(114 days)
ReBOSSIS85 is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. ReBOSSIS85 is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities and pelvis), and may be used without hydrated with blood. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
ReBOSSIS85 is a synthetic, resorbable bone void filler. It is composite material consisting of (by weight) 40% beta-tricalcium phosphate (8-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide-co-glycolide). The electrospining process used in manufacturing ReBOSSIS85 results in a glass wool-like physical form. Due to its physical form, ReBOSSIS85 is flexible and can easily fill defects in appropriate amounts. ReBOSSIS85 is provided sterile for single-patient, single-use.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text. It's important to note that this document is a 510(k) summary for a medical device (ReBOSSIS85), which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than strictly defining and meeting performance acceptance criteria in the same way a novel device might. Therefore, the "acceptance criteria" here are largely implied by demonstrating comparable performance to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Biocompatibility | Passed biocompatibility testing using methods described in AAMI/ANSI/ISO 10993-1, 10993-5, 10993-10, 10993-11, and 10993-12. Pyrogenicity and bacterial endotoxin testing passed using methods described in USP 39-NF 34 <151> and USP 39-NF 34 <85>. |
| Effectiveness (Bone Void Filling & Resorption): Comparable radiographic appearance to predicate.Comparable histologic evaluation to predicate.Comparable histomorphometric analysis to predicate. | In a rabbit distal femoral condyle critical-sized defect model, the radiographic, histologic, and histomorphometric performance of ReBOSSIS85 was demonstrated to be equivalent to that of the predicate Actifuse ABX device (K071206). Histology sections were graded according to AAMI/ANSI/ISO 10993-6 (Annex E). |
| Material Characteristics: Chemical composition similar to predicate.Physical characteristics similar (or justified differences). | ReBOSSIS85: 40% beta-tricalcium phosphate (β-TCP), 30% siloxane-containing vaterite (SiV), 30% poly(L-lactide-co-glycolide). Approximately 0.7% Si by weight.Primary Predicate (Actifuse ABX): Hydroxyapatite (HA), 0.8% Si by weight, resorbable polymer/aqueous gel carrier.Reference Predicate (REBOSSIS): 40% β-TCP, 30% SiV, 30% Poly(L-lactide). 1% Si by weight.Physical Form: ReBOSSIS85 and REBOSSIS are "glass wool-like, produced by electrospinning." Actifuse ABX is "Irregularly shaped granules premixed with an aqueous gel carrier." This difference is acknowledged but similarity to the reference predicate is highlighted. |
| Sterility & Shelf Life: Sterile and stable over time. | Sterilization validation (AAMI/ANSI/ISO 11137-1, 11137-2), sterile barrier shelf life (ASTM F1140/F1140M, ASTM F2096), and product shelf life testing performed. Provided sterile (gamma irradiation). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Animal Study: Not explicitly stated in the document, but it was tested in "a rabbit distal femoral condyle critical-sized defect model." The number of animals used is not provided.
- Data Provenance: The animal study was conducted to demonstrate substantial equivalence. The country of origin is not specified for the animal study, but the manufacturer (ORTHOREBIRTH Co., Ltd.) is located in Japan. The study is prospective in nature, as it involves implanting the device into animals and observing outcomes over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document mentions "decalcified histologic evaluation, and histomorphometric analysis. Histology sections also were graded according to AAMI/ANSI/ISO 10993-6 (Annex E)."
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified, but implied to be qualified histologists/pathologists who can grade sections according to ISO standards.
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method like 2+1 or 3+1. Histologic grading "according to AAMI/ANSI/ISO 10993-6 (Annex E)" suggests a standardized evaluation process, but details on how agreement or disagreement among multiple graders (if any were used) was resolved are not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a bone void filler, not an imaging analysis AI device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This question is not applicable. The device is a physical bone void filler, not an algorithm or AI. The performance studies evaluate the physical device's biological interaction and efficacy, not an algorithm's output.
