The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.

In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations .

In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

Device Description

BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant. Comprises two types of connections: Externa® and Interna® with a range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm) for various platforms, we refer to Table 5-1. BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the BTI Dental Implant System UnicCa®. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative table for the clinical study. However, the reported device performance is:

Attribute	Acceptance/Performance
Implant Survival	99.5% (implant-based) at 6 months post-implant insertion
Patient/Subject Survival	98.8% (subject-based) at 6 months post-implant insertion
Complications/Adverse Events	No complications or adverse events reported related to the use of BTI UnicCa implants

The study implicitly aims to demonstrate that these survival rates are comparable to or exceed commonly observed rates in the literature (90% to 98%).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): 170 patients with 430 BTI UnicCa implants.
Data Provenance: Retrospective observational study. The country of origin of the data is not specified in the document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study is described as an "observational retrospective study," which typically involves reviewing existing patient records or clinical outcomes, rather than having experts establish ground truth for a new test set. The criteria for "implant survival" are defined (stable prosthesis, no pain, infections, pathology, absence of radiopaque images around implant, no loss/fracture/significant bone loss/infection), implying a clinical assessment standard.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. 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

There is no indication of a Multi Reader Multi Case (MRMC) comparative effectiveness study or any involvement of AI in this document. The device is a dental implant, not an AI-powered diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a dental implant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on clinical outcomes and observations following implant insertion. This includes criteria such as:

Stable prosthesis without pain, infections, or any pathology
Absence of radiopaque images around the implant
No implant loss or fracture
Bone loss not exceeding 2-3mm
No infection

8. The Sample Size for the Training Set

There is no mention of a training set as this study is a clinical evaluation of a physical medical device, not an AI model.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an emblem with three stylized human profiles facing right, stacked on top of each other. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

May 2, 2016

B.T.I. Biotechnology Institute, S.L. Ms. Fernanda Olabarria Ros Regulatory Affairs Manager Parque Tecnologico De Álava, Leonardo DaVinci 14 01510 Miñano (Álava) SPAIN

Re: K151391

Trade/Device Name: BTI Dental Implant System UnicCa® Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: February 19, 2016 Received: February 22, 2016

Dear Ms. Ros:

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.

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Page 2 - Ms. Fernanda Olabarria Ros

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 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/Resourcesfor You/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,

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMS No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K151391

Device Name BTI Dental Implant System UnicCa®

Indications for Use (Describe)

In the case of Tiny® 3.0 UnicCa® implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

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)
---------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect of
this information collection, including suggestions for reducing this burden, to:

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'An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1
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5.0 510(k) Summary

I. SUBMITTER

B.T.I. Biotechnology Institute, SL.

Parque Tecnológico de Álava C/Leonardo Da Vinci 14 01510 Miñano (Alava) Spain

Phone: (+34) 945 297 030 Fax: (+34) 945 297 031

Contact Person: Ms. Fernanda Olabarría Date Prepared: April 20, 2016

II. DEVICE

Name of Device: BTI Dental Implant System UnicCa® Common or Usual Name: Root-form Endosseous Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Product Code: DZE

III. PREDICATE DEVICE

Primary Predicate	Reference Predicates
	K053355; BTI Interna Dental Implant System.
K022258;BTI Dental Implant System.	K091387; BTI Dental Implant 5.5 – 6.5.
	K092112; BTI Dental Implant Tiny® Ø 3.0.

