(198 days)
No
The description focuses on CAD software and 3D printing for creating a patient-specific orthosis based on a 3D scan, with no mention of AI or ML for analysis, design, or treatment planning.
Yes
The device is intended for medical purposes for infants with cranial deformities and works by controlling the growth of the skull to improve cranial symmetry and/or physiological shape. This directly addresses and corrects a physical ailment, which falls under the definition of a therapeutic device.
No
The device is a Cranial Remolding Orthosis, an orthopedic device used to correct cranial deformities, not to diagnose them. It is used after a diagnosis has already been made.
No
The device is a physical cranial remolding orthosis, which is a hardware device, even though its design process utilizes CAD software and 3D printing. The software mentioned (CCA) is for comparison and analysis, not the primary medical device itself.
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.
- Device Function: The Talee and Talee PostOp are physical medical devices (orthoses) that are worn externally on the infant's head. They work by applying pressure to reshape the skull.
- Intended Use: The intended use is to treat cranial deformities by physically remolding the skull, not by analyzing biological samples.
- Device Description: The description details the materials and manufacturing process of a physical orthosis, not a diagnostic test.
- Performance Studies: The performance studies focus on the mechanical properties, accuracy of manufacturing, and biocompatibility of the physical device, not on the accuracy of a diagnostic test.
The device is clearly a therapeutic medical device used for physical intervention, not a diagnostic tool that analyzes samples.
N/A
Intended Use / 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.
Product codes
MVA, OAN
Device Description
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 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. The modified shape of the infant's symmetrical head shape is created in CAD software (R4D CADCAM software, Rodin4D) 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
non-contact optical light 3D scanner
Anatomical Site
Infant's head/cranium
Indicated Patient Age Range
3 to 18 months of age
Intended User / Care Setting
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 a physician/clinician to ensure proper treatment at all times. All components are assembled into the finished product manually. Any assembly or adjustments are always done by a specifically trained professional.
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)
Non-clinical performance Testing:
- Software Cranial Comparison App (CCA): Accuracy and Capabilities Study
- Product Talee/Talee PostOp: Impact strength mechanical test
- Product Talee/Talee PostOp: Structural stiffness mechanical test
- Method Manufacturing: Manufacturing Test – Dimensional Accuracy of Laser Plotter
- Method Manufacturing: Accuracy Test – Manufacturing of Cranial Remolding Orthosis
- Biocompatibility evaluation: PE foam (Plastazote) for Cytotoxicity, Intracutaneous Irritation, and Guinea Pig Maximization Sensitization.
Key Results:
- 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.
- 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 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.
- Biocompatibility assessments 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. The material is non-cytotoxic, non-irritating, and non-sensitizing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
STARband, STARlight (K151979)
Reference Device(s)
STARband, STARlight (K142141), Boston Band (K111609)
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
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)
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, LLC
1800 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
4
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
5
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
difference |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 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. | The Cranial Remolding Orthosis has
contact with the head in prominent
regions where there is contact
pressure, while leaving precise, pre-
defined internal spaces in areas where
there is flattening. To improve cranial
symmetry and/or physiological shape,
the skull only has the possibility for
growth in that pre-defined space. | SAME |
Table 1 - Comparison of Predicate Device including Approved Scanners cleared in K151979 to proposed device
6
| Materials | Talee Outer Shell: | No risk for change. | |
|---|---|---|---|
| Material for STARband Side Opening | |||
| design and STARband Bi-Valve | |||
| design | 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. | Inner liner material | ||
| (contact with intact | |||
| skin): Similar | |||
| All devices' inner | |||
| liners are | |||
| manufactured from | |||
| a variety of | |||
| polyethylene foams. | |||
| • Outer shell of 5/32" copolymer | |||
| plastic | Talee Inner Material: | 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. | |||
| • An inner liner of 1/2" Pelite | |||
| polyethylene foam or 1/2" Aliplast | |||
| foam | Polyethylene foam (Plastazote) | ||
| Polyethylene foam, thickness varies | |||
| from 3 mm (1/8") to 12 mm (1/2") | |||
| Material for STARlight Side Opening | |||
| design and STARlight Bi-Valve design | Adjustment pad material (optional): | ||
| Polyethylene foam (Plastazote) & | |||
| Polyurethane elastic foam/ TPU, | |||
| thickness varies from 3mm (1/8") to | |||
| 19mm (3/4") | 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. | |||
| • 5/32" - 1/4" clear Surlyn or 1/8" – | |||
| 7/32" Clear Co-Polyester plastic | |||
| shell | Talee PostOp Outer Shell: | ||
| Material for STARlight PRO design | 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. | |||
| • 1/4" – 3/8" clear Surlyn | Talee PostOp Inner Material: | ||
| Closure for Bivalve design | Polyethylene foam (Plastazote) | ||
| Polyethylene foam, thickness varies | |||
| from 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") to | |||
| 19mm (3/4") | |||
| • Chicago screw (or similar) for top | |||
| sliding mechanism | Closure Mechanism (Talee, Talee | ||
| PostOp): | |||
| • 1" Velcro strap | Self-locking clip mechanism on | ||
| left/right sides, 3D printed clip | |||
| combined with BOA lanyard or Rubber | |||
| Band | |||
| • 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 STARlight Side Opening | |||
| design and the STARlight PRO | |||
| design: | |||
| • 1" Velcro Strap | |||
| • 1" chafe buckle | |||
| • Optional tamper resistant strap | |||
| (qty 2 for the STARlight PRO design) |
7
| Product
design | Custom made Cranial Orthosis,
approximately 6 to 10oz in weight.
