(268 days)
No
The device description and performance studies focus on the biological and material properties of the bone void filler, with no mention of AI or ML.
Yes
The device is a bone void filler intended to facilitate bone healing and growth in the skeletal system, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is described as a "resorbable bone void filler" intended to be "gently packed into bony voids or gaps of the skeletal system." Its function is to facilitate healing by being replaced with bone, not to identify, analyze, or monitor a medical condition.
No
The device description clearly states it is a resorbable bone void filler combining physical materials (Human Demineralized Bone Matrix, cancellous bone powder, carboxymethylcellulose). It is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is a resorbable bone void filler made of bone matrix and other materials. It is designed to be implanted in the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition. The performance studies focus on bone growth and osteoinductive potential, which are related to its function as a bone void filler, not a diagnostic test.
IVD devices are used outside the body to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used inside the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
SurFuseTM Gel, SurFuseTM Putty, ExFuse™ Gel, ExFuseTM Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bone structure. They are intended to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products resorb and are replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MOV, MBP
Device Description
Device Identification and Materials of Use: The submitted devices are resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with cancellous bone powder and carboxymethylcellulose (CMC). The primary component of SurFuse™ and ExFuse™ is demineralized particle bone which is derived from human donor cortical bone. The additional bone powder in the ExFuse™ is derived from human donor cancellous bone. The CMC is added to enhance the cohesiveness of the composition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
institutional health care or hospital environments.
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)
Osteoconduction and Performance as a Bone Void Filler: The submitted devices were tested successfully to fully assess the performance to grow bone in the in vivo rabbit unicortical defect model.
Osteoinductive Potential: 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 device 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.
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
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
February 22, 2018
Hans Biomed Corporation % Patsy J. Trisler, JD, RAC Regulatory Consultant Trisler Consulting 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815
Re: K171568
Trade/Device Name: SurFuse™ Gel. SurFuse™ Putty. ExFuse™ Gel. ExFuse™ Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV, MBP Dated: January 12, 2018 Received: January 16, 2018
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.
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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K171568
Device Name
SurFuseTM Gel, SurFuseTM Putty, ExFuse™ Gel, ExFuseTM Putty
Indications for Use (Describe)
SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bone structure. They are intended to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products resorb and are replaced with bone during the healing process.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5.0 510(k) SUMMARY
| Submitter Name: | Hans Biomed Corp. |
|---|---|
| Submitter Address: | 64, Yuseong-daero 1628beon-gil, Yuseong-gu, Daejeon, |
| Republic of Korea | |
| Contact Person: | Ms. Lucy Choi |
| Phone Number: | 82 2 466 2266 |
| Fax Number: | 82 2 463 1554 |
| Date Prepared: | May 30, 2017 |
| Device Trade Name: | SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, ExFuse™ Putty |
| Device Common Name: | Resorbable Calcium Salt Bone Void Filler Device |
| Classification Number: | 21 CFR 888.3045 |
| Product Code: | MQV, MBP |
| Classification Name: | Filler, bone void, calcium compound |
| Device Class: | II |
| Predicate Devices: | Primary: K103784, DBX® Demineralized Bone Matrix Putty, |
| Musculoskeletal Transplant Foundation | |
| Reference: K113728, SurFuse™ Gel, SurFuse™ Putty, ExFuse™ | |
| Gel, ExFuse™ Putty, Hans Biomed Corp. | |
| Statement of Intended | |
| Use: | SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, ExFuse™ Putty |
| products are indicated for bony voids or gaps that are not intrinsic | |
| to the stability of the bone structure. They are intended to be | |
| gently packed into bony voids or gaps of the skeletal system as a | |
| bone void filler in the extremities and pelvis. These defects may be | |
| surgically created osseous defects or osseous defects created from | |
| traumatic injury to the bone. These products resorb and are | |
| replaced with bone during the healing process. | |
| Device Description | Device Identification and Materials of Use: |
| The submitted devices are resorbable bone void filler, combining | |
| Human Demineralized Bone Matrix (DBM) with cancellous bone | |
| powder and carboxymethylcellulose (CMC). | |
| The primary component of SurFuse™ and ExFuse™ is | |
| demineralized particle bone which is derived from human donor | |
| cortical bone. The additional bone powder in the ExFuse™ is | |
| derived from human donor cancellous bone. | |
| The CMC is added to enhance the cohesiveness of the composition. |
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Device Characteristics:
The submitted devices are provided in several volumes ranging from 0.3cc to 10 cc. The devices are supplied sterile for single patient use.
Body Contact:
The submitted devices are a permanent resorbable device, implanted in bone tissue.
Mechanism of Action:
The submitted devices resorb over time and remodel providing an osteoconductive scaffold for regeneration of new bone. In addition, because the devices are composed primarily of DBM, they have osteoinductive potential.
Environment of Use:
The submitted devices are for use only in institutional health care or hospital environments.
Serological Testing & Biocompatibility:
The donor bone is obtained from AATB-certified tissue banks in the United States and screened for:
- antibodies to the human immunodeficiency virus, type1 and type2 (anti- HIV-1 and anti-HIV-2);
- . nucleic acid test (NAT) for HIV-1:
- . hepatitis B surface antigen (HBsAg);
- . nucleic acid test (NAT) for the hepatitis B virus (HBV);
- total antibodies to hepatitis B core antigen (anti-HBc-total, meaning IgG and IgM);
- o antibodies to the hepatitis C virus (anti-HCV);
- nucleic acid test (NAT) for HCV; and
- syphilis (a non-treponemal or treponemal-specific assay may o be performed)
The manufacturing and sterilization processes were assessed for viral inactivation potency by a validation assessment which includes Human Immunodeficiency Virus-1 (HIV-1), Bovine Herpes Virus (BHV), Bovine Viral Diarrhea Virus (BVDV), Hepatitis A Virus (HAV) and Porcine Parvovirus (PPV). The validation assessment observed complete inactivation of inoculated viral titers.
Biocompatibility testing, according to ISO 10993, has been performed and the device has been shown to be safe, non-toxic and biocompatible.
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| Performance: | Osteoconduction and Performance as a Bone Void Filler: |
|---|---|
| The submitted devices were tested successfully to fully assess the | |
| performance to grow bone in the in vivo rabbit unicortical defect | |
| model. | |
| Osteoinductive Potential: | |
| 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 device 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 | The submitted devices have the same intended use as the primary |
| Predicate Devices: | predicate device. |
| The devices contain the same base osteoconductive material, | |
| DBM, as all predicate devices. They are provided in a syringe | |
| package and contain an additional carrier, as all predicate devices. | |
| The submitted devices are manufactured in the same facility and | |
| sterilized in the same establishment as the supporting predicate | |
| devices, SurFuse™ Gel & Putty and ExFuse™ Gel & Putty | |
| (Κ113728). | |
| Substantial Equivalence | The comparisons summarized above and the study data presented |
| Conclusion: | in the 510(k) lead to the conclusion that the submitted bone void |
| filler devices are substantially equivalent to the primary and | |
| supporting predicate devices. |