(44 days)
Unknown
The description mentions "Specific images are then selected and sent to the cloud to be processed into a detailed 3D digital model of the patient's cranium." While this involves image processing, the summary does not explicitly state whether AI/ML algorithms are used in this processing step. It could be traditional image processing techniques. Without further information, it's impossible to confirm the presence of AI/ML.
Yes
The device is a custom-made cranial orthosis intended to correct cranial deformities in infants by applying mild pressure to prominent regions of the cranium and redirecting head growth. This constitutes a therapeutic function.
No
The device is a custom-made cranial orthosis (STARband, STARlight, and St. Louis Band) designed to apply mild pressure to an infant's cranium to improve cranial symmetry and/or shape. It is a treatment device, not a diagnostic one. While it uses 3D imaging to capture the head shape, this is for the purpose of creating and modifying the orthosis, not for diagnosing a condition.
No
The device description clearly states that the STARband, STARlight, and St. Louis Band are "custom made cranial orthoses," which are physical devices. While the submission includes a software component (CurveCapture application) used for capturing 3D images for the creation of these orthoses, the overall device being cleared is the cranial orthosis itself, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The STARband, STARlight, and St. Louis Band are cranial orthoses (medical devices worn externally) used to reshape an infant's head. They work by applying physical pressure to the skull.
- Intended Use: The intended use is to improve cranial symmetry and/or shape in infants with positional plagiocephaly or post-surgical cranial deformities. This is a physical intervention, not a diagnostic test performed on a biological sample.
- Method of Operation: The device uses physical pressure and is custom-made based on a 3D model of the head. The CurveCapture application is used to create this 3D model, which is a measurement and modeling tool, not a diagnostic test.
The device is a Class II medical device (as indicated by the K numbers for the predicate devices), but it falls under the category of orthopedic devices or similar external support devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
OAN, MVA
Device Description
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium
Indicated Patient Age Range
3 to 18 months of age
Intended User / Care Setting
Not Found
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)
Cranial Shape Capture Accuracy Study 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.
Material Biocompatibility Testing:
- Cytotoxicity - Agar Diffusion: Surlyn exhibited no reactivity (Grade 0), Copolymer with Pelite Foam exhibited no reactivity (Grade 0), Copolymer with Aliplast Foam exhibited slight reactivity (Grade 1). All concluded non-cytotoxic.
- Closed Patch Sensitization: Surlyn, Copolymer with Pelite Foam, and Copolymer with Aliplast Foam all scored 0.00/0.00 (Test/Control) for Incidence and Severity in 24 and 48 hour scoring, concluding Not a Sensitizer, No Erythema or Edema Formation.
- Primary Dermal Irritation: Surlyn had a Primary Irritation Index of 0.00, Copolymer with Pelite Foam had an index of 0.06, and Copolymer with Aliplast Foam had an index of 0.00. All concluded Negligible Dermal Response.
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.
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.
K001167, K021207, K082950, K081994, K063395
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
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) |
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K180109 510(k) Summary
I. Submitter Information
| Name: | Orthomerica Products, Inc. |
|---|---|
| Address: | 6333 North Orange Blossom Trail |
| Orlando, 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 of | |
| bossing or protrusion and creates voids | ||
| over areas of depression or flattening to | ||
| redirect cranial growth toward greater | ||
| symmetry. | Maintains total contact over areas of | |
| bossing or protrusion and creates voids | ||
| over areas of depression or flattening to | ||
| redirect cranial growth toward greater | ||
| symmetry. | ||
| Materials | Material for STARband® Side Opening | |
| design and STARband® Bi-Valve design |
- Outer shell of 5/32" copolymer
plastic - An inner liner of 1/2" Pelite
polyethylene foam or 1/2"
Aliplast foam | Material for STARband® Side Opening
