The St. Louis Band 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. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

Device Description

The St. Louis Band redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3dimensional image 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 St. Louis Band provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, 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 St. Louis Band directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The St. Louis Band (formally known as the O&P Bivalve Molding Helmet) was released in K063395. The St. Louis Band is a Bi-Valve design made with an outer shell of 1/4" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/4" Aliplast foam (closed cell polyethylene). The Bi-Valve design consists of two plastic shells that overlap and are held together with rivet fasteners. The St. Louis Band utilizes a Velcro® strap with chafe and loop for a secure fit.

The proposed device modifications include:

(1) A clarification to the indications for use for the St. Louis Band. This change would have the device 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.

(2) The addition of two new 3-dimensional shape capture methods, specifically, the STARscanner™ Data Acquisition System and the SmartSocTM System. The STARscanner is a stationary system that uses Class I Lasers and cameras to record surface data for shape capture. The SmartSoc System is a hand held system that uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade digital camera with it's a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source. Both of these shape capture systems are cleared with the STARband predicate device (K151979).

AI/ML Overview

The provided text describes the acceptance criteria and study proving the device meets them for the Orthomerica Products, Inc. "St. Louis Band" cranial orthosis (K161138), primarily focusing on the addition of new 3D shape capture methods (STARscanner and SmartSoc System) rather than the orthosis itself.

Here's an analysis of the requested information, based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Reported Device Performance
Repeatability and Reproducibility (R&R) Analysis	The shape capture devices (STARscanner and SmartSoc System) passed the acceptance criteria. The relevancy of the tests determined substantial equivalence of the proposed shape capture devices to the casting process.
Cranial Shape Capture Accuracy Study	The shape capture devices (STARscanner and SmartSoc System) passed the acceptance criteria for all parameters (A-P, M-L, P-D, various radius parameters, squareness, and flatness). The relevancy of the test determined substantial equivalence of the proposed shape capture device to the casting process.
Material Biocompatibility Testing (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, concluding "Not a Sensitizer" and "No Erythema or Edema Formation." Primary Dermal Irritation: Primary Irritation Index: 0.00, concluding "Negligible Dermal Response." Cytotoxicity – Agar Diffusion: Cell culture treated with test sample exhibited slight reactivity (Grade 1), concluding "Non-cytotoxic."

Study Details for Shape Capture Devices

This document primarily focuses on the validation of the new 3D shape capture methods (STARscanner and SmartSoc System) for manufacturing the St. Louis Band, not clinical efficacy of the band itself with these new methods.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- 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." The specific number of shapes or scans is not provided.
- Cranial Shape Capture Accuracy Study: "Utilized a representative cranial shape that possesses a predefined shape with known dimensions." The specific number of shapes or scans is not provided.
- Data Provenance: Not specified, but given the manufacturing context, it's likely internal testing by the manufacturer. It is not specified if it was retrospective or prospective, but the nature of the tests suggests bespoke testing/data collection.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- For both R&R and Accuracy studies, the ground truth was established by "uniform shapes with known dimensions" and a "representative cranial shape that possesses a predefined shape with known dimensions." This implies engineered or measured physical models, not human expert assessment of clinical cases. Therefore, no clinical experts were used for ground truth for these specific tests on the shape capture devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as the ground truth was based on physical models with known dimensions. There was no clinical adjudication process described for these engineering validation tests.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC or comparative effectiveness study involving human readers or AI assistance in a clinical diagnostic context was described. The testing focused on the accuracy and precision of the shape capture devices for manufacturing, comparing them to a traditional casting method.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The "standalone" performance here refers to the device's ability to accurately capture shape data compared to a physical reference ("casting process" or "known dimensions"). This was evaluated. The results indicate that the STARscanner and SmartSoc System "passed the acceptance criteria" and were "substantially equivalent" to the casting method in terms of accuracy and repeatability/reproducibility.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the R&R and Accuracy studies of the shape capture devices, the ground truth was based on known dimensions of uniform/representative physical shapes/models, not clinical data from patients or expert consensus.
The sample size for the training set
- The document does not describe a "training set" in the context of an AI/machine learning algorithm. The tests are for the accuracy and precision of a measurement device, not a classification or diagnostic algorithm.
How the ground truth for the training set was established
- Not applicable as no AI/ML training set is mentioned or implied. The ground truth for the validation tests was established by physical models with precisely known dimensions.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 20, 2016

