(44 days)
The STARband, STARlight, and St. Louis Band are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for infants from 3 to 18 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 STARband®, STARlight®, and St. Louis Band are custom made cranial orthoses. The STARband® and STARlight® redirect head growth to improve proportion and symmetry in infants with moderate-to-severe non-synostotic positional plagiocephaly. The practitioner takes a plaster impression or 3-dimensional captured image the head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® and STARlight® provide total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband® and STARlight® directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion. The St. Louis Band is a Bi-Valve design made with an outer shell of 1/4" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/4" Aliplast foam (closed cell polyethylene). The Bi-Valve design consists of two plastic shells that overlap and are held together with rivet fasteners. The St. Louis Band utilizes a Velcro® strap with chafe and loop for a secure fit. The proposed device modification is the addition of the CurveCapture application for iOS enabled device for a previously cleared shape capture method, the Net Virta SmartSoc™ System distributed by Orthomerica Products, Inc, used with the STARband, STARlight, and St. Louis Band devices. The system uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade mobile phone device with a camera and a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source. The CurveCapture™ application uses the camera on the device to take video footage of the patient wearing the SmartSoc. Specific images are then selected and sent to the cloud to be processed into a detailed 3D digital model of the patient's cranium.
The provided text describes a 510(k) submission for a medical device (cranial orthoses STARband, STARlight, and St. Louis Band) with a modification related to the associated 3D imaging system called SmartSoc. The modification involves the addition of an iOS-compatible application (CurveCapture) for the SmartSoc system. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and non-clinical performance data, particularly an accuracy study.
Here's a breakdown of the information requested based on the provided text:
Acceptance Criteria and Device Performance:
The document broadly states that the "Cranial Shape Capture Accuracy Verification was performed concluding that the SmartSoc™ System for iOS enabled device yields a safe and effective product that is substantially equivalent to the predicate device." It also mentions that the study compared the proposed device to a cast and the predicate device, considering "Associated Coordinate Planes (A-P; M-L; P-D and various Radius Parameters; Squareness; Flatness)."
However, specific numerical acceptance criteria (e.g., "accuracy must be within X mm") and the reported device performance values against those criteria are not explicitly stated in a quantitative table format within this summary. The text only indicates that the device met the criteria for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric (if available) | Acceptance Threshold (if available) | Reported Device Performance (if available) |
|---|---|---|---|
| Cranial Shape Capture Accuracy | Accuracy in various coordinate planes (A-P; M-L; P-D), Radius Parameters, Squareness, Flatness | Not explicitly stated numerically | Device yields "a safe and effective product that is substantially equivalent to the predicate device" in cranial shape capture accuracy. |
| Biocompatibility | Cytotoxicity (Agar Diffusion) | Grade 0 (Non-cytotoxic) or Grade 1 for slight reactivity (Non-cytotoxic) | All materials tested (Surlyn, Copolymer with Pelite Foam, Copolymer with Aliplast Foam) showed "Non-cytotoxic" results (Grade 0 or Grade 1 as noted in table 3). |
| Closed Patch Sensitization | Not a Sensitizer, No Erythema or Edema Formation | All materials showed "Not a Sensitizer" and "No Erythema or Edema Formation". | |
| Primary Dermal Irritation | Negligible Dermal Response (e.g., Primary Irritation Index: 0.00 or 0.06 as noted in table 3). | All materials showed "Negligible Dermal Response". | |
| Safety | Eye Protection Requirement | Safe to use on infants without any eye protection. | "The system uses a consumer grade camera and is safe to use on infants without any eye protection." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Cranial Shape Capture Accuracy Study" but does not specify the sample size for the test set (i.e., how many cranial shapes or subjects were included in this accuracy study). It also does not specify the geographic origin (country of origin) of the data or whether the study was retrospective or prospective. It only states that the study "Utilized a representative cranial shape that possesses a predefined shape with known dimensions" and "Compared proposed device to cast and predicate device."
3. Number of Experts and Qualifications for Ground Truth:
The document does not mention the involvement of experts in establishing the ground truth for the test set. The ground truth seems to be based on a "representative cranial shape that possesses a predefined shape with known dimensions" and comparison to a physical "cast," implying an objective measurement rather than expert consensus on images.
