(163 days)
The P-POD Plagiocephaly Orthosis Device is 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 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 helmet. As the chemical 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.
Here's an analysis of the provided text regarding the P-POD Plagiocephaly Orthosis Device, focusing on acceptance criteria and the supporting study:
The provided document, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval. It does not contain a detailed study proving device meets specific acceptance criteria in terms of efficacy metrics (e.g., specific improvement in cranial symmetry measurements). Instead, it relies on demonstrating that its technological characteristics are equivalent to legally marketed devices and that its unique manufacturing process does not introduce new risks, as validated by human factors studies and biocompatibility testing.
Therefore, many of the requested fields regarding performance metrics and clinical study design cannot be filled from the given text.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria Mentioned in Document | Reported Device Performance / Evaluation Outcome |
|---|---|---|
| Biocompatibility | No cytotoxicity (ISO 10993-5) | Cell culture treated with test sample exhibited no reactivity (Grade O). Conclusion: Non-toxic. |
| No sensitization reaction (ISO 10993-10) | Albino guinea pigs treated with test sample did not elicit a sensitization response (Grade O). Conclusion: No sensitization reaction. | |
| No irritation (ISO 10993-10) | Rabbits treated with test samples exhibited no irritation (Grade 0). Conclusion: Non-irritating. | |
| Functional / Material | Foam Stiffness (Durometer A) | $45 \pm 4.61$ (Min: 39, Max: 54) |
| Foam Thickness | 0.1875 inches minimum | |
| Human Factors | Naive users can be trained via video and IFU to produce a helmet. | Human factors studies 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. |
| Naive users can appropriately accept or reject a helmet based on defined criteria. | Human factors studies 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. | |
| Infants (4-18 months) can tolerate the treatment. | Human factors studies performed to ensure the infants in the intended treatment range of 4 to 18 months can tolerate the treatment. The human factors studies also stated that it showed "physicians can make the helmet and determine adequacy of helmet for child." | |
| Manufacturing Process | Molding process accuracy (implicitly, that it produces a functional and safe helmet) | Evaluation of molding process accuracy was performed. The non-clinical evaluation confirmed device equivalency. The human factors study showed the production process can be successfully produced by clinicians. |
| Equivalence to Predicates | Equivalence in indication for use, device classification, product code, environment of use, principles of operation. | The entire 510(k) submission and comparative table are dedicated to demonstrating this, concluding that the device is "substantially equivalent." Differences in manufacturing are evaluated to ensure "No New Risk." |
| No new risks from differences in manufacturing process. | "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." |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided document. The human factors studies involved "naive users" and "infants in the intended treatment range," but no specific numbers are given.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not specified.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The document mentions "clinical practitioner" monitors optimum fit and alignment, and "physicians can make the helmet and determine adequacy of helmet for child" based on human factors studies, but details on expert qualifications for ground truth are absent.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. The document describes human factors studies and biocompatibility testing, not an assessment requiring adjudication of diagnostic outcomes.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This type of study (MRMC, AI assistance) was not conducted or mentioned for this device. The device is a physical cranial orthosis, not an imaging or diagnostic AI tool.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a physical orthosis, not an algorithm. The "human factors studies" refer to human interaction with the physical device and its assembly process, not a human-in-the-loop AI system.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility, the ground truth was established by adherence to ISO standards for cytotoxicity, sensitization, and irritation.
- For human factors, the ground truth likely involved direct observation of the training process, the ability of users to produce helmets correctly, and infant tolerance, as evaluated by study personnel (implicitly, clinical experts, but not explicitly defined as "ground truth experts" in a diagnostic sense).
- For foam stiffness and thickness, the ground truth was quantitative measurement against specifications.
-
The sample size for the training set:
- Not applicable/Not specified. There is no mention of a "training set" in the context of an AI/machine learning model. The "training" mentioned refers to training human users on the device's manufacturing process.
-
How the ground truth for the training set was established:
- Not applicable. Assuming "training set" refers to an AI/machine learning context, this is not relevant. If it refers to the training of human users, the "ground truth" for their performance was likely established by predetermined criteria for correct helmet production and acceptance/rejection, as stated.
