(195 days)
No
The device description and performance studies focus on traditional measurement and comparison methods of 3D models, with no mention of AI or ML algorithms for analysis, prediction, or decision support. The software components (CCU and MCU) are described as tools for presenting and comparing measurements, not for performing intelligent analysis.
Yes
The device is intended to treat moderate-to-severe non-synostotic positional plagiocephaly and cranial deformities in infants by applying mild pressure to improve cranial symmetry and/or shape, which is a therapeutic purpose.
No.
The device, including its software components (CCU and MCU), is described as being used to measure and track progress of cranial shape and symmetry over time, primarily to guide the treatment provided by the STARband and STARlight devices. While it involves measurements and assessment of existing conditions, its primary function is not to diagnose a disease or condition, but rather to monitor and facilitate treatment for an already identified condition (positional plagiocephaly or post-surgical cranial deformities). The intended use explicitly states its purpose is for "improving cranial symmetry and/or shape" by applying mild pressure, and the software components are for "tracking progress" and "incorporating into the patient assessment", not for initial diagnosis.
No
The device description clearly details physical components made of plastic, foam, and Velcro, which are hardware. While the submission includes software components (CCU and MCU), the overall device system includes physical orthoses.
Based on the provided text, 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 described devices (STARband, STARlight, St. Louis Band) are cranial orthoses (helmets/bands) used externally on the infant's head to reshape it. They work by applying pressure to guide bone growth.
- Intended Use: The intended use clearly states they are for treating non-synostotic positional plagiocephaly and post-surgical cranial deformities by applying external pressure.
- Device Description: The description details the physical construction of the bands and the process of creating a custom fit based on a 3D model of the infant's head.
- No Biological Samples: There is no mention of collecting or analyzing any biological samples from the infant.
The software components (CCU and MCU) are used to analyze 3D models of the head and track progress, which is also not an in vitro diagnostic activity.
Therefore, these devices fall under the category of external medical devices, specifically cranial orthoses, and are not IVDs.
N/A
Intended Use / Indications for Use
The STARband, STARlight, and St. Louis Band are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.
Product codes (comma separated list FDA assigned to the subject device)
OAN, MVA
Device Description
The STARband® and STARlight® redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured inage 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® 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 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 Cranial Comparison Utility (CCU) is a software component for a previously cleared shape capture method, the STARscanner Data Acquisition System. The CCU is a separate software program that is designed to present specific measurements derived from a three-dimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.
The proposed addition is a new software component for a previously cleared shape capture method, the NetVirta SmartSoc Data Acquisition System. The new software component is the Measurement Comparison Utility (MCU). The MCU is a separate software program, not used in manufacturing, which is designed to present specific measurements derived from a three-dimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3-dimensional captured image
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)
MCU Accuracy and Capabilities Study:
- Study type: Accuracy and Capabilities Study
- Sample size: Not specified
- Data source: Not specified
- Annotation protocol: Not specified
- Key results: Utilized representative cranial shapes that reflect symmetrical and asymmetrical cranial shapes. Compared MCU to manual measurements and 3D-CAD software. Accessed accuracy of measurements and capabilities of model alignment, differential maps, calculations, and reporting. The MCU software program provides accurate information of 3D digital models from the SmartSoc Data Acquisition System. The MCU was determined to be substantially equivalent to the predicate CCU.
Repeatability and Reproducibility (R&R) Analysis:
- Study type: Repeatability and Reproducibility Analysis
- Sample size: Not specified
- Data source: Not specified
- Annotation protocol: Not specified
- Key results: 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 include A-P and M-L. Proposed device is substantially equivalent to predicate device.
Cranial Shape Capture Accuracy Study:
- Study type: Accuracy Study
- Sample size: Not specified
- Data source: Not specified
- Annotation protocol: Not specified
- Key results: 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.
