(198 days)
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.
The Talee and the Talee PostOp are Cranial Remolding Orthoses which are individually designed and manufactured medical devices class II. 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. The Cranial 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 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.
The device under consideration is "Talee and Talee PostOp", Cranial Remolding Orthoses.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Tested Area | Acceptance Criteria (Implied from stated results) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing to intact skin. | Plastazote foam: - Cytotoxicity (ISO 10993-5): No reactivity (Grade 0). - Intracutaneous Irritation (ISO 10993-10): No irritation (Scores 0). - Guinea Pig Maximization Sensitization (ISO 10993-10): No sensitization response (Grade 0). Overall: Biocompatibility assessments revealed no adverse effects on patients under intended conditions of wear. Materials are not reported to cause skin irritation or toxic effects. |
| Software (CCA - Cranial Comparison App) | Comparable accuracy to manual and CAD methods; same or greater capabilities than manual or CAD. | CCA software program met all acceptance criteria, providing comparable accuracy to manual and CAD methods, and possessing the same (or greater) capabilities. |
| Product (Talee/Talee PostOp) Mechanical Strength | Equivalent safety and equivalent (or higher) structural strength compared to predicate devices. | Tested devices (Talee and Talee PostOp) showed equivalent safety and equivalent (or higher) structural strength than the predicate devices in impact strength and structural stiffness mechanical tests. |
| Manufacturing Accuracy | Ensured required dimensional accuracy and accurate device fit. | Manufacturing Test – Dimensional Accuracy of Laser Plotter and Accuracy Test – Manufacturing of Cranial Remolding Orthosis showed all acceptance criteria were met, ensuring required dimensional accuracy and accurate device fit. |
2. Sample size used for the test set and the data provenance:
- Biocompatibility:
- Cytotoxicity: Not specified, but generally refers to in-vitro testing.
- Intracutaneous Irritation: Rabbits (number not specified).
- Guinea Pig Maximization Sensitization: Albino guinea pigs (number not specified).
- Data Provenance: The document does not specify the country of origin for these tests; they are reported as per ISO standards. These are typically laboratory-based tests.
- Software (CCA) Accuracy and Capabilities Study: The study is described as having "utilized a representative cranial shape that possesses a predefined shape with known dimensions" and compared CCA to "manual measurements and 3D-CAD software". The sample size (number of "representative cranial shapes") is not explicitly stated. The provenance is not specified.
- Mechanical Tests (Impact strength, Structural stiffness): The document refers to "tested devices Talee and Talee PostOp". The number of devices tested is not specified. The provenance is not specified.
- Manufacturing Test and Accuracy Test: These refer to internal manufacturing processes. The number of instances tested is not specified. The provenance is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
The document does not mention the involvement of external experts to establish ground truth for any of the non-clinical tests. The "ground truth" for the software accuracy study was based on a "predefined shape with known dimensions" and "manual measurements and 3D-CAD software," implying a comparative approach rather than expert consensus on clinical cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
No explicit adjudication method is mentioned. The non-clinical tests described follow laboratory or engineering validation methodologies against defined acceptance criteria or comparisons to known standards (manual measurements, CAD software).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was conducted or described in the provided text. The device is a cranial orthosis, and its associated software (CCA) is for reporting measurements derived from 3D models, not for diagnostic assistance to human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The software (Cranial Comparison App - CCA) underwent an "Accuracy and Capabilities Study" which compared its measurements to "manual measurements and 3D-CAD software." This can be interpreted as a standalone performance evaluation of the algorithm's measurement capabilities. However, it's not described as an "AI algorithm" in the common sense of machine learning for diagnosis or prediction. Its function is to present measurements from a 3D digital model.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Ground truth is established by standard ISO test protocols (e.g., observing lack of cellular reactivity, irritation, or sensitization in biological models).
- Software (CCA) Accuracy and Capabilities Study: The ground truth was established by comparing the software's output to a "representative cranial shape that possesses a predefined shape with known dimensions" and measurements obtained through "manual measurements and 3D-CAD software." This is a metrological ground truth rather than a clinical one.
- Mechanical Tests: Ground truth is against engineering standards for impact strength and structural stiffness, comparing to predicate device performance.
- Manufacturing Tests: Ground truth is against manufacturing specifications for dimensional accuracy.
8. The sample size for the training set:
The document does not mention a training set, as the device and its associated software are not described as using machine learning or AI models that require traditional training data in the context of diagnostic or predictive tasks. The software primarily processes geometrical data from existing 3D scans.
