ShefaBone SCPC Resorbable Bioactive Bone Graft, is a silica-calcium phosphate composite, synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. Typical uses include:

Periodontal / infrabony defects
Ridge augmentation (sinusotomy, osteotomy, cystectomy)
Extraction sites (ridge maintenance/augmentation, implant preparation/ placement)
Sinus lifts
Cystic cavities
Oral and maxillofacial augmentation

Device Description

ShefaBone SCPC Resorbable Bioactive Bone Graft, is a silica-calcium phosphate composite, synthetic bone graft material. It is resorbable and has a porous structure with a particle size of 90-710 micron. It is processed by thermal treatment to bond the chemical components together. It is packaged in a sealed glass vial containing 1 gm (1cc) of SCPC particles, sealed in an aluminum sterilization pouch, and sterilized by Gama radiation.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a 510(k) premarket notification approval letter for a medical device (ShefaBone SCPC Resorbable Bone Graft) and includes a summary comparing it to a predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be emerging from a single form. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

July 14, 2016

Shefabone Incorporated % Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082

Re: K153230

Trade/Device Name: ShefaBone SCPC Resorbable Bone Graft Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: LYC Dated: June 7, 2016 Received: June 8, 2016

Dear Elaine Duncan:

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.

{1}------------------------------------------------

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 (OS) 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 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,

Michael J. Ryan -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153230

Device Name ShefaBone SCPC Resorbable Bone Graft

Indications for Use (Describe)

Resorbable Bone Graft

(Describe)

· Periodontal / infrabony defects
· Ridge augmentation (sinusotomy, osteotomy, cystectomy)
· Extraction sites (ridge maintenance/augmentation, implant preparation/ placement)
Sinus lifts
· Cystic cavities
· Oral and maxillofacial augmentation

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

{4}------------------------------------------------

510(K) SUMMARY

Submitted on behalf of: Shefabone Incorporated c/o Ahmed El-Ghannam President 9016 Cliff Cameron Drive, Ste 201

Charlotte, NC 28269

à^K

Ò|æ ^´Ö´ } & } & É É È È È È È È È È È (CONTACT PERSON) Ú¦¹•ãã^} dÃ√≥ dÃ√ áããã ÁT ^ â ãã có 8 ã UUAOI CAI EA Scal, actif baile G Ï FÍ ÐÏ Í JË €H Á I FI E I JE HI €A

ÖŒ½ÒÁ½ÜÒÚŒÏÒÖ½Á

Rǐ |ˆ Â Ê´œFÎ Á

A VÜC£ÖÒÍÞŒ ÒK ÔUT T UÞÁŒ Ó½ ÖSCEJURIOS OF OFF OF OK ÙÜÙ ÆÕÙ ÕÕÍÀ

V4| @} vK

Øger Krister Area Bron

ShefaBone SCPC Resorbable Bone Graft Ó[ } ^송[ ãÁã|^! Ó[ } ^Áð¦æðã *Á æð¹ľæÁÁ
ŠÝÔÁ

DESCRIPTION of the DEVICE:

ShefaBone SCPC Áã Áæ¹·ˆ} o@ ããÁ¦^•[ ¹àæ│½Á[ • ୯ [ { } à´ & & Âà[ } ^ ^ ^ åÁ¹ Áº ã¾ } Á[ ďâ^ 원 ] @ •] @ [ ˘ • A çã • Ê çã • Ê çã • Ê çã • E • E • E • E • E • E • E • E • E • A • A • A • A • A • A • A • A • A • A • A • A • A • A • A • A • A • A • A • A • A • A • A • A • ] සංඛ්‍යා රිස රි | [ [ •

INDICATIONS FOR USE:

Ù@¬æÍ¡¡^ÑÔÚÔÁÏ^•[ ¹àæà¦^ÍÓã æð㺹ÍÓ[ ]^Ñͦæðãæ ÍøÁãßâßâßã{ Á¸Œ•] œæºÍß { [ ] [ •㺠д ] ^ Á * æð ætt ætt í í í • 7 þ. í í • 1 þ. í . • 1 ° • 1 ° • 1 ° • 1 ° • 8 á í í æ á í í æði • • 1 ° • 8 8 ° å ^ • 8 8 ° å ^ í ˜ΆΜΙã â[ } œÀи ÐæÐ½ ½ Áâ^ Ð & © Â

˜Ä½¥¹½½¨¹‹Í‹¡ Œ¤ã ½ Á¸Ç¡ · [ ç { ˆÊ´···· [ { { ˆÊ‰·¢·&q { ´ □Á
˝´Öødædã¡ Á Æ·· Çããˆ^Á æ çº) æ âºಡಾ¨ { ^} œ¤ } д [ ˆ ] æ q | ¹ ] ææã } и | œÁ } и çÁ | ″ÀJã ˘ • Áãc Á
"ÃÖˆ• Œâ½æçã㺷 Á
˝Ά〕¹ æ½£ å Á〖 æ²ã‖[ æðã¼[ æð〠* { ^} çæã¡ } Á

SUBSTANTIAL EQUIVALENCE:

Comparison of Differences of Indication for Use to (Primary) Predicate: ປ່າໄລ *ເຂົ້າ (A § [ ] [ · · н · çã · Æ å æ å å · Å · Å å Ø Ø · Å · Æ · Å · Å · Å · Å · Å · Å · Å Å Å Å Å Å Å Å Å Å Å Å Å Å Å Å Å Å Å Å Å Å Å Å • ٱلْى ٱلْأَأَأَ ½ ٱلْ أَحْوَكُمَ } ^ أَ أَ ‫( ^ مُط ^ أَ ^ ^ مَكِه أَ [ • A äَ @ أَ [ • A äَ @ أَ [ • A äَ @ أَ [ • A äَ @ [ ] • A ä @ [ • • ] ´ • ] ´ • ] ´ • ] ´ • à[ } ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ •˜¬ãã¡ dá[ ] ^Á[ { æã } Á£ { ^} dí© fæç^ [æÀíãã ^Íæс: ¡ { [ o@ v od ækçã } Ð√ @ ' ^ } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } ạ ki@Aza ^ (g c) â^âÁ xe Á½ ậ • Ậ • ̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣̣ ^ˇ˘ãçæ} of AU·lã * |æ·A¡ : (@@Aæ = ^/ } aã æ == } A¡ ! A· ^ EA

র্ব

Parameters	Novabone—PRIMARY PREDICATE	SHEFABONE (SCPC)
510(k) #	K 040278	pending
Classification & ProCode	Class II, LYC	Class II, LYC
Intended Use	Bone void filler	Bone void filler
Indication for Use	PerioGlas - Bioglass Bone GraftParticulate is indicated to be packedinto bony voids or gaps to fill and/oraugment oral, dental intraosseous, andcranio~facial defects. These defects mayinclude: periodontal/infrabony defects;	ShefaBone SCPC Resorbable Bioactive BoneGraft, is a silica-calcium phosphate composite,synthetic bone graft material for use in oral,dental intraosseous, and maxillofacial bonedefects. Typical uses include:• Periodontal / infrabony defects

{5}------------------------------------------------

510(k) Summary-Continued

Parameters	Novabone-PRIMARY PREDICATE	SHEFABONE (SCPC)
	alveolar ridge augmentation(sinusotomy, osteotomy, cystectomy);dental extraction sites (ridgemaintenance, implantpreparation/placement); sinus lifts;cystic defects; craniofacialaugmentation. PerioGlas may be usedalone in a manner comparableto autogenous bone graft chips orallograft bone particulate(demineralized freeze dried bone), or itmay be mixed with either as a bonegraft extender.	• Ridge augmentation (sinusotomy, osteotomy,cystectomy)• Extraction sites (ridgemaintenance/augmentation, implantpreparation/ placement)• Sinus lifts• Cystic cavities• Oral and maxillofacial augmentation
Material Description	ionic Si, Ca, P and Na.	ionic Si, Ca, P and Na.
	Resorbable	Resorbable
Processing	thermal treatment to bond thechemical components together	thermal treatment to bond the chemicalcomponents together
Porosity	Dense	Porous
Particle Size	90-710 micron	90-710 micron
Packaging Format	Sealed Plastic cup contains 0.5 CC orNovabone Perioglass particles. Sterilizedby Gama radiation	Sealed glass vial contains 1 gm (1cc) of SCPCparticles. The vial is sealed in aluminumsterilization pouch. Sterilized by Gama radiation