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 27, 2021
Orthomerica Products Inc. Colton Carter Regulatory and Compliance Engineer 6333 North Orange Blossom Trail Orlando, Florida 32810
Re: K203098
Trade/Device Name: STARband, STARlight, St. Louis Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN, MVA Dated: January 27, 2021 Received: January 28, 2021
Dear Colton Carter:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203098
Device Name
STARband, STARlight, and St. Louis Band Cranial Orthosis
Indications for Use (Describe)
The STARband, STARlight, and St. Louis Band are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ✖ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | □ |
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AND THE A
11:58
510(k) Summary K203098
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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: | Colton Carter, Regulatory and Compliance Engineer |
|---|---|
| Address: | 6333 North Orange Blossom Trail |
| Orlando, FL 32810 | |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
| Email: | ccarter@orthomerica.com |
| Date: | April 27th, 2021 |
II. Submission Information
| Type: | Traditional 510(k) Submission |
|---|---|
| Proprietary Name: | STARband®, STARlight®, and St. Louis Band |
| 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 inage 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 last cleared in K180109 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 St. Louis Band (formally known as the O&P Bivalve Molding Helmet in K063395) was last cleared in K180109 by Orthomerica Products Inc. 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.
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The Cranial Comparison Utility (CCU) is a software component for a previously cleared shape capture method, the STARscanner Data Acquisition System, distributed by Orthomerica Products, Inc. The CCU is a separate software program that is designed to present specific measurements derived from a three-dimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.
The proposed addition is a new software component for a previously cleared shape capture method, the NetVirta SmartSoc Data Acquisition System, distributed by Orthomerica Products, Inc. The new software component is the Measurement Comparison Utility (MCU). The MCU is a separate software program, not used in manufacturing, which is designed to present specific measurements derived from a threedimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.
V. Indications for Use and Intended Use
Indications for Use:
The STARband®, STARlight®, and St. Louis Band are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for 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.
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Intended Use:
The STARband®, STARlight®, and St. Louis Band 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®, STARlight®, or St. Louis Band for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. The STARband®, STARlight®, and St. Louis Band 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 and Reference Devices
Predicate Device:
- STARband and STARlight with Cranial Comparison Utility (CCU) K142141 ■
Reference Devices:
VII. Summary of Technological Characteristics
The MCU proposed in this 510(k) is an added software program for a previously cleared shape capture method, the SmartSoc Data Acquisition System, that was cleared for use in the fabrication of the STARband , STARlight , and St. Louis Band Cranial Orthosis. The technological characteristics and the underlying principles of operation of the STARband , STARlight , and St. Louis Band Cranial Orthosis shall remain exactly the same. The inclusion of the MCU 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 MCU is also indicated in the Testing section.
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| Feature | K142141 | K203098 |
|---|---|---|
| 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. | ||
| 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. | 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. | ||
| 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 | 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 |
| Feature | K142141 | K203098 |
| | A Gap Block made from ½"
firm Pelite polyethylene foam
Large Flange, Blind Rivet | 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
1" chafe buckle
Optional tamper resistant
strap (qty 2 for the STARlight
PRO design) | Closure for STARlight Side Opening
design and the STARlight PRO design:
1" Velcro Strap
1" chafe buckle
Optional tamper resistant strap
(qty 2 for the STARlight PRO
design) |
| Biocompatibility | All materials have been used
extensively in Orthotics and Prosthetics | All materials have been used
extensively in Orthotics and Prosthetics |
| Sterility | Not provided Sterile | Not provided Sterile |
| 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
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 | STARscanner I
STARscanner II
Omega Scanner
scanGogh-II
3dMDhead System
3dMDcranial System
3dMDflex System
M4DScan/BodyScan System
Spectra 3D Scanner
SmartSoc System for Android
