(74 days)
Not Found
No
The description focuses on traditional orthotic design and fabrication methods, including scanning, CAD modification (which is not inherently AI/ML), and physical fabrication. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for medical purposes to improve cranial proportion and symmetry and to treat abnormally shaped craniums in infants, which qualifies it as a therapeutic device.
No
The Boston Band is a cranial orthosis used to treat abnormally shaped craniums in infants, not to diagnose a condition. Its purpose is therapeutic (guiding growth), not diagnostic.
No
The device description explicitly states it is a "cranial orthosis" composed of physical materials like thermoformable plastic and polyethylene foam, and includes a strap. While it utilizes scanning and CAD modification software in its fabrication process, the final medical device is a physical object worn by the infant.
Based on the provided information, the Boston Band is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Boston Band is a physical orthosis applied externally to the infant's head. It does not analyze blood, tissue, or any other bodily fluid or substance.
- The intended use is to physically reshape the skull. The device's function is mechanical and structural, not diagnostic or analytical of biological samples.
- The device description focuses on materials and fabrication. The description details the components of the orthosis and how it is made, which is typical for a medical device but not an IVD.
- The performance studies evaluate the accuracy of scanning and modification techniques. These studies are relevant to the manufacturing and fitting of the orthosis, not to the performance of a diagnostic test.
The Boston Band is a medical device, specifically a cranial orthosis, used for treatment of cranial deformities.
N/A
Intended Use / Indications for Use
The Boston Band is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial proportion and symmetry in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes. The device is also indicated for adjunctive use for infants from three to eighteen 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 Boston Band is a cranial orthosis used to treat abnormally shaped craniums in infants three to eighteen months of age. This condition is clinically known as Positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened-areas of the skull into the created spaces to improve proportion and symmetry. The Boston Band is only available if prescribed by a physician. The device is also indicated for adjunctive use for infants from three to eighteen 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 Boston Band is essentially the same device as released by K072862. It is an orthosis designed for each patient from a cast or scan of the infant's head. The mold, either plaster from a cast, or foam, carved from the scan, is modified and prepared for fabrication according to the instructions provided by the treating practitioner using plaster/CAD modification techniques. Each orthosis is composed of an outer shell of thermoformable plastic, a single layer of ½ inch or 5-6 layers of 1/8 inch, or a combination of 1 - 2 1/4 inch layers with 1/8 inch layers of hypoallergenic polyethylene foam (Aliplast/Plastazote) and a strap for securing the orthosis. It has a top and side opening. Optimum fit and alignment is insured and monitored by the same clinical practitioner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fastscan hands free class II laser scanner, Fastscan hands free class I laser scanner, Creaform class I laser scanner sold as Ohio Willow Wood Omega/handycam.
Anatomical Site
Cranium / skull
Indicated Patient Age Range
three to eighteen 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The effectiveness of the scanning device (Fastscan hands free class I laser scanner) was evaluated through accuracy and repeatability testing. Positive foam models were scanned, then carved and measured to compare to the original model. Each device met the predetermined acceptance criteria and was found acceptable.
The effectiveness of the Rodin4D CADCAM software for 3D rectification was evaluated through accuracy and repeatability testing. A comparison was made between hand modified and Rodin4D modifications of the same models. Four models were selected. Hand modifications were done on carved models and CAD modifications were done on the electronic models. The electronic models were then carved. All models were then measured and compared. The results showed that both modification techniques produced an acceptable model for fabrication.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5970 Cranial orthosis.
(a)
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).
0
K11609
Section 5-1
Boston Brace AUG 2 2 2011
510(k) Summary
The following summary is provided in pursuant to Section 513 (I)(3)(A) of the Federal Food, Drug and Cosmetic Act.
1) Applicant Information
- Applicant's Name and Address: Boston Brace International, Inc., 20 Ledin Drive, Avon, MA 02322, Telephone: (508) 588 - 6060, Fax: (800) 634 - 5048
- FDA Establishment Registration Number: 3001967835 ●
- Contact: James H. Wynne, CPO, Vice President, Director of Education, ● Telephone: (508) 588 - 6060, x-244
- Submission Correspondent: Same as Contact ●
- . Summary Date - Oct 1, 2010
2) Submission Information
- . Type: Traditional 510(k) Submission
- Proprietary Name: The Boston Band .
