(550 days)
The SnugKap is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional Plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 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 SnugKap devices are cranial orthoses intended to be utilized on infant patients that suffer from head shape abnormalities. The SnugKap devices are additively manufactured from a 3D scan file of the patient's head. The scan file is digitally modified to address the anatomical/shape abnormalities in the skull. The SnugKap is then 3D printed and fabricated according to the case plan approved by the orthotist. The SnugKap is manufactured from a copolymer made of polylactic acid; additional parts are made of a variety of materials including thermoplastic polyurothane, polypropylene, and Plastazote® (white or pink) polymer foam.
This FDA 510(k) summary for the SnugKap cranial orthosis does not contain specific acceptance criteria or a detailed study report with performance metrics in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance study with defined acceptance criteria and calculated performance.
However, based on the information provided under "Performance Testing Summary" and the "Substantial Equivalence Summary" table, we can infer the types of testing performed and the general intent, but not specific numerical acceptance criteria or quantitative performance results.
Here's an attempt to structure the answer based on the available information, noting where specific details are missing:
The provided FDA 510(k) summary for the SnugKap cranial orthosis primarily demonstrates substantial equivalence to predicate devices, rather than a standalone performance study with explicit acceptance criteria and quantitative performance results for clinical metrics. The performance testing described is focused on ensuring the device functions as intended and is safe.
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria and direct performance metrics (e.g., success rates for cranial symmetry improvement) are not reported in this 510(k) summary, the table below reflects what types of testing were performed and the implied "acceptance" as demonstrated by the conclusion of substantial equivalence.
| Acceptance Criteria Category (Inferred) | Specific Test Performed | Reported Device Performance (Inferred/Abstract) |
|---|---|---|
| Mechanical Performance | Strength Testing (Band) | Passed (Implicitly, as substantial equivalence was concluded) |
| Durability Testing (Open-Close Test) | Passed (Implicitly, as substantial equivalence was concluded) | |
| Pressure Testing | Passed (Implicitly, as substantial equivalence was concluded) | |
| Biocompatibility | Sensitization, Cytotoxicity, Irritation | Passed (Implicitly, as substantial equivalence was concluded and materials have prior medical use) |
| Manufacturing Process / Software | Software Validation | Validated (Implicitly, as substantial equivalence was concluded) |
| 3D Printing Validation | Validated (Implicitly, as substantial equivalence was concluded) | |
| Process Validation | Validated (Implicitly, as substantial equivalence was concluded) | |
| Indications for Use / Clinical Efficacy | (No specific clinical efficacy study with numerical targets presented in this summary) | Demonstrated "similar" and "equivalent" indications for use to predicate devices, implying similar intended clinical outcomes. |
Missing Information:
- Specific numerical acceptance criteria for strength, durability, and pressure tests (e.g., minimum force, number of cycles, pressure range).
- Quantitative results for any of the performance tests.
- Clinical efficacy outcomes (e.g., percentage of infants achieving a certain degree of cranial symmetry improvement).
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for test sets in the context of clinical efficacy, as it's not a clinical trial report. The performance tests mentioned (strength, durability, pressure, biocompatibility) would have involved samples of the device materials or finished products for engineering and lab testing. The sample size for these lab tests is not specified.
Data provenance (country of origin, retrospective/prospective) is not applicable or detailed for efficacy/test sets, as there is no human clinical data presented for this purpose in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as a test set requiring expert ground truth (e.g., for image interpretation or diagnosis) is not described in this 510(k) summary. The ground truth for biocompatibility and mechanical tests would be established by standardized testing protocols and analytical results.
4. Adjudication Method for the Test Set
Not applicable, as there is no expert-adjudicated test set described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. The device is a physical cranial orthosis, not an AI-assisted diagnostic tool typically assessed with MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable in the conventional sense of an AI algorithm. The device itself is the physical orthosis. While there is "Software Validation" and "3D Printing Validation" mentioned, these refer to the manufacturing process for creating the custom orthosis and not an independent, standalone diagnostic or assistive algorithm.
7. The Type of Ground Truth Used
For the engineering and biocompatibility tests:
- Mechanical Performance: Ground truth would be established by engineering specifications, material properties, and relevant industry standards.
- Biocompatibility: Ground truth would be established by recognized standards for biological evaluation of medical devices (e.g., ISO 10993 series) using established laboratory tests.
