ENDOBON XENOGRAFT GRANULES by BIOMET 3I

Endobon Xenograft Granules consist of bovine derived hydroxyapatite ceramic granules. Endobon - hydroxyapatite xenograft granules are derived from cancellous bovine bone that are used as an implantable material to function as a non-resorbable osteoconductive scaffold for dental applications. A two-step, high-temperature manufacturing process (pyrolysis at a temperature above 900 ℃ and sintering at a temperature above 1200ºC) allows complete deproteinization as well as destruction of potential residual bacteria, virus and prions. The slow resorption rate attributed to Endobon and other similar materials processed in the same manner relates to the crystalline-like structure of 95% of the hydroxyapatite (HA) in Endobon. The resorption rate of hydroxyapatite (HA) increases as crystallinity decreases, and the crystallinity is highly dependent on the sintering temperature. High sintering increase in crystallinity. The precise chemical name of the hydroxyapatite is pentacalcium hydroxide (tris) phosphate [Ca5 (PO4)3 OH].

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a medical device called "Endobon Xenograft Granules". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria as might be seen for novel devices or PMAs.

Therefore, the document does not contain all the information requested about acceptance criteria and a study proving device performance in the typical sense of a clinical trial. Instead, it focuses on demonstrating equivalence through comparison to an existing device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the traditional sense for a 510(k) submission focused on substantial equivalence. The "acceptance criteria" here relate to demonstrating that the new device (Endobon Xenograft Granules) is as safe and effective as the predicate device (BioOss).

The document states:

"Endobon Xenograft Granules has the same intended use and, physiochemical properties as BioOss."
"Any differences in material, chemical composition, or physical structure, do not raise any new questions of safety or effectiveness."
"Extensive equivalency assessments demonstrates that Endobon Xenograft Granules is as safe and effective as BioOss."

Therefore, the "acceptance criteria" implicitly are that the new device's properties and performance are comparable to the predicate device to the extent that no new questions of safety or effectiveness are raised. The "reported device performance" is that it meets this equivalency.

A table of chemical composition is provided comparing Endobon and Bio-Oss, which serves as part of the "reported device performance" for demonstrating physicochemical similarity:

	Ca		P		Na		Si		Mg		Cl
	Wt %	At %	Wt %	At %	Wt %	At %	Wt %	At %	Wt %	At %	Wt %	At %
Endobon	68.2	61.3	26.4	30.6	1.6	2.5	0.6	0.7	3.3	4.9	0	0
Bio-Oss	64.4	59.3	27.2	31.4	2.9	4.5	1.6	2.0	1.6	2.4	0.4	0.4

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states "Nonclinical Performance Data: N/A" and "Clinical Data: N/A". This indicates that no specific new test set or clinical study was conducted for this 510(k) submission. The assessment relies on comparison to the predicate device and potentially prior literature, as mentioned in the conclusion "literature review and equivalency assessment".

3. 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)

Not applicable. As no new test set or clinical data was generated, there was no need for experts to establish ground truth in the context of this submission. The chemical comparison data is from a published study (Jensen et al. 1996).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set requiring adjudication was used.

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

Not applicable. This device is a bone grafting material, not an AI software. No MRMC study was conducted.

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

Not applicable. This device is a bone grafting material, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on the established safety and effectiveness of the predicate device (BioOss), which is legally marketed. The submission aims to demonstrate that Endobon Xenograft Granules are sufficiently similar to BioOss to infer the same safety and effectiveness. The chemical composition data from Jensen et al. 1996 provides empirical evidence for this similarity.

8. The sample size for the training set

Not applicable. No training set was used as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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MAY 1 3 2011

K110449

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92

Submitter:	BIOMET 3i
Address:	4555 Riverside Drive Palm Beach Gardens, FL 33410
Establishment Registration Number:	1038806
Contact Person:	Martha I. Garay Sr. Regulatory Affairs Specialist BIOMET 3i
Telephone/Fax/Email:	Tel. 561-776-6923 Fax. 561-514 6316 Email martha.garay@biomet.com
Date Prepared:	02/14/2011
Trade/Proprietary Name:	Endobon Xenograft Granules
Address of Sponsor:	BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410
Common/Usual Name:	Xenograft Hydroxyapatite Bovine Derived Granules
Classification Name:	Class II 21 CFR §872.3930/LYC
Device Classification:	The Office of Device Evaluation Center for Devices and Radiological Health - Dental Devices Branch Food and Drug Administration, has classified Bone Grafting Material as Class II