9. How the ground truth for the training set was established:
As no training set is mentioned for an AI/machine learning model, this question is not applicable.
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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 (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)
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)
| 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
| Submitter:Address: | Invent Medical USA, LLC1800 Mearns Rd, Suite Y, Warminster, PA 18974, USA |
|---|---|
| Phone number: | 1 (267) 368-8165 |
| Contact person: | Jiri Rosicky |
| Phone number: | 1 (267) 368-8165 |
| 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 ofdifference |
|---|---|---|---|
| IntendedUse | Maintains total contact over areasof bossing or protrusion and createsvoids over areas of depression orflattening to redirect cranial growthtoward greater symmetry. | The Cranial Remolding Orthosis hascontact with the head in prominentregions where there is contactpressure, while leaving precise, pre-defined internal spaces in areas wherethere is flattening. To improve cranialsymmetry and/or physiological shape,the skull only has the possibility forgrowth 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 Openingdesign and STARband Bi-Valvedesign | 3D printed perforated and contouredmulti-layer shell structure fromPolyamide/Nylon (PA11, PA12 or CBPA12), thickness varies from 0.8 mm(1/32") to 4 mm (5/32") with optionalwater-based color coating. | Inner liner material(contact with intactskin): SimilarAll devices' innerliners aremanufactured froma variety ofpolyethylene foams. | |
| • Outer shell of 5/32" copolymerplastic | Talee Inner Material: | Outer shell andInterlayer materials:Differences inmaterials used forCranial Orthosis donot affect intendeduse, safety ofmedical device oreffectiveness oftreatment. | |
| • An inner liner of 1/2" Pelitepolyethylene foam or 1/2" Aliplastfoam | Polyethylene foam (Plastazote)Polyethylene foam, thickness variesfrom 3 mm (1/8") to 12 mm (1/2") | ||
| Material for STARlight Side Openingdesign and STARlight Bi-Valve design | Adjustment pad material (optional):Polyethylene foam (Plastazote) &Polyurethane elastic foam/ TPU,thickness varies from 3mm (1/8") to19mm (3/4") | All materials havebeen previouslyused for medicalapplications and arenot expected tocause any adverseevents when incontact with skin orhair. | |
| • 5/32" - 1/4" clear Surlyn or 1/8" –7/32" Clear Co-Polyester plasticshell | Talee PostOp Outer Shell: | ||
| Material for STARlight PRO design | 3D printed perforated and contouredmulti-layer shell structure fromPolyamide/Nylon (PA11, PA12 or CBPA12), thickness varies from 0.8 mm(1/32") to 6 mm (1/4") with optionalwater-based color coating. | ||
| • 1/4" – 3/8" clear Surlyn | Talee PostOp Inner Material: | ||
| Closure for Bivalve design | Polyethylene foam (Plastazote)Polyethylene foam, thickness variesfrom 3 mm (1/8") to 12 mm (1/2") | ||
| • Sliding/Overlap closure system | Adjustment pad material (optional):Polyethylene foam (Plastazote) &Polyurethan elastic foam/TPU,thickness varies from 3mm (1/8") to19mm (3/4") | ||
| • Chicago screw (or similar) for topsliding mechanism | Closure Mechanism (Talee, TaleePostOp): | ||
| • 1" Velcro strap | Self-locking clip mechanism onleft/right sides, 3D printed clipcombined with BOA lanyard or RubberBand | ||
| • 1" chafe buckle | |||
| • Speedy rivets | |||
| Closure for STARband Side Openingdesign | |||
| • 1 ½" Velcro Strap | |||
| • 1 ½" chafe buckle | |||
| • A Gap Block made from ½" firmPelite polyethylene foam | |||
| • Large Flange, Blind Rivet | |||
| Closure for STARlight Side Openingdesign and the STARlight PROdesign: | |||
| • 1" Velcro Strap | |||
| • 1" chafe buckle | |||
| • Optional tamper resistant strap(qty 2 for the STARlight PRO design) |
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| Productdesign | Custom made Cranial Orthosis,approximately 6 to 10oz in weight.STARlight PRO weighs 12.5 to 18.5oz. | The Cranial Remolding Orthoses, Taleeand Talee PostOp, are madeindividually as a patient-specific device.The weight of a Talee orthosis variesfrom approx. 155 to 250g (5 to 8 oz).Talee PostOp orthosis weight variesfrom approx. 215 to 370g (7 to 12 oz). | No risk for change.Differences inproduct design ofCranial Orthosis donot affect intendeduse, safety ofmedical device oreffectiveness oftreatment.Talee/Talee PostOporthoses are lighterthan predicateddevices. |
