(176 days)
No
The summary describes a physical implant made of collagen and PLLA, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for "reinforcement of soft tissue where weakness exists" and for "reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery." This indicates it's used to treat a condition or injury, fitting the definition of a therapeutic device.
No
Explanation: The BioBrace™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue, not for diagnostic purposes. Its description focuses on its material composition and mechanical properties as an implant, and its performance studies evaluate its effectiveness for tissue reinforcement, not its ability to detect or identify medical conditions.
No
The device is a physical implant made of collagen and PLLA, intended for surgical reinforcement of soft tissue. It is not software.
Based on the provided information, the BioBrace™ Implant is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the BioBrace™ Implant is for "reinforcement of soft tissue where weakness exists" and "reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery". This describes a device used in vivo (within the body) to provide structural support and aid in tissue repair.
- Device Description: The description details a bioresorbable implant made of collagen and PLLA, designed to be surgically implanted. This is consistent with a medical device used for tissue augmentation and reinforcement, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions. There is no mention of reagents, assays, or analytical procedures.
In summary, the BioBrace™ Implant is a surgically implanted medical device intended for structural support and tissue reinforcement, which falls under the category of a medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioBrace™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.
Product codes
OWW, OWY
Device Description
The BioBrace™ implant is a bioresorbable, biocomposite scaffold composed of a highly-porous collagen sponge made from insoluble bovine tendon type-1 collagen, and reinforced with poly-L-lactic-acid (PLLA) multifilament yarn (75 denier, 15 um filament diameter). The BioBrace implant is 80% porous, average density of 0.2 grams/cm³, and median pore diameter of 19 µm. The highly-porous collagen sponge comprises the majority of implant surface area (0.7 m²/gram) versus the PLLA filaments alone (0.2 m²/gram), creating a large biologic matrix for cellular ingrowth. BioBrace implants are approximately 3 mm thick, provided in two rectangular sizes of 5 x 250mm and 23 x 30mm, and are designed for soft tissue and tendon augmentation and reinforcement. The BioBrace implant is single-use and supplied sterile with SAL of 10°.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rotator cuff, patellar, Achilles, biceps, or quadriceps tendons
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The characterization of the physical, biomechanical, and biocompatibility properties of the BioBrace Implant were based on the FDA guidance documents for "Preparation of a Premarket Notification Application for a Surgical Mesh" and "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and 510(k) pre-submission Q190638.
The subject and predicate devices were evaluated in vitro for mechanical properties at time zero and after degradation in PBS at 37 C, and in ovine studies of rotator cuff repair in sheep with follow up of 6- and 12-weeks. The data from the ovine studies showed the increase in strength of soft tissue repair was statistically significant from 6 to 12 weeks, with equivalent strength at 6 weeks, and again at 12 weeks for the subject and predicate devices. The in vivo data demonstrated equivalent cellular response for the subject and predicate devices per ISO 10993-6.
Characterization of physical, mechanical, and materials properties of BioBrace devices were measured at t=0 and after in vitro degradation (37C saline) for 6wks, 12wks, and 26wks. Mechanical properties measures included ultimate tensile strength, tear resistance strength, suture pull-through strength, and ball burst strength per ASTM standards D882-10, D226, and D3787, with PLLA polymer fiber properties measured per ASTM D2857 and D3418, and collagen, fluid uptake, and absorbance properties per ASTM F2212.
Evaluation of BioBrace augmented doubled-over ovine extensor tendon in a Sawbones (20 pcf) in vitro model demonstrated a statistically significant increase in pull-out strength and stiffness (P
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
April 30, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Biorez, Inc. % Robert Poggie, Ph.D. President BioVera, Inc. 65 Promenade Saint Louis Notre Dame de L'Ile Perrot, Quebec J7V7P2 Canada
Re: K203267
Trade/Device Name: The BioBrace™ Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWW, OWW, OWY Dated: March 24, 2021 Received: March 29, 2021
Dear Dr. Poggie:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
for
Laura C. Rose, 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) K203267
Device Name
The BioBrace™ Implant
Indications for Use (Describe)
The BioBrace™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.
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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3
510(k) Summary for the BioBrace™ Implant
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of the BioBrace™ Implant.
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, Inc. |
|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, Notre-Dame-de-L'Ile-Perrot, |
| Quebec, J7V 7P2, CANADA | |
| Contact Person: | Robert A. Poggie, PhD |
| Phone & Fax Numbers: | 514-901-0796 |
| Date of Submission: | March 24, 2021 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | Biorez, Inc. |
|---|---|
| Manufacturer Address: | 470 James Street, Suite 14, New Haven, CT, 06513 USA |
| Registration Number: | TBD |
| Contact Name: | Kevin Rocco |
| Title: | CEO |
| Device Trade Name: | The BioBrace™ Implant |
| Device Common Name: | Surgical mesh; soft tissue augmentation implant |
| Classification Name: | mesh, surgical, absorbable, orthopaedics, reinforcement of tendon |
| Classification Code: | OWW and OWY |
| Classification Panel: | General and Plastic Surgery Devices |
| Regulation Number: | 21 CFR sections 878.3300 |
C1. PRIMARY PREDICATE DEVICE K121216 Soft Tissue Regeneration's STR GRAFT C2. REFERENCE DEVICES K112423 Rotation Medical's Collagen Tendon Sheet K071887 Artelon Tissue Reinforcement K192112 International Life Sciences FlexBand, FlexPatch, FlexBand Plus K032245 Arthrex Fiber Tape Family (Internal Brace)
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D. DEVICE DESCRIPTION
The BioBrace™ implant is a bioresorbable, biocomposite scaffold composed of a highly-porous collagen sponge made from insoluble bovine tendon type-1 collagen, and reinforced with poly-L-lactic-acid (PLLA) multifilament yarn (75 denier, 15 um filament diameter). The BioBrace implant is 80% porous, average density of 0.2 grams/cm³, and median pore diameter of 19 µm. The highly-porous collagen sponge comprises the majority of implant surface area (0.7 m²/gram) versus the PLLA filaments alone (0.2 m²/gram), creating a large biologic matrix for cellular ingrowth. BioBrace implants are approximately 3 mm thick, provided in two rectangular sizes of 5 x 250mm and 23 x 30mm, and are designed for soft tissue and tendon augmentation and reinforcement. The BioBrace implant is single-use and supplied sterile with SAL of 10°.
