(58 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 plagiocephalicand 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 PostOp) has contact with the head in the prominent regions, an 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 Remolding Orthosis is made individually as a patient-specific device according to the type of deformity and disposition of the patient. The adjustments are made to the device as needed to accommodate growth and/or optimize the function of the Cranial Orthosis.
The Cranial Remolding Orthosis is made by 3D printing from thermoplastic material with inner soft foam layer.
This document describes a 510(k) premarket notification for a medical device called "Talee, Talee PostOp," which are Cranial Remolding Orthoses. The submission seeks to demonstrate substantial equivalence to a previously cleared predicate device (K230444). The provided text focuses on the device's technological characteristics and non-clinical performance testing. It does not describe a study involving an AI algorithm and human readers, nor does it contain information about the performance of a device that uses AI. Therefore, I cannot extract information related to AI acceptance criteria, human reader improvement, or training/test set details for an AI model from this document.
The document primarily focuses on the physical characteristics and non-clinical testing of the cranial orthoses to demonstrate substantial equivalence to a predicate device.
However, I can provide a table of the acceptance criteria and the claimed performance based on the non-clinical tests mentioned, as well as general information about the study type.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Predetermined per document) | Reported Device Performance (Implied by "All testing passed acceptance criteria and demonstrated that the subject device is substantially equivalent") |
|---|---|---|
| Sensitization testing (ISO 10993-10:2010) | Met criteria of ISO 10993-10:2010 | Passed (Non-sensitizing) |
| Cytotoxicity testing (ISO 10993-5:2009) | Met criteria of ISO 10993-5:2009 | Passed (Non-cytotoxic) |
| Irritation testing (ISO 10993-10:2010) | Met criteria of ISO 10993-10:2010 | Passed (Non-irritant) |
| Accuracy and Capabilities Study | Predetermined acceptance criteria met | Passed (Device demonstrated accuracy and capabilities) |
| Impact strength mechanical test | Predetermined acceptance criteria met | Passed (Device exhibited sufficient impact strength) |
| Structural stiffness mechanical test | Predetermined acceptance criteria met | Passed (Device exhibited sufficient structural stiffness) |
| Manufacturing Test - Dimensional Accuracy of Laser Plotter | Predetermined acceptance criteria met | Passed (Laser plotter demonstrated required dimensional accuracy) |
| Accuracy Test - Manufacturing of Cranial Remolding Orthosis | Predetermined acceptance criteria met | Passed (Manufactured orthoses met accuracy specifications) |
| New material PA (polyamide) inhalation and dermal exposure (off-gassing and wipe tests) | Predetermined acceptance criteria met | Passed (New PA material met safety standards for inhalation and dermal exposure) |
| Biological evaluation of medical devices ISO 10993-1:2018-08 (Risk Management) | Met criteria of ISO 10993-1 | Passed (Biological risk managed effectively) |
| Biological evaluation of medical devices ISO 10993-17:2002-12-01 and 2023-09 (Leachable Limits) | Met criteria of ISO 10993-17 | Passed (Leachable substances were within allowable limits) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample size for any of the non-clinical tests. These tests typically involve a defined number of material samples or manufactured devices rather than a patient test set in the way an AI model would be evaluated.
- Data Provenance: Not applicable in the context of this device's non-clinical testing. The tests are general material and mechanical property tests conducted in a lab setting, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the provided document. The device is a physical cranial orthosis, not an AI diagnostic/prognostic device that requires expert-established ground truth from medical images or patient data. The "ground truth" for these tests relates to established material science and mechanical engineering standards (e.g., ISO standards for biocompatibility, material strength).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical studies or expert review processes for AI/diagnostic devices, not for non-clinical material and mechanical property testing.
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:
This information is not applicable. The device (cranial orthosis) is not an AI-assisted diagnostic tool that human readers would use.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. There is no AI algorithm discussed in the context of the device's performance that would require standalone testing. The document refers to "CAD software" used for design, but this is a design tool, not a medical AI algorithm subject to performance validation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests described is based on established scientific and engineering standards (e.g., ISO 10993 for biocompatibility, standard methods for mechanical testing). These standards define acceptable performance metrics.
8. The sample size for the training set:
This information is not applicable. The document does not describe an AI model that would require a training set. The device is a physical medical device.
9. How the ground truth for the training set was established:
This information is not applicable. As there is no AI training set, there is no ground truth establishment process for it.
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August 30, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Invent Medical USA, LLC Jiri Rosicky CEO 1800 Mearns Road, Suite Y Warminster, Pennsylvania 18974
Re: K241957
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: July 1, 2024 Received: July 3, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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her requirements, the Quality System (QS) regulation (21 CFR Part
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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: 2024.08.30 13:48:40 -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
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
Talee, Talee PostOp
Indications for Use (Describe)
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 plagiocephalicand scaphocephalic- shaped heads.
Type of Use (Select one or both, as applicable)
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: | 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: | August 30, 2024 |
| Submission Type: | Traditional 510(k) |
| 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 (K230444)
Reference device: Talee, Talee PostOp (K220681)
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 PostOp) has contact with the head in the prominent regions, an 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 Remolding Orthosis is made individually as a patient-specific device according to the type of deformity and disposition of the patient. The adjustments are made to the device as needed to accommodate growth and/or optimize the function of the Cranial Orthosis.
The Cranial Remolding Orthosis is made by 3D printing from thermoplastic material with inner soft foam layer.
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 scaphocephalicshaped 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.