4. Adjudication Method:
Given that expert involvement is not mentioned, an adjudication method (like 2+1 or 3+1) for the test set is not applicable and not described in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. This study focuses on the accuracy of the imaging system itself in capturing shape, not on the improvement of human readers' performance with or without AI assistance. The device is a shape capture system for orthotic fabrication, not a diagnostic imaging interpretation tool for humans.
6. Standalone (Algorithm Only) Performance:
The "Cranial Shape Capture Accuracy Study" described is essentially a standalone (algorithm only) performance study as it evaluates the ability of the SmartSoc System for iOS to accurately capture the "predefined shape with known dimensions" and compare it to a cast and the predicate device. It assesses the algorithm's output (3D digital model) directly.
7. Type of Ground Truth Used:
The ground truth used for the accuracy verification was:
- An objective, known "predefined shape with known dimensions" (likely a phantom or a precisely manufactured model).
- Comparison to a physical "cast" of a cranial shape.
This is not expert consensus, pathology, or outcomes data, but rather a direct measurement against a known physical standard.
8. Sample Size for the Training Set:
The document does not specify any training set size for the CurveCapture application or the SmartSoc system. This suggests that the development of the CurveCapture application might have relied on existing algorithms from the Android version, or that the training data details are not considered part of this simplified FDA summary for a Special 510(k). For a Special 510(k), significant changes to the algorithm often require more detailed information on training, but here the focus is on the "firmware expansion" and consistent technological characteristics.
9. How Ground Truth for Training Set was Established:
Since a training set is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2018
Orthomerica Products, Inc J. Schulte Design Engineer 6333 North Orange Blossom Trail Orlando, Florida 32810
Re: K180109
Trade/Device Name: STARband, STARlight, and St. Louis Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN, MVA Dated: January 9, 2018 Received: January 16, 2018
Dear J. Schulte:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
{1}------------------------------------------------
Page 2 - J. Schulte
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K180109
Device Name
STARband®, STARlight®, and St. Louis Band
Indications for Use (Describe)
The STARband, STARlight, and St. Louis Band are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for infants from 3 to 18 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K180109 510(k) Summary
I. Submitter Information
| Name: | Orthomerica Products, Inc. |
|---|---|
| Address: | 6333 North Orange Blossom TrailOrlando, FL 32810 |
| Telephone: | (407) 290-6592 |
| Fax: | (407) 290-2419 |
Contact Information
| Contact Person: | Tyler Schulte, Design Engineer |
|---|---|
| Email: | tschulte@orthomerica.com |
| Date Prepared: | March 1, 2018 |
II. Subject Device Information
| Submission Type: | Special 510(k) |
|---|---|
| Proprietary Name: | STARband®, STARlight®, and St. Louis Banc |
| Common Name: | Cranial Orthosis |
| Product Code: | OAN (Orthosis, Cranial, Laser Scan) |
| Secondary: | MVA (Cranial Orthosis) |
| Classification: | 21 CFR 882.5970, Cranial Orthosis, Class II |
III. Predicate Device
| K151979 | STARband, STARlight |
|---|---|
| Product Code | OAN, MVA |
| K161138 | St. Louis Band |
| Product Code | OAN, MVA |
IV. Description of Device Modification
The proposed device modification is the addition of the CurveCapture application for iOS enabled device for a previously cleared shape capture method, the Net Virta SmartSoc™ System distributed by Orthomerica Products, Inc, used with the STARband, STARlight, and St. Louis Band devices. The system uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade mobile phone device with a camera and a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source. Because the system utilizes a consumer grade camera with a non-coherent light source for a flash, it is safe to use on infant patients under all circumstances.
The proposed modification allows the CurveCapture™ application to be run on an iOS enabled device.
{4}------------------------------------------------
The CurveCapture™ application uses the camera on the device to take video footage of the patient wearing the SmartSoc. Specific images are then selected and sent to the cloud to be processed into a detailed 3D digital model of the patient's cranium. The proposed CurveCapture™ system for iOS enabled device functions the same way as the previously CurveCapture™ system for Android™ enabled devices.
