(105 days)
Not Found
No
The description focuses on the physical design and modification process of the cranial orthosis, with no mention of AI or ML for analysis, design, or treatment planning. The 3D imaging is used for creating a physical model, not for AI/ML processing.
Yes.
Explanation: The device is intended for medical purposes to correct cranial deformities in infants by applying mild pressure and redirecting head growth to improve symmetry and/or shape. This aligns with the definition of a therapeutic device which aims to treat or correct a medical condition.
No
The provided text clearly states that the STARband is intended for "improving cranial symmetry and/or shape" by applying mild pressure to the infant's cranium, and for redirecting head growth, rather than for diagnosing conditions. It describes a treatment device.
No
The device description clearly details a physical cranial orthosis made of plastic and foam, with Velcro straps and a living hinge. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- STARband Function: The STARband is a physical device (a cranial orthosis) that is worn externally on an infant's head. Its purpose is to physically reshape the skull by applying pressure.
- Lack of Biological Sample Analysis: The device description and intended use clearly indicate that the STARband does not analyze any biological samples from the infant. It works by physically interacting with the external structure of the head.
Therefore, the STARband falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STARband is intended for medical purposes for use on infants from three to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, 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 three to eighteen months of age whose synostosis has been surgically corrected, but who will have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic- shaped heads.
Product codes
OAN, MVA
Device Description
The STARband® redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3 dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® 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® 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 are 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 STARband® 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) across the side opening. The STARband® Bi-Valve design consists 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 STARband® Plus cranial orthosis device proposed in this submission has identical indications for use to the predicate submission K082950. The difference with this proposed device is a structural change to a dual side opening design with a living hinge at the top. The indications for use, the intended use, and the underlying principles of operation of the STARband® cranial orthosis remain exactly the same.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3-dimensional imaging device, traditional plaster cast
Anatomical Site
Cranium / head
Indicated Patient Age Range
infants from three 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)
For the STARband Plus non-clinical performance test, it is assumed the cranial remolding orthosis is donned and doffed roughly 4 times a day for 6 months. The goal is to introduce localized fatigue at the living hinge by applying a repeated stress for 1440 cycles. Once the part has achieved 1440 cycles or fatigue life, whichever is reached first, the helmet will be removed from the machine/fixture and all materials located at the hinge (both plastic and foam), will be visually assessed for signs of wear or failure (fracture or yield). The success criteria for this test is determined by the living hinge achieving, or exceeding, 1440 cycles without experiencing failure.
All STARband Plus configurations (1/2" Aliplast, (4) 1/8" Aliplast, and ½" Pelite) successfully completed 1440 cycles without fatigue/failure impacting the living hinge. The sample population included both deformational and post-operative patients. STARband Plus living hinge design exceeded the normal application life cycle. The helmet durability across all liner types is verified at confidence level to structurally withstand the donning/doffing process throughout a 6-month treatment.
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
August 17, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Orthomerica Products, Inc. Najiba Katir Regulatory Compliance Manager 6333 North Orange Blossom Trail Orlando, Florida 32810
Re: K211376
Trade/Device Name: STARband Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN, MVA Dated: July 2, 2021 Received: July 6, 2021
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 (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
1
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
2
Indications for Use
510(k) Number (if known) K211376
Device Name STARband
Indications for Use (Describe)
The STARband is intended for medical purposes for use on infants from three to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, 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 three to eighteen months of age whose synostosis has been surgically corrected, but who will have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic- shaped heads.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K211376
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: | Najiba Katir, Regulatory Compliance Manager |
|---|---|
| Address: | 6333 North Orange Blossom Trail |
| Orlando, FL 32810 | |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
| Email: | nkatirr@orthomerica.com |
| Date Prepared: | August 12th, 2021 |
II. Submission Information
| Type: | Special 510(k) Submission |
|---|---|
| Proprietary Name: | STARband® |
| Classification: | Class II (special controls); OAN; MVA; 21 CFR 882.5970 |
| Classification Name: | Cranial Orthosis |
III. Manufacturer Site
| Name: | Orthomerica Products, Inc. | |
|---|---|---|
| Address: | 6333 North Orange Blossom Trail | |
| Orlando, FL 32810 | ||
| Telephone: | (407) 290-6592 | |
| Facsimile: | (407) 290-2419 | |
| FDA Establishment Registration Number: | 1058152 |
4
IV. Description of Device/Modification
The STARband® 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 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 further modified 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® Side Opening design and STARband® Bi-Valve design are 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 STARband® 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) across the side opening. The STARband® Bi-Valve design consists 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 STARband® Plus cranial orthosis device proposed in this submission has identical indications for use to the predicate submission K082950. The difference with this proposed device is a structural change to a dual side opening design with a living hinge at the top. The indications for use, the intended use, and the underlying principles of operation of the STARband® cranial orthosis remain exactly the same.
