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.

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.

AI/ML Overview

The Boston Band is a cranial orthosis used to treat abnormally shaped craniums in infants between three and eighteen months of age. The document outlines a 510(k) submission for the Boston Band, focusing on proposed changes and comparing it to predicate devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative thresholds for clinical performance metrics (e.g., specific percentages of cranial symmetry improvement). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and effectiveness with expanded indications and updated manufacturing processes.

However, based on the non-clinical performance data section, we can infer some criteria and how the device met them:

Acceptance Criterion (Inferred)	Reported Device Performance
Laser Scanner Safety (Class I)	The Fastscan hands-free class I laser scanner was found to be "inherently safe for use without eye protection under all normal operating conditions." This aligns with Class I laser safety standards.
Laser Scanner Effectiveness (Accuracy & Repeatability)	"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." (Specific metrics for accuracy and repeatability are not provided, but the statement indicates meeting pre-defined thresholds.)
CADCAM Software Effectiveness (Accuracy & Repeatability)	"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." (Specific metrics are not provided.)
Manufacturing Process Equivalence (Carver Machine)	The updated 5-axis carver machine maintains equivalence with the predicate device's manufacturing process, with the "only major change is the speed of carving." This implies that the output quality and structural integrity remain consistent.
Clinical Equivalence to Predicate Devices	The Boston Band is stated to be "essentially the same device as released by K072862." The comparisons tables (Tables 1, 3, 5) consistently show "Same" for contraindications, warnings, precautions, adverse effects, instructions for use, and expiration date, indicating no new safety or effectiveness concerns with the proposed changes or expanded indications.
Expanded Indications Safety and Effectiveness	The core mechanism of the device (passively holding prominent cranial regions) remains the same. The expanded indications to include surgically corrected synostosis cases are considered safe and effective due to the device's fundamental function and similarity to predicate devices already approved for similar uses.

2. Sample Size for Test Set and Data Provenance:

Laser Scanner Testing: "Positive foam models were scanned." The exact number of models is not specified, but the plural "models" indicates more than one.
CADCAM Software Testing: "Four models were selected."
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given the nature of a 510(k) summary, which focuses on device characteristics and substantial equivalence, detailed clinical study data with provenance is often found in separate full study reports, not necessarily in this summary document. The context suggests these were internal engineering validation tests rather than large-scale clinical trials.

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly mention experts establishing ground truth for the test set for the scanner or CADCAM software testing. The "ground truth" for these tests seems to be the original physical models (for scanner accuracy) and the hand-modified carved models (for CADCAM modification equivalence).
For the overall device, the "predetermined acceptance criteria" mentioned for the scanner testing would likely have been established by Boston Brace International's internal engineering and quality control personnel. The "treating practitioner" and "clinical practitioner" are mentioned in the device description for prescribing, monitoring, and fitting, implying their expertise in clinical application but not in establishing ground truth for these specific non-clinical validation tests.

4. Adjudication Method for the Test Set:

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the non-clinical tests mentioned. The comparison was likely direct measurement against a reference or between two methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) summary. This type of study is typically used for AI-powered diagnostic tools where human readers interpret medical images with and without AI assistance. The Boston Band is a physical cranial orthosis, not an imaging analysis tool. Therefore, a study of this nature would not be relevant.

6. Standalone Performance Study (Algorithm Only):

No, a standalone (algorithm only without human-in-the-loop) performance study was not conducted in the context of an AI algorithm. The "Fastscan hands-free class I laser scanner" and "Rodin4D CADCAM software" are components of the manufacturing process, not standalone AI algorithms intended for clinical interpretation. Their performance was evaluated through accuracy and repeatability of scanning and modification, respectively.

7. Type of Ground Truth Used:

For Laser Scanner Testing: The "original model" (presumably the physical foam model before scanning) served as the ground truth against which the carved models from scanned data were compared for accuracy.
For CADCAM Software Testing: The "hand modified" carved models served as the ground truth for comparison with the CAD-modified and subsequently carved electronic models.

8. Sample Size for the Training Set:

The document does not mention any "training set." This device does not appear to involve machine learning or AI models that require training data in the conventional sense. The "modification software" is described as 3D rectification software that records modifications, implying a rule-based or guided modification process rather than an adaptive learning algorithm.

9. How Ground Truth for Training Set Was Established:

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this submission.