The STARband® and STARlight® redirect head growth to improve proportion and symmetry in infants with moderate-to-severe non-synostotic positional plagiocephaly. The practitioner takes a plaster impression or 3-dimensional captured image the head to acquire the existing shape. The mold is sealed and filled with plaster or the 3-dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® and STARlight® provide total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband® and STARlight® directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
The STARband® and STARlight® product families as it was cleared in K151979 and are fundamentally the same devices cleared in that 510(k). The STARband® Side Opening design and STARband® Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARlight® Side Opening design and the STARligh® Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight® PRO (Post-operative Remolding Orthosis) design is made of 1/4" to 3/8" clear Surlyn. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition, optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight® PRO design.
The STARband® Side Opening design and the STARlight® Side Opening design has a top opening and a side opening. The band is held in place by a Velcro® strap (1½' for STARband® Side Opening and 1" for STARlight® Side Opening) across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight® Bi-Valve design and the STARband® Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.
The St. Louis Band (formally known as the O&P Bivalve Molding Helmet) was first cleared in K063395 and later in K161138 and remains fundamentally the same device. The St. Louis Band is a Bi-Valve design made with an outer shell of 1/4" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/4" Aliplast foam (closed cell polyethylene). The Bi-Valve design consists of two plastic shells that overlap and are held together with rivet fasteners. The St. Louis Band utilizes a Velcro® strap with chafe and loop for a secure fit.
{5}------------------------------------------------
V. Intended Use
The STARband®, STARlight®, and St. Louis Band are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderateto-severe cranial deformities including plagiocephalic- and scaphocephalic- and scaphocephalicshaped heads.
Since growth is the driving factor in head shape correction, the infants wear the STARband® or STARlight® for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. 1 The STARband®, STARlight®, and St. Louis Band are also intended for unresolved head deformities in patients who have undergone surgery to correct craniosynostosis.2 The same principles of cranial remolding apply to positional deformities and post-operative patients.
Summary of Technological Characteristics VII.
The iOS compatible CurveCapture™ application for the SmartSoc™ System proposed in this Special 510(k) is a firmware expansion of a previously cleared shape capture method used for the fabrication of the STARband®, STARlight®, and St. Louis Band Cranial Orthosis. The technological characteristics and the underlying principles of operation of the SmartSoc™ System, the STARband®, the STARlight®, and the St. Louis Band Cranial Orthosis shall remain exactly the same. The inclusion of the iOS compatible CurveCapture™ application is the focus of this submission and the resulting change is indicated in Table 2 below within the feature section Approved 3-Dimensional Imaging Devices. The addition of the accuracy and capabilities study conducted on the iOS compatible CurveCapture™ application is also indicated in the Accuracy Verification section of the Design Controls Summary.
1 For a discussion of positional plagiocephaly, please reference the OPI Band 510(k) Summary for K001167, and the STARlight 510(k) Summary for K021207
2 For a discussion on Cranial Remolding after Corrective Craniosynostosis surgery, please reference the STARband 510(k) Summary for K082950 and the STARlight 510(k) Summary for K081994
{6}------------------------------------------------
| Feature | Predicate K151979 | K180109 |
|---|---|---|
| Intended Use | Maintains total contact over areas ofbossing or protrusion and creates voidsover areas of depression or flattening toredirect cranial growth toward greatersymmetry. | Maintains total contact over areas ofbossing or protrusion and creates voidsover areas of depression or flattening toredirect cranial growth toward greatersymmetry. |
