(89 days)
No
The description focuses on the physical design of the band and the methods for capturing head shape (plaster impression or 3D imaging). There is no mention of AI or ML being used for analysis, modification planning, or any other function of the device or its associated systems.
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 a therapeutic purpose.
No
Explanation: The St. Louis Band is a cranial orthosis designed to reshape an infant's head by applying pressure, not to diagnose a condition. While it utilizes measurements to aid in treatment, its primary function is therapeutic, not diagnostic.
No
The device description clearly describes a physical cranial band made of plastic and foam, which is a hardware component. While it mentions software for 3D shape capture, the core therapeutic device is a physical object.
Based on the provided information, the St. Louis Band is not an In Vitro Diagnostic (IVD) device.
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.
- St. Louis Band Function: The St. Louis Band is a physical device (a cranial orthosis) that is applied externally to the infant's head. Its purpose is to physically reshape the skull by applying pressure and guiding growth. It does not involve the analysis of biological specimens.
- Intended Use: The intended use clearly states it's for treating cranial deformities by applying pressure to the cranium. This is a physical intervention, not a diagnostic test performed on a specimen.
- Device Description: The description details the materials and construction of the band and how it's used to physically modify head shape. It does not mention any components or processes related to analyzing biological samples.
Therefore, the St. Louis Band falls under the category of a medical device, specifically a cranial orthosis, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The St. Louis Band is 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. This device is 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 St. Louis Band 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 3dimensional 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 St. Louis Band provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, 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 St. Louis Band directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
The St. Louis Band (formally known as the O&P Bivalve Molding Helmet) was released in K063395. The St. Louis Band is a Bi-Valve design made with an outer shell of 1/4" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/4" Aliplast foam (closed cell polyethylene). The Bi-Valve design consists of two plastic shells that overlap and are held together with rivet fasteners. The St. Louis Band utilizes a Velcro® strap with chafe and loop for a secure fit.
The proposed device modifications include:
(1) A clarification to the indications for use for the St. Louis Band. This change would have the device 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.
(2) The addition of two new 3-dimensional shape capture methods, specifically, the STARscanner™ Data Acquisition System and the SmartSocTM System. The STARscanner is a stationary system that uses Class I Lasers and cameras to record surface data for shape capture. The SmartSoc System is a hand held system that 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. Both of these shape capture systems are cleared with the STARband predicate device (K151979).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3-dimensional captured image (specifically, the STARscanner™ Data Acquisition System and the SmartSocTM System), traditional plaster cast
Anatomical Site
Cranium/Head
Indicated Patient Age Range
infants from 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) Analysis:
- Study type: Repeatability and Reproducibility (R&R) Analysis
- Sample size: Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age.
- Key results: The shape capture devices passed the acceptance criteria. The relevancy of the tests determined substantial equivalence of the proposed shape capture devices.
Cranial Shape Capture Accuracy Study:
- Study type: Cranial Shape Capture Accuracy Study
- Sample size: Utilized a representative cranial shape that possesses a predefined shape with known dimensions.
- Key results: The shape capture devices passed the acceptance criteria for all parameters. The relevancy of the test determined substantial equivalence of the proposed shape capture device.
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)).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2016
Orthomerica Products, Inc. Mr. David L. Hooper Manufacturing Engineer 6333 North Orange Blossom Trail Orlando, Florida 32810
Re: K161138
Trade/Device Name St. Louis Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: April 20, 2016 Received: April 22, 2016
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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 -S
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) K161138
Device Name St. Louis Band
Indications for Use (Describe)
The St. Louis Band is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-tosevere 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. This device is 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
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: | April 20th, 2016 |
II. Submission Information
| Type: | Traditional 510(k) Submission |
|---|---|
| Proprietary Name: | St. Louis Band |
| 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 St. Louis Band 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 3dimensional 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 St. Louis Band provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, 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 St. Louis Band directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
The St. Louis Band (formally known as the O&P Bivalve Molding Helmet) was released in K063395. The St. Louis Band is a Bi-Valve design made with an outer shell of 1/4" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/4" Aliplast foam (closed cell polyethylene). The Bi-Valve design consists of two plastic shells that overlap and are held together with rivet fasteners. The St. Louis Band utilizes a Velcro® strap with chafe and loop for a secure fit.