In addition, Shefabone SCPC is equivalent to aspects of the Reference Predicate K033611: October 1) E ÞæðÁÓ[] △ÁðÍÍ íÐÉнã Ñ' ÁнешÆÁшÐã ÁÍ Ð£ аш Ðð ( Áã ( Á) @ º) Œæ½ß″ ^) ¢¢œæðã Á §º·¢태경↑Á{ æ¹¹æďžíV®Á{ æ}Á§{ ¡ [ ] ^} ÁÇ | à DÍ ÁÙÓÚÓÁ¹Íæ}¨|^·ÁãÁæ¡ [ Áßí° · œঝಡಿ ^ÁºÍ áã' Á£áßã { Á ] @ •] @ • [ @ ] @ O O O O = ] [ ] ] • ] [ à ca | • ] ( · ) · · · · · å ( A [ / ] · / & × × ( / / / / × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × ] ✈ | | GBCOOOrg ar Occad | 760 개 = [ face / 제 / [ 1 ( 120 개 / [ 7 / 1 / 1 ( 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / / / / / / / / / / / / / / / / / / / / / / / / / / / / aj } / } } } {{ = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = ි ç[ ãƒ í ½ð ½ ½ ½ ½ ½ ½ Í Í í ½ × Í ð þ Á × Í × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × × ai | ^ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ി വേണ്ടി (എ വി.) എ (എ (എ (എ (എ (എ ) ) { æ x { } [ } ^} okt í Ã Dj + A l = {a = = ( } } { { } } } { } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } র্ব

SUMMARY of TESTING/ BASIS of SUBSTANTIAL EQUIVALENCE:

A

ිරිය { æk c' අී සිත ද වි පිහි සිං දි ද ' ' œ Á™¹} Íß[] 㘠8¢ãƒ Íð£ãß Ííðãð ݽ͸ã®ÍÙÚÍFEJJHÐÚдÆÍJHÐÁÐ ÁÆÍ ншãшншãшãÁ q Áâº{ []•៤æ Á^ˇ¨ã¡¢} & ÁàæàÁÝÜÖÁæ} æˆã ÁÍ·ÁœÁÍ œº·Á§{ ] [ •ム} Áà^·[ ! Íæð åÅæð¹Á* æ{ æ • ¢¹ãã æã¡£íºÒ¯ í æ âÓ¡ ^¡··· ¸Öã] ^¦•· ã^ Á ··· ã ··· ã ··· ã Á ··· ã Á ··· ã Á ··· ã Í ·· ã | Ð ã | Ð V@Å ප්‍යැංකී වි විසින් සිට දි පිහිටු විට දි { ^æ ` ! ^ ^ ^ ^ ^ ^ ^ ^ ^ { x ^ ^ { x } ^ ^ x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x ² { ÁæFi Á ^ ^ Áj ¦^ е | е | | | • Cæ âÅ׿ßeAUOÚÖÁãÆæÐ˜ ãæà½ | * | æ \ ´æ¹·ãƒÂµ | Áæ¹ | △ | ðº ð´ | ^} Ժ¢@ Â æç^[ |æð.Áæ* ^ Íæet \ Áf [ o@Å ¢d ækta } н

A CONCLUSION: #4

ර්ශයක් | | } සින්හ { | | සැකුකු රිනු දි | | |

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.