| Materials | Material for STARband® Side Openingdesign and STARband® Bi-Valve design- Outer shell of 5/32" copolymerplastic- An inner liner of 1/2" Pelitepolyethylene foam or 1/2"Aliplast foam | Material for STARband® Side Openingdesign and STARband® Bi-Valve design- Outer shell of 5/32" copolymerplastic- An inner liner of 1/2" Pelitepolyethylene foam or 1/2"Aliplast foam |
| Material for STARlight® Side Openingdesign and STARlight® Bi-Valve design- 5/32" - 1/4" clear Surlyn or 1/8" -7/32" Clear Co-Polyester plasticshell | Material for STARlight® Side Openingdesign and STARlight® Bi-Valve design- 5/32" - 1/4" clear Surlyn or 1/8" -7/32" Clear Co-Polyester plasticshell | |
| Material for STARlight® PRO design- 1/4" – 3/8" clear Surlyn | Material for STARlight® PRO design- 1/4" – 3/8" clear Surlyn | |
| Closure for Bivalve design- Sliding/Overlap closure system- Chicago screw (or similar) for topsliding mechanism- 1" Velcro strap- 1" chafe buckle- Speedy rivets | Closure for Bivalve design- Sliding/Overlap closure system- Chicago screw (or similar) for topsliding mechanism- 1" Velcro strap- 1" chafe buckle- Speedy rivets | |
| Closure for STARband® Side Openingdesign- 1 ½" Velcro Strap- 1 ½" chafe buckle- A Gap Block made from ½" firmPelite polyethylene foam- Large Flange, Blind RivetClosure for STARlight® Side Opening | Closure for STARband® Side Openingdesign- 1 ½" Velcro Strap- 1 ½" chafe buckle- A Gap Block made from ½" firmPelite polyethylene foam- Large Flange, Blind RivetClosure for STARlight® Side Opening | |
| design and the STARlight® PRO design: | design and the STARlight® PRO design: |
| Table 1 - Comparison of Predicate Device cleared in K151979 to the Subject Device | |
|---|---|
| ----------------------------------------------------------------------------------- | -- |
{7}------------------------------------------------
| Feature | Predicate K151979 | K180109 |
|---|---|---|
| 1" Velcro Strap1" chafe buckleOptional tamper resistant strap(qty 2 for the STARlight PROdesign) | 1" Velcro Strap1" chafe buckleOptional tamper resistant strap(qty 2 for the STARlight PROdesign) | |
| Product Design | Custom made cranial orthosis,approximately 6 to 10oz in weight.STARlight® PRO weighs 12.5 to 18.5 oz. | Custom made cranial orthosis,approximately 6 to 10oz in weight.STARlight® PRO weighs 12.5 to 18.5 oz. |
| Production | Form orthosis from a positivemold of infant's head | Form orthosis from a positivemold of infant's head |
| Positive mold is formed basedupon measurements of the infant'shead taken by an approved 3-dimensional imaging device fromwhich a 3-dimensional image ismade or from a traditional plastercast | Positive mold is formed basedupon measurements of the infant'shead taken by an approved 3-dimensional imaging device fromwhich a 3-dimensional image ismade or from a traditional plastercast | |
| The 3-dimensional image is usedto produce a positive mold using a5-axis routing machine | The 3-dimensional image is usedto produce a positive mold using a5-axis routing machine | |
| Approved 3-DimensionalImaging Devices | STARscanner ISTARscanner IIOmega ScannerscanGogh-II3dMDhead System3dMDcranial System3dMDflex SystemM4DScan/BodyScan SystemSpectra 3D ScannerSmartSoc System for AndroidDevice | STARscanner ISTARscanner IIOmega ScannerscanGogh-II3dMDhead System3dMDcranial System3dMDflex SystemM4DScan/BodyScan SystemSpectra 3D ScannerSmartSoc System for AndroidDeviceSmartSoc System for iOS Device |
| SmartSoc SystemMobile DeviceCharacteristics | Image Sensor10.0 Mega PixelsLens focal length | Image Sensor10.0 Mega PixelsLens focal length |
| F=24 mm (minimum)Focusing | F=24 mm (minimum)Focusing | |
| Auto- Focus (Center AF, MultiAF, Face Detection AF)Shooting | Auto- Focus (Center AF, MultiAF, Face Detection AF)Shooting | |
| Still images automaticVideo automaticImage Stabilization | Still images automaticVideo automaticImage Stabilization | |
| Optical Image StabilizationCapability | Optical Image StabilizationCapability | |
| Feature | Predicate K151979 | K180109 |
| Storage | Storage | |
| 4 Gb Total (minimum)1 Gb (minimum) for normal utilizationWireless Connectivity | 4 Gb Total (minimum)1 Gb (minimum) for normal utilizationWireless Connectivity | |
| Wi-Fi, 3G, 4GHTML BrowserWAP BrowserCPU/Processor | Wi-Fi, 3G, 4GHTML BrowserWAP BrowserCPU/Processor | |
| 1.04 GHz or fasterOperating System | 1.04 GHz or fasterOperating System | |
| Android 2.3.3 or Newer | Android 2.3.3 or NeweriOS 10.3 or Newer | |