7. The Type of Ground Truth Used
- The ground truth for the animal study was established through a combination of:
- Radiographic imaging: To assess bone regeneration.
- Micro-computed tomography (micro-CT) imaging: For detailed 3D assessment of bone architecture and defect filling.
- Decalcified histologic evaluation: Microscopic examination of tissue sections.
- Histomorphometric analysis: Quantitative measurement of tissue components from histological sections.
- These methods collectively provide a definitive biological and structural assessment of the device's performance in vivo.
8. The Sample Size for the Training Set
- This concept is not applicable to a physical medical device like a bone void filler. "Training set" refers to data used to train machine learning algorithms. The development of ReBOSSIS85 would have involved R&D, pre-clinical testing, and optimization, but not in the sense of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no "training set" in the context of an algorithm for this physical device. The understanding of appropriate materials and designs for bone void fillers would be based on established medical science, prior device development, and material science research, rather than a labeled training dataset.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ORTHOREBIRTH Co., Ltd. % Kevin A. Thomas. Ph.D. Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
June 23, 2017
Re: K170620
Trade/Device Name: REBOSSIS85 Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: May 18, 2017 Received: May 19, 2017
Dear Dr. Thomas:
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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. 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.
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.
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
510(k) Number (if known)
Device Name
ReBOSSIS85
Indications for Use (Describe)
ReBOSSIS85 is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. ReBOSSIS85 is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities and pelvis), and may be used without hydrated with blood. The device provides a bone void filler that is resorbed and replaced with host 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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Expiration Date: January 31, 2017
See PRA Statement below.
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510(k) Summary ORTHOREBIRTH Co., Ltd. ReBOSSIS85
February 28, 2017
ADMINISTRATIVE INFORMATION
| Manufacturer Name | ORTHOREBIRTH Co., Ltd. | |
|---|---|---|
| 3-17-43 Chigasaki Higashi | ||
| Tsuzuki-ku Yokohama, Kanagawa, 224-0033, Japan | ||
| Telephone: | +81-45532-3650 | |
| Fax: | +81-45532-3691 | |
| Official Contact | Yasutoshi Nishikawa, CEO | |
| Representative/Consultant | Kevin A. Thomas, PhD | |
| Floyd G. Larson, MS, MBA | ||
| PaxMed International, LLC | ||
| 12264 El Camino Real, Suite 400San Diego, CA 92130 | ||
| Telephone: | +1-858-792-1235 | |
| Fax: | +1-858-792-1236 | |
| Email: | kthomas@paxmed.com | |
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | ReBOSSIS85 |
|---|---|
| Common Name | Filler, bone void, calcium compound |
| Classification Name | Resorbable calcium salt bone void filler device |
| Classification RegulationsProduct Code | 21 CFR 888.3045, Class IIMQV |
| Classification PanelReviewing Branch | Orthopaedic and Rehabilitation Devices PanelRestorative and Repair Devices Branch (RRDB) |
PREDICATE DEVICE INFORMATION
Primary Predicate K071206, Actifuse™ ABX E-Z-fil Putty Bone Graft Substitute, ApaTech Limited.
Reference Predicate K142090, REBOSSIS, ORTHOREBIRTH Co., Ltd.
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INDICATIONS FOR USE
ReBOSSIS85 is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. ReBOSSIS85 is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities and pelvis), and may be used without hydrated with blood. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
DEVICE DESCRIPTION
ReBOSSIS85 is a synthetic, resorbable bone void filler. It is composite material consisting of (by weight) 40% beta-tricalcium phosphate (8-TCP), 30% siloxane-containing vaterite (a form of calcium carbonate, CaCO3), and 30% poly(L-lactide-co-glycolide). The electrospining process used in manufacturing ReBOSSIS85 results in a glass wool-like physical form. Due to its physical form, ReBOSSIS85 is flexible and can easily fill defects in appropriate amounts. ReBOSSIS85 is provided sterile for single-patient, single-use.
