(163 days)
Not Found
No
The description focuses on the physical components and a chemical process for customization, with no mention of AI or ML.
Yes
The device is intended for medical purposes to improve cranial symmetry or shape in infants with non-synostotic positional plagiocephaly, which is a therapeutic goal.
No
The device is described as a cranial orthosis intended to treat positional plagiocephaly by applying pressure to an infant's cranium to improve symmetry or shape. It is a treatment device, not one used for diagnosis.
No
The device is a physical cranial orthosis (helmet) with an inflatable bladder and foam, designed to apply pressure to an infant's head. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The P-POD Plagiocephaly Orthosis Device is a physical device (a helmet) that is applied externally to an infant's head. It works by applying pressure to reshape the skull as the infant grows.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is purely mechanical and external.
The description clearly outlines a physical orthosis used for external cranial reshaping, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
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-synostotic plagiscephalic-, brachycephalic-, brachycephalic-, scaphocephalic-shaped heads.
Product codes
MVA
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium / head
Indicated Patient Age Range
four to eighteen months
Intended User / Care Setting
Physician / doctor's office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing included biocompatibility tests (ISO Cytotoxicity MEM Elution, Guinea Pig Maximization, Intracutaneous Irritation Reactivity), evaluation of molding process accuracy, and foam stiffness.
Human factors studies were performed to ensure:
- Naive users can be trained via a video and reading the IFU to produce a helmet and 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.
The human factors study showed that physicians can make the helmet and determine adequacy of the helmet for the child, and that the device production process can be successfully produced by clinicians and is well tolerated by the intended infant population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K072566 Hanger Cranial Band™, K021918 Clarren Helmet
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5970 Cranial orthosis.
(a)
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.(b)
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)).
0
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 |
| 750 Old Ludlow Ave. | |
| Cincinnati, OH 45220 | |
| Phone 440-315-7830 | |
| Fax 513-221-2905 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 (direct) | |
| 855-MED-DEV1 (office) | |
| LGB@SecureBME.com | |
| Trade Name | Plagiocephaly Orthosis Device |
| Common Name | Cranial Orthosis |
| Code Classification | MVA 21 CFR 882.5970 : Class II |
| Predicate Devices | K072566 Hanger Cranial Band™ |
| 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
1
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 | ||
| According to ISO 10993-5 Biological evaluation of | ||
| medical devices: Part 5 Tests for In vitro Cytotoxicity | Cell culture treated with test sample | |
| exhibited no reactivity (Grade O) | Non-toxic | |
| Guinea Pig Maximization | ||
| According to ISO 10993-10 Biological evaluation of | ||
| medical devices: Part 10 Tests for irritation and | ||
| delayed hypersensitivity | Albino guinea pigs treated with test | |
| sample did not elicit a sensitization | ||
| response (Grade O) | No sensitization | |
| reaction | ||
| Intracutaneous Irritation Reactivity | ||
| According to ISO 10993-10 Biological evaluation of | ||
| medical devices: Part 10 Tests for irritation and | ||
| delayed hypersensitivity | Rabbits treated with test samples | |
| exhibited no irritation (Grade 0) | Non-irritating |
2
- 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
Plagiocephaly Orthosis
Device | Clarren | Hanger Cranial
BandTM | Evaluation of
Differences |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | TBD | K021918 | K072566 | N/A |
| Product
Classification | Class II
882.5970
MVA | Class II
882.5970
MVA | Class II
882.5970
MVA | Same |
| Use | Prescription Use
Part 21 CFR 801 Subpart D | Prescription Use
Part 21 CFR 801
Subpart D | Prescription Use
Part 21 CFR 801
Subpart D | Same |
| Intended
Population | 4 to 18 months | 3 to 18 months | 3 to 18 months | No risk for change;
P-POD more
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
individual's specifications | Cranial orthosis
made to individual's
specifications | Cranial orthosis
made to
individual's
specifications | Same |
| Biocompatible
Components | Yes | Yes | Yes | Same |
| Materials:
Outer Shell | Polypropylene
USP Class VI certified | Polypropylene
customized to
individual | Polypropylene or
Polypropylene-
Polyethylene
Copolymer | Same or Equivalent |
| Materials:
Bladder / Liner | Polyurethane liner filled
with polyurethane foam | Polyurethane | Polyethylene foam | Same or Equivalent |
| Trait | P-POD
Plagiocephaly Orthosis
Device | Clarren | Hanger Cranial
BandTM | Evaluation of
Differences |
| Helmet
Production | Casting
Manufactured by Physician
in doctor's office on infant | Computer scan,
Casting
Manufactured by
Orthotist | Computer scan,
Casting
Manufactured by
Orthotist | No New Risk
Differences in
manufacturing
helmets will not
affect quality of
final product.
Human factors
studies for P-POD
helmet show
physicians can make
the helmet and
determine
adequacy of helmet
for child. |
| Foam Stiffness | Durometer A
$45 \pm 4.61$
Min: 39
Max: 54 | Durometer A
$64 \pm 6.71$
Min: 55
Max: 74 | Durometer A
$50 \pm 9.36$
Min: 39
Max: 65 | Equivalent |
| Foam
Thickness | 0.1875 inches minimum | 0.1875 inches | Not measured | Same |
| Daily Wearing
Time | 23 hours | 23 hours | 23 hours | Same |
| Daily Care | Cleaning daily with water
and isopropyl alcohol | Cleaning daily with
water and isopropyl
alcohol | Cleaning daily with
water and
isopropyl alcohol | Same |
| Time from
initial
evaluation to
application of
treatment | Same day;
Helmet is made onsite at
the physician's office. As
soon as a clinical need is
determined, the treatment
can start immediately | Typically 2 to 4
weeks delay from
diagnosis to
beginning of
treatment | Typically 2 to 4
weeks delay from
diagnosis to
beginning of
treatment | P-POD allows the
immediate
treatment of a
diagnosed condition
whereas predicates
delay treatment for
weeks |
| Adverse
Effects | Device may cause skin
irritations or breakdown | Device may cause
skin irritations or
breakdown | Device may cause
skin irritations or
breakdown | Same |
| Caregiver
Instructions
for Use | Wear and care guide
provided to caregiver | Wear and care guide
provided to
caregiver | Wear and care
guide provided to
caregiver | Same |
| Discontinuanc
e of Device
Use | When infant outgrows the
cranial helmet or orthosis
is discontinued for any
reason | When infant
outgrows the cranial
helmet or orthosis is
discontinued for any
reason | When infant
outgrows the
cranial helmet or
orthosis is
discontinued for
any reason | Same |
3
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
4
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.
·
5
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
6
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
7
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.
8
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