(28 days)
The STARband® 3D™ 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 to improve cranial symmetry and/or shape.
The STARband® 3D™ redirects the head growth to improve proportion and symmetry. The practitioner takes a 3-dimensional captured image of the infant's head to acquire the existing shape. The 3-dimensional positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® 3D™ 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 further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband® 3D™ directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
This document is an FDA 510(k) clearance letter and summary for a medical device called STARband 3D. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific studies conducted to prove acceptance criteria for a new, independent device.
Therefore, the information required to accurately answer the prompt (acceptance criteria, specific study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text. The document states that:
- "Nonclinical performance testing performed for the predicate device and reference device remains applicable as there was no design change to the device."
- "Validation was conducted to evaluate one potential risk identified during design control activities and no impact on safety or effectiveness was identified."
- "These tests are referenced in the submission." (But the submission itself is not provided).
Without the actual submission that details the non-clinical performance tests and their results, I cannot provide the specific information requested in the prompt regarding the device's acceptance criteria and the study that proves it meets them.
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March 15, 2024
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Orthomerica Products Inc. Najiba Katir Regulatory Compliance Manager 6333 North Orange Blossom Trail Orlando, Florida 32810
Re: K240466
Trade/Device Name: STARband 3D Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN, MVA Dated: February 16, 2024 Received: February 16, 2024
Dear Najiba Katir:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Digitally signed Adam D . by Adam D. Pierce -S Pierce -S Date: 2024.03.15 09:19:21 -04'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological
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and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
STARband 3D
Indications for Use (Describe)
The STARband® 3D™ 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 to improve cranial symmetry and/or shape.
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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510(k) Summary
I. Applicant Information
| Name: | Orthomerica Products, Inc. |
|---|---|
| Address: | 6333 North Orange Blossom TrailOrlando, FL 32810 |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
FDA Establishment Registration Number
1058152
Contact Information
| Contact Person: | Najiba Katir, Regulatory Compliance Manager |
|---|---|
| Address: | 6333 North Orange Blossom TrailOrlando, FL 32810 |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
| Email: | nkatir@orthomerica.com |
| Date Prepared: | March 13th, 2024 |
II. Device Information
STARband® 3D™ Proprietary Name: Classification: Class II (special controls); OAN; MVA; 21 CFR 882.5970 Classification Name: Cranial Orthosis
Legally Marketed Predicate Device and Reference Device VI.
- Predicate Device: STARband® 3D™ Cranial Orthosis K223238 I
- I Reference Device: STARband® Cranial Orthosis - K211376
IV. Device Description/Modification Summary
The STARband® 3D™ redirects the head growth to improve proportion and symmetry. The practitioner takes a 3-dimensional captured image of the infant's head to acquire the existing shape. The 3-dimensional positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® 3D™ 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 further modified by the practitioner to provide
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space for growth to occur in the flat or depressed areas. The shape of the STARband® 3D™ directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
Proposed Modification:
The STARband® 3D™ cranial orthosis device proposed in this submission has identical indications for use to the predicate submission K223238. The difference with this proposed device is the addition of scanning technologies which were already cleared by Orthomerica Products Inc. for use with its reference device K211376 and have undergone no change since the reference device clearance.
The indications for use, the intended use, and the underlying principles of operation of the STARband® 3D™ cranial orthosis remain the same.
V. Indications for Use and Intended Use
Indications for Use:
The STARband® 3D™ is intended for medical purposes for use on infants from three 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.
Intended Use:
The STARband® 3D™ 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 STARband® 3D™ for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. The same principles of cranial remolding apply to positional deformities.
Indications for Use Comparison
The indications for use of the proposed device are identical to the ones of the predicate device and the reference device.
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Summary of Technological Characteristics Comparison VII.
The STARband® 3D™ cranial orthosis device proposed in this submission has the same indications for use, intended use, underlying principles of operations and basic design as the predicate device as illustrated in Table 1 below.
