P-POD

K133397 · P-Pod · MVA · Apr 18, 2014 · Neurology

Device Facts

• Record ID: K133397
• Device Name: P-POD
• Applicant: P-Pod
• Product Code: MVA · Neurology
• Decision Date: Apr 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The P-POD Helmet is a cranial orthosis device intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

Device Story

P-POD Plagiocephaly Orthosis Device is a cranial orthosis for infants (4-18 months) with non-synostotic positional plagiocephaly. Device consists of a standardized hard outer shell (polypropylene) with an internal inflatable bladder. Clinical practitioner uses modeling putty to fill flattened regions of the infant's head; a pre-measured liquid solution is poured into the bladder via a top port. Exothermic reaction cures the liquid into a solid foam, creating a custom negative mold of the infant's skull. Device is worn by the infant to promote skull re-contouring through growth. Used in physician offices; enables immediate treatment (same-day) compared to traditional 2-4 week scanning/molding processes. Output is a custom-fitted helmet; clinical benefit is improved cranial symmetry. Effectiveness monitored by practitioner.

Clinical Evidence

Bench testing only. Included biocompatibility testing (ISO 10993-5 cytotoxicity, ISO 10993-10 sensitization and irritation) showing non-toxic, non-sensitizing, and non-irritating results. Human factors studies validated the on-site casting process, confirming naive users can produce the helmet and infants tolerate the treatment.

Technological Characteristics

Cranial orthosis; hard polypropylene outer shell (USP Class VI); polyurethane bladder/liner with polyurethane foam. Dimensions: standardized (2 sizes). Energy: exothermic chemical reaction for foam curing. Connectivity: none. Sterilization: N/A. Software: none.

Indications for Use

Indicated for infants 4-18 months old with moderate to severe non-synostotic positional plagiocephaly (plagiocephalic, brachycephalic, or scaphocephalic head shapes) to improve cranial symmetry or shape via static/gentle pressure.

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

• Hanger Cranial Band™ (K072566)
• Clarren Helmet (K021918)

Submission Summary (Full Text)

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#### APR 1 8 2014 510(k) Summary of Safety and Effectiveness

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the P-POD Plagiocephaly Orthosis Device is provided below.

| Date | 4/15/2014 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor/Sponsor | Lorica Scientific LLC<br>750 Old Ludlow Ave.<br>Cincinnati, OH 45220<br>Phone [phone]<br>Fax [phone] |
| 510(k) Contact | Secure BioMed Evaluations<br>Linda Braddon, Ph.D.<br>7828 Hickory Flat Highway<br>Suite 120<br>Woodstock, GA 30188<br>770-837-2681 (direct)<br>855-MED-DEV1 (office)<br>[e-mail] |
| Trade Name | Plagiocephaly Orthosis Device |
| Common Name | Cranial Orthosis |
| Code Classification | MVA 21 CFR 882.5970 : Class II |
| Predicate Devices | K072566 Hanger Cranial Band™<br>K021918 Clarren Helmet |

#### Device Description

The Lorica Scientific LLC P-POD Plagiocephaly Helmet is a Class II cranial orthosis intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads. The P-POD helmet is similar to the predicate devices in such that it is an orthosis designed for each patient from a cast of the infant's head. Each orthosis is composed on an outer shell with a layer of foam and a side strap for securing the orthosis. Additionally, the helmet has a top vent and side opening as typically seen with the predicates. Optimum fit and alignment is insured and monitored by the clinical practitioner.

The Lorica Scientific LLC P-POD Plagiocephaly Helmet differs from the predicate devices in that the device is made in the physician's office via a simplified casting process that can be performed in approximately 30 minutes. The predicate devices rely on a 2 to 4 week process of sending the child for a 3-D scan and then using casting and molding processes to create a customized helmet.

The P-POD standardized (2 sizes) helmet consists of a hard outer shell with an inflatable bladder lining the inside. Modeling putty is used to fill in the flattened portion of the infants head to form the desired

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symmetrical shape and the helmet is placed on the infant. The physician then mixes a pre-measured solution in an easy-to-use, pre-measured pouch and pours the mixed solution into the bladder of the helmet through a specially designed filling port located at the top of the hemical solution cures, there is an exothermic foaming process from a liquid to solid foam which expands to fill the empty space in the bladder thus customizing the helmet to the shape making a negative copy of the infant's skull. Since the putty is used to fill in the undesired negative regions of the skull deformity, once the foam is completely cured and putty removed, the resulting helmet provides an ideal cast to help promote proper skull re-contouring. As with all other similar cranial orthosis devices, as the infant wears the helmet, the head grows into the shape formed by the foam, thereby correcting the deformity.

