(261 days)
Sorrento Bone Graft Substitutes are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the bony structure. Sorrento Bone Graft Substitutes are also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitutes must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed and replaced with bone during the healing process
Sorrento BioGlass Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) and Bioglass 45S5 (ASTM F1538) dispersed throughout. The implant is provided as sterile, for single-use in double peel packages.
The document is a 510(k) summary for the Sorrento™ Bioglass Bone Graft Substitute. It does NOT describe an AI/ML powered device, nor does it detail an AI/ML study.
Therefore, I cannot provide the requested information about acceptance criteria or a study proving an AI device meets acceptance criteria. The document focuses on demonstrating substantial equivalence of a bone graft substitute to predicate devices through biocompatibility, bench testing, and animal studies.
Here's an analysis of what the document does provide, structured to address your points, though many will be flagged as "Not Applicable (N/A)" for an AI device:
1. Table of Acceptance Criteria and Reported Device Performance
As this is not an AI/ML device, the acceptance criteria and performance are related to the material properties and biological response of the bone graft substitute, not AI model metrics.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2009 for biological evaluation; Acceptable biological safety profiles (Material-Mediated Pyrogenicity, Cytotoxicity, Irritation, Sensitization, Implantation); Endotoxin level within established acceptance criteria. | Biocompatibility testing performed according to ISO 10993-1:2009 and FDA Guidance. Showed acceptable biological safety profiles for Material-Mediated Pyrogenicity, Cytotoxicity, Irritation, Sensitization, and Implantation. Bacterial endotoxin testing confirmed an endotoxin level within the established acceptance criteria. |
| Bench Testing | Compliance with ASTM F1088 (beta tricalcium phosphate), ASTM F2212 (collagen), and ASTM F1538 (Bioglass). Ability to form an in vitro layer of apatite. | Substantial equivalence supported by evaluation per ASTM F1088, ASTM F2212, and ASTM F1538. Bioactivity evaluated by SEM and FTIR confirmed the ability of the subject device to form an in vitro layer of apatite. |
| Animal Study | Demonstrate substantial equivalence to predicate and reference devices in terms of performance (radiographically and histomorphometrically) at 3, 6, and 12 weeks post-implantation. | A distal femoral defect model in rabbits compared the subject device to the predicate (Sorrento Bone Graft Substitute K141429) and reference (Vitoss Foam Bone Graft Substitute K083033) at 3, 6, and 12 weeks. Study data demonstrated that the subject device is substantially equivalent with the predicate and reference devices. Also supported by evaluation per ASTM F1088 (beta tricalcium phosphate), ASTM F2212 (collagen), and ASTM F1538 (Bioglass). |
| Material Composition | Bioglass 45S5 per ASTM F1538, Highly purified collagen (ASTM F2212), high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088). Chemical Composition: Calcium salt with Type I bovine collagen and Bioglass (~90:5:5 w/w). Mineral Phase: Beta-Tricalcium Phosphate Ca3(PO4)2. Porosity: >80% (beta-TCP), 64-78% (Bioglass). Pore Size: ~1-732 μm (312 ± 140 μm) bioglass. Resorption: Resorbable. | Subject device meets these specifications as described in the "Technological Characteristics" table. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: For the animal study, the document mentions "rabbits" but does not specify the exact number of animals used.
- Data Provenance: The animal study was conducted to compare the device with predicate and reference devices. No country of origin is specified. It is a prospective animal study.
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)
- N/A. This device does not involve expert-established ground truth in the context of AI/ML. The evaluation involved radiographic and histomorphometric analysis in an animal model, which would typically be performed by trained veterinary pathologists or researchers, but no specific number or qualifications are provided in this regulatory summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. This is not relevant for the type of study described (biocompatibility, bench testing, animal study for a bone graft).
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
- N/A. This document describes a bone graft substitute, not an AI device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This document describes a bone graft substitute, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the animal study, "performance was evaluated radiographically and histomorphometrically." Histopathological and radiographic findings in animal models serve as the "ground truth" to assess bone regeneration and material integration.
