(251 days)
No
The device description focuses on the material composition and physical properties of a synthetic bone graft, with no mention of software, algorithms, or any form of computational analysis.
Yes
The device is a synthetic bone graft material used to treat bone defects, which is a therapeutic purpose.
No
The device is described as a synthetic bone graft material used for repairing bone defects, not for diagnosing conditions.
No
The device description clearly states it is a "silica-calcium phosphate composite, synthetic bone graft material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that ShefaBone SCPC is a synthetic bone graft material used for filling bone defects in oral, dental, and maxillofacial areas. It is a physical material implanted into the body to aid in bone regeneration.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples, detect biomarkers, or provide any diagnostic information about a patient's health status.
Therefore, ShefaBone SCPC Resorbable Bioactive Bone Graft is a medical device, specifically a bone graft material, and not an IVD.
N/A
Intended Use / Indications for Use
Resorbable Bone Graft (Describe) 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
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, dental intraosseous, and maxillofacial bone defects
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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
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
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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
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A
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 Ðæн ½ Áâ^ Ð & © Â
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˝´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 Graft | |
| Particulate is indicated to be packed | ||
| into bony voids or gaps to fill and/or | ||
| augment oral, dental intraosseous, and | ||
| cranio~facial defects. These defects may | ||
| include: periodontal/infrabony defects; | 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 |
5
510(k) Summary-Continued
| Parameters | Novabone-PRIMARY PREDICATE | SHEFABONE (SCPC) |
|---|---|---|
| alveolar ridge augmentation | ||
| (sinusotomy, osteotomy, cystectomy); | ||
| dental extraction sites (ridge | ||
| maintenance, implant | ||
| preparation/placement); sinus lifts; | ||
| cystic defects; craniofacial | ||
| augmentation. PerioGlas may be used | ||
| alone in a manner comparable | ||
| to autogenous bone graft chips or | ||
| allograft bone particulate | ||
| (demineralized freeze dried bone), or it | ||
| may be mixed with either as a bone | ||
| graft extender. | • Ridge augmentation (sinusotomy, osteotomy, | |
| cystectomy) | ||
| • Extraction sites (ridge | ||
| maintenance/augmentation, implant | ||
| preparation/ 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 the | |
| chemical components together | thermal treatment to bond the chemical | |
| components together | ||
| Porosity | Dense | Porous |
| Particle Size | 90-710 micron | 90-710 micron |
| Packaging Format | Sealed Plastic cup contains 0.5 CC or | |
| Novabone Perioglass particles. Sterilized | ||
| by Gama radiation | Sealed glass vial contains 1 gm (1cc) of SCPC | |
| particles. The vial is sealed in aluminum | ||
| sterilization 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 à 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 ݽã®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 âÅßeAUOÚÖÁãÆæИ ãæའ| * | æ \ ´æ¹·ãƒÂµ | Áæ¹ | △ | ðº ð´ | ^} Ժ¢@  æç^[ |æð.Áæ* ^ Íæet \ Áf [ o@Å ¢d ækta } н
A CONCLUSION: #4
A
ර්ශයක් | | } සින්හ { | | සැකුකු රිනු දි | | |