(86 days)
Not Found
No
The document describes a physical cranial orthosis and a laser scanning method for capturing head shape. There is no mention of AI or ML being used in the design, modification, or function of the device or the scanning process. The modifications described are physical adjustments to the orthosis based on the captured shape.
Yes
The device is intended for medical purposes, specifically to improve cranial symmetry and/or shape in infants with moderate-to-severe non-synostotic positional plagiocephaly, and as an adjunctive treatment after surgical correction of synostosis. This directly addresses and treats a medical condition.
No.
This device is a cranial orthosis intended to reshape the cranium of infants, not to diagnose a condition. The scanGogh-II is used to capture the shape of the head for the creation of the orthosis, not for diagnostic purposes.
No
The device description clearly details physical components made of plastic and foam, designed to apply pressure to the infant's head. While a scanner is used for shape capture, the core therapeutic device is a physical orthosis, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat moderate-to-severe non-synostotic positional plagiocephaly and cranial deformities after surgical correction of synostosis by applying pressure to the infant's cranium to improve symmetry and shape. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is a cranial orthosis (a helmet or band) that physically reshapes the infant's head. It uses a scan or mold of the head to create a custom device. This is a physical therapy/orthopedic device, not a diagnostic tool that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing information about a disease or condition based on such analysis. The device's function is entirely mechanical and external.
The device is a medical device, specifically a cranial orthosis, used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The STARlight is 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. 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-, brachycephalicand scaphocephalic-shaped heads.
Product codes (comma separated list FDA assigned to the subject device)
OAN, MVA
Device Description
The STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or a scan of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARlight provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
The STARlight product family as it was released in K090587 are essentially still the same devices. The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4'' to 3/8" clear Surlyn. The STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic and an inner liner of 1/2" pelite polyethylene foam. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.
The STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.
The proposed device modification is the addition of a new shape capture method. specifically the scanGogh-11" by Vorum Research, Inc. This scanner uses one laser, either Class 1 or Class 2 depending on the option, and one camera to capture shape data. The Class I laser option of the scanGogh-II is as safe as other scanner devices previously cleared for the STARlight and will not require any extra safety precautions. The Class 2 laser option is safe to use on infant patients when used in conjunction with eye protection. The Class I laser option of the scanGogh-II shall be the recommended option for scanning infants. If the Class 2 option of the scanGogh-II is used, the infant should wear eye protection as instructed in the proposed labeling.
There have been changes made to the STARlight Side Opening and the STARlight PRO. The modifications involve the changing of the closure straps for the STARlight Side Opening and the STARlight PRO. The closure strap is a chafe and loop system similar to those used in the Bi-Valve designs. The STARlight Side Opening and the STARlight PRO also have the option of having a tamper resistant Velcro strap for the closure system. These were minor and determined to not require a 510(k) submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranium / Head
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Repeatability and Reproducibility (R&R) Analysis: Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age. Compared proposed device (scanGogh-II) to cast and predicate device. Associated parameters includes A-P and M-L. Proposed device is substantially equivalent to predicate device.
Cranial Shape Capture Accuracy Study: Utilized a representative cranial shape that possesses a predefined shape with known dimensions. Compared proposed device (scanGogh-II) to cast and predicate device. Associated Coordinate Planes (A-P; M-L: P-D and various Radius Parameters; Squareness: Flatness). Proposed device is substantially equivalent to predicate device.
Eye Shield Fit Assessment: A specific eye shield would properly fit infants. Assess coverage, fit and effectiveness. Proposed eye shields pass the assessment and provide safe and effective protection.
Material Biocompatibility Testing: Cytotoxicity -Agar Diffusion, Closed Patch Sensitization, Primary Dermal Irritation were performed. The materials Surlyn, Copolymer with Pelite Foam, and Copolymer with Aliplast Foam showed no sensitization, negligible dermal response, and were non-cytotoxic.
The scanGogh-II accuracy performed superior to the Cast method for Proximal Radius, Proximal Anterior Radius, Anterior Radius, Anterior Posterior Length, M-L Width Anterior, M-L Width Posterior, Posterior Panel Flatness, Lateral Panel Flatness, L-P Panels Square, Medial Panels Flatness, and M-P Panels Squares.
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
:
JAN 16 2014 STARlight® Cranial Orthosis
.
