(157 days)
Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed with bone during the healing process
Sorrento 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) dispersed throughout. The implant is provided as sterile, for single-use in double peel packages.
The provided document ([K191074](https://510k.innolitics.com/search/K191074)) is a 510(k) premarket notification for a medical device called Sorrento™ Bone Graft Substitute. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Crucially, this document is a 510(k) premarket notification for a bone graft substitute, which is a physical device, and not an AI/ML-driven device. Therefore, the concepts of acceptance criteria, test sets, training sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not applicable to this document. The document describes a traditional medical device approval process based on biocompatibility, bench testing, and an animal study, not an AI/ML software validation study.
Therefore, I cannot extract the requested information about acceptance criteria and study that proves an AI/ML device meets them from this document. The document does not contain information about an AI/ML device.
If you intended to provide a document related to an AI/ML medical device, please provide that document.
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Xenco Medical, LLC % Gustavo R. Prado, Ph.D. President Converg Engineering, LLC 2305 Historic Decatur Road, Suite 100 San Diego, California 92106
Re: K191074
Trade/Device Name: Sorrento™ Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: August 21, 2019 Received: August 30, 2019
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, 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
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191074
Device Name Sorrento™ Bone Graft Substitute
Indications for Use (Describe)
Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed 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) |
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Image /page/3/Picture/0 description: The image shows a green hexagon with the text "XMOOC" written in white. The hexagon is made up of several smaller triangles of varying shades of green. Below the hexagon is the text "K191074".
510(k) SUMMARY
l. SUBMITTER
Xenco Medical, LLC.
Contact Person: Jason Haider Email: jhaider@xencomedical.com
9930 Mesa Rim Road San Diego, CA 92121 USA Phone: 858-202-1505 ext 202 Fax: 858-202-1549 Date Prepared: 12/15/2018 Establishment Registration: 3011181154
APPLICATION CORRESPONDENT II.
Converg Engineering, LLC Contact Person: Gustavo R. Prado, Ph.D. Email: gprado@convergeng.com
III. DEVICE
SUBJECT DEVICE
Trade Name: Sorrento™ 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 | SorrentoTM BoneGraft Substitute | Xenco Medical, LLC. |
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Image /page/4/Picture/0 description: The image is a logo for XMind, a mind mapping and brainstorming software. The logo features a green hexagon with a geometric pattern on its surface. The text "XMind" is written in white inside the hexagon, with the "X" being larger than the "Mind". The logo has a modern and professional look.
| K082166 | MQV | Mastergraft Strip | Medtronic, Inc. |
|---|
IV. DEVICE DESCRIPTION
Sorrento 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) dispersed throughout. The implant is provided as sterile, for single-use in double peel packages.
V. INDICATIONS FOR USE
This submission expands the indications for use of Sorrento Bone Graft Substitute for fusion in the posterior lateral spine when used with autograft bone:
Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). Sorrento Bone Graft Substitute is 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 Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed and replaced with bone during the healing process
VI. 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(Subject Device) | Sorrento(Predicate, K141429) | Mastergraft Strip(Predicate, K082166) |
|---|---|---|---|
| Materials | • Beta TricalciumPhosphate per ASTMF1088• Type I bovine collagen perASTM F2212 | • Beta TricalciumPhosphate per ASTMF1088• Type I bovine collagenper ASTM F2212 | • Beta TricalciumPhosphate per ASTMF1088• Hydroxyapatite per ASTMF1185• Type I bovine collagen |
Chart comparing subject device to the predicate devices:
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Image /page/5/Picture/0 description: The image is a logo with a green hexagon as the background. Inside the hexagon, there is the text "XM" with "X" on top of "M". The text is white. The logo has a modern and clean design.
| Xenco Medical, LLC. – Sorrento™ Bone Graft Substitute |
|---|
| September 27th, 2019 |
| Physical Structure(Form) | • Porous collagen sponge(strip) with beta-TCPgranules• Trabecular structuresimilar to cancellous bone | • Porous collagen sponge(strip) with beta-TCPgranules• Trabecular structuresimilar to cancellousbone | • Porous collagen sponge(strip) with beta-TCP andHydroxyapatite granules• Trabecular structuresimilar to cancellous 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)• 10 cc (100 x 25 x 4 mm)• 10 cc (25 x 50 x 8)• 20 cc (100 x 25 x 8 mm)• 24 cc (25 x 240 x 4 mm)• 30 cc (75 x 100 x 4 mm) |
| ChemicalComposition(Chemistry) | • Calcium salt with Type Ibovine collagen (~95:5w/w) | • Calcium salt with Type Ibovine collagen (~95:5w/w) | • Calcium salt with Type Ibovine collagen (~80:20w/w), |
| Mineral Phase | • Beta-TricalciumPhosphate $Ca_3(PO4)_2$ | • Beta-TricalciumPhosphate $Ca_3(PO4)_2$ | • Beta-TricalciumPhosphate $Ca_3(PO4)_2$ |
PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility performance data was not required to determine substantial equivalence. No changes to the product was made from the original submission.
Bench Testing
Biocompatibility performance data was not required to determine substantial equivalence. No changes to the product was made from the original submission.
Animal Study
A comprehensive Posterior Lateral Fusion (PLF) animal study was conducted and has demonstrated substantial equivalence to the Predicate Device Mastergraft Strip (K082166) with regards to the expansion of the indications for use.
Clinical Studies
Clinical performance data was not required to determine substantial equivalence
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Image /page/6/Picture/0 description: The image shows a green hexagon with the letters 'XM' in white on top of it. The letters are stylized, with the 'X' being larger than the 'M'. Below the hexagon is the alphanumeric code 'K191074' in black.
VIII. 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.