The proposed device modifications include:
(1) A clarification to the indications for use for the St. Louis Band. This change would have the device 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.
(2) The addition of two new 3-dimensional shape capture methods, specifically, the STARscanner™ Data Acquisition System and the SmartSocTM System. The STARscanner is a stationary system that uses Class I Lasers and cameras to record surface data for shape capture. The SmartSoc System is a hand held system that 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. Both of these shape capture systems are cleared with the STARband predicate device (K151979).
5
V. Statement of Indications and Intended Use
Statement of Indications:
The St. Louis Band is 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. This device is 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 St. Louis Band is 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 St. Louis Band for approximately 22 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. However, due to new minimally invasive surgical techniques for infants with craniosynostosis, post-surgical plagiocephaly, brachycephaly, and scaphocephaly are emerging as a growing patient group.
Craniosynostosis is caused by the premature fusion of one or more cranial sutures of the skull, causing the head to grow in an unusual shape. Some types of craniosynostosis have a clinical presentation similar to deformational (positional) plagiocephaly. Therefore, in cases where the physician cannot make a definitive diagnosis, patients are referred to specialists such as neurosurgeons or cranio-facial surgeons. These specialists will order a test like a CT scan or MRI to confirm the diagnosis of craniosynostosis. If a baby has craniosynostosis, surgery is indicated to realign the plates of the skull and allow normal brain and skull growth to occur.
In general, the first year of life is the optimum time frame for surgical correction since infants are growing at such an accelerated rate during that time. No matter which surgical technique is used, the end result is a patient with no fused sutures. At this point, the same principles that guide cranial remolding of deformational head shapes are applicable. In both deformational head shapes and post-surgical head shapes, the St. Louis Band is designed to maintain total contact over areas where growth is not desired and allow for space over areas where growth is desired. The St. Louis Band provides a pathway for the baby's head growth, directing it toward a more normal shape.
6
Predicate Devices VI.
- STARband and STARlight, Cranial Orthosis, K151979
- I O&P Bivalve Cranial Molding Helmet, Cranial Orthosis, K063395
Summary of Technological Characteristics VII.
The proposed changes involve the indications for use and the use of additional methods to capture the infant's head shape for the fabrication of St. Louis Band. The technological characteristics and the underlying principles of operation of the St. Louis Band Cranial Orthosis shall remain exactly the same. The inclusion of the STARscanner and SmartSoc System is indicated in Table 1 under the Approved 3-Dimensional Imaging Devices section.
| Feature | From K063395 | 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 | O&P Bivalve Molding Helmet |
- 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 from a traditional
plaster cast | - 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 |
Table 1 – Comparison of Predicate Device cleared in K063385 to the Proposed Device
7
| Feature | From K063395 | Proposed Device |
|---|---|---|
| Approved 3- | ||
| Dimensional | ||
| Imaging | ||
| Devices | - None | to produce a positive mold using a |
| 5-axis routing machine |
-
STARscanner II
-
SmartSoc System |
| Testing | Material Biocompatibility Testing -
Cytotoxicity -Agar Diffusion
-
Closed Patch Sensitization
-
Primary Dermal Irritation | 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
Parameters; Squareness; Flatness) -
Proposed device is substantially
equivalent to predicate device
Material Biocompatibility Testing -
Cytotoxicity -Agar Diffusion
-
Closed Patch Sensitization
-
Primary Dermal Irritation |
| Feature | From K151979
(STARband Bi-Valve Only) | 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 | STARband Bi-Valve -
Outer shell of 5/32" copolymer
plastic -
An inner liner of 1/2" Pelite
Polyethylene foam or 1/2" Aliplast
foam -
Bi-Valve Closure
-
Sliding/Overlap Closure System
-
Chicago Screw (or similar) for top
sliding mechanism -
1" Velcro strap
-
1" chafe buckle
-
Speedy rivets | St. Louis Band
-
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 I -
STARscanner II
-
Omega Scanner
-
scanGogh-II
-
3dMDhead System
-
3dMDcranial System
-
3dMDflex System
-
SmartSoc System
-
M4DScan/BodyScan System
-
Spectra 3D Scanner | - STARscanner II
-
SmartSoc System |
Both the STARscanner and the SmartSoc System are cleared as an approved 3D imaging system for the predicate devices (STARband and STARlight) cleared under K151979. The St. Louis Band is substantially equivalent to these devices as they have the same intended use, underlying operating principles, and production processes. The St. Louis Band is specifically equivalent to the Bi-Valve design of the STARband as they are both a Bi-Valve design, consist of the same materials and have similar strapping mechanism. Table 2 is a comparison of the STARband Bi-Valve cleared under K151979 and the proposed device.