:
510(k) Summary
I. Applicant Information
.
| Name: | Orthomerica Products, Inc. |
|---|---|
| Address: | 6333 North Orange Blossom Trail |
| Orlando, FL 32810 | |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
FDA Establishment Registration Number
1058152
Contact Information
| Contact Person: | David Hooper, Manufacturing Engineer |
|---|---|
| Address: | 6333 North Orange Blossom Trail |
| Orlando, FL 32810 | |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
| Email: | dhooper@orthomerica.com |
| Date Prepared: | October 16, 2013 |
II. Submission Information
| Type: | Traditional 510(k) Submission |
|---|---|
| Proprietary Name: | STARlight® |
| Common Name: | Cranial Orthosis |
| Classification: | Class II (special controls); OAN; MVA; 21 CFR 882.5970 |
| Classification Name: | Cranial Orthosis |
III. Manufacturer Site
.
| Name: | Orthomerica Products, Inc. |
|---|---|
| Address: | 6333 North Orange Blossom Trail |
| Orlando, FL 32810 | |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
| FDA Establishment Registration Number: | 1058152 |
1
IV. Description of Device/Modification
The STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or a scan of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARlight provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
The STARlight product family as it was released in K090587 are essentially still the same devices. The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4'' to 3/8" clear Surlyn. The STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic and an inner liner of 1/2" pelite polyethylene foam. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.
The STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.
The proposed device modification is the addition of a new shape capture method. specifically the scanGogh-11" by Vorum Research, Inc. This scanner uses one laser, either Class 1 or Class 2 depending on the option, and one camera to capture shape data. The Class I laser option of the scanGogh-II is as safe as other scanner devices previously cleared for the STARlight and will not require any extra safety precautions. The Class 2 laser option is safe to use on infant patients when used in conjunction with eye protection. The Class I laser option of the scanGogh-II shall be the recommended option for scanning infants. If the Class 2 option of the scanGogh-II is used, the infant should wear eye protection as instructed in the proposed labeling.
2
There have been changes made to the STARlight Side Opening and the STARlight PRO. The modifications involve the changing of the closure straps for the STARlight Side Opening and the STARlight PRO. The closure strap is a chafe and loop system similar to those used in the Bi-Valve designs. The STARlight Side Opening and the STARlight PRO also have the option of having a tamper resistant Velcro strap for the closure system. These were minor and determined to not require a 510(k) submission. Table 1 illustrates the minor differences between the cleared device (K090587) and the devices as it currently is marketed.
V. Statement of Indications and Intended Use
Statement of Indications:
The STARlight is 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. 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-, brachycephalicand scaphocephalic-shaped heads.
Intended Use:
The STARlight is designed to treat infants with abnormal head shapes from age 3 months to 18 months and is available by prescription only. Since growth is the driving factor in head shape correction, the infants wear the STARlight for approximately 23 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. The STARlight has also been cleared to treat unresolved head deformities in patients who have undergone surgery to correct craniosynostosis. The same principles of cranial remolding apply to positional deformities and post-operative patients.
VI. Predicate Devices
3
VI. Summary of Technological Characteristics
The modification proposed is the use of an additional tool which can be used to capture the infant's head shape; the technological characteristics and the underlying principles of operation of the STARlight Cranial Orthosis will remain exactly the same. The other modifications include the removal of the STARlight Cap, the addition of a chafe buckle and an optional tamper resistant strap for the STARlight Side Opening and STARlight PRO designs. This table illustrates that the device will in fact remain the same.
