(261 days)
No
The summary describes a software component (CCU) that performs measurements and comparisons on 3D cranial models. While it processes data, there is no mention of AI or ML algorithms being used for analysis, prediction, or learning from data. The performance studies focus on accuracy and repeatability of measurements, not on the performance of an AI/ML model.
Yes.
The device's intended use is to improve cranial symmetry and/or shape in infants, directly treating a medical condition (positional plagiocephaly and cranial deformities).
No
The STARband and STARlight devices are therapeutic devices designed to reshape an infant's cranium. While the Cranial Comparison Utility (CCU) software component provides "detailed shape data that can be incorporated into the patient evaluation/assessment and for tracking cranial head shape changes," its primary purpose is to assist in the treatment planning and monitoring of the craniosynostosis condition, not to diagnose the condition itself. The "Intended Use" section explicitly states these devices are for "applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape," indicating a treatment rather than diagnostic function.
No
The device description clearly details physical components (plastic shells, foam liners, Velcro straps) that constitute the STARband and STARlight devices. While a new software component (CCU) is mentioned, it is described as a separate program that processes data from a 3D digital model, which is acquired from a physical impression or 3D capture of the infant's head. The core therapeutic devices (STARband and STARlight) are physical orthoses.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The STARband and STARlight are physical devices (orthoses) worn externally on an infant's head to reshape the skull. The associated software (CCU) processes 3D images of the head to provide measurements and tracking information.
- Lack of Biological Sample Analysis: The device and its software do not analyze any biological samples from the patient. They work with external measurements and images of the head.
Therefore, the STARband and STARlight, along with the Cranial Comparison Utility software, fall under the category of medical devices, but not In Vitro Diagnostics.
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, including infants with plagiocephalic-, 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 (comma separated list FDA assigned to the subject device)
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 a new software component for a previously cleared shape capture method, the STARscanner™ Data Acquisition System. The new software component is the Cranial Comparison Utility (CCU). The CCU is a separate software program that is designed to present specific measurements derived from a threedimensional (3D) digital model of a patient's cranium. These features are useful to medical professionals by providing more detailed shape data that can be incorporated into the patient evaluation/assessment and for tracking cranial head shape changes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium, infant's head
Indicated Patient Age Range
3 to 18 months of age
Intended User / Care Setting
Medical professionals, practitioner
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)
The software program provides accurate information of 3D digital models from the STARscanner Data Acquisition System. The accuracy and reliability of the STARscanner has already been proven through accuracy analysis as well as repeatability and reproducibility (R&R) studies. An accuracy and capability study was conducted on the CCU and was determined to be acceptable. With sufficient accuracy, no concerns with the safety of the software program and the fact that it is not used in the manufacturing of the STARband and STARlight Cranial Orthosis, the CCU demonstrated a safety and effectiveness profile similar to the predicate device for measuring pediatric head shapes digital models provided from the STARscanner.
CCU Accuracy and Capabilities Study
- Utilized a representative cranial shape that possesses a predefined shape with known dimensions
- Compared CCU to manual measurements and 3D-CAD software
- Accessed accuracy of measurements and capabilities of model alignment, differential maps, calculations and reporting
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2015
Orthomerica Products, Inc. Mr. David L. Hooper Manufacturing Engineer 6333 North Orange Blossom Trail Orlando, Florida 32810
Re: K142141 Trade/Device Name: STARband®, STARlight® Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: March 18, 2015 Received: March 20, 2015
Dear Mr. Hooper,
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 -5D/△
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) K142141
Device Name STARband and STARlight
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, including infants with plagiocephalic-, 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Applicant Information I.
| Orthomerica Products, Inc. | |
|---|---|
| 6333 North Orange Blossom Trail | |
| Orlando, FL 32810 | |
| (407) 290-6592 | |
| (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: | August 1, 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 |
4
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 a new software component for a previously cleared shape capture method, the STARscanner™ Data Acquisition System. The new software component is the Cranial Comparison Utility (CCU). The CCU is a separate software program that is designed to present specific measurements derived from a threedimensional (3D) digital model of a patient's cranium. These features are useful to
5
medical professionals by providing more detailed shape data that can be incorporated into the patient evaluation/assessment and for tracking cranial head shape changes.
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.
VI. Predicate Devices
- I STARband and Starlight, Cranial Orthosis, K140353
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VII. Summary of Technological Characteristics
The CCU proposed in this 510(k) is an added software program for a previously cleared shape capture method used 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 CCU is the focus of this submission and the resulting change is indicated in Table 1 within the feature section Reporting Software. The addition of the accuracy and capabilities study conducted on the CCU is also indicated in the Testing 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. | ||
| 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 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
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
design and the STARlight PRO design: | 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 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 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 |
| Feature | From K140353 | Proposed Device |
| | - 1" Velcro Strap | - 1" Velcro Strap |
| | - 1" chafe buckle | - 1" chafe buckle |
| | - Optional tamper resistant strap
(qty 2 for the STARlight PRO
design) | - 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 |
| Reporting
Software | None | Cranial Comparison Utility
(CCU) |
| Testing | Repeatability and Reproducibility (R&R)
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 includes
A-P and M-L - 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 | Repeatability and Reproducibility (R&R)
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 includes
A-P and M-L - 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 |
| Feature | From K140353 | Proposed Device |
| | - Proposed device is substantially equivalent to predicate device | - Proposed device is substantially equivalent to predicate device |
| | Material Biocompatibility Testing - Cytotoxicity -Agar Diffusion
- Closed Patch Sensitization
- Primary Dermal Irritation | CCU Accuracy and Capabilities Study
- Utilized a representative cranial shape that possesses a predefined shape with known dimensions
- Compared CCU to manual measurements and 3D-CAD software
- Accessed accuracy of measurements and capabilities of model alignment, differential maps, calculations and reporting |
| | | Material Biocompatibility Testing - Cytotoxicity -Agar Diffusion
- Closed Patch Sensitization
- Primary Dermal Irritation |
Table 1 - Comparison of Predicate Device cleared in K140353 to the Proposed Device
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8
The STARband and STARlight Cranial Orthosis have previously received FDA 510(k) clearance with the STARscanner Data Acquisition System under K011350 for the STARband and under K021207 for the STARlight. The CCU does not affect the operation of the STARscanner and is not used for manufacturing of the STARband or STARlight. The CCU is a separate software program designed to present specific measurements derived from a 3D digital model of the patient's cranium. The STARband and STARlight are the same devices as previously cleared with the predicate devices. The shape capture device has the same technological characteristics. Therefore, the STARband and STARlight Cranial Orthosis 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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| 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
VIII. Summary and Conclusions of Non-Clinical Performance Data
The software program provides accurate information of 3D digital models from the STARscanner Data Acquisition System. The accuracy and reliability of the STARscanner has already been proven through accuracy analysis as well as repeatability and reproducibility (R&R) studies. An accuracy and capability study was conducted on the CCU and was determined to be acceptable. With sufficient accuracy, no concerns with the safety of the software program and the fact that it is not used in the manufacturing of the STARband and STARlight Cranial Orthosis, the CCU demonstrated a safety and effectiveness profile similar to the predicate device for measuring pediatric head shapes digital models provided from the STARscanner.