- . Common Name: Cranial Orthosis
- Classification: Class II (Special Controls); OAN, CFR 882.5970 .
- . Classification Name: Cranial Orthosis
- Predicate Devices: STARband Cranial Remolding Orthosis K082950 . Boston Band Cranial Remolding Orthosis - K072862 Hanger Cranial Band - K072566
3) Manufacturing Site:
20 Ledin Drive, Avon, MA 02322, Telephone: (800) 262-2235, Facsimile: (800) 634-5048
1
FDA Establishment Registration Number: 3001967835
4) Device Description
The Boston Band is a cranial orthosis used to treat abnormally shaped craniums in infants three to eighteen months of age. This condition is clinically known as Positional or Deformational Plagiocephaly. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened-areas of the skull into the created spaces to improve proportion and symmetry. The Boston Band is only available if prescribed by a physician. The device is also indicated for adjunctive use for infants from three to eighteen 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 Boston Band is essentially the same device as released by K072862. It is an orthosis designed for each patient from a cast or scan of the infant's head. The mold, either plaster from a cast, or foam, carved from the scan, is modified and prepared for fabrication according to the instructions provided by the treating practitioner using plaster/CAD modification techniques. Each orthosis is composed of an outer shell of thermoformable plastic, a single layer of ½ inch or 5-6 layers of 1/8 inch, or a combination of 1 - 2 1/4 inch layers with 1/8 inch layers of hypoallergenic polyethylene foam (Aliplast/Plastazote) and a strap for securing the orthosis. It has a top and side opening. Optimum fit and alignment is insured and monitored by the same clinical practitioner.
5) Statement of Indications and Intended Use
Statement of Indications:
The Boston Band is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial proportion and symmetry in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes. The device is also indicated for adjunctive use for infants from three to eighteen 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.
2
Section 5- 3
Intended Use:
The Boston Band is design to treat infants with abnormally shape craniums from age three to eighteen months. It is available by prescription only. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. However, due to new surgical techniques for infants with craniosynostosis. post-surgical plagiocephaly, brachycephaly,and and scaphocephaly are a growing patient group.
6) Summary of Technological Characteristics
The proposed changes involve: A) expansion of the indications for use to include infants of the same age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads, B) how the infants head is captured (class of laser change), C) the method to modify the 3- dimensional (3D) mode (CAD vs. hand modification), D) the use of different thicknesses of the foam inner liner (both aliplast and plastazote) and E) the use of an updated carver machine that is an industry standard. There have been some minor changes to the original K072862 that were determined to not require a 510(k) submission. The overall design of the cranial orthosis will remain the same. The following table illustrates the minor differences between the cleared device (K072862) and the device as it is currently marketed.
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Table 1 Comparison of Boston Band Cranial Remolding Orthosis (K072862) to proposed device: The Boston Band
Note: No changes will be made to the current device as a result of the proposed indications and shape capture change in this submission
| Feature | Predicate Device
K072862 | The Boston Band |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial proportion and symmetry in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes. | Intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial proportion and symmetry in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes. The device is also indicated for adjunctive use for infants from three to eighteen 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. |
| Materials | - outer shell of thermoformable plastic (1/4 or 3/16 copolymer plastic) | - outer shell of thermoformable plastic (1/4 or 3/16 copolymer plastic) |
| | - 5-6 layers of 1/8 inch hypoallergenic polyethylene foam (Aliplast) | - a single layer of ½ inch or 5-6 layers of 1/8 inch, or a combination of 1 - 2 1/4 inch layers with 1/8 inch layers of pelite hypoallergenic polyethylene foam or Aliplast |
| | - Velcro strap (pile) sticky back Velcro hook | Velcro strap (pile) sticky back Velcro hook |
| Product
Design | Cranial Orthosis -made to individual's specifications | Cranial Orthosis - made to individual's specifications |
| Production | -Model of the infants head from a negative impression (cast) of the infants head
-Scan of the infants head from a Fastscan hands free class II laser scanner
- Scan of the infants head using the Orthomerica Starscaner class I laser scanner
- Foam model of the infants head carved using an industry standard 5 axis scanner | -Model of the infants head from a negative impression (cast) of the infants head
-Scan of the infants head from a Fastscan hands free class II laser scanner
-Scan of the infants head using a Fastscan handheld class I laser scanner - Scan of the infants head using the Creaform class I laser scanner sold as Ohio Willow Wood Omega/handycam