|---|---|---|---|
| Production | • Form orthosis from a positivemold of infant's head• Positive mold is formed basedupon measurements of the infant'shead taken by an approved 3-dimensional imaging device fromwhich a 3-dimensional image ismade or from a traditional plastercast• The 3-dimensional image is usedto produce a positive mold using a5-axis routing machine | • The Orthosis is assembled from outershell and inner soft foam parts.• The outer shell of the Orthosis isproduced by 3D printing, based on CADmodel.• CAD model is based on modifiedshape of infant's head.• Modified shape of infant's head inCAD software is created from the datafrom 3D scanners (see the list ofapproved scanners - Table 4). | No risk for change.Differences inproduction ofCranial Orthosis donot affect intendeduse, safety ofmedical device oreffectiveness oftreatment. |
| Approved 3-DimensionalImagingDevices | • STARscanner I• STARscanner II• Omega Scanner• scanGogh-II• 3dMDhead System• 3dMDcranial System• 3dMDflex System• SmartSoc System• M4DScan/BodyScan System• Spectra 3D Scanner | FDA 510k cleared devices:• Omega Scanner (K151979, K111609)• 3dMDhead System (K151979)• 3dMDflex System (K151979)• M4DScan/BodyScan System(K151979)• Spectra 3D Scanner (K151979) | SAMEWe only usescanners cleared bypredicate: K151979or reference:K111609 |
| Testing | Non - clinical performance testing:• Impact Strength mechanical test• Structural Stiffness mechanical test• Biocompatibility evaluation -Plastazote• Accuracy Test - Manufacturing ofCranial Remolding Orthosis• Manufacturing Test - Accuracy ofLaser Plotter | ||
| IntendedUse | Maintains total contact over areasof bossing or protrusion andcreates voids over areas ofdepression or flattening to redirectcranial growth toward greatersymmetry. | The Cranial Remolding Orthosis hascontact with the head in prominentregions where there is contact pressure,while leaving precise, pre-definedinternal spaces in areas where there isflattening. To improve cranial symmetryand/or physiological shape, the skullonly has the possibility for growth inthat pre-defined space. The sameCranial Remolding principle is applied topatients with positional plagiocephalyand to post-operative patients. | SAME |
| Materials | Material for STARband SideOpening design and STARband Bi-Valve design Outer shell of 5/32" copolymerplastic An inner liner of 1/2" Pelitepolyethylene foam or 1/2" Aliplastfoam Material for STARlight SideOpening design and STARlight Bi-Valve design 5/32" - 1/4" clear Surlyn or 1/8" -7/32" Clear Co-Polyester plasticshell Material for STARlight PRO design 1/4" – 3/8" clear Surlyn Closure for Bivalve design Sliding/Overlap closure system Chicago screw (or similar) for topsliding mechanism 1" Velcro strap 1" chafe buckle Speedy rivets Closure for STARband Side Openingdesign 1 ½" Velcro Strap 1 ½" chafe buckle A Gap Block made from ½" firmPelite polyethylene foam Large Flange, Blind Rivet Closure for STARlight Side Openingdesign and the STARlight PROdesign: 1" Velcro Strap 1" chafe buckle Optional tamper resistant strap(qty 2 for the STARlight PROdesign) | Talee Outer Shell:3D printed perforated and contouredmulti-layer shell structure fromPolyamide/Nylon (PA11, PA12 or CBPA12), thickness varies from 0.8 mm(1/32") to 4 mm (5/32") with optionalwater-based color coating.Talee Inner Material:Polyethylene foam (Plastazote)Polyethylene foam, thickness variesfrom 3 mm (1/8") to 12 mm (1/2")Adjustment pad material (optional):Polyethylene foam (Plastazote) &Polyurethane elastic foam/TPU,thickness varies from 3mm (1/8") to19mm (3/4")Talee PostOp Outer Shell:3D printed perforated and contouredmulti-layer shell structure fromPolyamide/Nylon (PA11, PA12 or CBPA12), thickness varies from 0.8 mm(1/32") to 6 mm (1/4") with optionalwater-based color coating.Talee PostOp Inner Material:Polyethylene foam (Plastazote)Polyethylene foam, thickness variesfrom 3 mm (1/8") to 12 mm (1/2")Adjustment pad material (optional):Polyethylene foam (Plastazote) &Polyurethane elastic foam/TPU,thickness varies from 3mm (1/8") to19mm (3/4")Closure Mechanism (Talee/TaleePostOp):Self-locking clip mechanism on left/rightsides, 3D printed clip combined withBOA lanyard or Bubber Band | No risk for change.Inner liner material(contact with intactskin): SimilarAll devices' innerliners aremanufactured froma variety ofpolyethylene foams.Outer shell andInterlayer materials:Differences inmaterials used forCranial Orthosis donot affect intendeduse, safety ofmedical device oreffectiveness oftreatment.All materials havebeen previouslyused for medicalapplications and arenot expected tocause any adverseevents when incontact with skin orhair. |