| Feature | From K090587 | Proposed Device |
|---|---|---|
| Intended Use | Maintains total contact over areas of bossing or protrusion and creates voids over areas of depression or flattening to redirect cranial growth toward greater symmetry. | Maintains total contact over areas of bossing or protrusion and creates voids over areas of depression or flattening to redirect cranial growth toward greater symmetry. |
| Materials | Material for STARlight Side Opening. | |
| STARlight Bi-Valve, STARlight Cap | ||
| 5/32" - 1/4" clear Surlyn or 1/8" – | ||
| 7/32" Clear Co-Polyester plastic shell | Material for STARlight Side Opening and | |
| STARlight Bi-Valve | ||
| 5/32" - 1/4" clear Surlyn or 1/8" – | ||
| 7/32" Clear Co-Polyester plastic shell | ||
| Material for STARlight PRO | ||
| 1/4" - 3/8" clear Surlyn | Material for STARlight PRO | |
| 1/4" - 3/8" clear Surlyn | ||
| Material for STARband Bivalve | ||
| Outer shell of 5/32" copolymer plastic | ||
| An inner liner of 1/2" pelite polyethylene foam | Material for STARband Bivalve | |
| Outer shell of 5/32" copolymer plastic | ||
| An inner liner of 1/2" pelite polyethylene foam | ||
| Closure for Bivalve design | ||
| Sliding/Overlap closure system | ||
| Chicago screw (or similar) for top sliding mechanism | ||
| 1" Velcro strap | ||
| 1" chafe buckle | ||
| Speedy rivets | Closure for Bivalve design | |
| Sliding/Overlap closure system | ||
| Chicago screw (or similar) for top sliding mechanism | ||
| 1" Velcro strap | ||
| 1" chafe buckle | ||
| Speedy rivets | ||
| Closure for STARlight Side Opening | ||
| design and the STARlight PRO design: | ||
| 1" Velcro Strap | ||
| (qty 2 for the STARlight PRO design) | Closure for STARlight Side Opening | |
| design and the STARlight PRO design: | ||
| 1" Velcro Strap | ||
| 1" chafe buckle | ||
| Optional tamper resistant strap | ||
| (qty 2 for the STARlight PRO design) | ||
| Product Design | Custom made cranial orthosis, | |
| approximately 7 to 10oz in weight. | ||
| STARlight PRO weighs 12.5 to 18.5 oz. | Custom made cranial orthosis, | |
| approximately 7 to 10oz in weight. | ||
| STARlight PRO weighs 12.5 to 18.5 oz. | ||
| Feature | From K090587 | Proposed Device |
| 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, or the OWW Omega Scanner from which a 3-dimensional image is made or from a traditional plaster cast
- The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine | - 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, or the scanGogh-II from which a 3-dimensional image is made or from a traditional plaster cast
- The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine |
| Testing | Repeatability and Reproducibility (R&R) Analysis - Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age
- Compared proposed device to cast and predicate device
- Associated parameters includes A-P and M-L
- Proposed device is substantially equivalent to predicate device
Material Biocompatibility Testing - Cytotoxicity -Agar Diffusion
- Closed Patch Sensitization
- Primary Dermal Irritation | Repeatability and Reproducibility (R&R) Analysis
- Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age
- Compared proposed device (scanGogh-II) to cast and predicate device
- Associated parameters includes A-P and M-L
- Proposed device is substantially equivalent to predicate device
Cranial Shape Capture Accuracy Study - Utilized a representative cranial shape that possesses a predefined shape with known dimensions
- Compared proposed device (scanGogh-II) to cast and predicate device
- Associated Coordinate Planes (A-P; M-L: P-D and various Radius Parameters; Squareness: Flatness)
- Proposed device is substantially equivalent to predicate device
Eye Shield Fit Assessment - A specific eye shield would properly fit infants
- Assess coverage, fit and effectiveness
- Proposed eye shields pass the assessment and provide safe and effective protection
Material Biocompatibility Testing - Cytotoxicity -Agar Diffusion
- Closed Patch Sensitization
- Primary Dermal Irritation |
Table 1 – Comparison of Predicate Device cleared in K090587 to the Proposed Device
4
and the state of the same of the same
5
The inclusion of the scanGogh-II is the focus of this submission and that change is indicated in Table 1 under the production section. Additional testing was performed on the scanGogh-II to ensure substantial equivalence, that change is indicated in Table 1 under the testing section. Table 2 shows the additional accuracy testing performed and the comparison results of the scanGogh-II. The term Pass within Table 2 indicates the scanGogh-11 accuracy performed superior to the Cast method.
| Proximal
Radius | Proximal
Anterior
Radius | Anterior
Radius | Anterior
Posterior
Length | M-L
Width
Anterior | M-L
Width
Posterior | Posterior
Panel
Flatness | Lateral
Panel
Flatness | L-P
Panels
Square | Medial
Panels
Flatness | M-P
Panels
Squares |
|--------------------------------------------------|--------------------------------|--------------------|---------------------------------|--------------------------|---------------------------|--------------------------------|------------------------------|-------------------------|------------------------------|--------------------------|
| scanGogh-II
vs. Cast
Cranial Head
Shape | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass |
| Table 2 - scanGogh-11 Accuracy Comparison Summary | |
|---|---|
| --------------------------------------------------- | -- |
The scanGogh-II has already received FDA clearance for the STARband Cranial Orthosis (K124023) which is also held by Orthomerica Products, Inc. The STARband and the STARlight are essentially the same device. They have the same indications for use and undergo the same manufacturing process. The main difference between the STARlight and the STARband are the materials used to produce them. The STARband and STARlight materials have been biocompatibility tested, and the results of the tests are listed below. Given that the technological characteristics of the STARband are the same as the proposed device, these devices are substantially equivalent.