- Foam model of the infants head carved using an industry standard 5 axis scanner |
| Labeling | Predicate Device (K072862) | The Boston Band |
| Indications | Infants from three to eighteen months of age,
with nonsynostotic positional plagiocephaly,
including infants with plagiocephic,
brachycephalic and scaphocephalic patterned
head shapes | Same and to include the
adjunctive use for infants from
three to eighteen 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. |
| Contraindications | Infants with Craniosynostosis or hydrocephalus | Same |
| Warnings | Evaluate head circumference measurements
and neurological status at intervals appropriate
to the infant's age and rate of growth. Describe
to caregiver steps that should be taken to
reduce the potential restrictions of cranial
growth and possible impairments to brain
growth and development. A clinician or
caregiver must evaluate the patient's skin at
frequent intervals. | Same |
| Precautions | If the positional plagiocephaly is associated
with torticollis, the torticollis must also be
treated. Evaluate the device's structural
integrity and fit it according to fitting
instructions. Wear and care guide to be
reviewed and provided to caregiver.(copy
attached) | Same |
| Adverse Effects | This device may cause skin irritations or
breakdown | Same |
| Instructions for
Use | Wear and care guide provided to caregiver | Same |
| Expiration date | When the infant outgrows the cranial helmet or
the orthosis is discontinued for any reason, the
referring physician is contacted. If another
helmet is requested by the family to try to
further correction, refer back to their physician
for reevaluation and a new prescription. | Same |
| Feature | Predicate Device
(K082950) | The Boston Band |
| Intended
Use | The STARband is intended for medical
purposes for use on infants from three to
eighteen 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. The
device is also indicated for adjunctive use
for infants from three to eighteen months
of age whose synostosis has been
surgically corrected but who still have
moderate to severe cranial deformities
including plagiocephalic brachycephalic
and scaphocphalic shaper heads | Intended for medical purposes to passively
hold prominent cranial regions of an
infant's skull in order to improve cranial
proportion and symmetry in infants from
three to eighteen months of age, with
nonsynostotic positional plagiocephaly,
including infants with plagiocephic,
brachycephalic and scaphocephalic
patterned head shapes. The device is also
indicated for adjunctive use for infants
from three to eighteen 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. |
| Materials | - outer shell of .156 copoly plsitc) - An inner liner of $½$ " pelite
polyethylene foam or $½$ Aliplast - Strap of 1 $½$ " Dacron
- A 1 $½$ " chafe buckle
- Large Flange, Blind Rivet
- A Gap Block made from $½$ ' firm
pelite polyethylene foam - A nylon washer | outer shell of thermoformable plastic (1/4 or
3/16 copolymer plastic) - a single layer of $½$ inch or 5-6 layers of 1/8
inch, or a combination of 1 - 2 $1/4$ inch layers
with 1/8 inch layers of pelite hypoallergenic
polyethylene foam or Aliplast - Velcro strap (pile) sticky back Velcro hook |
| Product
Design | Cranial orthosis - made to individual's
specifications - approx 6 oz in weight | Cranial orthosis -made to individual's specifications |
| Production | - Form orthosis from a positive mold
of infant's head - Positive mold is formed based upon
measurements of the infant's head
taken by the STARscanner the
OWW Omega Scanner from which
a 3-dimensional image is made or
from a traditional plaster case - The 3-ddimensional image is used to
produce a positive mold using 5-axis
routing machine | Model of the infants head from a negative
impression (cast) of the infants head
-Scan of the infants head from a Fastscan hands free
class II laser scanner
-Scan of the infants head using a Fastscan handheld
class I laser scanner - Scan of the infants head using the Creaform class 1
laser scanner sold as Ohio Willow Wood
Omega/handycam - Foam model of the infants head carved using an
industry standard 5 axis scanner |
| Labeling | Predicate Device (K082950) | The Boston Band |
| Indications | The STARband is intended for medical purposes
for use on infants from three to eighteen 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. The device is also indicated for
adjunctive use for infants from three to eighteen
months of age whose synostosis has been
surgically corrected but who still have moderate
to severe cranial deformities including
plagiocephalic brachycephalic and scaphocephalic
shaper heads | Same and to include the
adjunctive use for infants from
three to eighteen 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. |
| Contraindications | Infants with Craniosynostosis or hydrocephalus | Same |
| Warnings | Evaluate head circumference measurements and
neurological status at intervals appropriate to the
infant's age and rate of growth. Describe to
caregiver steps that should be taken to reduce the
potential restrictions of cranial growth and
possible impairments to brain growth and
development. A clinician or caregiver must
evaluate the patient's skin at frequent intervals. | Same |
| Precautions | If the positional plagiocephaly is associated with
torticollis, the torticollis must also be treated.
