(345 days)
Not Found
No
The summary describes a bone filling material composed of processed human allograft bone and a resorbable carrier. There is no mention of AI or ML technology in the device description, intended use, or performance studies. The focus is on the material properties and biological performance.
No.
The device is a bone filling material intended to augment bone in specific anatomical sites, not to treat or cure a disease or condition in the conventional sense of a therapeutic medical device. While it promotes bone growth, its primary function is structural augmentation rather than direct therapeutic intervention against a pathology.
No
The device description indicates it is a bone filling material designed to promote bone growth, not to diagnose conditions.
No
The device description clearly states it is a bone filling material derived from human allograft bone tissue, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "bone filling material" for treating various dental, oral, and maxillofacial defects. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details the composition of the putty, which is derived from human bone tissue and a carrier. This is a material intended for implantation or filling, not for analyzing samples from the human body to provide diagnostic information.
- Performance Studies: The performance studies focus on the device's ability to grow bone in vivo (in living organisms), demonstrating its therapeutic function. IVD performance studies would typically involve evaluating the accuracy and reliability of a test in detecting a specific condition or substance in a sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is directly applied to the body to facilitate bone growth.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NUN
Device Description
The SurFuse ™ II Putty and ExFuse ™ II Putty are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty-like consistency. The ExFuse ™ II Putty also contains cancellous bone powder. They are provided sterile for single patient use. The products are provided sterile for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental intraosseous, oral and maxillofacial 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)
The devices were tested to characterize their osteoconductive ability to grow bone in vivo in the dog alveolar bone model. They also have been tested in vivo in the athymic (nude) rat muscle pouch model and were shown to have osteoinductive potential, in that new bone grew within the muscle tissue. The osteoinductive potential also was evaluated with a surrogate, in vitro BMP-2 ELISA, assay. Results from that assay were correlated with results from the same lots in which bone successfully formed in the athymic rat.
Each lot of the SurFuse™ II and ExFuse™ II devices will be evaluated for osteoinductive potential using the in vitro assay. Osteoinduction assay results observed in surrogate assessments should not be interpreted to predict clinical performance in human subjects.
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.
Not Found
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
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 |
| Seongdong-gu | |
| 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, |
| ExFuse TM II Putty | |
| Device Common Name: | Bone grafting material, Human |
| Classification Number: | 21 CFR 872.3930 |
| Product Code and Classification Name | NUN |
| Bone grafting material, human source | |
| Device Class | II |
| Predicate Devices: | K113728, SurFuse TM Putty, ExFuse TM Putty, |
| HansBiomed Corp | |
| K051188, GRAFTON® DBM, Osteotech, Inc. | |
| K091217, DBX Demineralized bone matrix putty, | |
| Musculoskeletal Transplant Foundation. | |
| Indications for Use: | The SurFuse TM II Putty and ExFuse TM 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 Description: | The SurFuse TM II Putty and ExFuse TM II Putty are derived from |
| human allograft bone tissue that is processed into a powder and | |
| demineralized using a hydrochloric acid process. The | |
| demineralized bone matrix (DBM) is combined with a resorbable | |
| carrier, carboxymethylcellulose (CMC) and formulated into a | |
| putty-like consistency. The ExFuse TM II Putty also contains | |
| cancellous bone powder. They are provided sterile for single | |
| patient use. The products are provided sterile for single patient | |
| use. |
Page 1 of 2
1
| Submitter:
Hans Biomed Corp. | SurFuse™ and ExFuse™
Traditional 510(k) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Serological Testing
& Biocompatibility | The donor bone is obtained from AATB-certified tissue banks in
the United States and the donor suitability criteria used to screen
donors are in compliance with the FDA regulations published in
21 CFR Part 1270 and Part 1271 Human Tissue Intended for
Transplantation. |
| | Further the manufacturing and sterilization processes were
assessed for viral inactivation potency by a validation
assessment, which included Human Immunodeficiency Virus-1
(HIV-1), Bovine Herpes Virus (BHV), Bovine Viral Diarrhea Virus
(BVDV), Hepatitis A Virus (HAV) and Porcine Parvovirus (PPV). |
| | Biocompatibility testing, according to ISO 10993, has been
performed and the devices have been shown to be non-toxic
and biocompatible. |
| Performance: | The devices were tested to characterize their osteoconductive
ability to grow bone in vivo in the dog alveolar bone model. |
| | They also have been tested in vivo in the athymic (nude) rat
muscle pouch model and were shown to have osteoinductive
potential, in that new bone grew within the muscle tissue. The
osteoinductive potential also was evaluated with a surrogate, in
vitro BMP-2 ELISA, assay. Results from that assay were
correlated with results from the same lots in which bone
successfully formed in the athymic rat. |
| | Each lot of the SurFuse™ II and ExFuse™ II devices will be
evaluated for osteoinductive potential using the in vitro assay. |
| | Osteoinduction assay results observed in surrogate
assessments should not be interpreted to predict clinical
performance in human subjects. |
| Comparison to the
Predicate Devices: | The SurFuse™ II and ExFuse™ II devices, with respect to
Intended Use as bone void fillers, are the same as the both
predicate families of devices; and with respect to the Indications
for Use to augment intraosseous, oral and maxillofacial defects,
are the same as the Grafton® DBM predicate. |
| | The SurFuse™ II and ExFuse™ II devices are identical in all
respects including composition, processing, manufacturing and
packaging to the parent predicate SurFuse™ II and ExFuse™ II
devices and substantially equivalent in material composition and
device characteristics to the Grafton® DBM predicate. |
| Substantial
Equivalence
Conclusion | The comparisons and study data presented in the 510(k) lead to
the conclusion that the SurFuse™ II Putty and ExFuse™ II Putty
are substantially equivalent to the predicate devices. |
Page 2 of 2
. .
2
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.
3
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 (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" (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 (800) 638-2041 or (301) 796-7100 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
4
510(k) Number (if known):
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)
S. Runner -S 2.0 1:09 435 21 -05'00'
Section 4.0
Page 1 of 1