ßGran Synthetic Osteoconductive Scaffold Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated for use in the treatment of surgically created osseous defects or osseous defects caused by traumatic injury to the bone. ßGran Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

ßGran Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following implantation the calcium phosphate matrix will be resorbed and is replaced with bone during the healing process.

Device Description

BGran is a porous, resorbable osteoconductive scaffold constructed of highly pure ß tri-calcium phosphate for use in the repair of bony defects. The material is designed and manufactured to achieve the specification set out in the standard ASTM F 1088-87 (1992) e-1.

The interconnected pores provide a three-dimensional scaffold that mimics the geometry of human cancellous bone matrix. The three-dimensional platform provided by BGran's osteoconductive scaffold guides the regenerating bone throughout the defect into which it has been implanted. Pore diameters ranging from 1 pm to 700 m support re-vascularisation and cellular invasion throughout the matrix

Studies have shown that when ß tri-calcium phosphate is implanted in direct contact with host bone, which has a viable blood supply, that it responds physiologically. Throughout the healing process the matrix resorbs and is replaced by bone and connective tissue. Complete resobption takes between 3 to 12 months

BGran is supplied as granules, available in three sieve sizes, sterile for single patient use

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (BGran™ synthetic osteoconductive scaffold) seeking premarket notification, indicating it's for regulatory clearance rather than a study report proving device performance against acceptance criteria in the context of AI/software.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, and expert involvement for an AI medical device is not available in this document. This document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, materials, design, and performance characteristics.

The tables within the document compare the BGran device to predicate devices (Vitoss™ Scaffold and CerasorbORTHO) regarding design and performance characteristics but do not present acceptance criteria for a study or device performance against those criteria in the manner you've described for an AI/software device. For instance, "Osteoconductivity" is listed as a performance characteristic, with the device and predicates all reporting "Osteoconductive." Similarly, "Resorption" is described with expected timelines but not as a quantitative acceptance criterion with a specific study result.

Summary

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K041616

AUG	2 5 2004
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510(k) Summary ßGran synthetic osteoconductive scaffold

Prepared & Submitted by:	Orthos (UK) Limited
Contact Person:	Mr Alan Rorke
Address:	The Stables, Leigh Court,Abbots LeighBristolNorth SomersetBS8 3RAUnited Kingdom	Tel:Fax:Email:	+44 1275 376 377+44 1275 376 378post@orthos.com

Trade Name	βGran™ syntheticosteoconductive scaffold	Vitoss™ Scaffold SyntheticCancellous Bone Void Filler	CerasorbORTHO
510(k) Registration No:		K032409	K014156
Common Name	Resorbable Synthetic Bone Void Filler/Bone Graft Substitute
Classification Name	Resorbable Calcium Salt Bone Void Filler Device

