SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY

K130235 · Hans Biomed Corp. · NUN · Jan 10, 2014 · Dental

Device Facts

• Record ID: K130235
• Device Name: SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
• Applicant: Hans Biomed Corp.
• Product Code: NUN · Dental
• Decision Date: Jan 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SurFuse™ II Putty and ExFuse™ II Putty are bone filling materials indicated for dental intraosseous, oral and maxillofacial defects, including periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects.

Device Story

SurFuse™ II and ExFuse™ II Putty are human allograft-derived bone void fillers. Human bone tissue is processed into powder, demineralized via hydrochloric acid, and combined with a carboxymethylcellulose (CMC) carrier to form a putty. ExFuse™ II additionally contains cancellous bone powder. Devices are provided sterile for single-patient use. Used by dental professionals in oral and maxillofacial surgical procedures to fill bone defects and support bone regeneration. The putty consistency allows for easy placement into surgical sites. Osteoinductive potential is evaluated per lot using an in vitro BMP-2 ELISA assay, correlated with rat muscle pouch model performance. The device acts as an osteoconductive scaffold to facilitate bone growth in the defect site.

Clinical Evidence

No human clinical data provided. Evidence includes bench testing for biocompatibility (ISO 10993) and viral inactivation validation. Osteoconductive ability demonstrated in dog alveolar bone model. Osteoinductive potential demonstrated in athymic (nude) rat muscle pouch model and correlated with in vitro BMP-2 ELISA assay results. Each lot is evaluated for osteoinductive potential using the in vitro assay.

Technological Characteristics

Human allograft bone tissue, demineralized via hydrochloric acid process. Carrier: carboxymethylcellulose (CMC). ExFuse™ II includes cancellous bone powder. Form factor: putty. Sterilization: provided sterile. Biocompatibility: ISO 10993 compliant. Osteoinductive assessment: in vitro BMP-2 ELISA assay.

Indications for Use

Indicated for dental intraosseous, oral, and maxillofacial defects including periodontal/infrabony defects, alveolar ridge augmentation, dental extraction sites, sinus lifts, and cystic defects in patients requiring bone grafting.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SurFuse™ Putty, ExFuse™ Putty (K113728)
• GRAFTON® DBM, Osteotech, Inc. (K051188)
• DBX Demineralized bone matrix putty, Musculoskeletal Transplant Foundation (K091217)

Submission Summary (Full Text)

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K130Z3S

,

Submitter:
Hans Biomed Corp.

·

SurFuse™ and ExFuse™
Traditional 510(k)

.

JAN 100 2014

## 510(k) SUMMARY

| Submitter Name: | HansBiomed Corp. |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 8 Floor SK Building Seongsu 1-ga<br>Seongdong-gu<br>Seoul, 133-110 Korea |
| Contact Person: | Ms. Lucy Choi |
| Phone Number: | 0082 2 466 2266 |
| Fax Number: | 0082 2 463 1554 |
| Date Prepared: | January 30, 2013 |
| Device Trade Name: | SurFuse ^TM II Putty,<br>ExFuse ^TM II Putty |
| Device Common Name: | Bone grafting material, Human |
| Classification Number: | 21 CFR 872.3930 |
| Product Code and Classification Name | NUN<br>Bone grafting material, human source |
| Device Class | II |
| Predicate Devices: | K113728, SurFuse ^TM Putty, ExFuse ^TM Putty,<br>HansBiomed Corp<br>K051188, GRAFTON® DBM, Osteotech, Inc.<br>K091217, DBX Demineralized bone matrix putty,<br>Musculoskeletal Transplant Foundation. |
| Indications for Use: | The SurFuse ^TM II Putty and ExFuse ^TM II Putty are bone filling<br>materials indicated for dental intraosseous, oral and maxillofacial<br>defects, including periodontal/infrabony defects; alveolar ridge<br>augmentation; dental extraction sites; sinus lifts; cystic defects. |
| Device Description: | The SurFuse ^TM II Putty and ExFuse ^TM II Putty are derived from<br>human allograft bone tissue that is processed into a powder and<br>demineralized using a hydrochloric acid process. The<br>demineralized bone matrix (DBM) is combined with a resorbable<br>carrier, carboxymethylcellulose (CMC) and formulated into a<br>putty-like consistency. The ExFuse ^TM II Putty also contains<br>cancellous bone powder. They are provided sterile for single<br>patient use. The products are provided sterile for single patient<br>use. |

