PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS

K012804 · Scott E Allen CP · MVA · Jan 17, 2002 · Neurology

Device Facts

• Record ID: K012804
• Device Name: PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
• Applicant: Scott E Allen CP
• Product Code: MVA · Neurology
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The indications for use would include infants from three to eighteen months of age to be diagnosed with Plagiocephalic, Brachycephalic, or scaphocephalic shaped heads by a medical physician. The purpose of a P.A.P. Orthosis is to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. This orthosis is to be prescribed by a physician in writing indicating the need for cranial positional molding due to the above diagnoses. The device is indicated to treat moderate to severe nonsynostotic positional plagiocephaly.

Device Story

P.A.P. Orthosis is a cranial orthosis designed to improve cranial symmetry and shape in infants. Device consists of a transparent ionomer-based thermoplastic molded shell that encompasses the infant's cranium. It functions by applying mechanical pressure to prominent regions of the skull to guide growth. Used in clinical settings under physician supervision; prescribed by a physician in writing. The orthosis is worn by the infant to treat moderate to severe nonsynostotic positional plagiocephaly. By providing controlled pressure, the device facilitates corrective shaping of the cranium, potentially benefiting the patient by correcting head shape deformities.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, intended use, and material characteristics compared to predicate devices.

Technological Characteristics

Cranial orthosis constructed from transparent ionomer-based thermoplastic. Device is a molded shell designed to encompass the infant's cranium. Operates via passive mechanical pressure application. No energy source or electronic components. Non-invasive, custom-fitted form factor.

Indications for Use

Indicated for infants 3-18 months old with moderate to severe nonsynostotic positional plagiocephaly, brachycephaly, or scaphocephaly. Requires physician diagnosis and written prescription.

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

• D.O.C. band (K964992)
• STARband (K001167)

Submission Summary (Full Text)

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JAN 1 7 2002

K012804

## 510 (k) Section - E-1

## 510(k) Summary

Application Date: August 14, 2001

| Applicant Name: | Scott E. Allen, C.P. | Phone No: | [phone] |
|-----------------|--------------------------------------------------|-----------|---------------|
| Address: | 50 South 900 East #1<br>Salt Lake City, UT 84102 | Fax No: | [phone] |

Scott E. Allen, C.P. Contact Person Trade Name: Plagiocephalic Applied Pressure Orthosis P.A.P. Orthosis Common Name: Orthosis Classification: Cranial Orthosis

The P.A.P. is similar in function and purpose to both the D.O.C. band, manufactured by cranial Technologies Inc. and is classified by the FDA as a cranial Orthosis #510 (k) K964992. And the STARband, manufactured by Orthomerica and is classified by the FDA as a cranial Orthosis #510 (k) k001167. It is a proprietary transparent ionomer based thermoplastic molded orthosis extended for medial purposes to apply pressure to the prominent regions of an infants cranium to improve cranial symmetry and to shape. This orthosis is used to treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synastolic positional Plagiocephaly. The D.O.C. band (K964992) is a band that goes around the infants head made from copolymer plastic lined with a single thickness of aliplast foam. The intended use is to treat moderate to severe nonsynostotic positional plagiocephaly. The STARband (K001167) is more encompassing than the D.O.C. band it goes around the infant's head made from copolymer plastic lined with one or more pieces of aliplast foam. The intended use is to treat moderate to severe nonsynostotic positional Plagiocephaly. The P.A.P orthosis more completely encompasses the cranium with clear copolymer plastic. The intended use is the same as the D.O.C. and STARband orthoses. s. This material has been widely used in upper and lower extremity orthotics, body jackets, and flexible prosthetic sockets.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three horizontal lines forming its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

Scott E. Allen President Personal Performance Medical Corp. Fit-Well Prosthetic and Orthotic Center 50 South, 900 East #1 Salt Lake City, UT 84102

Re: K012804

Trade/Device Name: Plagiocephalic Applied Pressure (P.A.P.) Orthosis Regulation Number: 21 CFR 890.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: October 20, 2001 Received: October 24, 2001

Dear Mr. Allen:

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. Scott E. Allen

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse of substantial equivalence of your device to a legally premiures noticated 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 Oinsi gonetar in 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,

Sincerely yours,

Mark N. Melkerson

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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Section D-2

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Applicant: Scott E. Allen C.P.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K012804

Device Name: Plagiocephalic Applied Pressure Orthosis (P.A.P. orthosis)

The indications for use would include infants from three to eighteen months of age to be The Indications for accombalic, Brachycephalic, or scaphocephalic shaped heads by a diagnosed with Flagloophalls, Brathy P.A.P. Orthosis is to apply pressure to prominent medical physiolan: The pulpose or an to improve cranial symmetry and/or shape. This regions of an intent of cribed by a physician in writing indicating the need for cranial positional molding due to the above diagnoses. The device is indicated to treat moderate to severe nonsynostotic positional plagiocephaly.

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

for

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

| 510(k) Number | K012804 |
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| Prescription Use | <div>✓</div> | OR | Over-The-Counter Use |
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(Per 21 CFR 801.109) (Optional Format 1-2-96)