#### Intended Use

The P-POD Helmet is a cranial orthosis device intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

#### Technological Characteristics

The P-POD helmet is essentially the same as the predicate devices in such that it is an orthosis designed for each patient from a cast of the infant's head. Each orthosis is composed on an outer shell with a layer of foam and a strap for securing the orthosis. It has a top vent and side opening. Optimum fit and alignment is insured and monitored by the clinical practitioner.

The Lorica Scientific LLC P-POD Plagiocephaly Helmet differs from the predicate devices in that the device is made in the physician's office via a simplified casting process that can be performed in approximately 30 minutes.

#### Non-Clinical Performance Testing Conclusion

Non-clinical performance testing included biocompatibility with the following results:

| Biocompatibility Tests | Results | Conclusions |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------|
| ISO Cytotoxicity MEM Elution<br>According to ISO 10993-5 Biological evaluation of<br>medical devices: Part 5 Tests for In vitro Cytotoxicity | Cell culture treated with test sample<br>exhibited no reactivity (Grade O) | Non-toxic |
| Guinea Pig Maximization<br>According to ISO 10993-10 Biological evaluation of<br>medical devices: Part 10 Tests for irritation and<br>delayed hypersensitivity | Albino guinea pigs treated with test<br>sample did not elicit a sensitization<br>response (Grade O) | No sensitization<br>reaction |
| Intracutaneous Irritation Reactivity<br>According to ISO 10993-10 Biological evaluation of<br>medical devices: Part 10 Tests for irritation and<br>delayed hypersensitivity | Rabbits treated with test samples<br>exhibited no irritation (Grade 0) | Non-irritating |

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- Evaluation of molding process accuracy ●
- . Foam stiffness

Human factors studies were performed to ensure the following:

- . Naive users can be trained via a video and reading the IFU to produce a helmet and י appropriately accept or reject a helmet based on defined criteria
- . The infants in the intended treatment range of 4 to 18 months can tolerate the treatment

## Substantial Equivalence Summary (Conclusion)

The Lorica Scientific LLC P-POD Helmet is very similar to cranial orthosis devices that are legally commercially available. A comparison between the P-POD Helmet and the predicate devices is shown in the following table.