8. The sample size for the training set
- N/A. This document describes a bone graft substitute. There is no AI model, and therefore no training set.
9. How the ground truth for the training set was established
- N/A. This document describes a bone graft substitute. There is no AI model, and therefore no training set or ground truth establishment method for it.
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September 13, 2018
Xenco Medical, LLC Gustavo R. Prado, Ph.D. Vice President, R&D 9930 Mesa Rim Road San Diego, California 92121
Re: K173933
Trade/Device Name: Sorrento™ Bioglass Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 14, 2018 Received: August 15, 2018
Dear Dr. Prado:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173933
Device Name Sorrento™ Bioglass Bone Graft Substitute
Indications for Use (Describe)
Sorrento Bone Graft Substitutes are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the bony structure. Sorrento Bone Graft Substitutes are also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitutes must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed and replaced with 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) |
scription Use (Part 21 CFR 601 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY
l. SUBMITTER
Xenco Medical, LLC.
Contact Person: Gustavo Prado PhD Email: gprado@xencomedical.com
9930 Mesa Rim Road San Diego, CA 92121 USA Phone: 858-202-1505 ext 202 Fax: 858-202-1549 Date Prepared: 08/14/2018 Establishment Registration: 3011181154
II. DEVICE
SUBJECT DEVICE
Trade Name: Sorrento™ Bioglass Bone Graft Substitute Common Name: bone void filler Classification Name: Resorbable Calcium Salt Bone Void Filler Device Regulation: 21 CFR 888.3045 Device Class: Class II Product Code: MQV Review Panel: Orthopedic
PREDICATE DEVICE
| 510(k) Number | ProductCode | Trade Name | Manufacturer |
|---|---|---|---|
| K141429Primary | MQV | Sorrento™ BoneGraft Substitute | Xenco Medical, LLC. |
| K083033Reference | MQV | Vitoss® FoamBone GraftMaterial, Vitoss®Bioactive FoamBone GraftSubstitute | Orthovita, Inc. |
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lll. DEVICE DESCRIPTION
Sorrento BioGlass Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) and Bioglass 45S5 (ASTM F1538) dispersed throughout. The implant is provided as sterile, for single-use in double peel packages.
IV. INDICATIONS FOR USE
Sorrento Bone Graft Substitutes are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitutes are also indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitutes must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed and replaced with bone during the healing process
V. TECHNOLOGICAL CHARACTERISTICS
The subject device is substantially equivalent to the cited legally marketed predicate Sorrento (K141429) device. The subject device has equivalent technological characteristics including design, materials, operating principle and indications for use, physical structure, product sizing, chemical composition, mineral phase, porosity, and resorption.
