(121 days)
No
The description focuses on 3D scanning, CAD software for manual modification, and 3D printing. There is no mention of automated analysis, pattern recognition, or learning algorithms.
Yes
The device is described as a "Cranial Remolding Orthosis" intended for "medical purposes for infants" to treat "cranial deformities," indicating a direct therapeutic action on the patient's condition.
No
Explanation: The device, Talee and Talee PostOp, is a Cranial Remolding Orthosis. Its intended use is to correct cranial deformities, not to diagnose them. The 3D scan of the infant's head is used to design the orthosis, not to provide a diagnosis.
No
The device description explicitly states it is a physical Cranial Remolding Orthosis made from a 3D printed shell and foam layer, which are hardware components. While it uses software (CAD) in the design process, the final device is not software-only.
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 cranial remolding orthoses. These are external medical devices designed to physically reshape an infant's head.
- Mechanism of Action: The device works by applying gentle pressure to guide the growth of the infant's skull. It does not involve analyzing biological samples.
- Intended Use: The intended use is to treat cranial deformities, not to diagnose a condition through laboratory testing.
The device is a Class II medical device that is individually designed and manufactured based on a 3D scan of the infant's head. This aligns with the description of a physical orthotic device, not an in vitro diagnostic test.
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 (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical light 3D scanner
Anatomical Site
Cranial / head
Indicated Patient Age Range
3 to 18 months of age
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
The Cranial Remolding Orthosis is provided by a Certified Orthotist (CO) solely on the order (prescription) of a licensed physician.
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:
- Impact Strength mechanical test
- Structural Stiffness mechanical test
- Biocompatibility evaluation - Plastazote
- Accuracy Test - Manufacturing of Cranial Remolding Orthosis
- Manufacturing Test - Accuracy of Laser Plotter
Biocompatibility evaluation - PE foam (Plastazote) results:
- ISO Cytotoxicity MEM Elution: Cell culture treated with test sample exhibited no reactivity (Grade 0). Conclusion: Non-cytotoxic.
- ISO Intracutaneous Irritation: Rabbits treated with test samples exhibited no irritation (Scores 0). Conclusion: Non-irritating.
- ISO Guinea Pig Maximization Sensitization: Albino guinea pigs treated with test sample did not elicit a sensitization response (Grade 0). Conclusion: Non- sensitizer.
Key results: 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 comparable safety and comparable (or higher) structural strength than the predicate/reference 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. The Biocompatibility assessments included in the non-clinical performance testing of the materials in contact with intact skin revealed that these materials used are not expected to have adverse effects on the patients under the intended conditions of wear. All the results of this performance testing demonstrate identical conclusions as results of performance testing of cleared Predicate device Talee PostOp to the same tested reference device (STARband, STARlight PRO).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
June 22, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Invent Medical USA, LLC Jiri Rosicky 1800 Mearns Rd, Suite Y Warminster, Pennsylvania 18974
Re: K230444
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: May 22, 2023 Received: May 23, 2023
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 -S
Digitally signed by Adam D. Pierce -S Date: 2023.06.22 10:58:23 -04'00'
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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3
510(k) Summary
| Submitter: | Invent Medical USA, LLC |
|---|---|
| Address: | 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: | June 22, 2023 |
| 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: Talee, Talee PostOp (K220681) |
Reference device: MyCRO Band (K201426)
Description:
Product Summary
The Talee and the Talee PostOp are Cranial Remolding Orthoses which are individually designed and manufactured medical devices class II.
The Talee, Talee PostOp proposed device is identical to the existing predicate Talee, Talee PostOp cleared in K220681. There have been made the following modifications:
- New optional Firm pad manufactured from the same material as outer shell (PA11, PA12 or CB PA12) with Plastazote inner layer material as skin contacting material (cleared in K220681).
- Update in approved 3-dimensional imaging devices
Discussion of Design Changes and 3-dimensional imaging devices (Proposed device device K220681)
The design changes of Talee, Talee PostOp proposed device do not affect the intended use, the safety of the medical device or the effectiveness of treatment of the existing predicate Talee PostOp cleared in K220681.
- . The basic product design of the Talee, Talee PostOp proposed device is identical to the product design of the existing predicate Talee, Talee PostOp (K220681).
- Manufacturing process of the Talee, Talee PostOp proposed device is identical to the manufacturing process of the existing predicate Talee, Talee PostOp (K220681).
- . Skin contacting material of the Talee, Talee PostOp proposed device is identical to the material of the existing predicate Talee, Talee PostOp (K220681).
- The new optional Firm pad represents new choice to existing foam pads. The skin contacting material Plastazote of Firm pad is the same as skin contacting material of Foam pad used in predicate device.
4
- . The new approved 3D scanners work on identical principle to the previously approved devices. This update is a response to a wider device portfolio on the market.
