Talee, Talee PostOP

K220681 · Invent Medical USA, LLC · MVA · Sep 22, 2022 · Neurology

Device Facts

• Record ID: K220681
• Device Name: Talee, Talee PostOP
• Applicant: Invent Medical USA, LLC
• Product Code: MVA · Neurology
• Decision Date: Sep 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Talee and the Talee PostOp are the Cranial Remolding Orthoses intended for medical purposes for infants from 3 to 18 months of age with moderate-to-severe cranial deformities. The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic- and scaphocephalic- shaped heads and combination of these defects. The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic- and scaphocephalic- shaped heads.

Device Story

Talee/Talee PostOp are patient-specific cranial remolding orthoses. Input: 3D scan of infant head via non-contact optical light scanner. Process: CAD software (Rodin4D) modifies scan data to create a symmetrical head model; 3D printing (HP MJF) produces a perforated nylon outer shell; inner layer of polyethylene foam (Plastazote) added for skin contact. Operation: Clinician-adjusted device maintains contact with prominent regions while providing internal voids for growth; regular monthly clinical monitoring for fit/adjustments. Output: Physical orthosis. Benefit: Improves cranial symmetry/physiological shape. Used in clinical settings by orthotists/physicians.

Clinical Evidence

Bench testing only. Included biocompatibility (ISO 10993-5, 10993-10), impact strength, structural stiffness, and manufacturing accuracy tests. CCA software accuracy validated against manual and CAD methods. All acceptance criteria met.

Technological Characteristics

Patient-specific cranial orthosis. Outer shell: 3D printed nylon (PA11, PA12, CB PA12), 0.8-6mm thickness. Inner liner: Polyethylene foam (Plastazote), 3-12mm thickness. Fastening: Self-locking 3D printed clip with BOA lanyard or rubber band. Connectivity: Standalone. Sterilization: N/A (non-sterile).

Indications for Use

Indicated for infants 3-18 months with moderate-to-severe cranial deformities, including non-synostotic positional plagiocephaly (plagiocephalic/scaphocephalic) or post-surgical synostosis correction with residual deformities.

Regulatory Classification

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.

Special Controls

*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)).

In addition to the general controls of the act, the Dynamic Orthotic Cranioplasty - DOC™ Band is subject to the following special controls in order to provide reasonable assurance of the safety and effectiveness: (1) The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109. (2) The labeling must include (a) contraindications for the use of the device on infants with synostosis or with hydrocephalus; (b) warnings indicating the need: (i) to evaluate head circumference measurements and neurological status at intervals appropriate to the infant’s age and rate of head growth, and to describe steps that should be taken in order to reduce the potential for restriction of cranial growth and possible impairment of brain growth and development; (ii) to evaluate the skin at frequent intervals, e.g., every three to four hours, and to describe steps that should be taken if skin irritation or breakdown occurs; (c) precautions indicating the need: (i) to additionally treat torticollis, if the positional plagiocephaly is associated with torticollis; (ii) to evaluate device fit and to describe the steps that should be taken in order to reduce the potential for restriction of cranial growth, possible impairment of brain growth and development and skin irritation and/or breakdown; (iii) to evaluate the structural integrity of the device and to describe the steps that should be taken to reduce the potential for the device to slip out of place and cause asphyxiation or trauma to the eyes or skin; (d) adverse events, i.e., skin irritation and breakdown that have occurred with the use of this device; (e) clinician’s instructions for casting the infant, for fitting the device, and for care and use of the device; and (f) parents’ instructions for care and use of the device. (3) The materials must be assessed for biocompatibility with testing appropriate for long term direct skin contact.

Predicate Devices

• STARband, STARlight (K151979)

Reference Devices

• STARband, STARlight (K142141)
• Boston Band (K111609)

Submission Summary (Full Text)

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September 22, 2022

Invent Medical USA, LLC Jiri Rosicky 1800 Mearns Rd, Suite Y Warminster, Pennsylvania 18974

Re: K220681

Trade/Device Name: Talee, Talee PostOP Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: August 22, 2022 Received: August 23, 2022

Dear Jiri Rosicky:

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 ([e-mail]) or phone [phone] 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)

K220681

Device Name

Talee, Talee PostOp

The Talee and the Talee PostOp are the Cranial Remolding Orthoses intended for medical purposes for infants from 3 to 18 months of age with moderate-to-severe cranial deformities.