Device
SmartSoc System for iOS
Device |
| Reporting
Software | Cranial Comparison Utility
(CCU) | Cranial Comparison Utility
(CCU)
Measurement Comparison
Utility (MCU) |
| Feature | K142141 | K203098 |
| 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 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 | 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 |
| | 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 | 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 | MCU Accuracy and Capabilities Study
- Utilized representative cranial
shapes that reflect symmetrical
and asymmetrical cranial
shapes - Compared MCU to manual
measurements and 3D-CAD
software - Accessed accuracy of
measurements and capabilities
of modal alignmont |
| Feature | K142141 | K203098 |
| | | differential maps, calculations
and reporting |
Table 1.a – Comparison of Predicate Device cleared in K142141 to K203098
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Table 1.b – Comparison of Reference Device cleared in K161138 to K203098
| Table 1.b - Comparison of Reference Device cleared in K161138 to K203098 | ||
|---|---|---|
| Feature | From K161138 | K203098 |
| 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. | ||
| 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. | 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. | ||
| Materials | St. Louis Band |
- Sliding/Overlap Closure System
- Outer shell of 1/4" copolymer
- plastic
- An inner liner of 1/4" Aliplast
- foam
- Bi-Valve Closure
- Sliding/Overlap Closure
- System
- 1" Velcro strap
- 1" chafe buckle
- Speedy rivets | St. Louis Band
- Sliding/Overlap Closure System
- Outer shell of 1/4" copolymer
- plastic
- An inner liner of 1/4" Aliplast
- foam
- Bi-Valve Closure
- Sliding/Overlap Closure
- System
- 1" Velcro strap
- 1" chafe buckle
- Speedy rivets |
| Product Design | Custom made cranial orthosis,
approximately 7 to 10oz in weight. | Custom made cranial orthosis,
approximately 7 to 10oz in weight. |
| Production | Form orthosis from a positive
mold of infant's head
Positive mold is formed based
upon measurements of the
infant's head taken by an
approved 3-dimensional imaging
device from which a 3-
dimensional image is made or
from a traditional plaster cast | 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 |
| Feature | From K161138 | K203098 |
| | - The 3-dimensional image is used | - The 3-dimensional image is used |
| | to produce a positive mold using a | to produce a positive mold using a |
| | 5-axis routing machine | 5-axis routing machine |
| Approved 3-
Dimensional
Imaging
Devices | - STARscanner II
- SmartSoc System | - STARscanner II
- SmartSoc System |
| Reporting
Software | None | - Measurement Comparison Utility
(MCU) |
| 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
Parameters; Squareness; Flatness) - Proposed device is substantially
equivalent to predicate device
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
MCU Accuracy and Capabilities Study
- Utilized representative cranial
shapes that reflect symmetrical
and asymmetrical cranial shapes - Compared MCU to manual
measurements and 3D-CAD
software - Accessed accuracy of
measurements and capabilities of
model alignment, differential
maps, calculations and reporting |
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The STARband , STARlight , and St. Louis Band Cranial Orthosis have previously received FDA 510(k) clearance with the SmartSoc® Data Acquisition System under K141842 for the STARband and STARlight® and under K161138 for the St. Louis Band. The MCU does not affect the operation of the SmartSoc Data Acquisition System and is not used for manufacturing of the STARband , STARlight, or St. Louis Band. The MCU is a separate software program designed to capture specific measurements derived from a 3D digital model of the patient's cranium. The STARband", STARlight", and St. Louis Band are the same devices as previously cleared with the predicate devices. The SmartSoc Data Acquisition System shape capture device has the same technological characteristics. Therefore, the STARband , STARlight , and St. Louis Band Cranial Orthosis are substantially equivalent to the predicate device.
The STARband , STARlight , and St. Louis Band are essentially the same Cranial Orthosis. The main difference between the STARband®, STARlight®, and St. Louis Band are the materials used to produce them. The STARband , STARlight , and St. Louis Band materials have been biocompatibility tested in previous submissions. Since the MCU is a separate software program not used in manufacturing, and the STARband® STARlight , and St. Louis Band materials are unchanged, the manufacturing processes remain identical and biocompatibility testing for this submission is leveraged from previous submissions.
Summary and Conclusions of Non-Clinical Performance Data VIII.
The MCU software program provides accurate information of 3D digital models from the SmartSoc Data Acquisition System. The accuracy and reliability of the SmartSoc Data Acquisition System 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 MCU and was determined to be substantially equivalent to the predicate CCU.