Trade Name	BGran™ syntheticosteoconductive scaffold	Vitoss™ Scaffold SyntheticCancellous Bone Void Filler	CerasorbORTHO
510(k) Registration No:		K032409	K014156
Intended Use	The devices intended use isthe same as for thePredicate devices. i.e. thetreatment of osseousdefects, which are notintrinsic to the stability orintegrity of the skeleton.For complete details pleaserefer to the Intend UseStatement	As a bone void filler forvoids or gaps that are notintrinsic to the stability ofbone structures. It isindicated for use in thetreatment of surgicallycreated osseous defects orosseous defects cause bytraumatic injury to the bone.	As a bone void filler forvoids or gaps that are notintrinsic to the stability ofbone structures. It isindicated for filling of bonedefects, caused by surgery,trauma or degenerativeprocess.
Target Population	Individuals with bony defectsresulting from surgery ortrauma	Individuals with bony defectsresulting from surgery ortrauma	Patients with bone voids orgaps, caused by surgery,trauma or degeneration
Anatomical Locations	Bony voids or gaps of theskeletal system, i.e., theextremities, spine and pelvis	Bony voids or gaps of theskeletal system, i.e., theextremities, spine and pelvis	skeletal system,(extremities, spine, pelvis)
Labeling	Labeling contains sameintended use,contraindications andadverse events as predicatedevices	Labeling contains sameintended use,contraindications andadverse events as ßGransynthetic osteoconductivescaffold	Labeling contains sameintended use,contraindications andadverse events as ßGransynthetic osteoconductivescaffold
Materials	ß-Tricalcium PhosphateCa3(PO4)2 satisfies ASTM F1088	ß-Tricalcium PhosphateCa3(PO4)2 satisfies ASTM F1088	ß-Tricalcium PhosphateCa3(PO4)2
Design
Physical Structure	Interconnective porosity	Trabecular structure similarto cancellous bone	Interconnective porosity
Porosity	Approximately 70%	Approximately 90%	Approximately 60% to 70%
Pore Size (range)	<1µm - 700µm	1-1000µm	Micropores >0 <80µm
Performance
Osteoconductivity	Osteoconductive	Osteoconductive	Osteoconductive
Resorption	Complete resorptiondemonstrated as occurringbetween 3 and 12 months.	Demonstrated as 76%resorbed at six weeks and80% at twelve weeks	Resorption reported tooccur between 3 and 24months.
Mechanical Strength	Does not impart mechanicalstrength to surgical site	Does not impart mechanicalstrength to surgical site	Granules have no weightbearing capacity. Executionof osteosynthetic measureseventually necessary
Sterility	Sterilized by gammaradiation, single use only	Sterilized by gammaradiation, single use only	Sterilized by gammaradiation, single use only
Biocompatibility	Established	Established	Established
Presentation	Granules in 3 sieve sizes.250 – 500μm1 – 2.8 mm2 – 4 mm	Morsels 1-4mm andCylinders 9 x 23mm	Granules, and BlocksGranule sizes:500 - 1000μm1000 - 2000μm

Description of the device:

BGran is supplied as granules, available in three sieve sizes, sterile for single patient use

Intended Use of the Device:

BGran is intended for use by suitable trained surgical personnel only.

ßGran synthetic osteoconductive scaffold is only intended to be used as a bone void filler for use in the treatment of osseous defects, which can occur as a result of trauma, or in defects created surgically.

BGran is not intended too and will not provide any mechanical stability. It should not therefore be used in osseous defects, which are intrinsic to the stability or integrity of the skeleton without

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concurrent treatment to directly address the mechanical stability.

ßGran granules should be gently packed into the bony voids or defects of the skeletal system (i.e., long bones, extremities, spine and pelvis, mandible or maxilla). The granules may be combined with autogenous blood and/or bone marrow. The granules should not be crushed. Following implantation the calcium phosphate matrix will be resorbed and replaced with bone during the healing process.

Comparison to Predicate:

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Public Health Service

AUG 2 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alan Rorke Managing Director Orthos (UK) Limited The Stables, Leigh Court, Abbots Leigh Bristol North Somerset United Kingdom BS8 3RA

Re: K041616

Trade Name: BGran™ Synthetic Osteoconductive Scaffold Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: June 15, 2004 Received: June 15, 2004

Dear Mr. Rorke

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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): 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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Page 2 - Mr. Alan Rorke

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

L. Mark A Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Device Name: BGran Synthetic Osteoconductive Scaffold

Indications for Use:

ßGran Synthetic Osteoconductive Scaffold Bone Void Filler is intended for use as a bone void filler IfGran Synthelic Osteoconductive bandra Bone FBC of the bony structure. If cransage defects co for volds or gaps that are not insic to the basility or sheous defects or osseous defects created
indicated for use in the treatment of surgically created osseous defects cr indicated for use in the treathent of surgically of saiffeld should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

ßGron Scaffold is intended to be packed into bony voids or gaps of the sketal system (ite., the BGron Scaroid is intended to be packed this bony folse of golf
extremities, spine and pelvis) and may be combined with autogenous blood and is some is sopher extremittes, spine and peris) and that be combines that about of the same and is replaced with bone during the healing process.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mulkeren

510(k) Number K041616

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.