STARlight PRO weighs 12.5 to 18.5
oz. | The Cranial Remolding Orthoses, Talee
and Talee PostOp, are made
individually as a patient-specific device.
The weight of a Talee orthosis varies
from approx. 155 to 250g (5 to 8 oz).
Talee PostOp orthosis weight varies
from approx. 215 to 370g (7 to 12 oz). | No risk for change.
Differences in
product design of
Cranial Orthosis do
not affect intended
use, safety of
medical device or
effectiveness of
treatment.
Talee/Talee PostOp
orthoses are lighter
than predicated
devices. |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Production | • Form orthosis from a positive
mold of infant's head
• Positive mold is formed based
upon measurements of the infant's
head taken by an approved 3-
dimensional imaging device from
which a 3-dimensional image is
made or from a traditional plaster
cast
• The 3-dimensional image is used
to produce a positive mold using a
5-axis routing machine | • The Orthosis is assembled from outer
shell and inner soft foam parts.
• The outer shell of the Orthosis is
produced by 3D printing, based on CAD
model.
• CAD model is based on modified
shape of infant's head.
• Modified shape of infant's head in
CAD software is created from the data
from 3D scanners (see the list of
approved scanners - Table 4). | No risk for change.
Differences in
production of
Cranial Orthosis do
not affect intended
use, safety of
medical device or
effectiveness of
treatment. |
| Approved 3-
Dimensional
Imaging
Devices | • 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) | SAME
We only use
scanners cleared by
predicate: K151979
or reference:
K111609 |
| Testing | | Non - clinical performance testing:
• Impact Strength mechanical test
• Structural Stiffness mechanical test
• Biocompatibility evaluation -
Plastazote
• Accuracy Test - Manufacturing of
Cranial Remolding Orthosis
• Manufacturing Test - Accuracy of
Laser Plotter | |
| 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. | The Cranial Remolding Orthosis has
contact with the head in prominent
regions where there is contact pressure,
while leaving precise, pre-defined
internal spaces in areas where there is
flattening. To improve cranial symmetry
and/or physiological shape, the skull
only has the possibility for growth in
that pre-defined space. The same
Cranial Remolding principle is applied to
patients with positional plagiocephaly
and to post-operative patients. | SAME |
| Materials | Material for STARband Side
Opening design and STARband Bi-
Valve design Outer shell of 5/32" copolymer
plastic An inner liner of 1/2" Pelite
polyethylene foam or 1/2" Aliplast
foam Material for STARlight Side
Opening design and STARlight Bi-
Valve design 5/32" - 1/4" clear Surlyn or 1/8" -
7/32" Clear Co-Polyester plastic
shell Material for STARlight PRO design 1/4" – 3/8" clear Surlyn Closure for Bivalve design Sliding/Overlap closure system Chicago screw (or similar) for top
sliding mechanism 1" Velcro strap 1" chafe buckle Speedy rivets Closure for STARband Side Opening
design 1 ½" Velcro Strap 1 ½" chafe buckle A Gap Block made from ½" firm
Pelite polyethylene foam Large Flange, Blind Rivet Closure for STARlight Side Opening
design and the STARlight PRO
design: 1" Velcro Strap 1" chafe buckle Optional tamper resistant strap
(qty 2 for the STARlight PRO
design) | 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 Bubber Band | No risk for change.
Inner liner material
(contact with intact
skin): Similar
All 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 | Custom made Cranial Orthosis,
approximately 6 to 10oz in weight.
STARlight PRO weighs 12.5 to 18.5
OZ. | The Cranial Remolding Orthoses, Talee
and Talee PostOp, are made individually
as a patient-specific device.
The weight of a Talee orthosis varies
from approx. 155 to 250g (5 to 8 oz).
Talee PostOp orthosis weight varies
from approx. 215 to 370g (7 to 12 oz). | No risk for change.
Differences in
product design of a
Cranial Orthosis do
not affect intended
use, safety of
medical device or
effectiveness of
treatment.
