← Product Code [MVA](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MVA) · K193383 # SnugKap (K193383) _Headstart, Ltd. · MVA · Jun 7, 2021 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MVA/K193383 ## Device Facts - **Applicant:** Headstart, Ltd. - **Product Code:** [MVA](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MVA.md) - **Decision Date:** Jun 7, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5970 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic, Pediatric ## 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 Story SnugKap is a custom-fitted cranial orthosis for infants; treats nonsynostotic positional plagiocephaly and post-surgical synostosis. Input: 3D scan file of patient's head. Process: scan file digitally modified by orthotist to address anatomical abnormalities; device additively manufactured (3D printed) based on case plan. Output: custom cranial orthosis. Used in clinical settings; operated by orthotists. Principle of operation: static equilibrium; applies mild pressure to prominent cranial regions to improve symmetry/shape. Worn 23 hours/day after 3-day ease-in period. Benefits: improves cranial symmetry and shape in infants. ## Clinical Evidence Bench testing only. Studies included worst-case determination, strength testing (band), durability (open-close test), pressure testing, biocompatibility (sensitization, cytotoxicity, irritation), software validation, and 3D printing validation. No clinical data presented. ## Technological Characteristics Cranial orthosis; additively manufactured (3D printed). Materials: polylactic acid copolymer, thermoplastic polyurethane, polypropylene, and Plastazote (closed-cell cross-linked polypropylene foam). Principle: static equilibrium/pressure application. Dimensions: patient-specific. Connectivity: none. Cleaning: daily with isopropyl alcohol. ## Regulatory 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. ## Special Controls *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)). In addition to the general controls of the act, the Dynamic Orthotic Cranioplasty - DOC™ Band is subject to the following special controls in order to provide reasonable assurance of the safety and effectiveness: (1) The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109. (2) The labeling must include (a) contraindications for the use of the device on infants with synostosis or with hydrocephalus; (b) warnings indicating the need: (i) to evaluate head circumference measurements and neurological status at intervals appropriate to the infant’s age and rate of head growth, and to describe steps that should be taken in order to reduce the potential for restriction of cranial growth and possible impairment of brain growth and development; (ii) to evaluate the skin at frequent intervals, e.g., every three to four hours, and to describe steps that should be taken if skin irritation or breakdown occurs; (c) precautions indicating the need: (i) to additionally treat torticollis, if the positional plagiocephaly is associated with torticollis; (ii) to evaluate device fit and to describe the steps that should be taken in order to reduce the potential for restriction of cranial growth, possible impairment of brain growth and development and skin irritation and/or breakdown; (iii) to evaluate the structural integrity of the device and to describe the steps that should be taken to reduce the potential for the device to slip out of place and cause asphyxiation or trauma to the eyes or skin; (d) adverse events, i.e., skin irritation and breakdown that have occurred with the use of this device; (e) clinician’s instructions for casting the infant, for fitting the device, and for care and use of the device; and (f) parents’ instructions for care and use of the device. (3) The materials must be assessed for biocompatibility with testing appropriate for long term direct skin contact. ## Predicate Devices - KidCap ([K180568](/device/K180568.md)) ## Reference Devices - P-POD ([K133397](/device/K133397.md)) - STARBand, STARlight, St. Louis Band ([K180109](/device/K180109.md)) - Molded Cranial Helmet ([K012920](/device/K012920.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary K193383 | Device Trade Name: | SnugKap | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | HeadStart, Ltd.
801 – 625 5th Ave
New Westminster, BC V3M 1X4,
Canada
Phone: 1 (844) 744 3237 | | Contact: | Mr. Jason Goodnough
Chief Executive Officer
HeadStart Medical, Ltd.
801 – 625 5th Ave
New Westminster, BC V3M 1X4,
Canada
Phone: 1 (844) 744 3237
james@headstartmedical.com | | Additional Contact: | Mr. Dave McGurl
Director, Regulatory Affairs
MCRA, LLC
1050 K Street NW, Suite 1000
Washington, DC 20001
(202) 552-5797
dmcgurl@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 following
primary 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 {4}------------------------------------------------ #### 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: {5}------------------------------------------------ | | Subject Device | Primary
Predicate | Reference Devices | | | Comparison | |-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | SnugKap | KidCap | P-POD | STARBand,
STARlight, St. Louis
Band | Molded Cranial Helmet | (Subject Device vs.
