(550 days)
No
The description focuses on 3D scanning, digital modification, and 3D printing for custom orthoses, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment planning.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is intended for "medical purposes" to improve "cranial symmetry and/or shape" by "applying mild pressure to prominent regions of the infant's cranium," which describes a therapeutic action to correct a medical condition (positional Plagiocephaly and other cranial deformities).
No
The device description clearly states it is a "cranial orthosis" intended for "applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape," which is a treatment, not a diagnosis.
No
The device description explicitly states that the SnugKap is a physical cranial orthosis that is 3D printed and fabricated from various materials, indicating it is a hardware device, not software-only. While it uses a digital scan file and software for design modification, the final product is a physical object.
Based on the provided information, the SnugKap device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SnugKap's Function: The SnugKap is a cranial orthosis that is applied externally to the infant's head. It works by applying pressure to reshape the skull. It does not involve testing any biological samples.
- Intended Use: The intended use clearly states it's for treating cranial deformities by applying pressure, not for diagnostic testing.
- Device Description: The description details the physical construction and how it's manufactured based on a 3D scan, not how it analyzes biological samples.
Therefore, the SnugKap falls under the category of a therapeutic medical device, specifically a cranial orthosis, rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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.
Product codes
MVA
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D scan file
Anatomical Site
Cranium
Indicated Patient Age Range
3 to 18 months of age
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5970 Cranial orthosis.
(a)
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).
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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
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
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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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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
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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 | 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) |
| Biocompatibility | • Sensitization
• Cytotoxicity
• Irritation | • Materials are not
reported to
cause skin
irritation or any
toxic harms | • MEM Elution
• Guinea Pig
Maximization
• Intracutaneous
Reactivity | • Cytotoxicity -Agar
Diffusion
• Closed Patch
Sensitization
• Primary Dermal
Irritation | • Biocompatibility
Assessment | polyethylene foams.
All materials have
been previously used
for medical
applications and are
not expected to cause
any adverse events
when in contact with
skin and hair.
Equivalent |
| Manufacturing | A 3D image is
used to produce a
3D printed band | A 3D image is
used to produce a
positive mold from
which the band is
manufactured | A cast is made by
the physician. The
casting tools
include a hard
shell with an
inflatable bladder
lining, modeling
putty, and a pre-
mixed solution
that cures by
exothermic
foaming process | A 3D image is used to
produce a positive mold
from which the band is
manufactured with
plaster or carved out of
a polyurethane foam
blank | A plaster mold of the
users head is made by the
physician. Trimming and
sizing are prepared by an
orthotist and technicians
from the mold. | Different
The KidCap and
STARBand predicate
devices as well as the
subject device utilize
3D images to
manufacture the
orthosis in an
industrial manner.
The predicate P-POD
utilizes a manual
process in which the
orthosis can be
manufactured in the
physician's office.
The manufacturing
process of the orthosis
is different between
the subject device and |
| Attribute | Subject Device | | Reference Devices | | | Comparison
(Subject Device vs.
Predicate Devices) |
| | SnugKap | KidCap | P-POD | STARBand,
STARlight, St. Louis
Band | Molded Cranial Helmet | |
| | | | | | | predicate devices, in
which the subject
device is additively
manufactured instead
of |
| Performance | • Software
Validation,
Process
Validation
• 3D Printing
Validation
• Durability
Testing | • Software
Validation,
Process
Validation
• Dimensional
Equivalency
Comparison for
mold acquisition
method | • N/A | • Cranial Shape
Capture Accuracy
Study | • Literature articles for
safety and effectiveness | Similar:
Performance testing
ensures that the
subject devices
perform as intended. |
| Cleaning | Daily with
isopropyl alcohol | Daily with
isopropyl alcohol | Daily with
isopropyl alcohol | Daily with isopropyl
alcohol | Daily with isopropyl
alcohol | Identical |
| Discontinuation
of Device Use | When infant
outgrows the
cranial orthosis.
Approximately
12-18 weeks | N/A | When infant
outgrows the
cranial orthosis | N/A | N/A | Similar:
Even though labeling
between devices has
different wording, the
estimated lifespan of
the subject and
equivalent devices is
when the patient
outgrows the orthosis
which has been
estimated to be
approximately 4
months. |
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7
8
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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.