PERFORMANCE DATA
Non-clinical testing data submitted to demonstrate substantial equivalence included chemical characterization. physical characterization, sterilization, shelf life validation, biocompatibility, and in vivo (animal) performance.
Characterization of the ReBOSSIS85 material included: true density by pycnometry, chemical composition by energy dispersive x-ray spectrometry (EDX), trace elemental analysis by inductively coupled plasmalmass spectroscopy (ICP-MS) and inductively coupled plasma/atomic emission spectroscopy (ICP-AES), residual solvents by the methods described in USP <467>, surface microstructure by scanning electron microscopy (SEM), and polymer properties by gel permeation chromatography (GPC) and differential scanning calorimetry (DSC). ReBOSSIS85 also was characterized by a variety of techniques at baseline (time zero) and after immersion in TRIS-HCl buffer media at 37 °C. The evaluations performed included: in vitro release kinetics of Si, Ca, and P ions using inductively coupled plasma spectroscopy (ICP); the pH of the solution; imaging of the material (after drying) by scanning electron microscopy (SEM); and polymer weight-average molecular weight by gel permeation chromatography (GPC).
Sterilization validation, sterile barrier shelf life, and product shelf life testing were performed using methods described in AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 11137-2, ASTM F1140/F1140M, and ASTM F2096.
Biocompatibility testing was performed using methods described in AAMI/ANSI/ISO 10993-1, AAMI/ANSI/ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-12. Pyrogenicity and bacterial endotoxin testing were performed using methods described in USP 39-NF 34 <151> and USP 39-NF 34 <85>.
Animal testing performed to demonstrate substantial equivalence included determination of radiographic, histologic and histomorphometric characteristics of the subject device and the predicate device in a rabbit distal femoral condyle critical-sized defect model. The study time points included baseline (1 day), 6 weeks, and 12 weeks. Evaluation endpoints included radiography, micro-computed tomography (micro-CT) imaging, decalcified histologic evaluation, and histomorphometric analysis. Histology sections also were graded according to AAMI/ANSI/ISO 10993-6 (Annex E).
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EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the predicated above. A summary table comparing the Indications for Use and the technological characteristics of the subject device and the predicate devices is provided below.
| Comparison | Subject Device | Primary Predicate Device | Reference Predicate Device |
|---|---|---|---|
| K071206 | K142090 | ||
| ReBOSSIS85 | Actifuse™ ABX E-Z-fill Putty Bone Graft | REBOSSIS | |
| ORTHOREBIRTH Co., Ltd. | SubstituteApaTech Limited | ORTHOREBIRTH Co., Ltd. | |
| Indications for UseStatement | ReBOSSIS85 is intended for use in bony voids orgaps that are not intrinsic to the stability of thebony structure. These defects may be surgicallycreated osseous defects or osseous defects createdfrom traumatic injury to the bone. ReBOSSIS85 isindicated to be packed gently into bony voids orgaps of the skeletal system (extremities andpelvis), and may be used without hydration orhydrated with blood. The device provides a bonevoid filler that is resorbed and replaced with hostbone during the healing process. | Actifuse is a bone void filler intended only fororthopaedic applications as a filler for gaps andvoids that are not intrinsic to the stability of thebony structure. Actifuse is indicated to be packedgently into bony voids or gaps of the skeletalsystem, i.e., extremities, pelvis, and spine,including use in posterolateral fusion procedureswith appropriate stabilizing hardware. Thesedefects may be surgically created osseous defectsor osseous defects created from traumatic injuryto the bone. The product provides a bone voidfiller that resorbs and is replaced by bone duringthe healing process. | REBOSSIS is a bone void filler intended for usein bony voids or gaps that are not intrinsic to thestability of the bony structure. These defects maybe surgically created osseous defects or osseousdefects created from traumatic injury to the bone.REBOSSIS is indicated to be packed gently intobony voids or gaps of the skeletal system(extremities and pelvis), and may be used withouthydration or hydrated with bone marrow aspirateor blood. The device provides a bone void fillerthat is resorbed and replaced with host boneduring the healing process. |