The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic- and scaphocephalic- shaped heads and combination of these defects.

The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic- and scaphocephalic- shaped heads.

Type of Use (Select one or both, as applicable)

| | <div> <b> <span style="text-decoration: overline;">X</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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# 510(k) Summary

| Submitter:<br>Address: | Invent Medical USA, LLC<br>1800 Mearns Rd, Suite Y, Warminster, PA 18974, USA |
|------------------------|-------------------------------------------------------------------------------|
| Phone number: | 1 [phone] |
| Contact person: | Jiri Rosicky |
| Phone number: | 1 [phone] |
| Date prepared: | September 22, 2022 |
| Trade name: | Talee, Talee PostOp |
| Common name: | Cranial Orthosis |
| Product Code: | MVA, OAN Cranial Orthosis |
| Regulation: | 21 CFR 882.5970, Cranial Orthosis, Class II |

Substantial equivalence claimed to predicate device: STARband, STARlight (K151979)

| Reference devices: | STARband, STARlight (K142141) |
|--------------------|-------------------------------|
| | Boston Band (K111609) |

## Description:

### Product classification and indication for use

The Talee and the Talee PostOp are Cranial Remolding Orthoses which are individually designed and manufactured medical devices class II.

The Talee and the Talee PostOp are the Cranial Remolding Orthoses intended for medical purposes for infants from 3 to 18 months of age with moderate-to-severe cranial deformities.

The Talee is used for infants ages 3 to 18 months with moderate-to-severe, non-synostotic, positional plagiocephaly, including infants with plagiocephalic- and scaphocephalic- shaped heads or a combination of these defects.

The Talee PostOp is used for infants ages 3 to 18 months whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, and scaphocephalic-shaped heads.

### Remolding principle

The Cranial Remolding Orthosis (Talee/Talee PostOp) has contact with the prominent regions, and a precisely pre-defined internal space in the areas where flattening occurs. The skull only has the possibility to grow into that pre-defined space, which as a result improves the cranial symmetry and/or physiological shape. The same cranial remolding principle is applied to patients with positional plagiocephaly and to post-operative patients.

During treatment, the Cranial Orthosis is checked regularly by a physician/clinician to ensure proper treatment at all times. The infant is evaluated monthly by the clinician to monitor growth and ensure that a

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precise fit is maintained. Adjustments are made to the device as needed to accommodate growth and/or optimize the function of the Cranial Orthosis.

### Manufacturing process

The Cranial Remolding Orthosis is made individually as a patient-specific device according to the type of deformity and disposition of the patient.

The Cranial Orthosis is made according to the 3D scan of the infant´s head. The shape of the baby's head is scanned by a non-contact optical light 3D scanner that does not have any side effects on the child's health (see the list of approved scanners in Table 4).

The modified shape of the infant's symmetrical head shape is created in CAD software (R4D CADCAM software, Rodin4D, http://rodin4d.com/en/Products/rectification) from the 3D scan.

CAD model of the outer shell of the Orthosis is based on modified shape of infant's head. The outer shell of the Orthosis is produced by 3D printing (industrial HP MJF 3D printed shell provides stiffness of the Orthosis and the control of the desired head shape.

The Cranial Orthosis is assembled from two-part outer 3D printed shell and the inner soft foam layer. Inner soft foam layer is made from polyethylene foam (Plastazote), which ensures soft contact with the skin of the child's head. The Plastazote is held in place by double sided tape. On the left/right side of the orthosis there is a fastening mechanism, which is used for easy donning/doffing of the Cranial Orthosis.

## Specification of Materials

Talee - Outer shell:

3D printed perforated and contoured multi-layer shell structure from nylon (PA11, PA12 or CB PA12), thickness varies from 0.8mm (1/32") to 4mm (5/32")

Talee - Inner material:

Polyethylene foam (Plastazote), thickness varies from 3mm (1/8") to 12mm (1/2") Talee - Adjustment pads material (optional):

Oval pads – Polyethylene foam (Plastazote) thickness varies from 2mm (1/12") to 4mm (1/6")

Foam pad - Polyethylene foam (Plastazote) & Polyurethane elastic foam/ Thermoplastic polyurethane, thickness varies from 3mm (1/8") to 19mm (3/4"). Plastazote material at skin contacting side.