V. Indications for Use and Intended Use
Indications for Use:
The STARband® 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. The device is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who will have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic- shaped heads.
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Intended Use:
The STARband® 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® for approximately 23 hours per 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.
Predicate Device VI.
- I STARband® Cranial Orthosis - K082950
Summary of Technological Characteristics VII.
The STARband® Plus cranial orthosis device proposed in this submission has identical indications for use to the predicate submission K082950. The difference with this proposed device is a structural change to a dual side opening design with a living hinge at the top. The indications for use, the intended use, and the underlying principles of operation of the STARband® cranial orthosis remain exactly the same. The following Table 1 clearly illustrates the similarities and differences between the two submissions.
Note that several submissions occurred between the proposed submission and the time the predicate device was cleared. This explains some additions in the right column compared to the predicate device; additions which were cleared, remain unchanged and are not impacted by the proposed submission (e.g., Approved 3-Dimensional Imaging Devices and approximate weight of the STARlight PRO).
| Feature | From K082950 | K211376 |
|---|---|---|
| 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 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- | The STARband 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- |
| Table 1 - Comparison of Predicate Device cleared in K082950 to the Proposed Device | ||||||
|---|---|---|---|---|---|---|
| ------------------------------------------------------------------------------------ | -- | -- | -- | -- | -- | -- |
6
| Feature | From K082950 | K211376 |
|---|---|---|
| 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 three to | ||
| eighteen months of age whose synostosis | ||
| has been surgically corrected, but who will | ||
| have moderate to severe cranial | ||
| deformities including 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 three to | ||
| eighteen months of age whose synostosis | ||
| has been surgically corrected, but who will | ||
| have moderate to severe cranial | ||
| deformities including plagiocephalic-, | ||
| brachycephalic-, and scaphocephalic- | ||
| shaped heads. | 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 STARband® Side Opening
design, STARband® Bi-Valve design, and
STARband® Plus 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® Side Opening
design and STARlight® Bi-Valve design - 5/32" - 1/4" clear Surlyn or 1/8" –
7/32" Clear Co-Polyester plastic
shell |
| | Closure for Bivalve design - Sliding/Overlap closure system
- Chicago screw (or similar) for top
sliding mechanism - 1" Velcro strap
- 1" chafe buckle
- Speedy rivets | Material for STARlight® PRO design
- 1/4" – 3/8" clear Surlyn
Closure for Bivalve design - Sliding/Overlap closure system
- Chicago screw (or similar) for top
sliding mechanism - 1" Velcro strap
- 1" chafe buckle
- Speedy rivets |
| | Closure for STARband® Side Opening
design - 1 ½" Velcro Strap
- 1 ½" chafe buckle
- A Gap Block made from ½" firm
Pelite polyethylene foam - Large Flange, Blind Rivet | Closure for STARband® Side Opening
design - 1 ½" Velcro Strap
- 1½" chafe buckle
- A Gap Block made from ½" firm
Pelite polyethylene foam - Large Flange, Blind Rivet
Closure for STARband® Plus design - (2) 1" Velcro Strap
- (2) 1" chafe buckle
- Large Flange, Blind Rivet |
| | Closure for STARlight® Side Opening
design: | Large Flange, Blind Rivet
Closure for STARlight® Side Opening
design and the STARlight® PRO design: |
| Feature | From K082950 | K211376 |
| | - 1" Velcro Strap | - 1" Velcro Strap |
| | - 1" chafe buckle | - 1" chafe buckle |
| | Optional tamper resistant strap
(qty 2 for the STARlight PRO
design) | Optional tamper resistant strap
(qty 2 for the STARlight PRO
design) |
| Product
Weight | Custom made cranial orthosis,
approximately 6 to 10oz in weight. | STARband (Subject Device) weighs
approximately 6 to 10oz.