| DeviceCharacteristic | Subject Device | Predicate Device K223238 | Reference Device K211376 |
|---|---|---|---|
| Manufacturer | Orthomerica Products, Inc. | Orthomerica Products, Inc. | Orthomerica Products, Inc. |
| Trade Name | STARband 3D | STARband 3D | STARband |
| Product Code | OAN, MVA | OAN, MVA | OAN, MVA |
| Intended Use | Maintains total contact overareas of bossing orprotrusion and creates voidsover areas of depression orflattening to redirect cranialgrowth toward greatersymmetry. | Maintains total contact overareas of bossing orprotrusion and creates voidsover areas of depression orflattening to redirect cranialgrowth toward greatersymmetry. | Maintains total contact overareas of bossing orprotrusion and creates voidsover areas of depression orflattening to redirect cranialgrowth toward greatersymmetry. |
| Contraindications | Not for use on infants withsynostosis or hydrocephalus | Not for use on infants withsynostosis or hydrocephalus | Not for use on infants withsynostosis or hydrocephalus |
| Prescriptionrequired? | Prescription Use Only | Prescription Use Only | Prescription Use Only |
| Size Options | Patient-matched sizing byscanning an image ofpatient's head shape | Patient-matched sizing byscanning an image ofpatient's head shape | Patient-matched sizing byscanning an image ofpatient's head shape orplaster mold to makepositive mold of head shape |
| Software Used forShape | CAD software is used tomodify the shape of thescanned image to improvesymmetry and shape of thehelmet to be manufactured | CAD software is used tomodify the shape of thescanned image to improvesymmetry and shape of thehelmet to be manufactured | Customized and/or CADsoftware may be used tomodify the shape of thescanned image to improvesymmetry and shape of thehelmet to be manufactured |
| DesignComponents | Polymer helmet with bi-lateral side-opening,closures, and zone paddedlining | Polymer helmet with bi-lateral side-opening,closures, and zone paddedlining | Polymer helmet with sideopening closure and paddedlining |
| ApproximateDeviceWeight | 4 – 6.5 oz | 4 – 6.5 oz | 6 – 10 oz |
| DeviceCharacteristic | Subject Device | Predicate Device K223238 | Reference Device K211376 |
| ManufacturingProcess | Additively manufacturedorthosis based uponmeasurements of theinfant's head captured bypreviously cleared 3-dimensional imaging devices | Additively manufacturedorthosis based uponmeasurements of theinfant's head captured by apreviously cleared 3-dimensional imaging device | - Form orthosis from apositive mold of infant'shead- Positive mold is formedbased upon measurementsof the infant's head taken byan approved 3-dimensionalimaging device from which a3-dimensional image is madeor from a traditional plastercast- The 3-dimensional image isused to produce a positivemold using a 5-axis routingmachine |
| Approved 3-DimensionalImaging Devices | STARscanner ISTARscanner IISpectra 3D ScannerM4DScan/BodyScan System3dMDhead System3dMDcranial System3dMDflex SystemSmartSoc System forAndroid and iOS devices | STARscanner ISTARscanner II | Spectra 3D ScannerM4DScan/BodyScan SystemOmega Scanner3dMDhead System3dMDcranial System3dMDflex SystemscanGogh-IISTARscanner ISTARscanner IISmartSoc System for Androidand iOS devices |
| Testing | Nonclinical performancetesting performed for thepredicate device andreference device remainsapplicable as there was nodesign change to the device.Validation was conducted toevaluate one potential riskidentified during designcontrol activities and noimpact on safety oreffectiveness was identified.These tests are referencedin the submission | Test samples were additivelymanufactured from 3Dimages of representativecranial shapes using previouscleared scanning device(s).Process Validation includedDimensional Analysis, FitAssessment and MechanicalTesting of test samples toevaluate the additivemanufacturing processperformance, which wascompared to the processused for the predicatedevice. | Cranial Shape CaptureAccuracy Study utilized arepresentative cranial shapethat possesses a predefinedshape with knowndimensions, which comparedproposed device to cast andpredicate device. Associatedparameters analyzedincluded coordinate planes(A-P; M-L; P-D) and variousradius parameters,squareness, and flatness. |
| Biocompatibility | Material BiocompatibilityTestingSame as predicate | Material BiocompatibilityTesting●Cytotoxicity●Sensitization●Irritation | Material BiocompatibilityTesting●Cytotoxicity●Sensitization●Irritation |
Table 1 – Comparison of Subject Device, Predicate Device, and Reference Device.
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VIII. Summary and Conclusion of Non-Clinical Performance Data
Non-Clinical Performance tests conducted for the predicate and reference devices, and referenced in this submission, passed all verification and validation acceptance criteria and demonstrated their safety and effectiveness. Given that the change proposed for the subject device requires no additional performance testing, these tests remain valid for the subject device, and they support the determination of substantial equivalence between the proposed device and the predicate device.
IX. Conclusion on Substantial Equivalence
The STARband® 3D™ cranial orthosis device proposed in this submission is substantially equivalent to the predicate device in K223238, given that it has the same indications for use, intended use, and underlying principles of operation and that previous non-clinical performance test results support that determination.
§ 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)).