For overall effectiveness for the Indications for Use:
- The primary ground truth for demonstrating the device's acceptable performance is its substantial equivalence to legally marketed predicate devices that have established safety and effectiveness. The assumption is that if the new device is substantially equivalent in design, materials, and intended use, it will have similar effectiveness.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/machine learning device requiring a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
June 7, 2021
HeadStart, Ltd. % Dave McGurl Director, Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K193383
Trade/Device Name: SnugKap Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA Dated: May 7, 2021 Received: May 7, 2021
Dear Dave McGurl:
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
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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193383
Device Name SnugKap
Indications for Use (Describe)
The SnugKap is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional Plagiocephaly, infants with plagiocephalic-, brachycephalic-, and scaphocephalicshaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 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.
Type of Use (Select one or both, as applicable)
| Transportation Under CA STC 111.5(a) or Charter |
|---|
| On-Demand Service Under CA STC 111.5(b) |
|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 K193383
| Device Trade Name: | SnugKap |
|---|---|
| Manufacturer: | HeadStart, Ltd.801 – 625 5th AveNew Westminster, BC V3M 1X4,CanadaPhone: 1 (844) 744 3237 |
| Contact: | Mr. Jason GoodnoughChief Executive OfficerHeadStart Medical, Ltd.801 – 625 5th AveNew Westminster, BC V3M 1X4,CanadaPhone: 1 (844) 744 3237james@headstartmedical.com |
| Additional Contact: | Mr. Dave McGurlDirector, Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001(202) 552-5797dmcgurl@mcra.com |
| Date Prepared: | June 7, 2021 |
| Classifications: | 21 CFR 882.5970, Cranial Orthosis |
| Class: | II |
| Product Codes: | MVA |
| Primary Predicate: | The subject devices are substantially equivalent to the followingprimary predicate device and reference devices |
| Manufacturer | Device Name | K Number |
|---|---|---|
| Primary Predicate | ||
| Eastern Cranial Affiliates, LLC | KidCap | K180568 |
| Reference Devices | ||
| Lorica Scientific, LLC | P-POD | K133397 |
| Orthomerica Products, Inc. | STARBand, STARlight, St. Louis Band | K180109 |
| Fairview Orthopedic Laboratory | Molded Cranial Helmet | K012920 |
Table 1: Primary Predicate Device
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Indications for Use:
The SnugKap is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional Plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 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.
Device Description:
The SnugKap devices are cranial orthoses intended to be utilized on infant patients that suffer from head shape abnormalities. The SnugKap devices are additively manufactured from a 3D scan file of the patient's head. The scan file is digitally modified to address the anatomical/shape abnormalities in the skull. The SnugKap is then 3D printed and fabricated according to the case plan approved by the orthotist. The SnugKap is manufactured from a copolymer made of polylactic acid; additional parts are made of a variety of materials including thermoplastic polyurothane, polypropylene, and Plastazote® (white or pink) polymer foam.
Predicate Device:
The SnugKap is substantially equivalent to a previously cleared predicate devices and has the same indications for use and function; and similar design and materials. The primary predicate device is the KidCap (K180568). The reference devices are the P-POD. STARBand, and Molded Cranial Helmet (K133397, K180109, and K012920 respectively).
Performance Testing Summary:
Testing performed on the subject device includes worst case determination, strength testing (band), durability testing (open-close test), and pressure testing. Additional testing included biocompatibility, software validation and 3D printing validation testing. Each of these studies were designed to address risks and demonstrate substantially equivalent performance to predicate devices. Additional details on the testing is provided in the substantial equivalence table below.
Sterilization and Cleaning:
The SnugKap device is provided clean and non-sterile and is required to be cleaned prior to initial use and cleaned daily after each use. Shelf-life data is not needed to establish maintenance of device performance characteristics over the useful life period, because of the low likelihood of time-dependent material degradation.