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Technological Characteristics – Basis for Substantial Equivalence
The Cranial Remolding Orthoses Talee and Talee PostOp are substantially equivalent to the predical devices based on the technological characteristics including:
- Indication for use
- . Intended use
- Basic remolding principles
- Basic device design
The table below show the comparison between the Cranial Remolding Orthosis Talee PostOp and the predicate medical device features and approved 3D scanners (Table 1).
| Table 1 - Comparison of Predicate Device including Approved Scanners cleared in K230444 to Proposed | ||||||
|---|---|---|---|---|---|---|
| Device |
| Feature | Proposed Device | Predicate Device | Evaluation of difference |
|---|---|---|---|
| Trade NameCommon Name | Talee, Talee PostOpCranial Orthosis | Talee, Talee PostOpCranial Orthosis | IDENTICAL |
| Product Code | MVA, OAN | MVA, OAN | IDENTICAL |
| 510(k) | K241957 | K230444 | |
| Manufacturer | Invent Medical USA, LLC | Invent Medical USA, LLC | IDENTICAL |
| Intended Use | The Cranial Remolding Orthosis has contact with the head in prominentregions where there is contact pressure, while leaving precise, pre-defined internal spaces in areas where there is flattening. To improvecranial symmetry and/or physiological shape, the skull only has thepossibility for growth in that pre-defined space. | The Cranial Remolding Orthosis has contact with the head in prominentregions where there is contact pressure, while leaving precise, pre-defined internal spaces in areas where there is flattening. To improvecranial symmetry and/or physiological shape, the skull only has thepossibility for growth in that pre-defined space. | IDENTICAL |
| ContraindicationsTalee | Not for use on infants with craniosynostosis, hydrocephalus,microcephaly, younger than 3 months, Older than 18 months | Not for use on infants with craniosynostosis, hydrocephalus,microcephaly, younger than 3 months, Older than 18 months | IDENTICAL |
| Prescription | Prescription Use Only | Prescription Use Only | IDENTICAL |
| Sizes | The Cranial Remolding Orthosis has a patient-specific device size/shapebased on 3D scan of patient's head | The Cranial Remolding Orthosis has a patient-specific device size/shapebased on 3D scan of patient's head | IDENTICAL |
| Software Usedfor ShapeModification | The modified shape of the infant's symmetrical head shape is created inCAD software from the 3D scan to improve its symmetry and shape. CADmodel of the the Orthosis is used for manufacturing by 3D printing. | The modified shape of the infant's symmetrical head shape is created inCAD software from the 3D scan to improve its symmetry and shape. CADmodel of the the Orthosis is used for manufacturing by 3D printing. | IDENTICAL |
| Product Design | The Cranial Orthosis is assembledfrom two-part outer 3D printedshells and the inner soft foam layer.Inner soft foam layer is made frompolyethylene foam, which ensuressoft contact with the skin of thechild's head. On the left/right sideof the orthosis there is a fasteningmechanism, which is used for easydonning/doffing of the CranialOrthosis.A set of replaceable contoured shelllayers is added to outer shellstructure. | The Cranial Orthosis is assembledfrom two-part outer 3D printedshells and the inner soft foam layer.Inner soft foam layer is made frompolyethylene foam, which ensuressoft contact with the skin of thechild's head. On the left/right sideof the orthosis there is a fasteningmechanism, which is used for easydonning/doffing of the CranialOrthosis. | The designchanges of Talee,Talee PostOpproposed devicedo not affect theintended use, thesafety of themedical device orthe effectivenessof treatment ofthe predicateTalee, TaleePostOp cleared inK230444. |
| Product Weight | 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) | 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 |
| Material - InnerLayer | • Polyethylene foam | • Polyethylene foam | IDENTICAL |
| Material – 3DPrinted Parts | • Thermoplastic materials (thesame as in K230444)• New PA material | • Thermoplastic materials | No risk forchange.Differences in 3Dprinted partsmaterials do notaffect intendeduse, safety ofmedical device oreffectiveness oftreatment.Toxicological Riskand Assessmentwas performedwith new PAmaterial. |
| 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-DimensionalImaging 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• EinScan H2 | • 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 | No risk forchange.Scanner usedwith proposeddevice was foundcompatible withpredicate deviceK230444 |
| Testing | Non - clinical performance testing:• Impact Strength mechanical test• Structural Stiffness mechanical• Biocompatibility evaluation –Plastazote, new PA material• Accuracy Test – Manufacturing ofCranial Remolding Orthosis• Manufacturing Test – Accuracy ofLaser Plotter• Toxicological tests | Non - clinical performance testing:• Impact Strength mechanical test• Structural Stiffness mechanical• Biocompatibility evaluation –Plastazote• Accuracy Test – Manufacturing ofCranial Remolding Orthosis• Manufacturing Test – Accuracy ofLaser Plotter | No risk of changeIdenticalmethodology forperformancetesting showingsimilar results.New toxicologicaltest and riskassessment. |
| Biocompatibility | Biocompatibility Testing• Cytotoxicity• Sensitization• Irritation | Biocompatibility Testing• Cytotoxicity• Sensitization• Irritation | No risk of changeRisk assessmentof leachablesubstances |
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Test Summary
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
- New material PA (polyamide) inhalation and dermal exposure (off-gassing and wipe tests) -
- -Biological evaluation of medical devices ISO 10993-1: Fifth edition 2018-08 - Part 1: Evaluation and testing within a risk management process (Recognition Number: 2-258)
- -Biological evaluation of medical devices ISO 10993-17 First edition 2002-12-01 and ISO 10993-17 Second edition 2023-09 - Part 17: Establishment of allowable limits for leachable substances (Recognition Number: 2-237 and 2-303)
Conclusion
The Talee, Talee PostOp has identical indications for use as the predicate device in K230444. The fundamental technological characteristics of the Talee, Talee PostOp are the same as the previously cleared predicate device. All testing passed acceptance criteria and demonstrated that the subject device is substantially equivalent to the predicate device.
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)).