| Trait | P-POD<br>Plagiocephaly Orthosis<br>Device | Clarren | Hanger Cranial<br>BandTM | Evaluation of<br>Differences |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | TBD | K021918 | K072566 | N/A |
| Product<br>Classification | Class II<br>882.5970<br>MVA | Class II<br>882.5970<br>MVA | Class II<br>882.5970<br>MVA | Same |
| Use | Prescription Use<br>Part 21 CFR 801 Subpart D | Prescription Use<br>Part 21 CFR 801<br>Subpart D | Prescription Use<br>Part 21 CFR 801<br>Subpart D | Same |
| Intended<br>Population | 4 to 18 months | 3 to 18 months | 3 to 18 months | No risk for change;<br>P-POD more<br>conservative |
| Intended Use | See section 12.2.1 | See section 12.2.1 | See section 12.2.1 | Same |
| Product Design | Cranial orthosis made to<br>individual's specifications | Cranial orthosis<br>made to individual's<br>specifications | Cranial orthosis<br>made to<br>individual's<br>specifications | Same |
| Biocompatible<br>Components | Yes | Yes | Yes | Same |
| Materials:<br>Outer Shell | Polypropylene<br>USP Class VI certified | Polypropylene<br>customized to<br>individual | Polypropylene or<br>Polypropylene-<br>Polyethylene<br>Copolymer | Same or Equivalent |
| Materials:<br>Bladder / Liner | Polyurethane liner filled<br>with polyurethane foam | Polyurethane | Polyethylene foam | Same or Equivalent |
| Trait | P-POD<br>Plagiocephaly Orthosis<br>Device | Clarren | Hanger Cranial<br>BandTM | Evaluation of<br>Differences |
| Helmet<br>Production | Casting<br>Manufactured by Physician<br>in doctor's office on infant | Computer scan,<br>Casting<br>Manufactured by<br>Orthotist | Computer scan,<br>Casting<br>Manufactured by<br>Orthotist | No New Risk<br>Differences in<br>manufacturing<br>helmets will not<br>affect quality of<br>final product.<br>Human factors<br>studies for P-POD<br>helmet show<br>physicians can make<br>the helmet and<br>determine<br>adequacy of helmet<br>for child. |
| Foam Stiffness | Durometer A<br>$45 \pm 4.61$<br>Min: 39<br>Max: 54 | Durometer A<br>$64 \pm 6.71$<br>Min: 55<br>Max: 74 | Durometer A<br>$50 \pm 9.36$<br>Min: 39<br>Max: 65 | Equivalent |
| Foam<br>Thickness | 0.1875 inches minimum | 0.1875 inches | Not measured | Same |
| Daily Wearing<br>Time | 23 hours | 23 hours | 23 hours | Same |
| Daily Care | Cleaning daily with water<br>and isopropyl alcohol | Cleaning daily with<br>water and isopropyl<br>alcohol | Cleaning daily with<br>water and<br>isopropyl alcohol | Same |
| Time from<br>initial<br>evaluation to<br>application of<br>treatment | Same day;<br>Helmet is made onsite at<br>the physician's office. As<br>soon as a clinical need is<br>determined, the treatment<br>can start immediately | Typically 2 to 4<br>weeks delay from<br>diagnosis to<br>beginning of<br>treatment | Typically 2 to 4<br>weeks delay from<br>diagnosis to<br>beginning of<br>treatment | P-POD allows the<br>immediate<br>treatment of a<br>diagnosed condition<br>whereas predicates<br>delay treatment for<br>weeks |
| Adverse<br>Effects | Device may cause skin<br>irritations or breakdown | Device may cause<br>skin irritations or<br>breakdown | Device may cause<br>skin irritations or<br>breakdown | Same |
| Caregiver<br>Instructions<br>for Use | Wear and care guide<br>provided to caregiver | Wear and care guide<br>provided to<br>caregiver | Wear and care<br>guide provided to<br>caregiver | Same |
| Discontinuanc<br>e of Device<br>Use | When infant outgrows the<br>cranial helmet or orthosis<br>is discontinued for any<br>reason | When infant<br>outgrows the cranial<br>helmet or orthosis is<br>discontinued for any<br>reason | When infant<br>outgrows the<br>cranial helmet or<br>orthosis is<br>discontinued for<br>any reason | Same |

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This submission demonstrates the equivalency in the indication for use, device classification, product code, environment of use, and the equivalency of the principles of operation. The Lorica Scientific LLC P-POD

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Plagiocephaly Orthosis Device and the predicates underwent non-clinical evaluation which confirmed device equivalency. Additionally, the change in the helmet process was validated in a two part human factors study which showed the P-POD device production process can be successfully produced by clinicians and is well tolerated by the intended infant population.

·

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Image /page/5/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of human figures or a bird in flight.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 18, 2014

P-POD c/o Linda Braddon, Ph.D. Secure BioMed Evaluation 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188

Re: K133397

Trade/Device Name: P-POD Plagiocephaly Orthosis Device Regulation Number: 21 CFR 882.5970 Regulation Name: Plagiocephaly Orthosis Device Regulatory Class: Class II Product Code: MVA Dated: March 17, 2014 Received: March 20, 2014

Dear Dr. Braddon:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Linda Braddon, Ph.D.

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Felipe Aquel -S

Carlos L. Peña, Ph.D, M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K133397

#### Device Name

P-POD Plagiocephaly Orthosis Device

#### Indications for Use (Describe)

The P-POD Plagiocephaly Orthosis Device is intended for medical purposes to apply static or gentle presions of an infant's cranium to improve cranial symmery or shape. The device is infants from four to eighteen months of age with moderate to severe non-synostolic plagiscephalic-, brachycephalic-, brachycephalic-, scaphocephalic-shaped heads.

Type of Use (Select one or both, as applicable)

[ Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Date: 2014.04.18 10:59:53 -04'00'

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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