Orthomerica Products, Inc. Mr. David L. Hooper Manufacturing Engineer 6333 North Orange Blossom Trail Orlando, Florida 32810

Re: K161138

Trade/Device Name St. Louis Band Regulation Number: 21 CFR 882.5970 Regulation Name: Cranial Orthosis Regulatory Class: Class II Product Code: MVA, OAN Dated: April 20, 2016 Received: April 22, 2016

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 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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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 Industry and Consumer Education 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,

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161138

Device Name St. Louis Band

Indications for Use (Describe)

The St. Louis Band is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-tosevere 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. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. Applicant Information

Name:	Orthomerica Products, Inc.
Address:	6333 North Orange Blossom TrailOrlando, 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 TrailOrlando, FL 32810
Telephone:	(407) 290-6592
Facsimile:	(407) 290-2419
Email:	dhooper@orthomerica.com
Date Prepared:	April 20th, 2016

II. Submission Information

Type:	Traditional 510(k) Submission
Proprietary Name:	St. Louis Band
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

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IV. Description of Device/Modification

The proposed device modifications include:

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V. Statement of Indications and Intended Use

Statement of Indications:

The St. Louis Band 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. This 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.

Intended Use:

The St. Louis Band is designed to treat infants with abnormal head shapes from age 3 to 18 months and is available by prescription only. Since growth is the driving factor in head shape correction, the infants wear the St. Louis Band for approximately 22 hours per day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. However, due to new minimally invasive surgical techniques for infants with craniosynostosis, post-surgical plagiocephaly, brachycephaly, and scaphocephaly are emerging as a growing patient group.

Craniosynostosis is caused by the premature fusion of one or more cranial sutures of the skull, causing the head to grow in an unusual shape. Some types of craniosynostosis have a clinical presentation similar to deformational (positional) plagiocephaly. Therefore, in cases where the physician cannot make a definitive diagnosis, patients are referred to specialists such as neurosurgeons or cranio-facial surgeons. These specialists will order a test like a CT scan or MRI to confirm the diagnosis of craniosynostosis. If a baby has craniosynostosis, surgery is indicated to realign the plates of the skull and allow normal brain and skull growth to occur.

In general, the first year of life is the optimum time frame for surgical correction since infants are growing at such an accelerated rate during that time. No matter which surgical technique is used, the end result is a patient with no fused sutures. At this point, the same principles that guide cranial remolding of deformational head shapes are applicable. In both deformational head shapes and post-surgical head shapes, the St. Louis Band is designed to maintain total contact over areas where growth is not desired and allow for space over areas where growth is desired. The St. Louis Band provides a pathway for the baby's head growth, directing it toward a more normal shape.

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Predicate Devices VI.

STARband and STARlight, Cranial Orthosis, K151979
I O&P Bivalve Cranial Molding Helmet, Cranial Orthosis, K063395

Summary of Technological Characteristics VII.

The proposed changes involve the indications for use and the use of additional methods to capture the infant's head shape for the fabrication of St. Louis Band. The technological characteristics and the underlying principles of operation of the St. Louis Band Cranial Orthosis shall remain exactly the same. The inclusion of the STARscanner and SmartSoc System is indicated in Table 1 under the Approved 3-Dimensional Imaging Devices section.

