(164 days)
Not Found
No
The description focuses on the mechanical process of creating and modifying the orthosis based on a scan or impression, with no mention of AI or ML algorithms being used for analysis, modification, or treatment planning. The performance studies evaluate the accuracy of the scanning method and the fit of the device, not the performance of any AI/ML component.
Yes
The device is intended to treat moderate-to-severe non-synostotic positional plagiocephaly by applying mild pressure to the cranium to improve cranial symmetry and/or shape, which qualifies it as a therapeutic device.
No
The device description indicates that the STARband is used to "redirect head growth to improve proportion and symmetry" by applying pressure to the cranium. Its purpose is to correct cranial deformities, not to diagnose them. The "scangogh-II" component is used for shape capture, which is a measurement for the fitting of the orthosis, not for diagnosis.
No
The device description clearly details a physical orthosis (the STARband) made of copolymer and foam, which is a hardware component. While a scanner (scanGogh-II) is mentioned as a new shape capture method, the core medical device is the physical band.
Based on the provided information, the STARband is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- STARband's Function: The STARband is a cranial orthosis (a helmet or band) that is worn externally on the infant's head. It works by applying pressure to reshape the skull.
- No Specimen Analysis: The device description and intended use clearly indicate that the STARband does not involve the analysis of any biological specimens from the infant. It is a physical device used for external treatment.
- Shape Capture Method: While the device uses a laser scanner to capture the head shape, this is a method for obtaining anatomical measurements and creating a custom-fit device, not for analyzing biological samples.
Therefore, the STARband falls under the category of a medical device used for external treatment and is not an IVD.
N/A
Intended Use / Indications for Use
The STARband 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. The 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 (comma separated list FDA assigned to the subject device)
OAN
Device Description
The STARband redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or a scan of the baby's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape is carved from using 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 provides 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 modified further by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband 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 as it was released in K082950 is essentially still the same device. The STARband consists of a 5/32" outer copolymer shell with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). There is a top opening and a side opening. The strap across the side opening is 1 ½" Dacron and Velcro and is attached to the STARband with a chafe and loop. A ½" pelite polyethylene foam gap block fills any gap in the side opening. The proposed device modification is the addition of a new shape capture method, specifically the scanGogh-II" by Vorum Research, Inc. This scanner uses one laser and one camera to capture shape data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
scanGogh-II uses one laser and one camera to capture shape data.
Anatomical Site
Cranium / head
Indicated Patient Age Range
3 to 18 months of age
Intended User / Care Setting
Prescription Use
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
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 (scanGogh-II) to cast and predicate device. Associated parameters includes A-P and M-L.
Cranial Shape Capture Accuracy Study: Utilized a representative cranial shape that possesses a predefined shape with known dimensions. Compared proposed device (scanGogh-II) to cast and predicate device. Associated Coordinate Planes included A-P, M-L, P-D, and various Radius Parameters, Squareness, Flatness.
Eye Shield Fit Assessment: Assessed coverage, fit and effectiveness of a specific eye shield for infants.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The scanGogh-II was evaluated through accuracy, reproducibility and repeatability testing. 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 scanGogh-II yields a safe and effective product that is substantially equivalent to the predicate device. An Eye Shield Fit Assessment showed the eye shields were an acceptable fit for infants, providing safe and effective protection of the infant's eye during scanning.
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.
K082950, K072862, K081787, K111609
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.
Not Found
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
STARband® Cranial Orthosis
510(k) Summary
.
· ·
JUN 1 0 2013
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: | December 21, 2012 |
II. Submission Information
| Type: | Special 510(k) Submission |
|---|---|
| Proprietary Name: | STARband® |
| Common Name: | Cranial Orthosis |
| Classification: | Class II (special controls); OAN; MVA; 21 CFR 882.5970 |
| Classification Name: | Cranial Orthosis |
f
Manufacturer Site III.
.
| 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 |
1
IV. Description of Device/Modification
The STARband redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or a scan of the baby's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape is carved from using 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 provides 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 modified further by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband 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 as it was released in K082950 is essentially still the same device. The STARband consists of a 5/32" outer copolymer shell with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). There is a top opening and a side opening. The strap across the side opening is 1 ½" Dacron and Velcro and is attached to the STARband with a chafe and loop. A ½" pelite polyethylene foam gap block fills any gap in the side opening. The proposed device modification is the addition of a new shape capture method, specifically the scanGogh-II" by Vorum Research, Inc. This scanner uses one laser and one camera to capture shape data.
V. Statement of Indications and Intended Use
Statement of Indications:
The STARband 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. The 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-, brachycephalicand scaphocephalic-shaped heads.