Substantial Equivalence Summary:
Comparative information presented in the 510(k) supports the substantial equivalence of the SnugKap to the primary predicate devices. Comparisons were designed to show the indications, intended use, design, and performance are equivalent between the SnugKap and primary predicate devices. An evaluation table is provided below:
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| Subject Device | PrimaryPredicate | Reference Devices | Comparison | |||
|---|---|---|---|---|---|---|
| Attribute | SnugKap | KidCap | P-POD | STARBand,STARlight, St. LouisBand | Molded Cranial Helmet | (Subject Device vs.Predicate Devices) |
| 510(k) Number | K193383 | K180568 | K133397 | K180109 | K012920 | N/A |
| Company | HeadStartLtd. | Eastern CranialAffiliates, LLC | Lorica Scientific,LLC | Orthomerica Products,Inc. | Fairview OrthopedicLaboratory | N/A |
| Regulation | 21 CFR 882.5970 | 21 CFR 882.5970 | 21 CFR 882.5970 | 21 CFR 882.5970 | 21 CFR 882.5970 | Identical |
| Classification | II | II | II | II | II | Identical |
| Product Code | MVA | MVA | MVA | MVA, OAN | MVA | Identical |
| Indications forUse | The SnugKap isintended formedical purposesfor use on infantsfrom 3 to 18months of age,with moderate toseverenonsynostoticpositionalPlagiocephaly,including infantswithplagiocephalic-,brachycephalic-,andscaphocephalic-shaped heads byapplying mildpressure toprominent regionsof the infant'scranium in orderto improve cranialsymmetry and/orshape. The deviceis also indicatedfor adjunctive use | The KidCap is acranial orthosisused to treatabnormally shapedcraniums in infantsbetween the agesof three (3) monthsto eighteen (18)months of age. It isdesigned to addressabnormal cranialconfigurationsclassified asnonsynostoticpositionalplagiocephaly andpost-operativenonsynostoticplagiocephaly. Itincludes infantswithplagiocephalic,brachycephalic andscaphocephalicpatterned headshapes, and post-operativecraniosynostosis | The P-PODHelmet is a cranialorthosis deviceintended formedical purposesto apply static orgentle pressure toprominent regionsof an infant'scranium toimprove cranialsymmetry orshape. The deviceis intended to treatinfants from fourto eighteenmonths of agewith moderate tosevere non-synostoticpositionalplagiocephaly,includingplagiocephalic-,brachycephalic-,scaphocephalic-shaped heads. | The STARband,STARlight, and St.Louis Band are intendedfor medical purposes foruse on infants from 3 to18 months of age, withmoderate-to-severe non-synostotic positionalplagiocephaly,including infants withplagiocephalic-,brachycephalic- andscaphocephalic-shapedheads by applying mildpressure to prominentregions of the infant'scranium in order toimprove cranialsymmetry and/or shape.These devices are alsoindicated for adjunctiveuse for infants from 3to 18 months of agewhose synostosis hasbeen surgicallycorrected, but who stillhave moderate-to-severecranial deformities | The Molded CranialHelmet is used to treatchildren 3-18 months ofage for moderate to severenon-synostotic positionalplagiocephaly, includinginfants withplagiocephalic-.brachycephalic- andscaphocephalic-shapedheads. The device isintended for medicalpurposes to apply pressureto prominent regions of aninfant's cranium in orderto improve cranialsymmetry and/or shape.The device is for use by oron the order of aphysician. | Similar:The subject deviceand predicateddevices are cranialorthoses that improvesymmetry and cranialshape by using thestatic equilibriumprinciple by applyingpressure to prominentregions. |
| Attribute | Subject DeviceSnugKap | Primary PredicateKidCap | Reference DevicesP-POD | Reference DevicesSTARBand, STARlight, St. Louis Band | Reference DevicesMolded Cranial Helmet | Comparison(Subject Device vs. Predicate Devices) |
| for infants from 3 to 18 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. | management. The KidCap utilizes the principles of static equilibrium to influence the cranial plates while utilizing an anatomical kinetic chain to influence the bones comprising the orbits, cheek structure, and lower mandible. The orthosis is designed to intimately contact the prominences of the expanding cranium but will not initiate a force upon the cranium. | including plagiocephalic, brachycephalic- and scaphocephalic-shaped heads. | ||||
| Use | Prescription Use | Prescription Use | Prescription Use | Prescription Use | Prescription Use | Identical |
| Population | 3 to 18 months | 3 to 18 months | 4 to 18 months | 3 to 18 months | 3 to 18 months | Similar:The P-POD predicate device is limited to a lower age boundary of 4 months instead of 3 months. The rest of the predicate device share the exact same age range of infants. |
| Anatomical Site | Cranium | Cranium | Cranium | Cranium | Cranium | Identical |
| Subject Device | Reference Devices | Comparison(Subject Device vs.Predicate Devices) | ||||