Evaluate the device's structural integrity and fit it
according to fitting instructions. Wear and care
guide to be reviewed and provided to
caregiver.(copy attached) | Same |
| Adverse Effects | This device may cause skin irritations or
breakdown | Same |
| Instructions for
Use | Wear and care guide provided to caregiver | Same |
| Expiration date | When the infant outgrows the cranial helmet or
the orthosis is discontinued for any reason, the
referring physician is contacted. If another
helmet is requested by the family to try to further
correction, refer back to their physician for
reevaluation and a new prescription. | Same |
4
Table 2 Comparison of Boston Band Cranial Remolding Orthosis (K072862) to proposed device: The Boston Band
5
Table 3 Comparison of STARband Cranial Remolding Orthosis - K082950 to proposed device: The Boston Band
Note: No changes will be made to the current device as a result of the proposed indications and shape capture change in this submission
6
Table 4 Comparison of STARband Cranial Remolding Orthosis - K082950 to proposed device: The Boston Band
7
Table 5 Comparison of Hanger Cranial Band (K072566) to proposed device: The Boston Band
| Note: No changes will be made to the current device as a result of the proposed |
|---|
| indications and shape capture change in this submission |
| Feature | Predicate Device
K072566 | The Boston Band |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Intended for medical purposes to passively
hold prominent cranial regions of an infant's
skull in order to improve cranial proportion
and symmetry in infants from three to
eighteen months of age, with nonsynostotic
positional plagiocephaly, including infants
with plagiocephic, brachycephalic and
scaphocephalic patterned head shapes. | Intended for medical purposes to passively hold
prominent cranial regions of an infant's skull in
order to improve cranial proportion and symmetry
in infants from three to eighteen months of age,
with nonsynostotic positional plagiocephaly,
including infants with plagiocephic,
brachycephalic and scaphocephalic patterned head
shapes. The device is also indicated for adjunctive
use for infants from three to eighteen 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. |
| Materials | - outer shell of thermoformable plastic
- hypoallergenic polyethylene foam
- Velcro strap (pile) sticky back Velcro
hook | - outer shell of thermoformable plastic (1/4 or
3/16 copolymer plastic) - a single layer of ½ inch or 5-6 layers of 1/8
inch, or a combination of 1 - 2 1/4 inch
layers with 1/8 inch layers of
hypoallergenic polyethylene foam - Velcro strap (pile) sticky back Velcro hook |
| Product
Design | Cranial Orthosis -made to individual's
specifications | Cranial Orthosis -made to individual's
specifications |
| Production | - -Scan of the infants head from a Fastscan
hands free class II laser scanner - Foam model of the infants head carved
using an industry standard 5 axis scanner | - Model of the infants head from a negative
impression (cast) of the infants head
-Scan of the infants head from a Fastscan hands
free class II laser scanner
-Scan of the infants head using a Fastscan
handheld class I laser scanner - Scan of the infants head using the Creaform
class I laser scanner sold as Ohio Willow Wood
Omega/handycam - Foam model of the infants head carved using an
industry standard 5 axis scanner |
| Labeling | Predicate Device
K072566 | The Boston Band |
| | | |
| Indications | Intended for medical purposes to apply
static or gentle pressure to prominent
regions of an infant's cranium to
improve cranial symmetry or shape. To
treat infants from three to eighteen
months of age with moderate to severe
non-synostotic positional plagiocephaly,
including plagiocephalic-,
brachycephalic-, scaphocephalic-shaped
heads. | Intended for medical purposes to passively
hold prominent cranial regions of an infant's
skull in order to improve cranial proportion
and symmetry in infants from three to
eighteen months of age, with nonsynostotic
positional plagiocephaly, including infants
with plagiocephalic, brachycephalic and
scaphocephalic patterned head shapes. The
device is also indicated for adjunctive use
for infants from three to eighteen 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. |
| Contraindications | Infants with Craniosynostosis or
hydrocephalus | Same |
| Warnings | Evaluate head circumference
measurements and neurological status at
intervals appropriate to the infant's age
and rate of growth. Describe to caregiver
steps that should be taken to reduce the
potential restrictions of cranial growth
and possible impairments to brain
growth and development. A clinician or