Talee/Talee PostOp
orthoses are lighter
than reference
devices. |
| Production | • Form orthosis from a positive
mold of infant's head
• Positive mold is formed based
upon measurements of the infant's
head taken by an approved 3-
dimensional imaging device from
which a 3-dimensional image is
made or from a traditional plaster
cast
• The 3-dimensional image is used
to produce a positive mold using a
5-axis routing machine | • The orthosis is assembled from outer
shell and inner soft foam parts.
• The outer shell of the orthosis is
produced by 3D printing based on CAD
model.
• CAD model is based on modified
shape of infant's head.
• Modified shape of infant's head in
CAD software is created from the data
from 3D scanners (see the list of
approved scanners - Table 4). | No risk for change.
Differences in
production of
Cranial Orthosis do
not affect intended
use, safety of
medical device or
effectiveness of
treatment. |
| Approved 3-
Dimensional
Imaging
Devices | • 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) | SAME
We only use
scanners cleared by
predicate: K151979
or reference:
K111609 |
| Reporting
Software | Cranial Comparison Utility (CCU)
The CCU is a separate software
program designed to present
specific measurements derived
from a 3D digital model of the
patient's cranium. The CCU does
not affect the operation of the
STARscanner and is not used for
manufacturing of the STARband or
STARlight. | Cranial Comparison App (CCA)
The CCA is a separate 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. | SAME |
| Testing | CCU Accuracy and Capabilities
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
software | |
| | - 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 |
8
9
10
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): Similar | ||
| All 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 a
negative impression (cast) of the
infants head
• Scan of the infants head from a
Fastscan hands free class II laser
scanner
• Scan of the infants head using a
Fastscan handheld class I laser
scanner
• Scan of the infants head using the
Creaform class I laser scanner sold
as Ohio Willow Wood Omega /
handycam
• Foam model of the infants head
carved using an industry standard 5
axis scanner
The same CAD-CAM software, Rodin 4D, is used for 3D rectification. More
information in "Summary and Conclusion of Non-Clinical Performance Data"
(K111609). | • The Orthosis is assembled from outer
shell and inner soft foam parts.
• The outer shell of the Orthosis is
produced by 3D printing based on CAD
model.
• CAD model is based on modified
shape of infant's head.
• Modified shape of infant's head in
CAD software is created from the data
from 3D scanners (see the list of
approved scanners - Table 4). | No risk for change.
Differences in
production of
Cranial Orthosis do
not affect intended
use, safety of
medical device or
effectiveness of
treatment. | |
| Approved 3-
Dimensional
Imaging
Devices | 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 use
scanners cleared by
predicate: K151979
or reference:
K111609 | |
11
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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 Willow | |||||
| Wood | https://www.willowwoodco.com/ | Light | ||||
| scanner | up to 0.50 | 1.00 | K151979 | |||
| M4D | Rodin4D | http://rodin4d.com/ | Light | |||
| scanner | up to 0.50 | 1.00 | K151979 | |||
| BodyScan | Techmed3D | https://techmed3d.com | Light | |||
| scanner | up to 0.50 | 1.00 | K151979 | |||
| Spectra | VORUM | https://vorum.com/ | Light | |||
| scanner | 0.10 | N/A | K151979 | |||
| 3dMDhead | ||||||
| System | 3DMD | http://www.3dmd.com/ | Light | |||
| scanner | 0.20 | N/A | K151979 | |||
| 3dMDflex | ||||||
| System | 3DMD | http://www.3dmd.com/ | Light | |||
| scanner | 0.20-0.50 | N/A | K151979 |
13
Non-clinical performance Testing:
The following Non-clinical performance testing (Table 5) was conducted on Talee PostOp Cranial Orthoses.
| Tested Area | Performance Testing |
|---|---|
| Software | |
| Cranial Comparison App (CCA) | Accuracy and Capabilities Study |
| Product | |
| Talee/Talee PostOp | Impact strength mechanical test |
| Product | |
| Talee/Talee PostOp | Structural stiffness mechanical test |
| Method | |
| Manufacturing | Manufacturing Test – Dimensional Accuracy of Laser Plotter |
| Method | |
| Manufacturing | 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 Elution | |||
| ISO 10993-5 | Cell culture treated with test sample exhibited | ||
| no reactivity (Grade 0) | Non-cytotoxic | ||
| ISO Intracutaneous Irritation | |||
| ISO 10993-10 | Rabbits treated with test samples exhibited no | ||
| irritation (Scores 0) | Non-irritating | ||
| ISO Guinea Pig Maximization | |||
| Sensitization | |||
| ISO 10993-10 | Albino guinea pigs treated with test sample did | ||
| not 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 polyethylene | |||
| foam (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.
14
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.