(345 days)
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.
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.
The provided text describes the 510(k) summary for the SurFuse™ II Putty and ExFuse™ II Putty, which are bone grafting materials. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with specific acceptance criteria and performance metrics in the way a diagnostic device submission might. Therefore, many of the requested elements for acceptance criteria and study design are not explicitly present in the provided text.
Based on the information given, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria with numerical targets. Instead, it focuses on demonstrating equivalence through:
- Donor Suitability: Compliance with FDA regulations (21 CFR Part 1270 and Part 1271) and AATB-certified tissue banks for donor bone.
- Viral Inactivation: Validation assessment for potency against HIV-1, BHV, BVDV, HAV, and PPV.
- Biocompatibility: Demonstrated as non-toxic and biocompatible according to ISO 10993.
- Osteoconductivity: Ability to grow bone in vivo in the dog alveolar bone model.
- Osteoinductivity: Osteoinductive potential shown in vivo in the athymic (nude) rat muscle pouch model and correlated with an in vitro BMP-2 ELISA assay.
Since specific quantitative "performance" metrics for these criteria are not given (e.g., "X% reduction in viral load," "Y units of new bone growth"), a direct table with numerical acceptance criteria and reported values cannot be constructed from the provided text. The reported "performance" is qualitative, stating that the devices met these assessments.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Osteoconductivity Study: "dog alveolar bone model." The sample size (number of dogs) is not specified.
- Osteoinductivity Study: "athymic (nude) rat muscle pouch model." The sample size (number of rats) is not specified.
- Data Provenance: The studies are described as in vivo animal models. The country of origin for the studies is not specified, though the submitter is HansBiomed Corp. from Korea, and donor bone is sourced from AATB-certified tissue banks in the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable and not provided. The studies involve animal models and in vitro assays, not human clinical evaluations requiring expert interpretation of primary data (like images). The "ground truth" for osteoconductivity and osteoinductivity would be determined by histological analysis and quantitative measures in the animal models and biophysical/biochemical assays, typically assessed by pathologists or laboratory scientists, but the number and qualifications of such individuals are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for human reader studies where there's a need to resolve discrepancies in expert interpretations (e.g., radiology case readings). These methods are not relevant to the in vivo animal model or in vitro assay studies described.
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
This is not applicable and not provided. MRMC studies are for evaluating the impact of AI assistance on human diagnostic performance, typically in imaging. This device is a bone grafting material, and its evaluation does not involve AI or human readers for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not provided. This device is a physical material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Osteoconductivity and Osteoinductivity: The ground truth appears to be based on pathology/histology and biochemical assays (BMP-2 ELISA) from in vivo animal models. The formation of new bone in the different animal models is the objective ground truth.
- Biocompatibility: The ground truth is established by adherence to ISO 10993 standards for non-toxicity and biocompatibility, likely through in vitro and in vivo tests described in those standards.
- Viral Inactivation: The ground truth is based on the effectiveness of the manufacturing and sterilization processes in inactivating specified viruses, assessed by validation studies.
8. The sample size for the training set
This is not applicable and not provided. The assessment described here involves characterization of the material's biological properties, not machine learning or AI, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
{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-gaSeongdong-guSeoul, 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 | NUNBone grafting material, human source |
| Device Class | II |
| Predicate Devices: | K113728, SurFuse TM Putty, ExFuse TM Putty,HansBiomed CorpK051188, 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 fillingmaterials indicated for dental intraosseous, oral and maxillofacialdefects, including periodontal/infrabony defects; alveolar ridgeaugmentation; dental extraction sites; sinus lifts; cystic defects. |
| Device Description: | The SurFuse TM II Putty and ExFuse TM II Putty are derived fromhuman allograft bone tissue that is processed into a powder anddemineralized using a hydrochloric acid process. Thedemineralized bone matrix (DBM) is combined with a resorbablecarrier, carboxymethylcellulose (CMC) and formulated into aputty-like consistency. The ExFuse TM II Putty also containscancellous bone powder. They are provided sterile for singlepatient use. The products are provided sterile for single patientuse. |
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 inthe United States and the donor suitability criteria used to screendonors are in compliance with the FDA regulations published in21 CFR Part 1270 and Part 1271 Human Tissue Intended forTransplantation. |
| Further the manufacturing and sterilization processes wereassessed for viral inactivation potency by a validationassessment, 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 beenperformed and the devices have been shown to be non-toxicand biocompatible. | |
| Performance: | The devices were tested to characterize their osteoconductiveability to grow bone in vivo in the dog alveolar bone model. |
| They also have been tested in vivo in the athymic (nude) ratmuscle pouch model and were shown to have osteoinductivepotential, in that new bone grew within the muscle tissue. Theosteoinductive potential also was evaluated with a surrogate, invitro BMP-2 ELISA, assay. Results from that assay werecorrelated with results from the same lots in which bonesuccessfully formed in the athymic rat. | |
| Each lot of the SurFuse™ II and ExFuse™ II devices will beevaluated for osteoinductive potential using the in vitro assay. | |
| Osteoinduction assay results observed in surrogateassessments should not be interpreted to predict clinicalperformance in human subjects. | |
| Comparison to thePredicate Devices: | The SurFuse™ II and ExFuse™ II devices, with respect toIntended Use as bone void fillers, are the same as the bothpredicate families of devices; and with respect to the Indicationsfor 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 allrespects including composition, processing, manufacturing andpackaging to the parent predicate SurFuse™ II and ExFuse™ IIdevices and substantially equivalent in material composition anddevice characteristics to the Grafton® DBM predicate. | |
| SubstantialEquivalenceConclusion | The comparisons and study data presented in the 510(k) lead tothe conclusion that the SurFuse™ II Putty and ExFuse™ II Puttyare 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
§ 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.