8
Table 2 – Comparison of Predicate Device cleared in K151979 to the Proposed Device
9
Since the physical design of the St. Louis Band is not changing and the proposed shape capture device's technological characteristics are exactly the same as those cleared for the predicate device (K151979: STARband and STARlight); the St. Louis Band Cranial Orthosis is substantially equivalent to the predicate device. Table 3 below is a summary of the performance testing conducted on the STARscanner and the SmartSoc System and the results obtained when compared to the casting method.
| Test | Test Method Summary | Results |
|---|---|---|
| Repeatability and | ||
| Reproducibility | ||
| (R&R) Analysis | The purpose of this test is to analyze | |
| the repeatability and reproducibility | ||
| (components of precision) of the | ||
| proposed shape capture devices. The | ||
| data obtained is compared to the | ||
| casting process. | ||
| Utilized uniform shapes with known | ||
| dimensions that represent various sizes | ||
| of pediatric patients between ages 3 to | ||
| 18 months of age. Associated test | ||
| parameters include A-P and M-L. | The shape capture devices passed | |
| the acceptance criteria. The | ||
| relevancy of the tests determined | ||
| substantial equivalence of the | ||
| proposed shape capture devices. | ||
| Cranial Shape | ||
| Capture Accuracy | ||
| Study | The purpose of this test is to analyze | |
| the accuracy of the proposed shape | ||
| capture devices. The data obtained is | ||
| compared to the casting process. | ||
| Utilized a representative cranial shape | ||
| that possesses a predefined shape with | ||
| known dimensions. Associated | ||
| parameters analyzed include A-P, M- | ||
| L, P-D, various radius parameters, | ||
| squareness, and flatness. | The shape capture devices passed | |
| the acceptance criteria for all | ||
| parameters. The relevancy of the | ||
| test determined substantial | ||
| equivalence of the proposed shape | ||
| capture device. |
Table 3 - Performance Testing Summary for Shape Capture Devices
The St. Louis Band is essentially the same Cranial Orthosis as released in K063395. The St. Louis Band materials have been biocompatibility tested, and the results of the tests are listed below in Table 4.
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| Material | Test | Results | Conclusion |
|---|---|---|---|
| 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 4 - Biocompatibility Testing Summary for St. Louis Band Cranial Orthosis
VIII. Summary and Conclusions of Non-Clinical Performance Data
The St. Louis Band has been used successfully in clinical practice since its original clearance in 2006. The STARscanner and the SmartSoc System were evaluated for safety and efficacy. The primary safety issue for the STARscanner is the laser. The STARscanner is a Class I laser device and as such is inherently safe for use on infants without eye protection under all normal operating conditions. The SmartSoc System does not utilize lasers, but the flash feature from a consumer grade camera is used as a light source.
The shape capture repeatability and reproducibility for these systems were evaluated and determined to be acceptable. An additional, Cranial Shape Capture Accuracy Study was performed concluding that the STARscanner and SmartSoc System vield a product that is substantially equivalent to the predicate device. With sufficient accuracy and no concerns with the safety of the imaging devices, the STARscanner and SmartSoc System were determined to have a safety and effectiveness profile similar to the predicate device for capturing infant head shape data to manufacture the St. Louis Band Cranial Orthosis.