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IV. DEVICE DESCRIPTION

Table 5-1. Overview of BTI Dental Implant System UnicCa® connections, platforms, diameters and lengths:

Connection	Platform	Diameter(mm)	Length (mm)
Interna®	Wide	5.0	[6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15]
	Wide	5.5	[5.5 / 6.5]
	Wide	6.0	[5.5 / 6.5]
	Universal Plus	4.5	[5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15]
	Universal Plus	5.0	[5.5 / 6.5 / 7.5 / 8.5 / 10 / 11.5 / 13 / 15]
	Universal Plus	5.5	[5.5 / 6.5]
Interna®	Universal	3.3	[8.5 / 10 / 11.5 / 13 / 15]
	Universal	3.5	[7.5 / 8.5 / 10 / 11.5 / 13 / 15]
	Universal	3.75	[7.5 / 8.5 / 10 / 11.5 / 13 / 15]
	Universal	4.0	[7.5 / 8.5 / 10 / 11.5 / 13 / 15 / 18]
	Universal	4.25	[7.5 / 8.5 / 10 / 11.5 / 13 / 15]
Externa®	Wide	5.0	[7.5 / 8.5 / 10 / 11.5 / 13 / 15]
	Wide	5.5	[7.5 / 8.5 / 10 / 11.5 / 13 / 15]
	Universal Plus	4.5	[7.5 / 8.5 / 10 / 11.5 / 13 / 15]
	Universal Plus	5.0	[7.5 / 8.5 / 10 / 11.5 / 13 / 15]
	Universal	3.75	[7.5 / 8.5 / 10 / 11.5 / 13 / 15]
	Universal	4.0	[7.5 / 8.5 / 10 / 11.5 / 13 / 15 / 18]
Externa®	Tiny®	3.0	[11.5 / 13 / 15]
	Tiny®	3.3	[8.5 / 10 / 11.5 / 13 / 15]
	Tiny®	3.5	[7.5 / 8.5 / 10 / 11.5 / 13 / 15]
	Tiny®	3.75	[7.5 / 8.5 / 10 / 11.5 / 13 / 15]

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V. INDICATIONS FOR USE

In the case of 5.5 - 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations .

VI. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject dental implants are identical to the currently marketed BTI Dental Implant Systems in indications for use, materials and design.

The BTI Dental Implant System UnicCa® is manufactured using the same procedures and processes as currently utilized for the predicate BTI Dental Implants, with exception that an additional manufacturing step has been added which consists of applying a soluble calcium chloride salt which is deposited at the outermost part of the surface of the implants. The predicate implant surface is known as Optima®, the implant with surface treatment is referred to as UnicCa®. This treatment enhances hydrophilic profile of the implant, easing its wetting characteristics to polar liquids.

A comparison of the device features, indications for use, laboratory data and other information demonstrate that the modified BTI Dental Implant System UnicCa® is substantially equivalent to the predicate devices.

In the following pages, a comparison table has been provided, Table 5-2.