Talee PostOp - Outer shell:

3D printed perforated and contoured multi-layer shell structure from nylon (PA11, PA12 or CB PA12), thickness varies from 0.8mm (1/32") to 6mm (1/4")

Talee PostOp - Inner material:

Polyethylene foam (Plastazote), thickness varies from 3mm (1/8") to 12mm (1/2")

Talee PostOp - Adjustment pads material (optional):

Oval pads – Polyethylene foam (Plastazote) thickness varies from 2mm (1/12") to 4mm (1/6")

Foam pad - Polyethylene foam (Plastazote) & Polyurethane elastic foam/ Thermoplastic polyurethane, thickness varies from 3mm (1/8") to 19mm (3/4"). Plastazote material at skin contacting side.

Talee and Talee PostOp - Fastening mechanism: Self-locking clip mechanism on left/right sides, 3D printed with BOA lanyard or Rubber band.

### Product fitting, adjustments and reporting software

The Cranial Remolding Orthosis is provided by a Certified Orthotist (CO) solely on the order (prescription) of a licensed physician. During treatment, the Cranial Orthosis Talee and Talee PostOp is regularly checked by

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a physician/clinician to ensure proper treatment at all times. During an initial fitting and also at every follow up, the clinician will assess the need for further adjustments made by adding stabilization pads or removing them. All components are assembled into the finished product manually. Any assembly or adjustments are always done by a specifically trained professional.

The infant is evaluated monthly by the clinician to monitor growth and ensure that a precise fit is maintained. Adjustments are made to the device as needed to accommodate growth and/or optimize the function of the Cranial Orthosis. Cranial Comparison App (CCA) is a separate reporting software program designed to present specific measurements derived from a 3D digital model of the patient's cranium. The CCA does not affect the operation of the approved scanners (see the list of approved scanners). The CCA is not used for manufacturing of the Talee or Talee PostOp.

## Indications for Use:

The Talee and the Talee PostOp are Cranial Remolding Orthoses, intended for medical purposes, for infants from 3 to 18 months of age with moderate-to-severe cranial deformities.

The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic- and scaphocephalic- shaped heads and a combination of these defects.

The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic-, and scaphocephalic-shaped heads.

## Technological Characteristics:

The Cranial Remolding Orthoses Talee and Talee PostOp are substantially equivalent to the predicate medical devices. It is a Cranial Orthosis designed individually for each patient based on a 3D scan of the baby's head. The intended use is the same - the treatment of head shape deformities at a crucial growing period of an infant's life. The remolding principle of the Cranial Orthosis is the same.

The tables below show the comparison between Cranial Remolding Orthosis Talee/Talee PostOp and predicate Medical device features and Approved 3D scanners (Table 1). Other tables below show the comparison between Cranial Remolding Orthosis Talee/Talee PostOp and reference Medical devices, including Reporting Software (Table 2), other Approved 3D scanners and CAD design software (Table 3),

| Feature | K151979 STARband, STARlight | Proposed Device | Evaluation of<br>difference |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Intended<br>Use | Maintains total contact over areas<br>of bossing or protrusion and creates<br>voids over areas of depression or<br>flattening to redirect cranial growth<br>toward greater symmetry. | The Cranial Remolding Orthosis has<br>contact with the head in prominent<br>regions where there is contact<br>pressure, while leaving precise, pre-<br>defined internal spaces in areas where<br>there is flattening. To improve cranial<br>symmetry and/or physiological shape,<br>the skull only has the possibility for<br>growth in that pre-defined space. | SAME |

Table 1 - Comparison of Predicate Device including Approved Scanners cleared in K151979 to proposed device