Feature	From K063395	Proposed Device
IntendedUse	Maintains total contact over areas ofbossing or protrusion and creates voidsover areas of depression or flattening toredirect cranial growth toward greatersymmetry.	Maintains total contact over areas ofbossing or protrusion and creates voidsover areas of depression or flattening toredirect cranial growth toward greatersymmetry.
Materials	O&P Bivalve Molding Helmet- Sliding/Overlap Closure System- Outer shell of 1/4" copolymer- plastic- An inner liner of 1/4" Aliplast- foam- Bi-Valve Closure- Sliding/Overlap Closure- System- 1" Velcro strap- 1" chafe buckle- Speedy rivets	St. Louis Band- Sliding/Overlap Closure System- Outer shell of 1/4" copolymer- plastic- An inner liner of 1/4" Aliplast- foam- Bi-Valve Closure- Sliding/Overlap Closure- System- 1" Velcro strap- 1" chafe buckle- Speedy rivets
ProductDesign	Custom made cranial orthosis,approximately 7 to 10oz in weight.	Custom made cranial orthosis,approximately 7 to 10oz in weight.
Production	- Form orthosis from a positivemold of infant's head- Positive mold is formed basedupon measurements of the infant'shead taken by from a traditionalplaster cast	- Form orthosis from a positivemold of infant's head- Positive mold is formed basedupon measurements of the infant'shead taken by an approved 3-dimensional imaging device fromwhich a 3-dimensional image ismade or from a traditional plastercast

Table 1 – Comparison of Predicate Device cleared in K063385 to the Proposed Device

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Feature	From K063395	Proposed Device
Approved 3-DimensionalImagingDevices	- None	to produce a positive mold using a5-axis routing machine- STARscanner II- SmartSoc System
Testing	Material Biocompatibility Testing- Cytotoxicity -Agar Diffusion- Closed Patch Sensitization- Primary Dermal Irritation	Repeatability and Reproducibility (R&R)Analysis- Utilized uniform shapes withknown dimensions that representvarious sizes of pediatric patientsbetween ages 3 to 18 months ofage- Compared proposed device to castand predicate device- Associated parameters includesA-P and M-L- Proposed device is substantiallyequivalent to predicate deviceCranial Shape Capture Accuracy Study- Utilized a representative cranialshape that possesses a predefinedshape with known dimensions- Compared proposed device to castand predicate device- Associated Coordinate Planes (A-P; M-L; P-D and various RadiusParameters; Squareness; Flatness)- Proposed device is substantiallyequivalent to predicate deviceMaterial Biocompatibility Testing- Cytotoxicity -Agar Diffusion- Closed Patch Sensitization- Primary Dermal Irritation
Feature	From K151979(STARband Bi-Valve Only)	Proposed Device
IntendedUse	Maintains total contact over areas ofbossing or protrusion and creates voidsover areas of depression or flattening toredirect cranial growth toward greatersymmetry.	Maintains total contact over areas ofbossing or protrusion and creates voidsover areas of depression or flattening toredirect cranial growth toward greatersymmetry.
Materials	STARband Bi-Valve- Outer shell of 5/32" copolymerplastic- An inner liner of 1/2" PelitePolyethylene foam or 1/2" Aliplastfoam- Bi-Valve Closure- Sliding/Overlap Closure System- Chicago Screw (or similar) for topsliding mechanism- 1" Velcro strap- 1" chafe buckle- Speedy rivets	St. Louis Band- Outer shell of 1/4" copolymerplastic- An inner liner of 1/4" Aliplast foam- Bi-Valve Closure- Sliding/Overlap Closure System- 1" Velcro strap- 1" chafe buckle- Speedy rivets
ProductDesign	Custom made cranial orthosis,approximately 7 to 10oz in weight.	Custom made cranial orthosis,approximately 7 to 10oz in weight.
Production	- Form orthosis from a positive moldof infant's head- Positive mold is formed basedupon measurements of the infant'shead taken by an approved 3-dimensional imaging device fromwhich a 3-dimensional image ismade or from a traditional plastercast- The 3-dimensional image is used toproduce a positive mold using a 5-axis routing machine	- Form orthosis from a positivemold of infant's head- Positive mold is formed basedupon measurements of the infant'shead taken by an approved 3-dimensional imaging device fromwhich a 3-dimensional image ismade or from a traditional plastercast- The 3-dimensional image is usedto produce a positive mold using a5-axis routing machine
Approved 3-DimensionalImagingDevices	- STARscanner I- STARscanner II- Omega Scanner- scanGogh-II- 3dMDhead System- 3dMDcranial System- 3dMDflex System- SmartSoc System- M4DScan/BodyScan System- Spectra 3D Scanner	- STARscanner II- SmartSoc System