Summary

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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

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FDA Establishment Registration Number: 3001967835

4) Device Description

5) Statement of Indications and Intended Use

Statement of Indications:

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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 DeviceK072862	The Boston Band
IntendedUse	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
ProductDesign	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 patternedhead shapes	Same and to include theadjunctive use for infants fromthree to eighteen months of agewhose synostosis has beensurgically corrected, but whostill have moderate to severecranial deformities includingplagiocephalic, brachycephalic,and scaphocephalic shapedheads.
Contraindications	Infants with Craniosynostosis or hydrocephalus	Same
Warnings	Evaluate head circumference measurementsand neurological status at intervals appropriateto the infant's age and rate of growth. Describeto caregiver steps that should be taken toreduce the potential restrictions of cranialgrowth and possible impairments to braingrowth and development. A clinician orcaregiver must evaluate the patient's skin atfrequent intervals.	Same
Precautions	If the positional plagiocephaly is associatedwith torticollis, the torticollis must also betreated. Evaluate the device's structuralintegrity and fit it according to fittinginstructions. Wear and care guide to bereviewed and provided to caregiver.(copyattached)	Same
Adverse Effects	This device may cause skin irritations orbreakdown	Same
Instructions forUse	Wear and care guide provided to caregiver	Same
Expiration date	When the infant outgrows the cranial helmet orthe orthosis is discontinued for any reason, thereferring physician is contacted. If anotherhelmet is requested by the family to try tofurther correction, refer back to their physicianfor reevaluation and a new prescription.	Same
Feature	Predicate Device(K082950)	The Boston Band
IntendedUse	The STARband is intended for medicalpurposes for use on infants from three toeighteen months of age, with moderate tosevere non-synostotic positionalplagiocephaly, including infants withplagiocephalic, brachycephalic, andscaphocephalic shaped heads by applyingmild pressure to prominent regions of theinfant's cranium in order to improvecranial symmetry and/or shape. Thedevice is also indicated for adjunctive usefor infants from three to eighteen monthsof age whose synostosis has beensurgically corrected but who still havemoderate to severe cranial deformitiesincluding plagiocephalic brachycephalicand scaphocphalic shaper heads	Intended for medical purposes to passivelyhold prominent cranial regions of aninfant's skull in order to improve cranialproportion and symmetry in infants fromthree to eighteen months of age, withnonsynostotic positional plagiocephaly,including infants with plagiocephic,brachycephalic and scaphocephalicpatterned head shapes. The device is alsoindicated for adjunctive use for infantsfrom three to eighteen months of agewhose synostosis has been surgicallycorrected, but who still have moderate tosevere cranial deformities includingplagiocephalic-, brachycephalic-, andscaphocephalic-shaped heads.
Materials	- outer shell of .156 copoly plsitc)- An inner liner of $½$ " pelitepolyethylene foam or $½$ Aliplast- Strap of 1 $½$ " Dacron- A 1 $½$ " chafe buckle- Large Flange, Blind Rivet- A Gap Block made from $½$ ' firmpelite polyethylene foam- A nylon washer	outer shell of thermoformable plastic (1/4 or3/16 copolymer plastic)- a single layer of $½$ inch or 5-6 layers of 1/8inch, or a combination of 1 - 2 $1/4$ inch layerswith 1/8 inch layers of pelite hypoallergenicpolyethylene foam or Aliplast- Velcro strap (pile) sticky back Velcro hook
ProductDesign	Cranial orthosis - made to individual'sspecifications - approx 6 oz in weight	Cranial orthosis -made to individual's specifications
Production	- Form orthosis from a positive moldof infant's head- Positive mold is formed based uponmeasurements of the infant's headtaken by the STARscanner theOWW Omega Scanner from whicha 3-dimensional image is made orfrom a traditional plaster case- The 3-ddimensional image is used toproduce a positive mold using 5-axisrouting machine	Model of the infants head from a negativeimpression (cast) of the infants head-Scan of the infants head from a Fastscan hands freeclass II laser scanner-Scan of the infants head using a Fastscan handheldclass I laser scanner- Scan of the infants head using the Creaform class 1laser scanner sold as Ohio Willow WoodOmega/handycam- Foam model of the infants head carved using anindustry standard 5 axis scanner
Labeling	Predicate Device (K082950)	The Boston Band
Indications	The STARband is intended for medical purposesfor use on infants from three to eighteen monthsof age, with moderate to severe non-synostoticpositional plagiocephaly, including infants withplagiocephalic, brachycephalic, andscaphocephalic shaped heads by applying mildpressure to prominent regions of the infant'scranium in order to improve cranial symmetryand/or shape. The device is also indicated foradjunctive use for infants from three to eighteenmonths of age whose synostosis has beensurgically corrected but who still have moderateto severe cranial deformities includingplagiocephalic brachycephalic and scaphocephalicshaper heads	Same and to include theadjunctive use for infants fromthree to eighteen months of agewhose synostosis has beensurgically corrected, but who stillhave moderate to severe cranialdeformities includingplagiocephalic, brachycephalic,and scaphocephalic shaped heads.
Contraindications	Infants with Craniosynostosis or hydrocephalus	Same
Warnings	Evaluate head circumference measurements andneurological status at intervals appropriate to theinfant's age and rate of growth. Describe tocaregiver steps that should be taken to reduce thepotential restrictions of cranial growth andpossible impairments to brain growth anddevelopment. A clinician or caregiver mustevaluate the patient's skin at frequent intervals.	Same
Precautions	If the positional plagiocephaly is associated withtorticollis, the torticollis must also be treated.Evaluate the device's structural integrity and fit itaccording to fitting instructions. Wear and careguide to be reviewed and provided tocaregiver.(copy attached)	Same
Adverse Effects	This device may cause skin irritations orbreakdown	Same
Instructions forUse	Wear and care guide provided to caregiver	Same
Expiration date	When the infant outgrows the cranial helmet orthe orthosis is discontinued for any reason, thereferring physician is contacted. If anotherhelmet is requested by the family to try to furthercorrection, refer back to their physician forreevaluation and a new prescription.	Same