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| Materials | | Talee Outer Shell: | No risk for change. |
|-----------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Material for STARband Side Opening<br>design and STARband Bi-Valve<br>design | 3D printed perforated and contoured<br>multi-layer shell structure from<br>Polyamide/Nylon (PA11, PA12 or CB<br>PA12), thickness varies from 0.8 mm<br>(1/32") to 4 mm (5/32") with optional<br>water-based color coating. | Inner liner material<br>(contact with intact<br>skin): Similar<br>All devices' inner<br>liners are<br>manufactured from<br>a variety of<br>polyethylene foams. |
| | • Outer shell of 5/32" copolymer<br>plastic | Talee Inner Material: | Outer shell and<br>Interlayer materials:<br>Differences in<br>materials used for<br>Cranial Orthosis <b>do<br/>not affect intended<br/>use, safety of<br/>medical device or<br/>effectiveness of<br/>treatment.</b> |
| | • An inner liner of 1/2" Pelite<br>polyethylene foam or 1/2" Aliplast<br>foam | Polyethylene foam (Plastazote)<br>Polyethylene foam, thickness varies<br>from 3 mm (1/8") to 12 mm (1/2") | |
| | Material for STARlight Side Opening<br>design and STARlight Bi-Valve design | Adjustment pad material (optional):<br>Polyethylene foam (Plastazote) &<br>Polyurethane elastic foam/ TPU,<br>thickness varies from 3mm (1/8") to<br>19mm (3/4") | All materials have<br>been previously<br>used for medical<br>applications and are<br>not expected to<br>cause any adverse<br>events when in<br>contact with skin or<br>hair. |
| | • 5/32" - 1/4" clear Surlyn or 1/8" –<br>7/32" Clear Co-Polyester plastic<br>shell | Talee PostOp Outer Shell: | |
| | Material for STARlight PRO design | 3D printed perforated and contoured<br>multi-layer shell structure from<br>Polyamide/Nylon (PA11, PA12 or CB<br>PA12), thickness varies from 0.8 mm<br>(1/32") to 6 mm (1/4") with optional<br>water-based color coating. | |
| | • 1/4" – 3/8" clear Surlyn | Talee PostOp Inner Material: | |
| | Closure for Bivalve design | Polyethylene foam (Plastazote)<br>Polyethylene foam, thickness varies<br>from 3 mm (1/8") to 12 mm (1/2") | |
| | • Sliding/Overlap closure system | Adjustment pad material (optional):<br>Polyethylene foam (Plastazote) &<br>Polyurethan elastic foam/TPU,<br>thickness varies from 3mm (1/8") to<br>19mm (3/4") | |
| | • Chicago screw (or similar) for top<br>sliding mechanism | Closure Mechanism (Talee, Talee<br>PostOp): | |
| | • 1" Velcro strap | Self-locking clip mechanism on<br>left/right sides, 3D printed clip<br>combined with BOA lanyard or Rubber<br>Band | |
| | • 1" chafe buckle | | |
| | • Speedy rivets | | |
| | Closure for STARband Side Opening<br>design | | |
| | • 1 ½" Velcro Strap | | |
| | • 1 ½" chafe buckle | | |
| | • A Gap Block made from ½" firm<br>Pelite polyethylene foam | | |
| | • Large Flange, Blind Rivet | | |
| | Closure for STARlight Side Opening<br>design and the STARlight PRO<br>design: | | |
| | • 1" Velcro Strap | | |
| | • 1" chafe buckle | | |
| | • Optional tamper resistant strap<br>(qty 2 for the STARlight PRO design) | | |