| Productdesign | Custom made Cranial Orthosis,approximately 6 to 10oz in weight.STARlight PRO weighs 12.5 to 18.5OZ. | The Cranial Remolding Orthoses, Taleeand Talee PostOp, are made individuallyas a patient-specific device.The weight of a Talee orthosis variesfrom approx. 155 to 250g (5 to 8 oz).Talee PostOp orthosis weight variesfrom approx. 215 to 370g (7 to 12 oz). | No risk for change.Differences inproduct design of aCranial Orthosis donot affect intendeduse, safety ofmedical device oreffectiveness oftreatment.Talee/Talee PostOporthoses are lighterthan referencedevices. |
| Production | • Form orthosis from a positivemold of infant's head• Positive mold is formed basedupon measurements of the infant'shead taken by an approved 3-dimensional imaging device fromwhich a 3-dimensional image ismade or from a traditional plastercast• The 3-dimensional image is usedto produce a positive mold using a5-axis routing machine | • The orthosis is assembled from outershell and inner soft foam parts.• The outer shell of the orthosis isproduced by 3D printing based on CADmodel.• CAD model is based on modifiedshape of infant's head.• Modified shape of infant's head inCAD software is created from the datafrom 3D scanners (see the list ofapproved scanners - Table 4). | No risk for change.Differences inproduction ofCranial Orthosis donot affect intendeduse, safety ofmedical device oreffectiveness oftreatment. |
| Approved 3-DimensionalImagingDevices | • STARscanner I• STARscanner II• Omega Scanner• scanGogh-II• 3dMDhead System• 3dMDcranial System• 3dMDflex System | FDA 510k cleared devices:• Omega Scanner (K151979, K111609)• 3dMDhead System (K151979)• 3dMDflex System (K151979)• M4DScan/BodyScan System(K151979)• Spectra 3D Scanner (K151979) | SAMEWe only usescanners cleared bypredicate: K151979or reference:K111609 |
| ReportingSoftware | Cranial Comparison Utility (CCU)The CCU is a separate softwareprogram designed to presentspecific measurements derivedfrom a 3D digital model of thepatient's cranium. The CCU doesnot affect the operation of theSTARscanner and is not used formanufacturing of the STARband orSTARlight. | Cranial Comparison App (CCA)The CCA is a separate software programdesigned to present specificmeasurements derived from a 3D digitalmodel of the patient's cranium. The CCAdoes not affect the operation of theapproved scanners (see the list ofapproved scanners). The CCA is notused for manufacturing of the Talee orTalee PostOp. | SAME |
| Testing | CCU Accuracy and CapabilitiesStudy | 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-CADsoftware | ||
| - Accessed accuracy of | - Accessed accuracy of | ||
| measurements and capabilities of | measurements and capabilities of | ||
| model alignment, differential | model alignment, differential | ||
| maps, calculations and reporting | maps, calculations and reports |
Table 2 - Comparison of Reference Device including Reporting Software cleared in K142141 to proposed device
| Feature | K142141 STARband, STARlight |
|---|---|
| Proposed Device | Evaluation of difference |
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Table 3 - Comparison of Reference Device including CAD design cleared in K111609 to proposed device
| Feature | K111609 Boston Band | Proposed Device | Evaluation of difference |
|---|---|---|---|
| Intended Use | Intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial proportion and symmetry in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes. 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 still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. | 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-, brachycephalic- 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-, brachycephalic-, and scaphocephalic-shaped heads. | SAME |
| Materials | No risk for change. | ||