Remolding principle
The Cranial Remolding Orthosis (Talee PostOp) has contact with the head in 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 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 3).
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.
Firm pad - Polyamide pad made by 3D printing (PA11, PA12 or CB PA12), thickness varies from 0.8mm (1/32") to 6mm (1/4"). 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").
5
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. Firm pad - Polyamide pad made by 3D printing (PA11, PA12 or CB PA12), thickness varies from 0.8mm (1/32") to 6mm (1/4"). 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 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-, brachycephalic-, and scaphocephalic-shaped heads.
Technological Characteristics:
The Cranial Remolding Orthoses Talee PostOp are substantially equivalent to the predicate/reference 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 identical - the treatment of head shape deformities at a crucial growing period of an infant's life. The remolding principle of the Cranial Orthosis is identical.
The tables below show the comparison between the Cranial Remolding Orthosis Talee PostOp and the predicate medical device features and approved 3D scanners (Table 2 below shows the comparison between the Cranial Remolding Orthosis Talee PostOp and the reference medical device, including another approved 3D scanners in previously cleared 3D printed cranial orthosis.
6
| Feature | Talee, Talee PostOp
Proposed Device | K220681
Talee, Talee PostOp
Predicate Device | Evaluation of
difference |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | | IDENTICAL |
| Materials | | | |
| 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. | 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. | IDENTICAL |
| Talee Inner
Material: | Polyethylene foam (Plastazote)
Polyethylene foam, thickness
varies from 3 mm (1/8") to 12 mm
(1/2") | Polyethylene foam (Plastazote)
Polyethylene foam, thickness
varies from 3 mm (1/8") to 12
mm (1/2") | IDENTICAL |
| 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. | 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. | IDENTICAL |
| Talee PostOp
Inner Material: | Polyethylene foam (Plastazote)
Polyethylene foam, thickness
varies from 3 mm (1/8") to 12 mm
(1/2") | Polyethylene foam (Plastazote)
Polyethylene foam, thickness
varies from 3 mm (1/8") to 12
mm (1/2") | IDENTICAL |
| Adjustment pad
material
(Talee, Talee
PostOp)
(optional): | Polyethylene foam (Plastazote) &
Polyurethan elastic foam/TPU/
PA11, PA12, CB PA12, thickness
varies from 0.8mm (1/32") to
19mm (3/4") | Polyethylene foam (Plastazote) &
Polyurethan elastic foam/TPU,
thickness varies from 3mm (1/8")
to 19mm (3/4") | Differences in
interlayer
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 |
| Closure Mechanism
(Talee, Talee
PostOp): | Self-locking clip mechanism on
left/right sides, 3D printed clip
combined with BOA lanyard or
Rubber Band | Self-locking clip mechanism on
left/right sides, 3D printed clip
combined with BOA lanyard or
Rubber Band | IDENTICAL |
| Product design | 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). | | IDENTICAL |
| Production | • 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 | | IDENTICAL |
| Approved 3-
Dimensional
Imaging Devices | • Omega Scanner
• 3dMDhead System
• 3dMDflex System
• M4DScan/BodyScan System
• Spectra 3D Scanner
• Creaform HCP
• Creaform Peel 1
• Creaform Peel 2 (=Peel 3D)
• Artec Eva
• Artec Eva Lite
• Einscan H | • Omega Scanner
• 3dMDhead System
• 3dMDflex System
• M4DScan/BodyScan System
• Spectra 3D Scanner | Scanners used with
proposed device
were either found
compatible with
predicate:
K220681
or reference:
K201426
and passed V&V
processes. |
| 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 | | |
Table 1 - Comparison of Predicate Device including Approved Scanners cleared in K220681 to Proposed Device
7
| Table 2 - Comparison of Reference Device including Approved scanners cleared in K201426 to Proposed | ||||||
|---|---|---|---|---|---|---|
| Device |
| Feature | Talee, Talee PostOp
Proposed Device | K201426
MyCRO Band
Reference Device | Evaluation of
difference | |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended Use | 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 | Redirects head growth by
maintaining contact over cranial
areas which protrude and by
creating voids over areas of
depression or flattening in order
to improve symmetry. | IDENTICAL | |
| | possibility for growth in that pre- | | | |
| Materials | defined space. | | | |
| Outer Shell: | Talee, Talee PostOp:
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. | The orthosis is made of
thermoplastic material Polyamide
PA12 with a soft, washable
padded lining on the interior. | Differences in outer
and inner layer
materials used for
Cranial Orthosis do
not affect intended
use, safety of
medical device or
effectiveness of
treatment. | |
| Inner Material: | Talee, Talee PostOp:
Polyethylene foam (Plastazote)
Polyethylene foam, thickness
varies from 3 mm (1/8") to 12 mm
(1/2") | | effectiveness of
treatment.