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| Product<br>design | Custom made Cranial Orthosis,<br>approximately 6 to 10oz in weight.<br>STARlight PRO weighs 12.5 to 18.5<br>oz. | The Cranial Remolding Orthoses, Talee<br>and Talee PostOp, are made<br>individually as a patient-specific device.<br>The weight of a Talee orthosis varies<br>from approx. 155 to 250g (5 to 8 oz).<br>Talee PostOp orthosis weight varies<br>from approx. 215 to 370g (7 to 12 oz). | No risk for change.<br>Differences in<br>product design of<br>Cranial Orthosis do<br>not affect intended<br>use, safety of<br>medical device or<br>effectiveness of<br>treatment.<br>Talee/Talee PostOp<br>orthoses are lighter<br>than predicated<br>devices. |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Production | • Form orthosis from a positive<br>mold of infant's head<br>• Positive mold is formed based<br>upon measurements of the infant's<br>head taken by an approved 3-<br>dimensional imaging device from<br>which a 3-dimensional image is<br>made or from a traditional plaster<br>cast<br>• The 3-dimensional image is used<br>to produce a positive mold using a<br>5-axis routing machine | • The Orthosis is assembled from outer<br>shell and inner soft foam parts.<br>• The outer shell of the Orthosis is<br>produced by 3D printing, based on CAD<br>model.<br>• CAD model is based on modified<br>shape of infant's head.<br>• Modified shape of infant's head in<br>CAD software is created from the data<br>from 3D scanners (see the list of<br>approved scanners - Table 4). | No risk for change.<br>Differences in<br>production of<br>Cranial Orthosis do<br>not affect intended<br>use, safety of<br>medical device or<br>effectiveness of<br>treatment. |
| Approved 3-<br>Dimensional<br>Imaging<br>Devices | • STARscanner I<br>• STARscanner II<br>• Omega Scanner<br>• scanGogh-II<br>• 3dMDhead System<br>• 3dMDcranial System<br>• 3dMDflex System<br>• SmartSoc System<br>• M4DScan/BodyScan System<br>• Spectra 3D Scanner | FDA 510k cleared devices:<br>• Omega Scanner (K151979, K111609)<br>• 3dMDhead System (K151979)<br>• 3dMDflex System (K151979)<br>• M4DScan/BodyScan System<br>(K151979)<br>• Spectra 3D Scanner (K151979) | SAME<br>We only use<br>scanners cleared by<br>predicate: K151979<br>or reference:<br>K111609 |
| Testing | | Non - clinical performance testing:<br>• Impact Strength mechanical test<br>• Structural Stiffness mechanical test<br>• Biocompatibility evaluation -<br>Plastazote<br>• Accuracy Test - Manufacturing of<br>Cranial Remolding Orthosis<br>• Manufacturing Test - Accuracy of<br>Laser Plotter | |
| Intended<br>Use | Maintains total contact over areas<br>of bossing or protrusion and<br>creates voids over areas of<br>depression or flattening to redirect<br>cranial growth toward greater<br>symmetry. | The Cranial Remolding Orthosis has<br>contact with the head in prominent<br>regions where there is contact pressure,<br>while leaving precise, pre-defined<br>internal spaces in areas where there is<br>flattening. To improve cranial symmetry<br>and/or physiological shape, the skull<br>only has the possibility for growth in<br>that pre-defined space. The same<br>Cranial Remolding principle is applied to<br>patients with positional plagiocephaly<br>and to post-operative patients. | SAME |
| Materials | Material for STARband Side<br>Opening design and STARband Bi-<br>Valve design Outer shell of 5/32" copolymer<br>plastic An inner liner of 1/2" Pelite<br>polyethylene foam or 1/2" Aliplast<br>foam Material for STARlight Side<br>Opening design and STARlight Bi-<br>Valve design 5/32" - 1/4" clear Surlyn or 1/8" -<br>7/32" Clear Co-Polyester plastic<br>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<br>sliding mechanism 1" Velcro strap 1" chafe buckle Speedy rivets Closure for STARband Side Opening<br>design 1 ½" Velcro Strap 1 ½" chafe buckle A Gap Block made from ½" firm<br>Pelite polyethylene foam Large Flange, Blind Rivet Closure for STARlight Side Opening<br>design and the STARlight PRO<br>design: 1" Velcro Strap 1" chafe buckle Optional tamper resistant strap<br>(qty 2 for the STARlight PRO<br>design) | Talee Outer Shell:<br>3D printed perforated and contoured<br>multi-layer shell structure from<br>Polyamide/Nylon (PA11, PA12 or CB<br>PA12), thickness varies from 0.8 mm<br>(1/32") to 4 mm (5/32") with optional<br>water-based color coating.