| Attribute | SnugKap | KidCap | P-POD | STARBand,STARlight, St. LouisBand | Molded Cranial Helmet | |
| Product Design | Cranial orthosismade toindividual'sspecifications | Bivalved 2-piecepolymer shellwith paddedinterface | Cranial orthosismade toindividual'sspecifications | Cranial orthosis made toindividual'sspecifications | Cranial orthosis made toindividual's specifications | Identical |
| Patient ContactDuration(Wearing Time) | Day 1: 8 hrs./day(2x4 hrs.)Day 2: 8 hrs./day(1x8 hrs.)Day 3: 12 hrs./day(1x12 hrs.)Day 4: 16 hrs./day(1x16 hrs.)Subsequent days:23 hrs./day | N/A | 23 hours/day | 23 hours/day | N/A | Similar:The SnugKap deviceis meant to be worncontinuously for 23hours per day after anease-in period of threedays that follows arecommendedprogressive useschedule. The P-PODand STARBandequivalent devices,are also meant to beutilized for 23continuous hours perday. Therecommended ease-inperiod will allow thebaby to familiarizewith the SnugKap andincrease comfort. |
| Materials | • Polylactic acid• Plastazote(closed-cellcross-linkedpolypropylenefoam) white orpink• ThermoplasticPolyurothane• Polypropylene | • Durr Plex™• HypoallergenicSuspensionPadding | • Polypropylene(USP Class VIcertified)• Polyurethanefoam | • Copolymer plastic• Pelite polyethylenefoam• Aliplast foam• Clear surlyn• Clear co-polyester• Velcro strap• Chafe buckle | • Plastazote (closed-cellcross-linkedpolypropylene foam)• Polypropylene outershell | SimilarAll devices'shells/bands aremanufactured fromcopolymers. Alldevices' straps orancillary parts aremanufactured from avariety ofpolypropylene and |
| Attribute | Subject Device | PrimaryPredicate | Reference Devices | Comparison | ||
| SnugKap | KidCap | P-POD | STARBand,STARlight, St. LouisBand | Molded Cranial Helmet | (Subject Device vs.Predicate Devices) | |
| Biocompatibility | • Sensitization• Cytotoxicity• Irritation | • Materials are notreported tocause skinirritation or anytoxic harms | • MEM Elution• Guinea PigMaximization• IntracutaneousReactivity | • Cytotoxicity -AgarDiffusion• Closed PatchSensitization• Primary DermalIrritation | • BiocompatibilityAssessment | polyethylene foams.All materials havebeen previously usedfor medicalapplications and arenot expected to causeany adverse eventswhen in contact withskin and hair.Equivalent |
| Manufacturing | A 3D image isused to produce a3D printed band | A 3D image isused to produce apositive mold fromwhich the band ismanufactured | A cast is made bythe physician. Thecasting toolsinclude a hardshell with aninflatable bladderlining, modelingputty, and a pre-mixed solutionthat cures byexothermicfoaming process | A 3D image is used toproduce a positive moldfrom which the band ismanufactured withplaster or carved out ofa polyurethane foamblank | A plaster mold of theusers head is made by thephysician. Trimming andsizing are prepared by anorthotist and techniciansfrom the mold. | DifferentThe KidCap andSTARBand predicatedevices as well as thesubject device utilize3D images tomanufacture theorthosis in anindustrial manner.The predicate P-PODutilizes a manualprocess in which theorthosis can bemanufactured in thephysician's office.The manufacturingprocess of the orthosisis different betweenthe subject device and |
| Attribute | Subject Device | Reference Devices | Comparison(Subject Device vs.Predicate Devices) | |||
| SnugKap | KidCap | P-POD | STARBand,STARlight, St. LouisBand | Molded Cranial Helmet | ||
| predicate devices, inwhich the subjectdevice is additivelymanufactured insteadof | ||||||
| Performance | • SoftwareValidation,ProcessValidation• 3D PrintingValidation• DurabilityTesting | • SoftwareValidation,ProcessValidation• DimensionalEquivalencyComparison formold acquisitionmethod | • N/A | • Cranial ShapeCapture AccuracyStudy | • Literature articles forsafety and effectiveness | Similar:Performance testingensures that thesubject devicesperform as intended. |
| Cleaning | Daily withisopropyl alcohol | Daily withisopropyl alcohol | Daily withisopropyl alcohol | Daily with isopropylalcohol | Daily with isopropylalcohol | Identical |
| Discontinuationof Device Use | When infantoutgrows thecranial orthosis.Approximately12-18 weeks | N/A | When infantoutgrows thecranial orthosis | N/A | N/A | Similar:Even though labelingbetween devices hasdifferent wording, theestimated lifespan ofthe subject andequivalent devices iswhen the patientoutgrows the orthosiswhich has beenestimated to beapproximately 4months. |
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Conclusion:
The information and performance data demonstrate that the device is substantial equivalent and performs as well as the primary predicate device. The subject SnugKap is substantially equivate devices (K13397, K180568, K012920 and K180109), with respect to indications, design, materials, function, and performance.
§ 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)).