Predicate Devices) | | 510(k) Number | K193383 | K180568 | K133397 | K180109 | K012920 | N/A | | Company | HeadStart
Ltd. | Eastern Cranial
Affiliates, LLC | Lorica Scientific,
LLC | Orthomerica Products,
Inc. | Fairview Orthopedic
Laboratory | 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 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 | The KidCap is a
cranial orthosis
used to treat
abnormally shaped
craniums in infants
between the ages
of three (3) months
to eighteen (18)
months of age. It is
designed to address
abnormal cranial
configurations
classified as
nonsynostotic
positional
plagiocephaly and
post-operative
nonsynostotic
plagiocephaly. It
includes infants
with
plagiocephalic,
brachycephalic and
scaphocephalic
patterned head
shapes, and post-
operative
craniosynostosis | The P-POD
Helmet is a cranial
orthosis device
intended for
medical purposes
to apply static or
gentle pressure to
prominent regions
of an infant's
cranium to
improve cranial
symmetry or
shape. The device
is intended to treat
infants from four
to eighteen
months of age
with moderate to
severe non-
synostotic
positional
plagiocephaly,
including
plagiocephalic-,
brachycephalic-,
scaphocephalic-
shaped heads. | The STARband,
STARlight, and St.
Louis Band are intended
for medical purposes for
use on infants from 3 to
18 months of age, with
moderate-to-severe non-
synostotic 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.
These devices are 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 | The Molded Cranial
Helmet is used to treat
children 3-18 months of
age for moderate to severe
non-synostotic positional
plagiocephaly, including
infants with
plagiocephalic-.
brachycephalic- and
scaphocephalic-shaped
heads. The device 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.
The device is for use by or
on the order of a
physician. | Similar:
The subject device
and predicated
devices are cranial
orthoses that improve
symmetry and cranial
shape by using the
static equilibrium
principle by applying
pressure to prominent
regions. | | Attribute | Subject Device
SnugKap | Primary Predicate
KidCap | Reference Devices
P-POD | Reference Devices
STARBand, STARlight, St. Louis Band | Reference Devices
Molded 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. Louis
Band | Molded Cranial Helmet | | | Product Design | Cranial orthosis
made to
individual's
specifications | Bivalved 2-piece
polymer shell
with padded
interface | Cranial orthosis
made to
individual's
specifications | Cranial orthosis made to
individual's
specifications | Cranial orthosis made to
individual's specifications | Identical | | Patient Contact
Duration
(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 device
is meant to be worn
continuously for 23
hours per day after an
ease-in period of three
days that follows a
recommended
progressive use
schedule. The P-POD
and STARBand
equivalent devices,
are also meant to be
utilized for 23
continuous hours per
day. The
recommended ease-in
period will allow the
baby to familiarize
with the SnugKap and
increase comfort. | | Materials | • Polylactic acid
• Plastazote
(closed-cell
cross-linked
polypropylene
foam) white or
pink
• Thermoplastic
Polyurothane
• Polypropylene | • Durr Plex™
• Hypoallergenic
Suspension
Padding | • Polypropylene
(USP Class VI
certified)
• Polyurethane
foam | • Copolymer plastic
• Pelite polyethylene
foam
• Aliplast foam
• Clear surlyn
• Clear co-polyester
• Velcro strap
• Chafe buckle | • Plastazote (closed-cell
cross-linked
polypropylene foam)
• Polypropylene outer
shell | Similar
All devices'
shells/bands are
manufactured from
copolymers. All
devices' straps or
ancillary parts are
manufactured from a
variety of
polypropylene and | | Attribute | Subject Device | Primary
Predicate | Reference Devices | | | Comparison | | | SnugKap | KidCap | P-POD | STARBand,
STARlight, St. Louis
Band | Molded Cranial Helmet | (Subject Device vs.
Predicate Devices)… --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MVA/K193383](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/MVA/K193383) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com