<br>Talee Inner Material:<br>Polyethylene foam (Plastazote)<br>Polyethylene foam, thickness varies<br>from 3 mm (1/8") to 12 mm (1/2")<br>Adjustment pad material (optional):<br>Polyethylene foam (Plastazote) &<br>Polyurethane elastic foam/TPU,<br>thickness varies from 3mm (1/8") to<br>19mm (3/4")<br><br>Talee PostOp Outer Shell:<br>3D printed perforated and contoured<br>multi-layer shell structure from<br>Polyamide/Nylon (PA11, PA12 or CB<br>PA12), thickness varies from 0.8 mm<br>(1/32") to 6 mm (1/4") with optional<br>water-based color coating.<br>Talee PostOp Inner Material:<br>Polyethylene foam (Plastazote)<br>Polyethylene foam, thickness varies<br>from 3 mm (1/8") to 12 mm (1/2")<br>Adjustment pad material (optional):<br>Polyethylene foam (Plastazote) &<br>Polyurethane elastic foam/TPU,<br>thickness varies from 3mm (1/8") to<br>19mm (3/4")<br><br>Closure Mechanism (Talee/Talee<br>PostOp):<br>Self-locking clip mechanism on left/right<br>sides, 3D printed clip combined with<br>BOA lanyard or Bubber Band | No risk for change.<br><br>Inner liner material<br>(contact with intact<br>skin): Similar<br>All devices' inner<br>liners are<br>manufactured from<br>a variety of<br>polyethylene foams.<br><br>Outer shell and<br>Interlayer materials:<br>Differences in<br>materials used for<br>Cranial Orthosis do<br>not affect intended<br>use, safety of<br>medical device or<br>effectiveness of<br>treatment.<br><br>All materials have<br>been previously<br>used for medical<br>applications and are<br>not expected to<br>cause any adverse<br>events when in<br>contact with skin or<br>hair. |
| Product<br>design | Custom made Cranial Orthosis,<br>approximately 6 to 10oz in weight.<br>STARlight PRO weighs 12.5 to 18.5<br>OZ. | The Cranial Remolding Orthoses, Talee<br>and Talee PostOp, are made individually<br>as a patient-specific device.<br>The weight of a Talee orthosis varies<br>from approx. 155 to 250g (5 to 8 oz).<br>Talee PostOp orthosis weight varies<br>from approx. 215 to 370g (7 to 12 oz). | No risk for change.<br>Differences in<br>product design of a<br>Cranial Orthosis do<br>not affect intended<br>use, safety of<br>medical device or<br>effectiveness of<br>treatment.<br>Talee/Talee PostOp<br>orthoses are lighter<br>than reference<br>devices. |
| Production | • Form orthosis from a positive<br>mold of infant's head<br>• Positive mold is formed based<br>upon measurements of the infant's<br>head taken by an approved 3-<br>dimensional imaging device from<br>which a 3-dimensional image is<br>made or from a traditional plaster<br>cast<br>• The 3-dimensional image is used<br>to produce a positive mold using a<br>5-axis routing machine | • The orthosis is assembled from outer<br>shell and inner soft foam parts.<br>• The outer shell of the orthosis is<br>produced by 3D printing based on CAD<br>model.<br>• CAD model is based on modified<br>shape of infant's head.<br>• Modified shape of infant's head in<br>CAD software is created from the data<br>from 3D scanners (see the list of<br>approved scanners - Table 4). | No risk for change.<br>Differences in<br>production of<br>Cranial Orthosis do<br>not affect intended<br>use, safety of<br>medical device or<br>effectiveness of<br>treatment. |
| Approved 3-<br>Dimensional<br>Imaging<br>Devices | • STARscanner I<br>• STARscanner II<br>• Omega Scanner<br>• scanGogh-II<br>• 3dMDhead System<br>• 3dMDcranial System<br>• 3dMDflex System | FDA 510k cleared devices:<br>• Omega Scanner (K151979, K111609)<br>• 3dMDhead System (K151979)<br>• 3dMDflex System (K151979)<br>• M4DScan/BodyScan System<br>(K151979)<br>• Spectra 3D Scanner (K151979) | SAME<br>We only use<br>scanners cleared by<br>predicate: K151979<br>or reference:<br>K111609 |
| Reporting<br>Software | Cranial Comparison Utility (CCU)<br>The CCU is a separate software<br>program designed to present<br>specific measurements derived<br>from a 3D digital model of the<br>patient's cranium. The CCU does<br>not affect the operation of the<br>STARscanner and is not used for<br>manufacturing of the STARband or<br>STARlight. | Cranial Comparison App (CCA)<br>The CCA is a separate software program<br>designed to present specific<br>measurements derived from a 3D digital<br>model of the patient's cranium. The CCA<br>does not affect the operation of the<br>approved scanners (see the list of<br>approved scanners). The CCA is not<br>used for manufacturing of the Talee or<br>Talee PostOp. | SAME |
| Testing | CCU Accuracy and Capabilities<br>Study | CCA Accuracy and Capabilities Study | SAME |
| | - Utilized a representative cranial | - Utilized a representative cranial | |
| | shape that possesses a predefined | shape that possesses a predefined | |
| | shape with known dimensions | shape with known dimensions | |
| | - Compared CCU to manual | - Compared CCA to manual | |
| | measurements and 3D-CAD sw | measurements and 3D-CAD<br>software | |
| | - Accessed accuracy of…