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K110449

Biomet 3i
Traditional 510(k) Premarket Notification - Endobon Xenograft Granules

device pursuant to 21 C.F.R. § 872.3930 regulations. Legally Marketed Name of Manufacturer: GEISTLICH PHARMA AG CH -Predicate Devices: 6110 Wolhusen Switzerland Washington, DC 20036 Device Name: Xenograft Bone Granules (Bovine) Device Trade Name: BioOss Endobon Xenograft Granules is a modification to Endobon Purpose of the Traditional 510(k) Xenograft Granules, K980679. The purpose of this 510K is to notice: add Sinus Elevation to the current Indication for Use. Device Description: Endobon Xenograft Granules consist of bovine derived hydroxyapatite ceramic granules. Endobon Xenograft Granules are used in the following dental Intended Use: and/or surgical procedures: . Alveolar ridge augmentation/reconstruction, . Sinus elevation, . Filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall, . Filling of bone defects after apicectomy, ● Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications. Endobon - hydroxyapatite xenograft granules are derived from Technological Characteristics: cancellous bovine bone that are used as an implantable material to function as a non-resorbable osteoconductive scaffold for dental applications. A two-step, high-temperature manufacturing process (pyrolysis at a temperature above 900 ℃ and sintering at a temperature above 1200ºC) allows complete deproteinization as well as destruction of potential residual bacteria, virus and prions. The slow resorption rate attributed to Endobon and other similar materials processed in the same manner relates to the crystalline-like structure of 95% of the hydroxyapatite (HA) in Endobon. The resorption rate of hydroxyapatite (HA) increases as crystallinity decreases, and the crystallinity is highly dependent on the sintering temperature. High sintering

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K110449

Biomet 3i Traditional 510(k) Premarket Notification - Endobon Xenograft Granules

increase in crystallinity.

The precise chemical name of the hydroxyapatite is pentacalcium hydroxide (tris) phosphate [Ca5 (PO4)3 OH]. Semiquantitative Energy-Dispersive Spectrometry (EDS) analysis of the chemical composition of both Endobon and Bio-Oss grafting materials from Jensen et al. 1996 are presented in Table 1. The data demonstrates similarities in both weight percentage and atomic percentage of the elements.

	Ca		P		Na		Si		Mg		Cl
	Wt %	At %	Wt %	At %	Wt %	At %	Wt %	At %	Wt %	At %	Wt %	At %
Endobon	68.2	61.3	26.4	30.6	1.6	2.5	0.6	0.7	3.3	4.9	0	0
Bio-Oss	64.4	59.3	27.2	31.4	2.9	4.5	1.6	2.0	1.6	2.4	0.4	0.4

Table 1

NonclinicalPerformance Data:	N/A
Clinical Data:	N/A
PerformanceStandards:	Though there is a Guidance Document for this type of product:"Guidance for Industry and FDA Staff - Class II Special ControlsGuidance Document: Dental Bone Grafting Material Devices" itwas not utilized as part of this submission.
SubstantialEquivalence	Endobon Xenograft Granules has the same intended use and,physiochemical properties as BioOss. Any differences inmaterial, chemical composition, or physical structure, do not raiseany new questions of safety or effectiveness. Extensiveequivalency assessments demonstrates that Endobon XenograftGranules is as safe and effective as BioOss. Thus; the EndobonXenograft Granules is substantially equivalent to its predicatedevice.
Conclusion:	Base on the predicate comparison, literature review andequivalency assessment, Endobon Xenograft Granules issubstantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Ms. Martha I. Garay Senior Regulatory Affairs Specialist Biomet 31 4555 Riverside Drive Palm Beach Gardens, Florida 33410

MAY 1 3 2011

Re: K110449

Trade/Device Name: Endobon Xenograft Granules Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: May 6, 2011 Received: May 9, 2011

Dear Ms. Garay:

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. Garay

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 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Biomet 3i Traditional 510(k) Premarket Notification - Endobon Xenograft Granules

K110449

Indications for Use

510(k) Number (if known): K110449

Device Name: Endobon Xenograft Granules

Indications for Use:

Endobon® Xenograft Granules are used in the following dental and/or surgical procedures:

Alveolar ridge augmentation/reconstruction. .
. Filling of defects after root resection, apicoectomy, and cystectomy.
. Filling alveoli after tooth extraction.
. Sinus elevation.

This product should not be used in non-peridontal mandibular applications.

Prescription Use X

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of De ee Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110640

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.