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

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. The submitted devices are provided in several volumes ranging from 0.3cc to 10 cc. The devices are supplied sterile for single patient use.

AI/ML Overview

The provided text describes a 510(k) summary for medical devices (SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, ExFuse™ Putty), which are resorbable calcium salt bone void fillers. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance comparisons against acceptance criteria for an AI/software device.

Therefore, much of the requested information (acceptance criteria, sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not present in this document, as it pertains to a different type of device evaluation (e.g., AI/ML-based diagnostic software).

However, I can extract information related to the device's performance studies that were conducted to establish its substantial equivalence.

Here's the breakdown of what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria in the manner an AI study would (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated qualitatively through in vivo studies to show osteoconductive and osteoinductive potential, indicating equivalence to predicate devices.

Performance Characteristic	Reported Device Performance
Osteoconduction	Successfully demonstrated bone growth in the in vivo rabbit unicortical defect model.
Osteoinductive Potential	Demonstrated in the athymic (nude) rat muscle pouch model, showing new bone growth within muscle tissue. Correlated with in vitro BMP-2 ELISA assay results.

2. Sample size used for the test set and the data provenance

Rabbit unicortical defect model: The text states "in vivo rabbit unicortical defect model," but does not explicitly provide the number of rabbits or defects used.
Athymic (nude) rat muscle pouch model: The text states "in vivo in the athymic (nude) rat muscle pouch model," but does not explicitly provide the number of rats used.
Data Provenance: The in vivo animal studies are experimental, not retrospective or prospective human clinical data. The bone material itself is derived from human donors in the United States and screened.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. These are in vivo animal studies (rabbit, rat) and in vitro assays, not studies requiring expert human interpretation of medical images or clinical outcomes. The "ground truth" would be the biological outcome observed and quantified in these animal models (e.g., new bone formation assessed histologically or radiographically by researchers).

4. Adjudication method for the test set

Not applicable. This is not a study involving human readers or clinical adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes bone void filler devices, not AI-powered diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an algorithm. The in vitro BMP-2 ELISA assay is an in vitro test, which is a standalone lab test, but not an algorithm.

7. The type of ground truth used

For Osteoconduction and Osteoinductive Potential: The "ground truth" is established through direct observation and measurement of biological outcomes (new bone formation) in animal models. This would typically involve histological analysis, imaging (e.g., X-ray, micro-CT) and potentially biochemical markers.

8. The sample size for the training set

Not applicable. These are in vivo and in vitro performance studies for a medical device, not an AI/ML algorithm requiring a training set in the computational sense. Each lot of the device will be evaluated using the in vitro assay, implying ongoing quality control rather than a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML algorithm described.

Summary

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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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

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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 FoundationReference: K113728, SurFuse™ Gel, SurFuse™ Putty, ExFuse™Gel, ExFuse™ Putty, Hans Biomed Corp.
Statement of IntendedUse:	SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, ExFuse™ Puttyproducts are indicated for bony voids or gaps that are not intrinsicto the stability of the bone structure. They are intended to begently packed into bony voids or gaps of the skeletal system as abone void filler in the extremities and pelvis. These defects may besurgically created osseous defects or osseous defects created fromtraumatic injury to the bone. These products resorb and arereplaced with bone during the healing process.
Device Description	Device Identification and Materials of Use:The submitted devices are resorbable bone void filler, combiningHuman Demineralized Bone Matrix (DBM) with cancellous bonepowder and carboxymethylcellulose (CMC).The primary component of SurFuse™ and ExFuse™ isdemineralized particle bone which is derived from human donorcortical bone. The additional bone powder in the ExFuse™ isderived 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 voidfiller devices are substantially equivalent to the primary and
	supporting predicate devices.

Regulation Number and Section

§ 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.