K Number
K152077
Device Name
MaxiGen
Manufacturer
Date Cleared
2016-04-21

(269 days)

Product Code
Regulation Number
888.3045
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MaxiGen™ is an implant intended to fill bony voids or gaps of the skeletal system i.e., posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MaxiGen™ resorbs and is replaced with bone during the healing process
Device Description
MaxiGen™ is a resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with calcium sulfate and carboxymethylcellulose (CMC). MaxiGen™ comes in the form of a kit with a premeasured and premixed DBM, calcium sulfate, and CMC powder, premeasured mixing solution, the tools for mixing the components, and a 5cc syringe. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids, or it can be injected using the syringe supplied in the kit. This product is supplied sterile for permanent resorbable device, implanted in bone tissue.
More Information

Not Found

No
The summary describes a bone void filler material and its physical properties and performance in animal models, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Yes

Explanation: The device is intended to fill bony voids or gaps of the skeletal system and is replaced by bone during the healing process, indicating a direct therapeutic effect on the body.

No
MaxiGen™ is described as an implantable bone void filler used for surgical repair, not for diagnosing conditions.

No

The device description clearly states it is a resorbable bone void filler combining physical components (DBM, calcium sulfate, CMC) and is supplied as a kit with powder, solution, tools, and a syringe. This is a physical medical device, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that MaxiGen™ is an "implant intended to fill bony voids or gaps of the skeletal system". This describes a device that is surgically placed within the body to aid in bone healing.
  • Device Description: The description details a "resorbable bone void filler" that is mixed and then "handled and placed in the appropriate bone voids, or it can be injected using the syringe supplied in the kit." This is a description of a material used in a surgical procedure, not a test performed on a sample taken from the body.
  • IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. MaxiGen™ does not perform any such testing.
  • Performance Studies: The performance studies described involve in vivo testing in animal models to assess bone growth and osteoinductive potential. This is consistent with evaluating an implantable device, not an IVD.

Therefore, based on the provided information, MaxiGen™ is a surgical implant, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

MaxiGen™ is an implant intended to fill bony voids or gaps of the skeletal system i.e., posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MaxiGen™ resorbs and is replaced with bone during the healing process

Product codes (comma separated list FDA assigned to the subject device)

MQV, MBP

Device Description

Device Identification, Materials of Use and Characteristics: MaxiGen™ is a resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with calcium sulfate and carboxymethylcellulose (CMC). MaxiGen™ comes in the form of a kit with a premeasured and premixed DBM, calcium sulfate, and CMC powder, premeasured mixing solution, the tools for mixing the components, and a 5cc syringe. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids, or it can be injected using the syringe supplied in the kit. This product is supplied sterile for

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

skeletal system i.e., posterolateral spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

MaxiGen™ is for use only in 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: MaxiGen™ was tested successfully to fully assess the performance to grow bone in the in vivo rabbit spinal model. Osteoinductive Potential: The device also has 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 MaxiGen™ device will be evaluated for osteoinductive potential using the in vitro assay.

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.

K020895, K053319, K113728

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

§ 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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

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

Hans Biomed Corporation % Ms. Patsy J. Trisler, JD, RAC Regulatory Consultant Trisler Consulting 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815

April 21, 2016

Re: K152077

Trade/Device Name: MaxiGen™ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: March 15, 2016 Received: March 15, 2016

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

1

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 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/Resourcesfor You/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/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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K152077

Device Name

MaxiGen™

Indications for Use (Describe)

MaxiGer™ is an implant intended to fill bony voids or gaps of the skeletal system i.e., posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MaxiGen™ resorbs and is replaced with bone during the healing process

100 - 100 - 100

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)X Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)
X Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
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==============================================================================================================================================================================

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Section 5.0 510(k) SUMMARY

Submitter Name:Hans Biomed Corp.
Submitter Address:64, Yuseong-Daero 1628Beon-Gil, Yuseong-Gu, Korea,
Republic of, 305-811
Contact Person:Ms. Lucy Choi
Phone Number:0082 2 466 2266
Fax Number:0082 2 463 1554
Date Prepared:July 27, 2015
Device Trade Name:MaxiGen™
Device Common Name:Resorbable Calcium Salt Bone Void Filler
Classification Number:21 CFR 888.3045
Product Code:MQV, MBP
Classification Name:Filler, bone void, calcium compound
Device Class:II
PREDICATE DEVICESK020895, ALLOMATRIX® Putty,
Wright Medical Technology, Inc
K053319, ALLOMATRIX® Custom Putty,
Wright Medical Technology, Inc
K113728, SurFuse™ Gel & Putty and ExFuse™ Gel & Putty,
Hans Biomed Corp.
STATEMENT OF
INTENDED USEMaxiGen™ is an implant intended to fill bony voids or gaps of the
skeletal system i.e., posterolateral spine. These osseous defects are
surgically created or the result of traumatic injury to the bone and
are not intrinsic to the stability of the bony structure. MaxiGen™
resorbs and is replaced with bone during the healing process
DEVICE DESCRIPTIONDevice Identification, Materials of Use and Characteristics:
MaxiGen™ is a resorbable bone void filler, combining Human
Demineralized Bone Matrix (DBM) with calcium sulfate and
carboxymethylcellulose (CMC).
MaxiGen™ comes in the form of a kit with a premeasured and
premixed DBM, calcium sulfate, and CMC powder, premeasured
mixing solution, the tools for mixing the components, and a 5cc
syringe. After the powder is hydrated using all the mixing solution
supplied in the kit, the resultant putty can then be handled and
placed in the appropriate bone voids, or it can be injected using the
syringe supplied in the kit. This product is supplied sterile for
SUMMARY OF
TESTING
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, Type 1
and Type 2 (anti-HIV-1 and anti-HIV-2); Nucleic Acid Test (NAT) for HIV-1; Hepatitis B Surface Antigen (HBsAg); Total antibodies to Hepatitis B core antigen (anti-HBc-
total); Antibodies to the Hepatitis C Virus (anti-HCV); Nucleic Acid Test (NAT) for HCV; Syphilis
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). 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.
Performance:Osteoconduction and Performance as a Bone Void Filler:
MaxiGen™ was tested successfully to fully assess the performance
to grow bone in the in vivo rabbit spinal model.
Osteoinductive Potential:
The device also has been tested in vivo in the athymic (nude) rat
muscle pouch model and were shown to have osteoinductive

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Body Contact:

MaxiGen™ is a permanent resorbable device, implanted in bone tissue.

Mechanism of Action:

This device resorbs over time and remodels providing an osteoconductive scaffold for regeneration of new bone. In addition, because it contains DBM, it has osteoinductive potential.

Environment of Use:

MaxiGen™ is for use only in institutional health care or hospital environments.

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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 MaxiGen™ 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.

MaxiGen™ has the same intended use as a bone void filler as all COMPARISON TO PREDICATE DEVICES: three predicate devices, and the same indication for use in posterolateral spine fusion procedures as the two supporting predicate devices.

MaxiGen™ has the same material composition as the primary predicate, AlloMatrix® Putty. The other two predicates also include cancellous bone and the SurFuse™/ExFuse™ predicate does not contain calcium sulfate. All contain CMC as the carrier.

With respect to device form and packaging, MaxiGen™ is substantially equivalent to all three predicate devices.