Intended Use:
The STARband is designed to treat infants with abnormal head shapes from age 3 months to 18 months and is available by prescription only. Since growth is the driving factor in head shape correction, the infants wear the STARband for approximately 23 hours per
2
day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. The STARband has 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
- 트 STARband, Cranial Orthosis, K082950
- Boston Band Cranial Remolding Orthosis, K072862
- CAMLab Cranial Orthosis Helmet, K081787
- I Boston Band, K111609
VI. Summary of Technological Characteristics
The modification proposed is the use of an additional tool which can be used to capture the infants head shape; the technological characteristics and the underlying principles of operation of the STARband Cranial Orthosis will remain exactly the same. This table illustrates that the device will in fact remain the same.
| Feature | From K082950 | Proposed Device | | Proximal
Radius | Proximal
Anterior
Radius | Anterior
Radius | Anterior
Posterior
Length | M-L
Width
Anterior | M-L
Width
Posterior | Posterior
Panel
Flatness | Lateral
Panel
Flatness | L-P
Panels
Square | Medial
Panels
Flatness | M-P
Panels
Squares |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------|--------------------------------|--------------------|---------------------------------|--------------------------|---------------------------|--------------------------------|------------------------------|-------------------------|------------------------------|--------------------------|
| 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. | scanGogh-ll
vs. Cast
Cranial Head
Shape | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass |
| Materials | Outer shell of .156 copoly plastic
An inner liner of ½" pelite
polyethylene foam or ½" Aliplast
foam
- A strap of 1 ½" Dacron
- A 1 ½" chafe buckle
- Large Flange, Blind Rivet
- A Gap Block made from ½" firm
- pelite polyethylene foam
- A nylon washer | Outer shell of .156 copoly plastic
An inner liner of ½" pelite
polyethylene foam or ½" Aliplast
foam
- A strap of 1 ½" Dacron
- A 1 ½" chafe buckle
- Large Flange, Blind Rivet
- A Gap Block made from ½" firm
- pelite polyethylene foam
- A nylon washer | | | | | | | | | | | | |
| Product
Design | Custom made cranial orthosis, approx 6oz.
in weight | Custom made cranial orthosis, approx 6oz.
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 the STARscanner, or the OWW Omega Scanner 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 the STARscanner, the OWW Omega Scanner, or the scanGogh-II 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 | | | | | | | | | | | | |
| 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 | 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 (scanGogh-II) 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 (scanGogh-II) 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.
- Eye Shield Fit Assessment
-- A specific eye shield would properly fit infants - Assess coverage, fit and effectiveness
- Proposed eye shields pass the assessment and provide safe and effective protection | | | | | | | | | | | | |
Table 1 - Comparison of Predicate Device cleared in K082950 to the proposed device
3
STARband® Cranial Orthosis
The inclusion of the scanGogh-II is the focus of this submission. Additional testing was performed on the scanGogh-II to ensure substantial equivalence, that change is indicated in Table 1 under the testing section. Table 2 shows the additional accuracy testing
Orthomerica Products, Inc.
.
4
performed and the comparison results of the scanGogh-11. The term Pass within Table 2 indicates the scanGogh-II accuracy performed superior to the Cast method.
Table 2 - scanGogh-II Accuracy Comparison Summary
The actual scanner wand hardware (camera and laser included) of the scanGogh-II is also known as the Fastscan Handheld Laser Scanner by Polhemus, Inc. The Fastscan Scanner has already received FDA clearance as part of other Cranial Remolding Orthosis 510(k) submissions, by Boston Band Cranial Remolding Orthosis (K072862 and K111609) and the CAMLab Cranial Orthosis Helmet (K081787). These submissions used the STARband (K011350 and K082950) as their predicate device and given that the technological characteristics are the same as the proposed device, these devices are all substantially equivalent.
VII. Summary and Conclusions of Non-Clinical Performance Data
The STARband Cranial Orthosis has been successfully used in clinical practice since its original clearance in 2001. The scanGogh-II is the only proposed change. The scanGogh-II was evaluated through accuracy, reproducibility and repeatability testing. 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 scanGogh-II yields a safe and effective product that is substantially equivalent to the predicate device. An Eye Shield Fit Assessment showed the eye shields were an acceptable fit for infants, providing safe and effective protection of the infant's eye during scanning. With sufficient accuracy and proper laser safety procedures, the scanGogh-II was determined safe and effective for scanning infants for STARband Cranial Orthosis.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.
June 10, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Orthomerica Products, Inc. c/o Mr. David L. Hooper Manufacturing Engineer 6333 North Orange Blossom Trail Orlando, FL 32810
Re: K124023
Trade/Device Name: STARband® Cranial Orthosis Regulation Number: 21 CFR 882.5970 Regulation Name: Laser Scan Cranial Orthosis Regulatory Class: Class II Product Code: OAN Dated: April 22, 2013 Received: April 23, 2013
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":"Act":"equire":"approval":"a"premarket":"pproval":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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
6
Page 2 - Mr. David L. Hooper
forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K124023
Device Name: STARband® Cranial Orthosis
Indications For Use:
The STARband 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. The 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jovce Mi
(Division Sian Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K124023
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