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Characteristics	Current SubmissionBTI Dental Implant SystemUnicCa®(K151391)	Primary PredicateBTI Dental ImplantSystem(K022258)	BTI DentalImplant System(K053355)	Reference PredicatesBTI DentalImplant 5.5-6.5(K091387)	BTI DentalImplant Tiny®(K092112)
Indications for Use	The BTI Dental Implant SystemUnicCa® for oral implant surgeryis to be used for the partial ortotal replacement of teeth inedentulate patients. Once attachedto the bone, the implants act as ananchor for various fixed orremovable prosthetic solutionsthat can be used to improve orrestore a patient's masticationfunction.In the case of 5.5 - 6.5mm longUnicCa® implants should be usedin a two-stage surgical procedure.These implants are indicated fordelayed loading.These implants are indicated onlyfor straight abutments and tosupport permanently fixedrestorations.	The intended use of thesystem is therestoration of missingteeth in partially orfully edentulouspatients and/or thefixation ofoverdentures to restoreor enhance the chewingcapacity of patients.	Dental implantsystem comprisingendosseoustitanium implantsand prostheticelements to beattached to theimplants, as wellas auxiliaryelements forsurgical andprostheticprocedures. Theintended use of thesystem is therestoration ofmissing teeth inpartially or fullyedentulous patientsand/or the fixationof overdentures torestore or enhancethe chewingcapacity ofpatients.	BTI Dental implants5.5 - 6.5 mm areintended to be usedto restore missingteeth in partially orfully edentulouspatients and/or forthe fixation ofoverdentures torestore or enhancethe chewing capacityof patients. Thedevice should beused in a two-stagesurgical procedure.These implants arenot indicated forimmediate loading.These implants arenot indicated tosupport removableresilient retainedrestorations or angledabutments.	BTI Dental ImplantTiny® 3.0 areintended to be used torestore missing teethin partially or fullyedentulous patientsand/or the fixation ofoverdentures'to restoreor enhance thechewing capacity ofpatients.These implants shallbe used only toreplace maxillarylateral incisors andmandibular lateral andcentral incisors.Immediate loading isrecommended whenthere is good primarystability and anappropriate occlusalload.
	Current Submission	Primary Predicate	Reference Predicates
Characteristics	BTI Dental Implant SystemUnicCa®(K151391)	BTI Dental ImplantSystem(K022258)	BTI DentalImplant System(K053355)	BTI DentalImplant 5.5-6.5(K091387)	BTI DentalImplant Tiny®(K092112)
	In the case of Tiny® 3.0 UnicCa®implants: These implants shall beused only to replace maxillarylateral incisors and mandibularlateral and central incisors.Immediate loading isrecommended when there is goodprimary stability and anappropriate occlusal load.
	The indications for use statement for the BTI Dental Implant System UnicCa® has been written to encompass theindications for use statements provided with the primary predicate system (K022258) and other previously clearedconnections, platforms, diameters and lengths acting as a single consolidated system.In this sense, no labeling change that affects the indications for use of the device has been implemented. Informationrelevant to a specific use of an implant included in previously cleared premarket notifications for BTI Dental Implantsare carried forward and included within the labeling for the BTI Dental Implant System UnicCa®. The product continuesto be specifically indicated for patients undergoing oral implant surgery for the partial or total replacement of teeth inedentulate patients.
Characteristics	Current SubmissionBTI Dental Implant SystemUnicCa®(K151391)	Primary PredicateBTI Dental ImplantSystem (K022258)	Reference Predicates
			BTI DentalImplant System(K053355)	BTI DentalImplant 5.5-6.5(K091387)	BTI DentalImplant Tiny®(K092112)
Product Classification	Device Class IIRegulation No.:21 CFR 872.3640.Product code: DZE;Endosseous dental implant	Device Class IIRegulation No.:21 CFR 872.3640.Product code: DZE;Endosseous dentalimplant	Device Class IIRegulation No.: 21 CFR 872.3640.Product code: DZE; Endosseous dental implant
Implant Design/Geometry	Threaded, root form	Threaded, root form	Threaded, root form
Material	Commercially pure titaniumgrade 4	Commercially puretitanium grade 4	Commercially pure titanium grade 4
Abutment Compatibility/Connection	Internal (Interna) and External(Externa)	External (Externa)	External(Externa)	Internal (Interna)	External (Externa)
Dimensions (mm)	Interna	Diameter: 3.3to 6.0Lengths:5.5 to 18.0	Diameter:3.3 to 5.5Length:7.0 to 18.0	Diameter:3.3 to 5.0Length:7.0 to 18.0	Diameter:4.5 to 6.0Lengths:5.5 to 6.5	Diameter:3.0Lengths:11.5 to 15.0
	Externa	Diameter: 3.0to 5.5Lengths:7.0 to 18.0	Diameter:3.3 to 5.5Length:7.0 to 18.0	Diameter:3.3 to 5.0Length:7.0 to 18.0	Diameter:4.5 to 6.0Lengths:5.5 to 6.5	Diameter:3.0Lengths:11.5 to 15.0
Roughness	Same	$Neck: Sq = 0.7 ± 0.1 µm; Sdr^2= 50± 10%$$Thread: Sq≥ 1.2 µm;$$Sdr≥ 200%$	Same
Characteristics		Current Submission	Primary Predicate	Reference Predicates
		BTI Dental Implant SystemUnicCa®(K151391)	BTI Dental ImplantSystem (K022258)	BTI DentalImplant System(K053355)	BTI DentalImplant 5.5-6.5(K091387)	BTI DentalImplant Tiny®(K092112)
			Valleys: Sq= $1.0 \pm 0.2$ µm; Sdr= $85 \pm 15$ %
MechanicalProperties	Material(Titanium)	Same; in compliance with ISO5832-2 and ASTM F67.	Same; in compliancewith ISO 5832-2 andASTM F67.	Same; in compliance with ISO 5832-2 and ASTM F67.
	Fatigue	Equivalent; platform(diameter and length)dependent.	Equivalent; platform(diameter and length)dependent.	Equivalent; platform (diameter and length) dependent.
Hydrophilicity		Enhanced
Supplied Sterile		Yes	Yes	Yes
Sterilization		Gamma Radiation	e- beam	e- beam
SAL		1 x 10-6	1 x 10-6	1 x 10-6
Packaging		Unique container(vial with clamp)	Primary (vial+blister)+ Secondary (carboardbox)	Primary (vial+blister) + Secondary (carboard box)
Shelf-Life		5 years(based on accelerated studies,1 year real time data from on-going stability studies)	5 years	5 years