| Material | Test | Results | Conclusion |
|---|---|---|---|
| Surlyn | Closed Patch | ||
| Sensitization | A score of 0.00/0.00 (Test/Control) was given for both Incidence and Severity in the 24 hour and 48 hour scoring interval. | Not a Sensitizer | |
| No Erythema or | |||
| Edema Formation | |||
| Surlyn | Primary Dermal | ||
| Irritation | Primary Irritation Index: 0.00 | Negligible Dermal | |
| Response | |||
| Surlyn | Cytotoxicity - | ||
| Agar Diffusion | Cell culture treated with test sample exhibited no reactivity (Grade 0). | Non-cytotoxic | |
| Copolymer with | |||
| Pelite Foam | Closed Patch | ||
| Sensitization | A score of 0.00/0.00 (Test/Control) was given for both Incidence and Severity in the 24 hour and 48 hour scoring interval. | Not a Sensitizer | |
| No Erythema or | |||
| Edema Formation | |||
| Copolymer with | |||
| Pelite Foam | Primary Dermal | ||
| Irritation | Primary Irritation Index: 0.06 | Negligible Dermal | |
| Response | |||
| Copolymer with | |||
| Pelite Foam | Cytotoxicity - | ||
| Agar Diffusion | Cell culture treated with test sample exhibited no reactivity (Grade 0). | Non-cytotoxic | |
| Copolymer with | |||
| Aliplast Foam | Closed Patch | ||
| Sensitization | A score of 0.00/0.00 (Test/Control) was given for both Incidence and Severity in the 24 hour and 48 hour scoring interval | Not a Sensitizer | |
| No Erythema or | |||
| Edema Formation |
Biocompatibility Test Results
6
STARlight® Cranial Orthosis
| Copolymer with Primary Dermal | Primary Irritation Index: 0.00 | Negligible Dermal | |
|---|---|---|---|
| Aliplast Foam | Irritation | Response | |
| Copolymer with Cytotoxicity - | Cell culture treated with test sample | Non-cvtotoxic | |
| Aliplast Foam | Agar Diffusion | exhibited slight reactivity (Grade 1) |
VII. Summary and Conclusions of Non-Clinical Performance Data
The scanGogh-II was evaluated for safety and efficacy. The primary safety concern is the laser. The scanner uses either a Class 1 Laser or a Class 2 Laser. The Class 1 Laser version of the scanGogh-II is safe to use on infants without any extra protection. The Class 2 Laser version is safe as long as the patient has proper eye protection. An Eye Shield Fit Assessment was performed. The Eye Shield Fit Assessment showed the eye shields were an acceptable fit for infants as they completely covered the eye. Therefore, eye shields provide safe and effective protection of the infant's eye during scanning. The shape capture repeatability and reproducibility was evaluated and determined to be acceptable. An additional, Cranial Shape Capture Accuracy Study was performed concluding that the scanGogh-II yields a safe and effective product that is substantially equivalent to the predicate device. With sufficient accuracy and proper laser safety procedures, the scanGogh-II was determined safe and effective for scanning infants for STARlight Cranial Orthosis.
7
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
January 16, 2014
Orthoamerica Products, Inc. c/o Mr. David Elooper Manufacturing Engineer 6333 North Orange Blossom Trail Orlando. FL 32810
Re: K133250
- Trade/Device Name: STARlight Cranial Orthosis Regulation Number: 21 CER 882.5970 · Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: OAN. MVA Dated: October 16, 2013 Received: October 22, 2013
Dear Mr. Hooper:
、
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 mav, 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 is 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
8
Page 2 - Mr. David Hooper
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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.
Joyce M. Whang -S
for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K133250
Device Name: STARlight Cranial Orthosis
Indications For Use:
The STARlight is 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. 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)