| Characteristic | Sorrento BioGlass(Subject Device) | Sorrento(Predicate, K141429) | Vitoss Foam Bone GraftSubstitute and VitossBioactive Foam Bone GraftSubstitute(Reference, K083033) |
|---|---|---|---|
| Materials | • Beta TricalciumPhosphate per ASTMF1088• Type I bovine collagen perASTM F2212• Bioglass 45S5 per ASTMF1538 | • Beta TricalciumPhosphate per ASTMF1088• Type I bovine collagenper ASTM F2212 | • Beta TricalciumPhosphate per ASTMF1088• Type I bovine collagen perASTM F2212• Bioglass (Bioactiveversion only) |
| Physical Structure(Form) | • Porous collagen sponge(strip) with beta-TCP/Bioglass granules• Trabecular structuresimilar to cancellous bone | • Porous collagen sponge(strip) with beta-TCPgranules• Trabecular structuresimilar to cancellous | • Porous collagen sponge(strip) with beta-TCPgranules• Trabecular structuresimilar to cancellous bone |
Chart comparing subject device to the predicate devices:
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| bone | |||
|---|---|---|---|
| Dosage Forms(Sizing) | • 2cc (25 x 20 x 4 mm)• 5 cc (25 x 50 x 4 mm)• 10 cc (100 x 20 x 5 mm)• 12 cc (100 x 20 x 6 mm)• 20 cc (100 x 25 x 8 mm)• 24 cc (25 x 240 x 4 mm) | • 5 cc (25 x 50 x 4 mm)• 10 cc (100 x 20 x 5 mm)• 12 cc (100 x 20 x 6 mm)• 20 cc (100 x 25 x 8 mm)• 24 cc (25 x 240 x 4 mm) | • 2 cc (25 x 20 x 4mm)• 5 cc (25 x 50 x 4mm)(Bioactive)• 10 cc (100 x 25 x 4 mm)(Bioactive)• 10 cc (25 x 50 x 8)• 20 cc (100 x 25 x 8 mm)(Bioactive)• 24 cc (25 x 240 x 4 mm)• 30 cc (75 x 100 x 4 mm) |
| ChemicalComposition(Chemistry) | • Calcium salt with Type Ibovine collagen andBioglass (~90:5:5 w/w) | • Calcium salt with Type Ibovine collagen (~95:5w/w) | • Calcium salt with Type Ibovine collagen (~80:20w/w)• Calcium salt with Type Ibovine collagen andBioglass |
| Mineral Phase | • Beta-TricalciumPhosphate Ca3(PO4)2 | • Beta-TricalciumPhosphate Ca3(PO4)2 | • Beta-TricalciumPhosphate Ca3(PO4)2 |
| Porosity(beta-TCP) | • Highly porous, >80%• Bioglass 64-78% | • Highly porous, >80% | • Approximately 90% (non-Bioactive) |
| Pore Size (range)(Beta-TCP) | • ~1-732 μm (312 ±140 μm) bioglass | • ~1-732 μm (312 ± 140 μm) | • ~12-700 μm (non-Bioactive) |
| Resorption(Dissolution/Solubility) | • Resorbable | • Resorbable | • Demonstrated 80%resorbed at 12 weeks |
Xenco Medical, LLC. - Sorrento™ Bioglass Bone Graft Substitute September 11th, 2018
VI. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Analysis was performed according to ISO 10993-1:2009 and biological effects were considered based on FDA Guidance. "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Material-Mediated Pyrogenicity, Cytotoxicity, Irritation, Sensitization, and Implantation testing was performed and showed acceptable biological safety profiles. Bacterial endotoxin testing was performed and confirmed an endotoxin level within the established acceptance criteria.
Bench Testing
Substantial equivalence of the Sorrento BioGlass Bone Graft Substitute was supported by evaluation per ASTM F1088 (for beta tricalcium phosphate), ASTM F2212 (for collagen) and ASTM F1538 (Bioglass).
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Xenco Medical, LLC. - Sorrento™ Bioglass Bone Graft Substitute September 11th, 2018
Bioactivity was also evaluated through analysis by SEM and FTIR to confirm the ability of the subject device to form an in vitro layer of apatite.
Animal Study
A distal femoral defect model in rabbits was used to compare the subject device to the predicate device Sorrento Bone Graft Substitute (K141429) and the reference device Vitoss Foam Bone Graft Substitute (K083033) at 3, 6 and 12 weeks following implantation. Performance was evaluated radiographically and histomorphometrically. Study data demonstrated that the subject device is substantially equivalent with the predicate and reference devices. In addition, substantial equivalence of the Sorrento BioGlass Bone Graft Substitute was supported by evaluation per ASTM F1088 (for beta tricalcium phosphate) and ASTM F2212 (for collagen) and ASTM F1538 (Bioglass).
Clinical Studies
Clinical performance data was not required to determine substantial equivalence
VII. CONCLUSIONS
Conclusions drawn from the non-clinical tests demonstrated that the subject device possessed at least equivalent performance characteristics as the predicate device, and that overall the subject device is substantially equivalent.
§ 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.