STARlight® PRO (cleared after K082950)
weighs approximately 12.5 to 18.5 oz. |
| Production | - Form orthosis from a positive
mold of infant's head | - Form orthosis from a positive
mold of infant's head |
| | - Positive mold is formed based
upon measurements of the infant's
head taken by the STARscanner
or the OWW Omega scanner from
which a 3-dimensional image is
made or from a traditional plaster
cast | - Positive mold is formed based
upon measurements of the infant's
head taken by an approved 3-
dimensional imaging device from
which a 3-dimensional image is
made or from a traditional plaster
cast |
| | - The 3-dimensional image is used
to produce a positive mold using a
5-axis routing machine | - The 3-dimensional image is used
to produce a positive mold using a
5-axis routing machine |
| Approved 3-
Dimensional
Imaging
Devices | - STARscanner I -
STARscanner II -
Omega Scanner | - 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 |
| Testing | Material Biocompatibility Testing
-
Cytotoxicity -Agar Diffusion -
Closed Patch Sensitization -
Primary Dermal Irritation | Material Biocompatibility Testing -
Cytotoxicity -
Sensitization -
Irritation |
7
The STARband® Plus has the same intended use, indications, materials, basic design, and production as the predicate STARband® device in K082950. Therefore the STARband® Plus proposed in this submission is substantially equivalent to the previously cleared predicate device.
8
| Material | Test | Results | Conclusion |
|---|---|---|---|
| Adhesive with | |||
| AliPlast Foam | Sensitization – | ||
| Kligman | |||
| Maximization | 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 | |||
| Adhesive with | |||
| AliPlast Foam | Irritation – | ||
| Primary Dermal | Primary Irritation Index: 0.00 | Negligible Dermal | |
| Response | |||
| Adhesive with | |||
| AliPlast Foam | Cytotoxicity – | ||
| MEM Elution | Cell culture treated with test sample exhibited no reactivity (Grade 0). | Non-cytotoxic | |
| Copolymer with | |||
| Pelite Foam | Sensitization – | ||
| Closed Patch | A score of 0.00/0.00 (Test/Control) was given for both Incidence and Severity in the 24 hour and 48 hour scoring interval. | Not a Sensitizer | |
| No Erythema or | |||
| Edema Formation | |||
| Copolymer with | |||
| Pelite Foam | Irritation – | ||
| Primary Dermal | Primary Irritation Index: 0.06 | Negligible Dermal | |
| Response | |||
| Copolymer with | |||
| Pelite Foam | Cytotoxicity – | ||
| Agar Diffusion | Cell culture treated with test sample exhibited no reactivity (Grade 0). | Non-cytotoxic | |
| Copolymer with | |||
| Aliplast Foam | Sensitization – | ||
| Closed Patch | 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 | Irritation – | ||
| Primary Dermal | Primary Irritation Index: 0.00 | Negligible Dermal | |
| Response | |||
| Copolymer with | |||
| Aliplast Foam | Cytotoxicity – | ||
| Agar Diffusion | Cell culture treated with test sample exhibited slight reactivity (Grade 1) | Non-cytotoxic |
| Table 2 - Biocompatibility Testing Summary for STARband® Cranial Orthosis |
|---|
| --------------------------------------------------------------------------- |
Summary of Non-Clinical Performance Data VIII.
For the STARband Plus non-clinical performance test, it is assumed the cranial remolding orthosis is donned and doffed roughly 4 times a day for 6 months. The goal is to introduce localized fatigue at the living hinge by applying a repeated stress for 1440 cycles. Once the part has achieved 1440 cycles or fatigue life, whichever is reached first, the helmet will be removed from the machine/fixture and all materials located at the hinge (both plastic and foam), will be visually assessed for signs of wear or failure (fracture or yield). The success criteria for this test is determined by the living hinge achieving, or exceeding, 1440 cycles without experiencing failure.
All STARband Plus configurations (1/2" Aliplast, (4) 1/8" Aliplast, and ½" Pelite) successfully completed 1440 cycles without fatigue/failure impacting the living hinge. The sample population included both deformational and post-operative patients. STARband Plus living hinge design exceeded the normal application life cycle. The helmet durability across all liner types is verified at confidence level to structurally withstand the donning/doffing process throughout a 6-month treatment.
9
IX. Conclusion
The STARband® Plus cranial orthosis device proposed in this submission is substantially equivalent given that it has the same indications for use, intended use, and underlying principles of operation to the predicate submission K082950.