design and STARband® Bi-Valve design - Outer shell of 5/32" copolymer
plastic - An inner liner of 1/2" Pelite
polyethylene foam or 1/2"
Aliplast foam |
| | Material for STARlight® Side Opening
design and STARlight® Bi-Valve design - 5/32" - 1/4" clear Surlyn or 1/8" -
7/32" Clear Co-Polyester plastic
shell | Material for STARlight® Side Opening
design and STARlight® Bi-Valve design - 5/32" - 1/4" clear Surlyn or 1/8" -
7/32" Clear Co-Polyester plastic
shell |
| | 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 top
sliding mechanism - 1" Velcro strap
- 1" chafe buckle
- Speedy rivets | Closure for Bivalve design
- Sliding/Overlap closure system
- Chicago screw (or similar) for top
sliding mechanism - 1" Velcro strap
- 1" chafe buckle
- Speedy rivets |
| | Closure for STARband® Side Opening
design - 1 ½" Velcro Strap
- 1 ½" chafe buckle
- A Gap Block made from ½" firm
Pelite polyethylene foam - Large Flange, Blind Rivet
Closure for STARlight® Side Opening | Closure for STARband® Side Opening
design - 1 ½" Velcro Strap
- 1 ½" chafe buckle
- A Gap Block made from ½" firm
Pelite polyethylene foam - Large Flange, Blind Rivet
Closure 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 Strap | ||
| 1" chafe buckle | ||
| Optional tamper resistant strap | ||
| (qty 2 for the STARlight PRO | ||
| design) | 1" Velcro Strap | |
| 1" chafe buckle | ||
| Optional tamper resistant strap | ||
| (qty 2 for the STARlight PRO | ||
| design) | ||
| 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 positive | |
| mold of infant's head | Form orthosis from a positive | |
| mold of infant's head | ||
| Positive mold is formed based | ||
| upon measurements of the infant's | ||
| head taken by an approved 3- | ||
| dimensional imaging device from | ||
| which a 3-dimensional image is | ||
| made or from a traditional plaster | ||
| cast | Positive mold is formed based | |
| upon measurements of the infant's | ||
| head taken by an approved 3- | ||
| dimensional imaging device from | ||
| which a 3-dimensional image is | ||
| made or from a traditional plaster | ||
| cast | ||
| The 3-dimensional image is used | ||
| to produce a positive mold using a | ||
| 5-axis routing machine | The 3-dimensional image is used | |
| to produce a positive mold using a | ||
| 5-axis routing machine | ||
| Approved 3- | ||
| Dimensional | ||
| Imaging Devices | STARscanner I | |
| STARscanner II | ||
| Omega Scanner | ||
| scanGogh-II | ||
| 3dMDhead System | ||
| 3dMDcranial System | ||
| 3dMDflex System | ||
| M4DScan/BodyScan System | ||
| Spectra 3D Scanner | ||
| SmartSoc System for Android | ||
| Device | STARscanner I | |
| STARscanner II | ||
| Omega Scanner | ||
| scanGogh-II | ||
| 3dMDhead System | ||
| 3dMDcranial System | ||
| 3dMDflex System | ||
| M4DScan/BodyScan System | ||
| Spectra 3D Scanner | ||
| SmartSoc System for Android | ||
| Device | ||
| SmartSoc System for iOS Device | ||
| SmartSoc System | ||
| Mobile Device | ||
| Characteristics | Image Sensor | |
| 10.0 Mega Pixels | ||
| Lens focal length | Image Sensor | |
| 10.0 Mega Pixels | ||
| Lens focal length | ||
| F=24 mm (minimum) | ||
| Focusing | F=24 mm (minimum) | |
| Focusing | ||
| Auto- Focus (Center AF, Multi | ||
| AF, Face Detection AF) | ||
| Shooting | Auto- Focus (Center AF, Multi | |
| AF, Face Detection AF) | ||
| Shooting | ||
| Still images automatic | ||
| Video automatic | ||
| Image Stabilization | Still images automatic | |
| Video automatic | ||
| Image Stabilization | ||
| Optical Image Stabilization | ||
| Capability | Optical Image Stabilization | |
| Capability | ||
| Feature | Predicate K151979 | K180109 |
| Storage | Storage | |
| 4 Gb Total (minimum) | ||
| 1 Gb (minimum) for normal utilization | ||
| Wireless Connectivity | 4 Gb Total (minimum) | |
| 1 Gb (minimum) for normal utilization | ||
| Wireless 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 faster | ||
| Operating System | 1.04 GHz or faster | |
| Operating System | ||
| Android 2.3.3 or Newer | Android 2.3.3 or Newer | |
| iOS 10.3 or Newer | ||
| Testing | Cranial Shape Capture Accuracy Study | |
| Utilized a representative cranial shape that possesses a predefined shape with known dimensions | ||
| Compared proposed device to cast and predicate device | ||
| Associated 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 Study | |
| Utilized a representative cranial shape that possesses a predefined shape with known dimensions | ||
| Compared proposed device to cast and predicate device | ||
