band (constructed of USP Class<br>VI semi-rigid polypropylene-<br>polyethylene copolymer outer<br>surface thermobonded to a<br>medium density polyethylene<br>foam (Pelite) inner lining)<br>Plastic and Steel Fastener with<br>Velcro Strap<br>Strut (in Bi-Cal design only)<br>Elastic Bands (in Bi-Cal design<br>only) | Band constructed of USP Class VI<br>semi-rigid polypropylene-polyethylene<br>copolymer outer surface<br>thermobonded to a medium density<br>polyethylene foam (Pelite) inner<br>lining)<br>Plastic and Steel Fastener with Velcro<br>Strap<br>Elastic Bands (in Bi-Cal design only) |
| Biocompatibility | Yes. | Yes. |
| Sterilization | Not provided sterile. | Not provided sterile. |
| Standards with<br>which the Device<br>Complies | No performance standards apply.<br>The device complies with FDA's<br>special controls for cranial<br>orthosis devices. | No performance standards apply. The<br>device complies with FDA's special<br>controls for cranial orthosis devices. |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of three human profiles facing right, with flowing lines representing movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Mr. Timothy R. Littlefield, MS Vice President Cranial Technologies, Inc. 1395 West Auto Drive Tempe, Arizona 85284

Re: K042385

Trade/Device Name: DOC Band-PostOp™ Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: II Product Code: MVA Dated: December 9, 2004 Received: December 10, 2004

Dear Mr. Littlefield:

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. Timothy R. Littlefield, MS

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]. 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,

Alan Watts

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

510(k) Number (if known): K042385

Device Name: DOC Band-PostOp™

Indications for Use:

This DOC Band-PostOp is intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

The device is contraindicated for use on infants with craniosynostosis or hydrocephalus.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**(Division Sign-Off**

Page

Division of General, Restorative. and Neurological Devices

**510(k) Number** 1(012365