K Number
K191074
Device Name
Sorrento Bone Graft Substitute
Manufacturer
Date Cleared
2019-09-27

(157 days)

Product Code
Regulation Number
888.3045
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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
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.
More Information

Not Found

No
The summary describes a bone graft substitute material and its intended use, with no mention of AI or ML technology.

No.
The device is a bone void filler intended to fill voids or gaps in the skeletal system, which serves a structural purpose rather than a therapeutic one. It facilitates the natural healing process by providing a scaffold for bone regeneration but doesn't directly treat a disease or condition in a therapeutic manner.

No.
The device is a bone void filler intended for use in the skeletal system, which functions as a substitute material for bone during the healing process, not to diagnose a condition.

No

The device description clearly states it is a physical bone graft substitute made from collagen and tricalcium phosphate granules, which are hardware components.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Sorrento Bone Graft Substitute Function: This device is a material implanted directly into the body to fill bone voids and aid in bone healing. It does not perform any tests on samples taken from the body.

The provided information clearly describes a surgical implant used for bone repair, which falls under a different category of medical devices than IVDs.

N/A

Intended Use / Indications for Use

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

Product codes

MQV

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

skeletal system (extremities, pelvis, posterior lateral spine)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

K141429, K082166

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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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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 | Product
Code | Trade Name | Manufacturer |
|--------------------|-----------------|-------------------------------------|---------------------|
| K141429
Primary | MQV | SorrentoTM Bone
Graft Substitute | Xenco Medical, LLC. |

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K191074

K082166MQVMastergraft StripMedtronic, 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 Tricalcium
Phosphate per ASTM
F1088
• Type I bovine collagen per
ASTM F2212 | • Beta Tricalcium
Phosphate per ASTM
F1088
• Type I bovine collagen
per ASTM F2212 | • Beta Tricalcium
Phosphate per ASTM
F1088
• Hydroxyapatite per ASTM
F1185
• Type I bovine collagen |

Chart comparing subject device to the predicate devices:

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K191074

Xenco Medical, LLC. – Sorrento™ Bone Graft Substitute
September 27th, 2019

| Physical Structure
(Form) | • Porous collagen sponge
(strip) with beta-TCP
granules
• Trabecular structure
similar to cancellous bone | • Porous collagen sponge
(strip) with beta-TCP
granules
• Trabecular structure
similar to cancellous
bone | • Porous collagen sponge
(strip) with beta-TCP and
Hydroxyapatite granules
• Trabecular structure
similar 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) |
| Chemical
Composition
(Chemistry) | • Calcium salt with Type I
bovine collagen (~95:5
w/w) | • Calcium salt with Type I
bovine collagen (~95:5
w/w) | • Calcium salt with Type I
bovine collagen (~80:20
w/w), |
| Mineral Phase | • Beta-Tricalcium
Phosphate $Ca_3(PO4)_2$ | • Beta-Tricalcium
Phosphate $Ca_3(PO4)_2$ | • Beta-Tricalcium
Phosphate $Ca_3(PO4)_2$ |

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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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.