| outer shell of thermoformable plastic (1/4 or 3/16 copolymer plastic) a single layer of ½ inch or 5-6 layers of 1/8 inch, or a combination of 1 - 2 1/4 inch layers with 1/8 inch layers of pelite hypoallergenic polyethylene foam or Aliplast Velcro strap (pile) sticky back Velcro hook | Talee Outer Shell:3D printed perforated and contoured multi-layer shell structure from Polyamide/Nylon (PA11, PA12 or CB PA12), thickness varies from 0.8 mm (1/32") to 4 mm (5/32") with optional water-based color coating.Talee Inner Material:Polyethylene foam (Plastazote) Polyethylene foam, thickness varies from 3 mm (1/8") to 12 mm (1/2")Adjustment pad material (optional):Polyethylene foam (Plastazote) & Polyurethane elastic foam/TPU, thickness varies from 3mm (1/8") to 19mm (3/4")Talee PostOp Outer Shell:3D printed perforated and contoured multi-layer shell structure from Polyamide/Nylon (PA11, PA12 or CB PA12), thickness varies from 0.8 mm (1/32") to 6 mm (1/4") with optional water-based color coating.Talee PostOp Inner Material:Polyethylene foam (Plastazote) Polyethylene foam, thickness varies from 3 mm (1/8") to 12 mm (1/2")Adjustment pad material (optional):Polyethylene foam (Plastazote) & Polyurethane elastic foam/TPU, thickness varies from 3mm (1/8") to 19mm (3/4")Closure Mechanism (Talee/ Talee PostOp):Self-locking clip mechanism on left/right sides, 3D printed clip combined with BOA lanyard or Rubber Band | Inner liner material (contact with intact skin): SimilarAll devices' inner liners are manufactured from a variety of polyethylene foams.Outer shell and Interlayer materials: Differences in materials used for Cranial Orthosis do not affect intended use, safety of medical device or effectiveness of treatment.All materials have been previously used for medical applications and are not expected to cause any adverse events when in contact with skin or hair. | |
| Product design | Cranial Orthosis - made to individual's specifications | The Cranial Remolding Orthosis is made individually as a patient-specific device. | SAME |
| Production | |||
| • Model of the infants head from anegative impression (cast) of theinfants head• Scan of the infants head from aFastscan hands free class II laserscanner• Scan of the infants head using aFastscan handheld class I laserscanner• Scan of the infants head using theCreaform class I laser scanner soldas Ohio Willow Wood Omega /handycam• Foam model of the infants headcarved using an industry standard 5axis scannerThe same CAD-CAM software, Rodin 4D, is used for 3D rectification. Moreinformation in "Summary and Conclusion of Non-Clinical Performance Data"(K111609). | • The Orthosis is assembled from outershell and inner soft foam parts.• The outer shell of the Orthosis isproduced by 3D printing based on CADmodel.• CAD model is based on modifiedshape of infant's head.• Modified shape of infant's head inCAD software is created from the datafrom 3D scanners (see the list ofapproved scanners - Table 4). | No risk for change.Differences inproduction ofCranial Orthosis donot affect intendeduse, safety ofmedical device oreffectiveness oftreatment. | |
| Approved 3-DimensionalImagingDevices | FDA 510k cleared devices: | SAME | |
| • Fastscan (class II laser)• Fastscan II (class I laser)• Omega Scanner | • Omega Scanner (K151979, K111609)• 3dMDhead System (K151979)• 3dMDflex System (K151979)• M4DScan/BodyScan System(K151979)• Spectra 3D Scanner (K151979) | We only usescanners cleared bypredicate: K151979or reference:K111609 |
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Table 4 – Comparison of technical parameters of Approved Scanners
| 3D scanner | Manufacturer | Website | Type | Accuracy (mm) | Resolution (mm) | FDA 510k |
|---|---|---|---|---|---|---|
| OMEGA | Ohio WillowWood | https://www.willowwoodco.com/ | Lightscanner | up to 0.50 | 1.00 | K151979 |
| M4D | Rodin4D | http://rodin4d.com/ | Lightscanner | up to 0.50 | 1.00 | K151979 |
| BodyScan | Techmed3D | https://techmed3d.com | Lightscanner | up to 0.50 | 1.00 | K151979 |
| Spectra | VORUM | https://vorum.com/ | Lightscanner | 0.10 | N/A | K151979 |
| 3dMDheadSystem | 3DMD | http://www.3dmd.com/ | Lightscanner | 0.20 | N/A | K151979 |
| 3dMDflexSystem | 3DMD | http://www.3dmd.com/ | Lightscanner | 0.20-0.50 | N/A | K151979 |
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Non-clinical performance Testing:
The following Non-clinical performance testing (Table 5) was conducted on Talee PostOp Cranial Orthoses.