| Testing | Cranial Shape Capture Accuracy StudyUtilized a representative cranial shape that possesses a predefined shape with known dimensionsCompared proposed device to cast and predicate deviceAssociated Coordinate Planes (A-P; M-L; P-D and various Radius Parameters; Squareness; Flatness)Proposed device is substantially equivalent to predicate device | Cranial Shape Capture Accuracy StudyUtilized a representative cranial shape that possesses a predefined shape with known dimensionsCompared proposed device to cast and predicate deviceAssociated Coordinate Planes (A-P; M-L; P-D and various Radius Parameters; Squareness; Flatness)Proposed device is substantially equivalent to predicate device |
| Material Biocompatibility Testing | Material Biocompatibility Testing | |
| Cytotoxicity -Agar DiffusionClosed Patch SensitizationPrimary Dermal Irritation | Cytotoxicity -Agar DiffusionClosed Patch SensitizationPrimary Dermal Irritation | |
| Feature | Predicate K161138 | K180109 |
| Intended Use | Maintains total contact over areas ofbossing or protrusion and creates voidsover areas of depression or flattening toredirect cranial growth toward greatersymmetry. | Maintains total contact over areas ofbossing or protrusion and creates voidsover areas of depression or flattening toredirect cranial growth toward greatersymmetry. |
| Materials | St. Louis Band- Sliding/Overlap Closure System- Outer shell of 1/4" copolymerplastic- An inner liner of 1/4" Aliplastfoam- Bi-Valve Closure- Sliding/Overlap ClosureSystem- 1" Velcro strap- 1" chafe buckle- Speedy rivets | St. Louis Band- Sliding/Overlap Closure System- Outer shell of 1/4" copolymerplastic- An inner liner of 1/4" Aliplastfoam- Bi-Valve Closure- Sliding/Overlap ClosureSystem- 1" Velcro strap- 1" chafe buckle- Speedy rivets |
| Product Design | Custom made cranial orthosis,approximately 7 to 10oz in weight. | Custom made cranial orthosis,approximately 7 to 10oz in weight. |
| Production | - Form orthosis from a positivemold of infant's head- Positive mold is formed basedupon measurements of theinfant's head taken by anapproved 3-dimensional imagingdevice from which a 3-dimensional image is made orfrom a traditional plaster cast- The 3-dimensional image is usedto produce a positive mold using a5-axis routing machine | - Form orthosis from a positivemold of infant's head- Positive mold is formed basedupon measurements of the infant'shead taken by an approved 3-dimensional imaging device fromwhich a 3-dimensional image ismade or from a traditional plastercast- The 3-dimensional image is usedto produce a positive mold using a5-axis routing machine |
| Approved 3-DimensionalImaging Devices | - STARscanner II- SmartSoc System for AndroidDevice | - STARscanner II- SmartSoc System for AndroidDevice- SmartSoc System for iOS Device |
| SmartSoc SystemMobile DeviceCharacteristics | - Image Sensor- 10.0 Mega Pixels- Lens focal length- F=24 mm (minimum)- Focusing- Auto- Focus (Center AF, MultiAF, Face Detection AF)- Shooting- Still images automatic- Video automatic- Image Stabilization | - Image Sensor- 10.0 Mega Pixels- Lens focal length- F=24 mm (minimum)- Focusing- Auto- Focus (Center AF, MultiAF, Face Detection AF)- Shooting- Still images automatic- Video automatic- Image Stabilization |
| Feature | Predicate K161138 | K180109 |
| Optical Image Stabilization-CapabilityStorage | Optical Image Stabilization-CapabilityStorage | |
| 4 Gb Total (minimum)-1 Gb (minimum) for normal-utilizationWireless Connectivity | 4 Gb Total (minimum)-1 Gb (minimum) for normal-utilizationWireless Connectivity | |
| Wi-Fi, 3G, 4G-HTML Browser-WAP Browser-CPU/Processor | Wi-Fi, 3G, 4G-HTML Browser-WAP Browser-CPU/Processor | |
| 1.04 GHz or fasterCPU/Processor | 1.04 GHz or fasterCPU/Processor | |
| Android 2.3.3 or Newer-Operating System | Android 2.3.3 or Newer-iOS 10.3 or Newer-Operating System | |
| Testing | Material Biocompatibility Testing-Cytotoxicity -Agar Diffusion-Closed Patch Sensitization-Primary Dermal Irritation | Material Biocompatibility Testing-Cytotoxicity -Agar Diffusion-Closed Patch Sensitization-Primary Dermal Irritation |
{8}------------------------------------------------
Since the St. Louis Band relies on the same materials and fundamental technology and has the same intended use as the STARband® and STARlight® Cranial Orthosis, it is substantially equivalent to the device cleared in K151979. However, when the St. Louis Band was cleared in K161138, it was approved to use the STARscannerII and the SmartSoc System for Android Device as 3D imaging devices. The proposed change would only add the SmartSoc System for iOS device as an approved 3D imaging device as shown in Table 2, not all the approved 3D imaging devices used for STARband® and STARlight® shown above in Table 1.