caregiver must evaluate the patient's
skin at frequent intervals. | Same |
| Precautions | If the positional plagiocephaly is
associated with torticollis, the torticollis
must also be treated. Evaluate the
device's structural integrity and fit it
according to fitting instructions. Wear
and care guide to be reviewed and
provided to caregiver.(copy attached) | Same |
| Adverse Effects | This device may cause skin irritations or
breakdown | Same |
| Instructions for
Use | Wear and care guide provided to
caregiver | Same |
| Expiration date | When the infant outgrows the cranial
helmet or the orthosis is discontinued for
any reason, the referring physician is
contacted. If an other helmet is requested
by the family to try to further correction,
refer back to their physician for
reevaluation and a new prescription. | Same |
8
Table 6 Comparison of Hanger Cranial Band (K072566) to proposed device: The Boston Band
9
7) Summary and Conclusions of Non-Clinical Performance Data
The Boston Band Cranial Remolding Orthosis has been marketed in the US since its original clearance in 2007. Since that time advances have been made in surgical techniques to treat craniosynostosis, scanning technologies, computer aided design (CAD) software, and multi-axis carves.
The Fastscan hands free class II laser scanner was cleared in K072862. Fastscan now offers hands free class I laser scanner. With the laser scanners the safety issue is the class of laser. Like the predicate device (K082950), this class I laser is inherently safe for use without eye protection under all normal operating conditions. The effectiveness of this scanning device was evaluated through accuracy and repeatability testing. Positive foam models were scanned using the Fastscan hands free class I laser scanner. The scanned models were then carved and measured to compare to the original model. Each device met the predetermined acceptance criteria and was found acceptable.
Rodin4D CADCAM software ( http://www.rodin4d.com/en) is a 3D rectification software for manufacturing orthopedic devices. Currently carved positive models are modified by hand according to the needs of the patient. The software has now developed to where these modifications can be done in CAD. The original scanned model is saved and each step of modification is recorded in the software. The modifications are still to the needs of the patient and follow the same steps as if done by hand. The difference is that each step is now saved in the software. The effectiveness of this modification software was evaluated through accuracy and repeatability testing. A comparison was made between hand modified and Rodin4D modifications of the same models. Four models were selected. Hand modifications were done on carved models and CAD modifications were done on the electronic models. The electronic models were then carved. All models where then measured and compared. The results showed that both modification techniques produced an acceptable model for fabrication. Practitioners having CAD software will have the ability to modify the model electronically according to the needs of the patient.
Since the time of the predicated device approval (K072862) the 3-axis carver has been upgraded to remain current with carving machinery. The only major change is the speed of carving.
10
Image /page/10/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Boston Brace International, Inc. c/o James H. Wynne Vice President. Direction of Education 20 Ledin Drive Avon, MA 02322
Re: K111609
AUG 2 2 2011
Trade/Device Name: Boston Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial orthosis Regulatory Class: Class II Product Code: MV A Dated: May 24, 2011 Received: June 9, 2011
Dear Mr. Wynne:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements; including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
11
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Alexander
for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
12
[Type text]
Boston Brace
20 Ledin Drive
Avon, MA 02322
T: 800 262.2235
T: 508.588.6060
F: 800.634 5048
F: 508.587.8119
www.bostonbrace.com
Indications for Use Statement
510(k) Number (if known):
KIII 609
Device Name: Boston Band
Indications for Use:
The Boston Band is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial proportion and symmetry in infants from three to eighteen months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephic, brachycephalic and scaphocephalic patterned head shapes. The device is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, and scaphocephalic-shaped heads.
AND/OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
KIII 609 510(k) Number