E. INDICATIONS FOR USE
The BioBrace™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.
F. TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE
The BioBrace™ implant is composed of 75 denier PLLA microfilament yarn that bioresorbs by hydrolysis, and insoluble Type-1 bovine collagen in the form of a microporous sponge that biodegrades via collagenases and in turn bioresorbs. The BioBrace implant is 80% porous with median pore size of 19 µm. The predicate STR GRAFT is approximately 50% porous with median pore size of 20 um and entirely composed of PLLA. The subject BioBrace implant and predicate STR GRAFT devices are manufactured with the same 75 denier PLLA multifilament yarn that provides tensile strength at time zero and through the period of infiltration and healing by soft tissue. The subject and predicate devices are both designed to augment the strength of injured or deficient soft tissue and bioresorb over time, facilitating the transition in load bearing from the tissue plus device to the host tissue alone.
The subject BioBrace implant and reference device Collagen Tendon Sheet possess porous collagen matrices that absorb fluid on contact, facilitate the healing of injured soft tissues, biodegrade through the action of collagenase, and bioresorb over time. Physical characteristics of the BioBrace implant were measured and compared to commercially available Regeneten (Rotation Medical's Collagen Tendon Sheet) and Arthrex FiberTape (Internal Brace) devices. The BioBrace device's porosity was 80%, pore volume was 4.2 cm³/gram, internal pore surface area was 0.7 m²/gram, and permeability was 1520 mD. The porosity, pore volume, internal pore surface area, and permeability of the BioBrace implant was significantly higher than the Regeneten and FiberTape devices.
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Fluid uptake of BioBrace implant was greater than 300% as measured gravimetrically, per ASTM F-2212, which was significantly higher than FiberTape.
In summary, comparison of the characteristics of the predicate, reference, and BioBrace devices demonstrated the following:
- . Commonality in materials used to manufacture,
- . Commonality and cross over in size options,
- . Equivalence in strength of repair and cellular reaction of the primary predicate and subject devices per an ovine model of rotator cuff repair at 6 and 12 weeks,
- . Biocompatibility per ISO 10993-1, and
- Maintenance of mechanical integrity of the primary predicate and subject devices . through healing per in vitro testing at 37 C in PBS.
G. PERFORMANCE DATA
The characterization of the physical, biomechanical, and biocompatibility properties of the BioBrace Implant were based on the FDA guidance documents for "Preparation of a Premarket Notification Application for a Surgical Mesh" and "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and 510(k) pre-submission Q190638.
The subject and predicate devices were evaluated in vitro for mechanical properties at time zero and after degradation in PBS at 37 C, and in ovine studies of rotator cuff repair in sheep with follow up of 6- and 12-weeks. The data from the ovine studies showed the increase in strength of soft tissue repair was statistically significant from 6 to 12 weeks, with equivalent strength at 6 weeks, and again at 12 weeks for the subject and predicate devices. The in vivo data demonstrated equivalent cellular response for the subject and predicate devices per ISO 10993-6. Further detailed descriptions of these studies follow below.
Characterization of physical, mechanical, and materials properties of BioBrace devices were measured at t=0 and after in vitro degradation (37C saline) for 6wks, 12wks, and 26wks. Mechanical properties measures included ultimate tensile strength, tear resistance strength, suture pull-through strength, and ball burst strength per ASTM standards D882-10, D226, and D3787, with PLLA polymer fiber properties measured per ASTM D2857 and D3418, and collagen, fluid uptake, and absorbance properties per ASTM F2212.
Evaluation of BioBrace augmented doubled-over ovine extensor tendon in a Sawbones (20 pcf) in vitro model demonstrated a statistically significant increase in pull-out strength and stiffness (P 300% by weight, ●
- maintain mechanical integrity through the healing per in vitro testing at 37 C in PBS, ●
- are biocompatible per the chemical characterization via ISO 10993-18, toxicological risk ● assessment, and 10993-1 test results,
- . demonstrate rapid tissue and cellular infiltration (6-weeks) per an ovine model of rotator cuff repair,
- . exhibited low to no adverse tissue / cellular inflammation per ISO 10993-6 scoring, and
- statistically similar strength of tendon repair as the contralateral control tendon at 12 . weeks (2463 ± 484N versus 2707 ± 605N).
H. CONCLUSIONS
The BioBrace implant has similar indications for use, technological characteristics, and principles of operation as the primary predicate and reference devices. The technological differences between the subject, predicate, and reference devices do not raise new issues of safety or effectiveness. The in vitro and in vivo performance data demonstrate that the BioBrace implant is substantially equivalent to the predicate device.