All materials have
been previously | |
| Adjustment pad
material: | Talee, Talee PostOp (optional):
Polyethylene foam (Plastazote) &
Polyurethan elastic foam/TPU/
PA11, PA12, CB PA12, thickness
varies from 0.8mm (1/32") to
19mm (3/4") | N/A | used for medical
applications and
are not expected to
cause any adverse
events when in
contact with skin or
hair. | |
| Closure
Mechanism: | Talee, Talee PostOp:
Self-locking clip mechanism on
left/right sides, 3D printed clip
combined with BOA lanyard or
Rubber Band | One sided 3D printed closure
mechanism combined with elastic
band | The mechanisms
are similar.
Closure mechanism
of proposed device
has been previously
approved in
predicate device
K220681. | |
| Product design | 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). | Polymer helmet with side opening
closure and padded lining
4 – 6.5 oz
Patient-matched sizing by
scanning an image of patient's
head shape | Differences in
product design of a
Cranial Orthosis do
not affect intended
use, safety of
medical device or
effectiveness of
treatment. | |
| Production | • 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. | Additively manufacture the
orthosis based upon
measurements of the infant's
head taken by a previously
cleared 3-dimensional imaging
device | IDENTICAL | |
| | • Modified shape of infant's
head in CAD software is
created from the data from 3D
scanners (see the list of
approved scanners – Table 3). | | | |
| Approved 3-
Dimensional
Imaging Devices | • Omega Scanner
• 3dMDhead System
• 3dMDflex System
• M4DScan/BodyScan System
• Spectra 3D Scanner
• Creaform HCP
• Creaform Peel 1
• Creaform Peel 2 (=Peel 3D)
• Artec Eva
• Artec Eva Lite
• Einscan H | • Creaform HCP
• Creaform Peel1
• Creaform Peel 3D
• Rodin4D M4D Scan
• TechMed3D BodyScan
• OMEGA Scanner 3D
• Artec Eva
• Artec Eva Lite | Scanners used with
proposed device
are either cleared
by predicate:
K220681
or reference:
K201426
and passed V&V
processes. | |
8
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Non-clinical performance Testing:
The following Non-clinical performance testing (Table 4) was conducted on Talee PostOp Proposed Device.
| Tested Area | Performance Testing |
|---|---|
| Product | Impact strength mechanical test |
| Talee/Talee PostOp | Structural stiffness mechanical test |
| Method | |
| Manufacturing | Accuracy Test – Manufacturing of Cranial Remolding Orthosis |
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Biocompatibility evaluation:
Non-clinical performance testing included biocompatibility evaluation of materials in contact with intact skin. The results of these tests are in Table 5.
| 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. |
| Table 5 - Materials in contact with intact skin | ||||||
|---|---|---|---|---|---|---|
| ------------------------------------------------- | -- | -- | -- | -- | -- | -- |
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.
Test summary and discussion:
The Talee, Talee PostOp Proposed Device is identical to the K220681 Talee, Talee PostOp Predicate Device.
The following non-clinical tests were conducted for Talee and Talee PostOp and are valid for both proposed and predicate devices. 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
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Discussion
Talee, Talee PostOp Proposed device is identical to the K220681 Talee, Talee PostOp Predicate device with updates described above.
Full validation and verification (V&V) testing is not necessary for the proposed design changes. New V&V was performed to evaluate the specific design changes to ensure the changes do not alter the safety and effectiveness of the device. All these updates have passed Invent Medical's V&V processes. Overview of the non-clinical performance tests completed for the updates is in table 4.
Above in the test summary you can find an overview of tests performed for K220681 Talee, Talee PostOp predicate device and valid for Talee, Talee PostOp proposed device.
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 comparable safety and comparable (or higher) structural strength than the predicate/reference 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.
The Biocompatibility assessments included in the non-clinical performance testing of the materials in contact with intact skin revealed that these materials used are not expected to have adverse effects on the patients under the intended conditions of wear.
Conclusions of non-clinical performance data
The non-clinical performance testing mentioned above demonstrates that the differences in production of Cranial Orthosis do not affect performance, safety, or effectiveness of Medical Device Talee PostOp in comparison to K220681 Talee, Talee PostOp predicate device.
We tested Talee, Talee PostOp proposed device compared to the same tested reference device (STARband, STARlight PRO) that we used for performance testing of K220681 Talee, Talee PostOp predicate device.
All the results of this performance testing demonstrate identical conclusions as results of performance testing of cleared Predicate device Talee PostOp to the same tested reference device (STARband, STARlight PRO).
Substantial equivalence, safety and effectiveness are supported by Non-clinical Performance Testing (Software, Product, Manufacturing method) of Talee PostOp to primary predicate device (K220681 Talee, Talee PostOp).
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.