(90 days)
No
The description focuses on the physical design and modification process of the cranial orthosis and the method for capturing the head shape (plaster impression or 3D imaging). There is no mention of AI or ML being used in the design, modification, or analysis of the head shape data. The performance studies described are focused on the accuracy of the shape capture and the biocompatibility of the materials, not on any AI/ML-driven analysis or decision-making.
Yes
The device is intended to treat moderate-to-severe non-synostotic positional plagiocephaly and other cranial deformities in infants by applying mild pressure to reshape the cranium, indicating it is a therapeutic device.
No
Explanation: The device is a post-surgical and corrective treatment device that applies pressure to the cranium to improve symmetry and shape. It redirects head growth rather than diagnosing a condition. While it utilizes imaging to capture existing head shapes, this is for treatment planning and modification, not diagnosis.
No
The device description clearly details physical components like plastic shells, foam liners, and Velcro straps, indicating it is a physical medical device, not software-only. While it incorporates a 3D shape capture system which likely involves software, the core therapeutic device is hardware.
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 and STARlight are external devices applied to the infant's head to physically reshape the skull. They do not analyze biological specimens.
- Intended Use: The intended use is to improve cranial symmetry and/or shape in infants with specific head deformities by applying external pressure. This is a mechanical intervention, not a diagnostic test performed on a biological sample.
- Device Description: The description details the materials and mechanism of the orthosis, which is a physical device worn on the head. It also describes the process of creating a model of the head shape, which is for the purpose of fitting and modifying the orthosis, not for analyzing a biological sample.
The device is a cranial orthosis, which is a type of medical device used for external support or correction of the body.
N/A
Intended Use / Indications for Use
The STARband and STARlight are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, 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 adjunctive use 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
MVA, OAN
Device Description
The STARband and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's 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 released in K140353 are essentially still the same devices. 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 STARlight 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 proposed device modification is the addition of a new 3-dimensional shape capture, specifically, the NetVirta SmartSoc™ System distributed by Orthomerica Products, Inc. This system uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade digital camera with it's a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source. Because this 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium / head
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)
Repeatability and Reproducibility (R&R) Testing Analysis:
Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age. Compared proposed device to cast and predicate device. Associated parameters included A-P and M-L. Concluded that the proposed device is substantially equivalent to the 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). Concluded that the proposed device is substantially equivalent to the predicate device.
Material Biocompatibility Testing:
Conducted Cytotoxicity – Agar Diffusion, Closed Patch Sensitization, and Primary Dermal Irritation tests on Surlyn, Copolymer with Pelite Foam, and Copolymer with Aliplast Foam.
- Surlyn: Not a Sensitizer, No Erythema or Edema Formation, Negligible Dermal Response, Non-cytotoxic.
- Copolymer with Pelite Foam: Not a Sensitizer, No Erythema or Edema Formation, Negligible Dermal Response, Non-cytotoxic.
- Copolymer with Aliplast Foam: Not a Sensitizer, No Erythema or Edema Formation, Negligible Dermal Response, Non-cytotoxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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)).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2014
Orthomerica Products, Inc. % David Kerr Chief Executive Officer 6333 N Orange Blossom Trail Orlando, Florida 32810
Re: K141842 Trade/Device Name: Starband, starlight Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: July 3, 2014 Received: July 8, 2014
Dear David Kerr,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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. 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.
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,
Carlos L. Pena - SVA
Carlos L. Peña, PhD, MS 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) K141842
Device Name STARband and STARlight Cranial Orthosis
Indications for Use (Describe)
The STARband and STARlight are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, 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 adjunctive use 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) | |
|---|---|
| \u2612 Prescription Use (Part 21 CFR 801 Subpart D) | \u2610 Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
I. Applicant Information
| Name: | Orthomerica Products, Inc. | |
|---|---|---|
| Address: | 6333 North Orange Blossom Trail | |
| Orlando, FL 32810 | ||
| Telephone: | (407) 290-6592 | |
| Facsimile: | (407) 290-2419 |
FDA Establishment Registration Number
1058152
Contact Information
| Contact Person: | David Hooper, Manufacturing Engineer |
|---|---|
| Address: | 6333 North Orange Blossom Trail |
| Orlando, FL 32810 | |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
| Email: | dhooper@orthomerica.com |
| Date Prepared: | July 3, 2014 |
II. Submission Information
| Type: | Traditional 510(k) Submission |
|---|---|
| Proprietary Name: | STARband® and STARlight® |
| Common Name: | Cranial Orthosis |
| Classification: | Class II (special controls); OAN; MVA; 21 CFR 882.5970 |
| Classification Name: | Cranial Orthosis |
III. Manufacturer Site
| Name: | Orthomerica Products, Inc. |
|---|---|
| Address: | 6333 North Orange Blossom Trail |
| Orlando, FL 32810 | |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
| FDA Establishment Registration Number: | 1058152 |
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IV. Description of Device/Modification
The STARband and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's 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 released in K140353 are essentially still the same devices. 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 STARlight 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 proposed device modification is the addition of a new 3-dimensional shape capture, specifically, the NetVirta SmartSoc™ System distributed by Orthomerica Products, Inc. This system uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade digital camera with it's a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source. Because this system
5
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.