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Table 2 Comparison of Boston Band Cranial Remolding Orthosis (K072862) to proposed device: The Boston Band

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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

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Table 4 Comparison of STARband Cranial Remolding Orthosis - K082950 to proposed device: The Boston Band

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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 DeviceK072566	The Boston Band
IntendedUse	Intended for medical purposes to passivelyhold prominent cranial regions of an infant'sskull in order to improve cranial proportionand symmetry in infants from three toeighteen months of age, with nonsynostoticpositional plagiocephaly, including infantswith plagiocephic, brachycephalic andscaphocephalic patterned head shapes.	Intended for medical purposes to passively holdprominent cranial regions of an infant's skull inorder to improve cranial proportion and symmetryin infants from three to eighteen months of age,with nonsynostotic positional plagiocephaly,including infants with plagiocephic,brachycephalic and scaphocephalic patterned headshapes. The device is also indicated for adjunctiveuse for infants from three to eighteen months ofage whose synostosis has been surgicallycorrected, but who still have moderate to severecranial deformities including plagiocephalic-,brachycephalic-, and scaphocephalic-shapedheads.
Materials	- outer shell of thermoformable plastic- hypoallergenic polyethylene foam- Velcro strap (pile) sticky back Velcrohook	- outer shell of thermoformable plastic (1/4 or3/16 copolymer plastic)- a single layer of ½ inch or 5-6 layers of 1/8inch, or a combination of 1 - 2 1/4 inchlayers with 1/8 inch layers ofhypoallergenic polyethylene foam- Velcro strap (pile) sticky back Velcro hook
ProductDesign	Cranial Orthosis -made to individual'sspecifications	Cranial Orthosis -made to individual'sspecifications
Production	- -Scan of the infants head from a Fastscanhands free class II laser scanner- Foam model of the infants head carvedusing an industry standard 5 axis scanner	- Model of the infants head from a negativeimpression (cast) of the infants head-Scan of the infants head from a Fastscan handsfree class II laser scanner-Scan of the infants head using a Fastscanhandheld class I laser scanner- Scan of the infants head using the Creaformclass I laser scanner sold as Ohio Willow WoodOmega/handycam- Foam model of the infants head carved using anindustry standard 5 axis scanner
Labeling	Predicate DeviceK072566	The Boston Band

Indications	Intended for medical purposes to applystatic or gentle pressure to prominentregions of an infant's cranium toimprove cranial symmetry or shape. Totreat infants from three to eighteenmonths of age with moderate to severenon-synostotic positional plagiocephaly,including plagiocephalic-,brachycephalic-, scaphocephalic-shapedheads.	Intended for medical purposes to passivelyhold prominent cranial regions of an infant'sskull in order to improve cranial proportionand symmetry in infants from three toeighteen months of age, with nonsynostoticpositional plagiocephaly, including infantswith plagiocephalic, brachycephalic andscaphocephalic patterned head shapes. Thedevice is also indicated for adjunctive usefor infants from three to eighteen months ofage whose synostosis has been surgicallycorrected, but who still have moderate tosevere cranial deformities includingplagiocephalic-, brachycephalic-, andscaphocephalic-shaped heads.
Contraindications	Infants with Craniosynostosis orhydrocephalus	Same
Warnings	Evaluate head circumferencemeasurements and neurological status atintervals appropriate to the infant's ageand rate of growth. Describe to caregiversteps that should be taken to reduce thepotential restrictions of cranial growthand possible impairments to braingrowth and development. A clinician orcaregiver must evaluate the patient'sskin at frequent intervals.	Same
Precautions	If the positional plagiocephaly isassociated with torticollis, the torticollismust also be treated. Evaluate thedevice's structural integrity and fit itaccording to fitting instructions. Wearand care guide to be reviewed andprovided to caregiver.(copy attached)	Same
Adverse Effects	This device may cause skin irritations orbreakdown	Same
Instructions forUse	Wear and care guide provided tocaregiver	Same
Expiration date	When the infant outgrows the cranialhelmet or the orthosis is discontinued forany reason, the referring physician iscontacted. If an other helmet is requestedby the family to try to further correction,refer back to their physician forreevaluation and a new prescription.	Same

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Table 6 Comparison of Hanger Cranial Band (K072566) to proposed device: The Boston Band

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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.

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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

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[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:

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

Regulation Number and Section

§ 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)).