{9}------------------------------------------------
Table 2 – Comparison of Predicate Device cleared in K161138 to the Subject Device
{10}------------------------------------------------
The STARband® and STARlight® Cranial Orthosis and the St. Louis Band Cranial Orthosis have already received FDA 510(k) clearance under K151979 and K161138 respectively to be manufactured from a 3-dimensional image captured using the SmartSoc™ System for android enabled devices. The expansion of the SmartSoc™ System to include a CurveCapture application iOS enabled devices does not alter any of the fundamental technological principals of the SmartSoc™ System. Considering that STARband®, STARlight®, and St. Louis Band are still the same device as it was in the predicate device and that the shape capture devices have the same technological characteristics; the STARband®, STARlight®, and St. Louis Band Cranial Othosis are substantially equivalent to the predicate device.
The STARband®, STARlight®, and St. Louis Band are essentially the same Cranial Orthosis. The main difference between the STARband®, STARlight®, and St. Louis Band are the materials used to produce them. The STARband®, STARlight®, and St. Louis Band materials have demonstrated biocompatibility through testing, and the results of the tests are listed below in Table 3 below.
{11}------------------------------------------------
| Material | Test | Results | Conclusion |
|---|---|---|---|
| Surlyn | Closed PatchSensitization | A score of 0.00/0.00 (Test/Control) wasgiven for both Incidence and Severity inthe 24 hour and 48 hour scoring interval. | Not a SensitizerNo Erythema orEdema Formation |
| Surlyn | Primary DermalIrritation | Primary Irritation Index: 0.00 | Negligible DermalResponse |
| Surlyn | Cytotoxicity -Agar Diffusion | Cell culture treated with test sampleexhibited no reactivity (Grade 0). | Non-cytotoxic |
| Copolymer withPelite Foam | Closed PatchSensitization | A score of 0.00/0.00 (Test/Control) wasgiven for both Incidence and Severity inthe 24 hour and 48 hour scoring interval. | Not a SensitizerNo Erythema orEdema Formation |
| Copolymer withPelite Foam | Primary DermalIrritation | Primary Irritation Index: 0.06 | Negligible DermalResponse |
| Copolymer withPelite Foam | Cytotoxicity -Agar Diffusion | Cell culture treated with test sampleexhibited no reactivity (Grade 0). | Non-cytotoxic |
| Copolymer withAliplast Foam | Closed PatchSensitization | A score of 0.00/0.00 (Test/Control) wasgiven for both Incidence and Severity inthe 24 hour and 48 hour scoring interval. | Not a SensitizerNo Erythema orEdema Formation |
| Copolymer withAliplast Foam | Primary DermalIrritation | Primary Irritation Index: 0.00 | Negligible DermalResponse |
| Copolymer withAliplast Foam | Cytotoxicity -Agar Diffusion | Cell culture treated with test sampleexhibited slight reactivity (Grade 1). | Non-cytotoxic |
Table 3 - Biocompatibility Testing Summary for STARband, STARlight, and St. Louis Band Cranial Orthosis
Summary and Conclusions of Non-Clinical Performance Data VII.
The SmartSoc™ System for iOS device was evaluated for safety and efficacy. The system uses a consumer grade camera and is safe to use on infants without any eye protection. Cranial Shape Capture Accuracy Verification was performed concluding that the SmartSoc™ System for iOS enabled device yields a safe and effective product that is substantially equivalent to the predicate device. With sufficient accuracy and no concerns with the safety of the system, the SmartSoc™ System for iOS enabled device was determined safe and effective for capturing infant head shape data to manufacture the STARband®, STARlight®, and St. Louis Band Cranial Orthosis.
§ 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)).