| Product Code | MOV | MOV | MQV |
| Intended Use | Bone void filler for skeletal system (extremities,pelvis) | Bone void filler for skeletal system (extremities,pelvis) and posterolateral spine | Bone void filler for skeletal system (extremities,pelvis) |
| Design | |||
| Form | Glass wool-like, produced by electrospinning | Irregularly shaped granules premixed with anaqueous gel carrier | Glass wool-like, produced by electrospinning |
| Granule Size | Not applicable | 1-2 mm (1000 - 2000 um) | Not applicable |
| Fiber Size | nominal fiber diameter range: 3 um to 150 umspecification of maximum fiber diameter: 250 um | Not applicable | nominal fiber diameter range 10 um - 50 µm |
| Porosity | Approximately 98 % (dry, no hydration) | Not stated | > 98 % |
| Materials | |||
| Calcium salts | B-tricalcium phosphate, 40 % by weightSiloxane-containing vaterite (SiV), 30 % byweight | Hydroxyapatite (HA) | B-tricalcium phosphate, 40 % by weightSiloxane-containing vaterite (SiV), 30 % byweight |
| Silicon | Approximately 0.7 % by weightRange, 0.5 % - 1 % by weight | 0.8 % by weight | 1 % by weight |
| Scaffold/Binder | Poly(L-lactide-co-glycolide), 30% by weight | Resorbable polymer; aqueous gel carrier | Poly(L-lactide) |
| How Provided | |||
| Sizes | Provided in 0.5, 1, and 2 gram packagesApproximate volume:13-50 cc (dry, no hydration)5-20 cc (after hydration) | Provided in delivery syringeVolumes ranging from 1.5 mL to 20 mL | Provided in 2 gram packageApproximate volume: 70-80 cc |
| Sterility | Provided sterile to end-user | Provided sterile to end-user | Provided sterile to end-user |
| Sterilization | Gamma irradiation | Electron-beam irradiation | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
| Table of Substantial Equivalence | |
|---|---|
| ---------------------------------- | -- |
The primary predicate device is K071206 for substantial equivalence in the animal model performance testing. The reference predicate device is K142090 for support of substantial equivalence in the physical form and the material composition (same mineral components and similar resorbable polymer scaffolds).
The subject device and the predicate devices have the same intended uses, the same product classification and product code (MQV), and have similar Indications for Use statements. The subject device and the predicate devices are bone void fillers that are intended for bony voids or gaps that are not intrinsic to the stability of the bony structure. The subject device, predicate device K071206, and predicate device K142090 all have indications for use in the extremities and pelvis, and may be used without hydrated with bone marrow aspirate or blood (the subject device is to be hydrated with blood only). Although the subject device and the predicate devices have slightly different Indications for Use language, these differences do not change the intended use as a bone void filler in the extremities and pelvis.
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510(k) Summary Page 4 of 4
The subject device and the predicate devices all incorporate calcium phosphate materials with Si (ReBOSSIS85 approximately 0.7% Si by weight. Actifuse ABX approximately 0.8% by weight. REBOSSIS approximately 1% Si by weight), and all also incorporate a polymeric scaffold or binder. The subject device and the reference predicate device K142090 have very similar physical forms and material components. The subject device and the predicate devices are provided sterile for single-patient, single-use in similar ranges of graft volumes.
The radiographic, histologic and histomorphometric performance of the subject device were compared to that of the predicate device K071206 (Actifuse ABX) in a rabbit distal femoral condyle critical-sized defect model. The results of the study demonstrated that the performance of the subject ReBOSSIS85 device was equivalent to that of the predicate Actifuse ABX device.
No clinical data were included in this submission.
CONCLUSION
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate device listed above.
§ 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.