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| Submitter:<br>Hans Biomed Corp. | SurFuse™ and ExFuse™<br>Traditional 510(k) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Serological Testing<br>& Biocompatibility | The donor bone is obtained from AATB-certified tissue banks in<br>the United States and the donor suitability criteria used to screen<br>donors are in compliance with the FDA regulations published in<br>21 CFR Part 1270 and Part 1271 Human Tissue Intended for<br>Transplantation. |
| | Further the manufacturing and sterilization processes were<br>assessed for viral inactivation potency by a validation<br>assessment, which included Human Immunodeficiency Virus-1<br>(HIV-1), Bovine Herpes Virus (BHV), Bovine Viral Diarrhea Virus<br>(BVDV), Hepatitis A Virus (HAV) and Porcine Parvovirus (PPV). |
| | Biocompatibility testing, according to ISO 10993, has been<br>performed and the devices have been shown to be non-toxic<br>and biocompatible. |
| Performance: | The devices were tested to characterize their osteoconductive<br>ability to grow bone <i>in vivo</i> in the dog alveolar bone model. |
| | They also have been tested <i>in vivo</i> in the athymic (nude) rat<br>muscle pouch model and were shown to have osteoinductive<br>potential, in that new bone grew within the muscle tissue. The<br>osteoinductive potential also was evaluated with a surrogate, <i>in<br/>vitro</i> BMP-2 ELISA, assay. Results from that assay were<br>correlated with results from the same lots in which bone<br>successfully formed in the athymic rat. |
| | Each lot of the SurFuse™ II and ExFuse™ II devices will be<br>evaluated for osteoinductive potential using the <i>in vitro</i> assay. |
| | Osteoinduction assay results observed in surrogate<br>assessments should not be interpreted to predict clinical<br>performance in human subjects. |
| Comparison to the<br>Predicate Devices: | The SurFuse™ II and ExFuse™ II devices, with respect to<br>Intended Use as bone void fillers, are the same as the both<br>predicate families of devices; and with respect to the Indications<br>for Use to augment intraosseous, oral and maxillofacial defects,<br>are the same as the Grafton® DBM predicate. |
| | The SurFuse™ II and ExFuse™ II devices are identical in all<br>respects including composition, processing, manufacturing and<br>packaging to the parent predicate SurFuse™ II and ExFuse™ II<br>devices and substantially equivalent in material composition and<br>device characteristics to the Grafton® DBM predicate. |
| Substantial<br>Equivalence<br>Conclusion | The comparisons and study data presented in the 510(k) lead to<br>the conclusion that the SurFuse™ II Putty and ExFuse™ II Putty<br>are substantially equivalent to the predicate devices. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines that curve and flow together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.

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

January 10, 2014

HansBiomed Corporation C/O Ms. Patsy J. Trisler, JD, RAC Regulatory Consultant Trisler Consulting 5600 Wisconsin Ave., #509 Chevy Chase, MD 20815

Re: K130235

Trade/Device Name: SurFuse™ II Putty, ExFuse™ II Putty Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: II Product Code: NUN Dated: December 5, 2013 Received: December 11, 2013

Dear Ms. Trisler:

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. Trisler

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 [phone] or [phone] 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" (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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Image /page/3/Picture/7 description: The image shows a logo or emblem with some text. The text reads "Tejashri Purohit-Sheth, M.D., Clinical Deputy Director, DAGRID, FOR". The logo is stylized and appears to be a signature or some other kind of design.

Erin I. Keith, M.S. Acting 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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510(k) Number (if known):

K130235

Device Name:

SurFuse™ | Putty ExFuse™II Putty

## Indications for Use:

The SurFuse™II Putty and ExFuse™II Putty are bone filling materials indicated for dental intraosseous, oral and maxillofacial defects, including periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Section 4.0

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