Table 5-2. Comparison of the BTI Dental Implant System UnicCa® with Predicate BTI Dental Implant Systems:

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1 Sq: Root Square Mean Roughness.
² Sdr= Developped surface.

^2Sdr= Developed surface.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

Biocompatibility tests, in conformance with ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process were performed. Sample preparation for testing was made based on ISO 10993-12:2012.

	Biocompatibility Testing	Standard
	Cytotoxicity Test	ISO 10993-5:2009
Implant	Delayed Hypersensitivity	ISO 10993-10:2010
	Intracutaneous Reactivity	ISO 10993-10:2010
	Acute Systemic Toxicity	ISO 10993-11:2006
Container	Cytotoxicity Test	ISO 10993-5:2009
Solution	Establishment of allowable limits for	ISO 10993-17:2002
	leachable substances

Table 5-3. Biocompatibility Testing List:

Bench Testing

Bench testing has been performed for those attributes that may be impacted by the modifications made to the subject device which demonstrates that the proposed modified device met the required specifications for complete design verification tests. Fatigue Testing based on UNE-EN-ISO 14801:2008 (Dentistry. which included: Implants. Dynamic fatigue test for endosseous dental implants; ISO 14801:2007), Corrosion Testing, Surface Hydrophilicity TOF-SIMS Analysis, Packaging / Shelf-life Validation and Sterilization Evaluations.

Additionally, as a consequence of the modification of the packaging, a new sterilization method by gamma radiation is applied.

Sterilization validation successfully concluded that the gamma irradiation process, when performed per associated process specifications, can reliably sterilize the subject device to a Sterility Assurance Level of 106. Product integrity and characteristics are not affected by sterilization process, supporting the finding of substantial equivalence with primary and reference predicates.

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Clinical Testing

BTI conducted an observational retrospective study for BTI Dental Implant System UnicCa The subjects were over 18 years old, were partially or completely edentulous and required treatment with dental implants and were treated with one or more with at least 6 months of follow-up. Patients whose UniCa implants were still not loaded were excluded. 170 patients with 430 BTI UniCA implants were evaluated. The analysis demonstrated rates of 99.5% and 98.8% respectively for implant- and subject-based survival at 6 months post implant insertion. Implant survival was based upon a stable prosthesis without pain, infections, or any pathology and absence of radiopaque images around the implant, loss of implant, fracture, bone loss > 2-3mm, or infection. No complications or adverse events related to the use of BTI UniCa implants were reported. In comparison, commonly observed survival estimates reported in the literature generally range from 90% to 98%.As a consequence, it is considered that BTI Dental Implant System UnicCa® is substantially equivalent to the declared predicate devices.

VII. CONCLUSIONS

The results of the clinical and non-clinical testing and comparison of similarities and differences between the modified devices and the respective predicate devices demonstrate that the proposed and predicate devices are substantially equivalent.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.