| Associated 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 Diffusion | ||
| Closed Patch Sensitization | ||
| Primary Dermal Irritation | Cytotoxicity -Agar Diffusion | |
| Closed Patch Sensitization | ||
| Primary Dermal Irritation | ||
| Feature | Predicate K161138 | K180109 |
| Intended Use | Maintains total contact over areas of | |
| bossing or protrusion and creates voids | ||
| over areas of depression or flattening to | ||
| redirect cranial growth toward greater | ||
| symmetry. | Maintains total contact over areas of | |
| bossing or protrusion and creates voids | ||
| over areas of depression or flattening to | ||
| redirect cranial growth toward greater | ||
| symmetry. | ||
| Materials | St. Louis Band |
- Sliding/Overlap Closure System
- Outer shell of 1/4" copolymer
plastic - An inner liner of 1/4" Aliplast
foam - Bi-Valve Closure
- Sliding/Overlap Closure
System - 1" Velcro strap
- 1" chafe buckle
- Speedy rivets | St. Louis Band
- Sliding/Overlap Closure System
- Outer shell of 1/4" copolymer
plastic - An inner liner of 1/4" Aliplast
foam - Bi-Valve Closure
- Sliding/Overlap Closure
System - 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 positive
mold of infant's head - Positive mold is formed based
upon measurements of the
infant's head taken by an
approved 3-dimensional imaging
device from which a 3-
dimensional image is made or
from a traditional plaster cast - The 3-dimensional image is used
to produce a positive mold using a
5-axis routing machine | - Form orthosis from a positive
mold of infant's head - Positive mold is formed based
upon measurements of the infant's
head taken by an approved 3-
dimensional imaging device from
which a 3-dimensional image is
made or from a traditional plaster
cast - The 3-dimensional image is used
to produce a positive mold using a
5-axis routing machine |
| Approved 3-
Dimensional
Imaging Devices | - STARscanner II - SmartSoc System for Android
Device | - STARscanner II - SmartSoc System for Android
Device - SmartSoc System for iOS Device |
| SmartSoc System
Mobile Device
Characteristics | - Image Sensor - 10.0 Mega Pixels
- Lens focal length
- F=24 mm (minimum)
- Focusing
- Auto- Focus (Center AF, Multi
AF, 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, Multi
AF, Face Detection AF) - Shooting
- Still images automatic
- Video automatic
- Image Stabilization |
| Feature | Predicate K161138 | K180109 |
| | Optical Image Stabilization
Capability
Storage | Optical Image Stabilization
Capability
Storage |
| | 4 Gb Total (minimum)
1 Gb (minimum) for normal
utilization
Wireless Connectivity | 4 Gb Total (minimum)
1 Gb (minimum) for normal
utilization
Wireless 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 faster
CPU/Processor | 1.04 GHz or faster
CPU/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 Patch | ||
| Sensitization | A score of 0.00/0.00 (Test/Control) was | ||
| given for both Incidence and Severity in | |||
| the 24 hour and 48 hour scoring interval. | Not a Sensitizer | ||
| No Erythema or | |||
| Edema Formation | |||
| Surlyn | Primary Dermal | ||
| Irritation | Primary Irritation Index: 0.00 | Negligible Dermal | |
| Response | |||
| Surlyn | Cytotoxicity - | ||
| Agar Diffusion | Cell culture treated with test sample | ||
| exhibited no reactivity (Grade 0). | Non-cytotoxic | ||
| Copolymer with | |||
| Pelite Foam | Closed Patch | ||
| Sensitization | A score of 0.00/0.00 (Test/Control) was | ||
| given for both Incidence and Severity in | |||
| the 24 hour and 48 hour scoring interval. | Not a Sensitizer | ||
| No Erythema or | |||
| Edema Formation | |||
| Copolymer with | |||
| Pelite Foam | Primary Dermal | ||
| Irritation | Primary Irritation Index: 0.06 | Negligible Dermal | |
| Response | |||
| Copolymer with | |||
| Pelite Foam | Cytotoxicity - | ||
| Agar Diffusion | Cell culture treated with test sample | ||
| exhibited no reactivity (Grade 0). | Non-cytotoxic | ||
| Copolymer with | |||
| Aliplast Foam | Closed Patch | ||
| Sensitization | A score of 0.00/0.00 (Test/Control) was | ||
| given for both Incidence and Severity in | |||
| the 24 hour and 48 hour scoring interval. | Not a Sensitizer | ||
| No Erythema or | |||
| Edema Formation | |||
| Copolymer with | |||
| Aliplast Foam | Primary Dermal | ||
| Irritation | Primary Irritation Index: 0.00 | Negligible Dermal | |
| Response | |||
| Copolymer with | |||
| Aliplast Foam | Cytotoxicity - | ||
| Agar Diffusion | Cell culture treated with test sample | ||
| exhibited 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.