Both the STARscanner and the SmartSoc System are cleared as an approved 3D imaging system for the predicate devices (STARband and STARlight) cleared under K151979. The St. Louis Band is substantially equivalent to these devices as they have the same intended use, underlying operating principles, and production processes. The St. Louis Band is specifically equivalent to the Bi-Valve design of the STARband as they are both a Bi-Valve design, consist of the same materials and have similar strapping mechanism. Table 2 is a comparison of the STARband Bi-Valve cleared under K151979 and the proposed device.

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Table 2 – Comparison of Predicate Device cleared in K151979 to the Proposed Device

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Since the physical design of the St. Louis Band is not changing and the proposed shape capture device's technological characteristics are exactly the same as those cleared for the predicate device (K151979: STARband and STARlight); the St. Louis Band Cranial Orthosis is substantially equivalent to the predicate device. Table 3 below is a summary of the performance testing conducted on the STARscanner and the SmartSoc System and the results obtained when compared to the casting method.

Test	Test Method Summary	Results
Repeatability andReproducibility(R&R) Analysis	The purpose of this test is to analyzethe repeatability and reproducibility(components of precision) of theproposed shape capture devices. Thedata obtained is compared to thecasting process.Utilized uniform shapes with knowndimensions that represent various sizesof pediatric patients between ages 3 to18 months of age. Associated testparameters include A-P and M-L.	The shape capture devices passedthe acceptance criteria. Therelevancy of the tests determinedsubstantial equivalence of theproposed shape capture devices.
Cranial ShapeCapture AccuracyStudy	The purpose of this test is to analyzethe accuracy of the proposed shapecapture devices. The data obtained iscompared to the casting process.Utilized a representative cranial shapethat possesses a predefined shape withknown dimensions. Associatedparameters analyzed include A-P, M-L, P-D, various radius parameters,squareness, and flatness.	The shape capture devices passedthe acceptance criteria for allparameters. The relevancy of thetest determined substantialequivalence of the proposed shapecapture device.

Table 3 - Performance Testing Summary for Shape Capture Devices

The St. Louis Band is essentially the same Cranial Orthosis as released in K063395. The St. Louis Band materials have been biocompatibility tested, and the results of the tests are listed below in Table 4.

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Material	Test	Results	Conclusion
Copolymer withAliplast Foam	Closed PatchSensitization	A score of 0.00/0.00 (Test/Control)was given for both Incidence andSeverity in the 24 hour and 48 hourscoring interval.	Not a SensitizerNo Erythema orEdema Formation
Copolymer withAliplast Foam	Primary DermalIrritation	Primary Irritation Index: 0.00	Negligible DermalResponse
Copolymer withAliplast Foam	Cytotoxicity –Agar Diffusion	Cell culture treated with test sampleexhibited slight reactivity (Grade 1).	Non-cytotoxic

Table 4 - Biocompatibility Testing Summary for St. Louis Band Cranial Orthosis

VIII. Summary and Conclusions of Non-Clinical Performance Data

The St. Louis Band has been used successfully in clinical practice since its original clearance in 2006. The STARscanner and the SmartSoc System were evaluated for safety and efficacy. The primary safety issue for the STARscanner is the laser. The STARscanner is a Class I laser device and as such is inherently safe for use on infants without eye protection under all normal operating conditions. The SmartSoc System does not utilize lasers, but the flash feature from a consumer grade camera is used as a light source.

The shape capture repeatability and reproducibility for these systems were evaluated and determined to be acceptable. An additional, Cranial Shape Capture Accuracy Study was performed concluding that the STARscanner and SmartSoc System vield a product that is substantially equivalent to the predicate device. With sufficient accuracy and no concerns with the safety of the imaging devices, the STARscanner and SmartSoc System were determined to have a safety and effectiveness profile similar to the predicate device for capturing infant head shape data to manufacture the St. Louis Band Cranial Orthosis.

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)).