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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 LLC750 Old Ludlow Ave.Cincinnati, OH 45220Phone 440-315-7830Fax 513-221-2905 |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681 (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
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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 ElutionAccording to ISO 10993-5 Biological evaluation ofmedical devices: Part 5 Tests for In vitro Cytotoxicity | Cell culture treated with test sampleexhibited no reactivity (Grade O) | Non-toxic |
| Guinea Pig MaximizationAccording to ISO 10993-10 Biological evaluation ofmedical devices: Part 10 Tests for irritation anddelayed hypersensitivity | Albino guinea pigs treated with testsample did not elicit a sensitizationresponse (Grade O) | No sensitizationreaction |
| Intracutaneous Irritation ReactivityAccording to ISO 10993-10 Biological evaluation ofmedical devices: Part 10 Tests for irritation anddelayed hypersensitivity | Rabbits treated with test samplesexhibited 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-PODPlagiocephaly OrthosisDevice | Clarren | Hanger CranialBandTM | Evaluation ofDifferences |
|---|---|---|---|---|
| 510(k) number | TBD | K021918 | K072566 | N/A |
| ProductClassification | Class II882.5970MVA | Class II882.5970MVA | Class II882.5970MVA | Same |
| Use | Prescription UsePart 21 CFR 801 Subpart D | Prescription UsePart 21 CFR 801Subpart D | Prescription UsePart 21 CFR 801Subpart D | Same |
| IntendedPopulation | 4 to 18 months | 3 to 18 months | 3 to 18 months | No risk for change;P-POD moreconservative |
| Intended Use | See section 12.2.1 | See section 12.2.1 | See section 12.2.1 | Same |
| Product Design | Cranial orthosis made toindividual's specifications | Cranial orthosismade to individual'sspecifications | Cranial orthosismade toindividual'sspecifications | Same |
| BiocompatibleComponents | Yes | Yes | Yes | Same |
| Materials:Outer Shell | PolypropyleneUSP Class VI certified | Polypropylenecustomized toindividual | Polypropylene orPolypropylene-PolyethyleneCopolymer | Same or Equivalent |
| Materials:Bladder / Liner | Polyurethane liner filledwith polyurethane foam | Polyurethane | Polyethylene foam | Same or Equivalent |
| Trait | P-PODPlagiocephaly OrthosisDevice | Clarren | Hanger CranialBandTM | Evaluation ofDifferences |
| HelmetProduction | CastingManufactured by Physicianin doctor's office on infant | Computer scan,CastingManufactured byOrthotist | Computer scan,CastingManufactured byOrthotist | No New RiskDifferences inmanufacturinghelmets will notaffect quality offinal product.Human factorsstudies for P-PODhelmet showphysicians can makethe helmet anddetermineadequacy of helmetfor child. |
| Foam Stiffness | Durometer A$45 \pm 4.61$Min: 39Max: 54 | Durometer A$64 \pm 6.71$Min: 55Max: 74 | Durometer A$50 \pm 9.36$Min: 39Max: 65 | Equivalent |
| FoamThickness | 0.1875 inches minimum | 0.1875 inches | Not measured | Same |
| Daily WearingTime | 23 hours | 23 hours | 23 hours | Same |
| Daily Care | Cleaning daily with waterand isopropyl alcohol | Cleaning daily withwater and isopropylalcohol | Cleaning daily withwater andisopropyl alcohol | Same |
| Time frominitialevaluation toapplication oftreatment | Same day;Helmet is made onsite atthe physician's office. Assoon as a clinical need isdetermined, the treatmentcan start immediately | Typically 2 to 4weeks delay fromdiagnosis tobeginning oftreatment | Typically 2 to 4weeks delay fromdiagnosis tobeginning oftreatment | P-POD allows theimmediatetreatment of adiagnosed conditionwhereas predicatesdelay treatment forweeks |
| AdverseEffects | Device may cause skinirritations or breakdown | Device may causeskin irritations orbreakdown | Device may causeskin irritations orbreakdown | Same |
| CaregiverInstructionsfor Use | Wear and care guideprovided to caregiver | Wear and care guideprovided tocaregiver | Wear and careguide provided tocaregiver | Same |
| Discontinuance of DeviceUse | When infant outgrows thecranial helmet or orthosisis discontinued for anyreason | When infantoutgrows the cranialhelmet or orthosis isdiscontinued for anyreason | When infantoutgrows thecranial helmet ororthosis isdiscontinued forany 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 (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
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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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§ 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)).