| Tested Area | Performance Testing |
|---|---|
| SoftwareCranial Comparison App (CCA) | Accuracy and Capabilities Study |
| ProductTalee/Talee PostOp | Impact strength mechanical test |
| ProductTalee/Talee PostOp | Structural stiffness mechanical test |
| MethodManufacturing | Manufacturing Test – Dimensional Accuracy of Laser Plotter |
| MethodManufacturing | Accuracy Test – Manufacturing of Cranial Remolding Orthosis |
Biocompatibility evaluation
Non-clinical performance testing included biocompatibility evaluation of materials in contact with intact skin. The results of these tests are in Table 6.
| Table 6 – Materials in contact with intact skin | ||||
|---|---|---|---|---|
| -- | -- | -- | ------------------------------------------------- | -- |
| Biocompatibility evaluation - PE foam (Plastazote) | |||
|---|---|---|---|
| Test | Results | Conclusions | |
| ISO Cytotoxicity MEM ElutionISO 10993-5 | Cell culture treated with test sample exhibitedno reactivity (Grade 0) | Non-cytotoxic | |
| ISO Intracutaneous IrritationISO 10993-10 | Rabbits treated with test samples exhibited noirritation (Scores 0) | Non-irritating | |
| ISO Guinea Pig MaximizationSensitizationISO 10993-10 | Albino guinea pigs treated with test sample didnot elicit a sensitization response (Grade 0) | Non- sensitizer | |
| The material is in contact with the intact skin of the head. It is necessary to clean and disinfect polyethylenefoam (Plastazote) material each day by isopropyl alcohol as described in the Instructions for Use. |
The safety of the Cranial Orthosis is established under standard biocompatibility assessments. These assessments reveal that the device and the materials used are not expected to adversely affect the infants under the intended conditions of wear. (Polyethylene foam is commonly used to line orthoses). The materials are not reported to cause skin irritation or any toxic effects. Further, the product is designed to avoid improper migration or harmful levels of pressure. The interior of the device is smooth and poses no significant threat to the child during application within the normal scope of its intended use.
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Test summary and discussion:
The following non-clinical tests were conducted for Talee PostOp. The predetermined acceptance criteria were met:
- Sensitization testing per ISO 10993-10:2010 (Recognition Number: 2-174)
- Cytotoxicity testing per ISO 10993-5:2009 (Recognition Number: 2-245)
- Irritation testing per ISO 10993-10:2010 (Recognition Number: 2-174)
- . Accuracy and Capabilities Study
- Impact strength mechanical test
- Structural stiffness mechanical test
- Manufacturing Test - Dimensional Accuracy of Laser Plotter
- Accuracy Test Manufacturing of Cranial Remolding Orthosis ●
Discussion
- The Biocompatibility assessments included in the non-clinical performance testing revealed that the proposed device and the materials used are not expected to have adverse effects on the patients under the intended conditions of wear.
- Based on the Accuracy and Capabilities study, the CCA software program met all the acceptance . criteria and provides comparable accuracy to manual and CAD method. The CCA also has the same (or greater) capabilities as the manual or CAD method.
- According to the mechanical tests performed, the tested devices Talee and Talee PostOp, have equivalent safety and equivalent (or higher) structural strength than the predicate devices.
- The Manufacturing test and the Accuracy test mentioned above showed that all of the acceptance criteria were met, and the manufacturing process of the finished 3D printed cranial remolding orthosis ensures the required dimensional accuracy and that the devices fit accurately.
Conclusions of non-clinical performance data
- Substantial equivalence, safety, and effectiveness are supported by the Non-clinical Performance Testing (Software, Product, Manufacturing method) of Talee PostOp to primary predicate devices (STARband, STARlight PRO).
- The non-clinical performance testing mentioned above demonstrates that the differences in technological features of the Cranial Orthosis do not affect performance, safety, or effectiveness of Medical Device Talee/Talee PostOp in comparison to Predicate/Reference Device.
General conclusion:
Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the subject device Talee/Talee PostOp is substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act.
§ 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)).