V. Statement of Indications and Intended Use
Statement of Indications:
The STARband and STARlight 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 moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.
Intended Use:
The STARband and STARlight are designed to treat infants with abnormal head shapes from age 3 to 18 months and is available by prescription only. 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. The STARband and STARlight have also been cleared to treat unresolved head deformities in patients who have undergone surgery to correct craniosynostosis. The same principles of cranial remolding apply to positional deformities and post-operative patients.
Predicate Devices VI.
- STARband and Starlight, Cranial Orthosis, K140353
6
VI. Summary of Technological Characteristics
The SmartSoc System proposed in this 510(k) is an additional method to capture the infant's head shape for the fabrication of the STARband and STARlight Cranial Orthosis. The technological characteristics and the underlying principles of operation of the STARband and STARlight Cranial Orthosis shall remain exactly the same. The inclusion of the SmartSoc System is the focus of this submission and that change is indicated in Table 1 under the Approved 3-Dimensional Imaging Devices section.
| Feature | From K140353 | Proposed Device |
|---|---|---|
| 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. |
Table 1 - Comparison of Predicate Device cleared in K140353 to the Proposed Device
7
| Materials | K141842 - STARband® and STARlight® |
|---|---|
| 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 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: 1" Velcro Strap | Closure for STARlight Side Opening design and the STARlight PRO design: 1" Velcro Strap |
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| Feature | From K140353 | Proposed Device |
|---|---|---|
| 1" chafe buckle | ||
| Optional tamper resistant strap | ||
| (qty 2 for the STARlight PRO | ||
| design) | 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 | STARscanner I | |
| STARscanner II | ||
| Omega Scanner | ||
| scanGogh-II | ||
| 3dMDhead System | ||
| 3dMDcranial System | ||
| 3dMDflex System | ||
| SmartSoc System |
9
K141842 - STARband® and STARlight® Repeatability and Reproducibility (R&R) Repeatability and Reproducibility (R&R) Testing Analysis Analysis Utilized uniform shapes with Utilized uniform shapes with known dimensions that represent known dimensions that represent various sizes of pediatric patients various sizes of pediatric patients between ages 3 to 18 months of between ages 3 to 18 months of age age -Compared proposed device to cast -Compared proposed device to cast and predicate device and predicate device --Associated parameters includes Associated parameters includes A-P and M-L A-P and M-L Proposed device is substantially -Proposed device is substantially equivalent to predicate device equivalent to predicate device Cranial Shape Capture Accuracy Study Cranial Shape Capture Accuracy Study Utilized a representative cranial Utilized a representative cranial shape that possesses a predefined shape that possesses a predefined shape with known dimensions shape with known dimensions -Compared proposed device to cast -Compared proposed device to cast and predicate device and predicate device Associated Coordinate Planes (A---Associated Coordinate Planes (A-P; M-L; P-D and various Radius P; M-L; P-D and various Radius Parameters; Squareness; Flatness) Parameters; Squareness; Flatness) Proposed device is substantially Proposed device is substantially -equivalent to predicate device equivalent to predicate device
10
| Feature | From K140353 | Proposed Device |
|---|---|---|
| Material Biocompatibility Testing |
- Cytotoxicity –Agar Diffusion
- Closed Patch Sensitization
- Primary Dermal Irritation | Material Biocompatibility Testing
- Cytotoxicity –Agar Diffusion
- Closed Patch Sensitization
- Primary Dermal Irritation |
The STARband and STARlight Cranial Orthosis have already received FDA 510(k) clearance under K140353 for being manufactured from a 3-dimensional imaging device that utilizes a non-coherent light source and takes 2-dimensional (2D) images from triangulated positions for shape capture (3dMD Systems). The SmartSoc System also utilizes a non-coherent light source and takes 2D images from triangulated positions for shape capture. Considering that STARband and STARlight 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 and STARlight Cranial Othosis are substantially equivalent to the predicate device.
The STARband and STARlight are essentially the same Cranial Orthosis. The main difference between the STARband and STARlight are the materials used to produce them. The STARband and STARlight materials have been biocompatibility tested, and the results of the tests are listed below in Table 2.
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| Orthosis | |||
|---|---|---|---|
| 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 2 - Biocompatibility Testing Summary for STARband and STARlight Cranial Orthosis
Summary and Conclusions of Non-Clinical Performance Data VII.
The SmartSoc System was evaluated for safety and efficacy. The system uses a consumer grade camera and is safe to use on infants without any eye protection. The shape capture repeatability and reproducibility was evaluated and determined to be acceptable. An additional, Cranial Shape Capture Accuracy Study was performed concluding that the SmartSoc System yields a safe and effective product that is substantially equivalent to the predicate device.4 With sufficient accuracy and no concerns with the safety of the system, the SmartSoc System was determined safe and effective for capturing infant head shape data to manufacture the STARband and STARlight Cranial Orthosis.