(269 days)
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
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.
The provided text does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device called "MaxiGen™," which is a resorbable calcium salt bone void filler. It describes the device's indications for use, materials, testing for biocompatibility and performance (osteoconduction and osteoinduction), and comparison to predicate devices, but it does not involve any AI technology or related performance metrics.
Therefore, I cannot provide the requested information.
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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
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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) |
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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 DEVICES | K020895, ALLOMATRIX® Putty,Wright Medical Technology, IncK053319, ALLOMATRIX® Custom Putty,Wright Medical Technology, IncK113728, SurFuse™ Gel & Putty and ExFuse™ Gel & Putty,Hans Biomed Corp. |
| STATEMENT OFINTENDED USE | MaxiGen™ is an implant intended to fill bony voids or gaps of theskeletal system i.e., posterolateral spine. These osseous defects aresurgically created or the result of traumatic injury to the bone andare not intrinsic to the stability of the bony structure. MaxiGen™resorbs and is replaced with bone during the healing process |
| DEVICE DESCRIPTION | Device Identification, Materials of Use and Characteristics:MaxiGen™ is a resorbable bone void filler, combining HumanDemineralized Bone Matrix (DBM) with calcium sulfate andcarboxymethylcellulose (CMC).MaxiGen™ comes in the form of a kit with a premeasured andpremixed DBM, calcium sulfate, and CMC powder, premeasuredmixing solution, the tools for mixing the components, and a 5ccsyringe. After the powder is hydrated using all the mixing solutionsupplied in the kit, the resultant putty can then be handled andplaced in the appropriate bone voids, or it can be injected using thesyringe supplied in the kit. This product is supplied sterile for |
| SUMMARY OFTESTINGSerological Testing &Biocompatibility: | The donor bone is obtained from AATB-certified tissue banks inthe United States and screened for:Antibodies to the Human Immunodeficiency Virus, Type 1and 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 assessedfor viral inactivation potency by a validation assessment whichincluded Human Immunodeficiency Virus-1 (HIV-1), BovineHerpes Virus (BHV), Bovine Viral Diarrhea Virus (BVDV),Hepatitis A Virus (HAV) and Porcine Parvovirus (PPV). Thevalidation assessment observed complete inactivation of inoculatedviral titers. | |
| Biocompatibility testing, according to ISO 10993, has beenperformed and the device has been shown to be safe, non-toxic andbiocompatible. | |
| Performance: | Osteoconduction and Performance as a Bone Void Filler:MaxiGen™ was tested successfully to fully assess the performanceto grow bone in the in vivo rabbit spinal model.Osteoinductive Potential:The device also has been tested in vivo in the athymic (nude) ratmuscle 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.
§ 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.