(107 days)
Not Found
No
The summary describes a collagen-based implant and its clinical performance, with no mention of AI or ML technologies used in the device itself or its operation.
Yes
The device is indicated for the treatment of Anterior Cruciate Ligament (ACL) injuries and aids in the restoration and healing of the torn ligament, which aligns with the definition of a therapeutic device.
No
The BEAR® Implant is a treatment device, specifically an implant designed to stabilize blood in torn ACLs to facilitate healing. It does not perform any diagnostic function.
No
The device description clearly states it is a physical implant made of collagen and extracellular matrix, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of ACL injuries by providing a scaffold for tissue regeneration. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is an implant made of collagen and extracellular matrix, designed to be surgically implanted. This is a medical device used for treatment, 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 (blood, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The BEAR® Implant does not fit this description.
N/A
Intended Use / Indications for Use
The BEAR® (Bridge-Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for adults, adolescents and children with a complete or partial rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair. Children with open physes must have sufficient bone in the femoral and tibial epiphyses on either side of the intended tunnel locations to avoid disruption of the growth plates.
Product codes (comma separated list FDA assigned to the subject device)
QNI
Device Description
The BEAR® Implant (nominal 22 mm in diameter and 44 mm in length) is cylindrical in shape and comprised of collagen and extracellular matrix derived from bovine connective tissue, which has been cleaned, disinfected and processed by a proprietary manufacturing method. The implant has been terminally sterilized by electron-beam irradiation and is intended to be used with up to 10 ml of autologous blood drawn during the surgical implantation procedure. The BEAR® Implant stabilizes the blood in the gap between the tom ligament ends. The BEAR® Implant is resorbed within 8 weeks and replaced with a fibrovascular repair tissue.
Children with open physes must have sufficient bone in the femoral and tibial epiphyses to accommodate a 2.4 mm cannulated drill pin with at least 2-3 mm of bone on either side of the intended tunnel locations to avoid disruption of the growth plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
anterior cruciate ligament (ACL)
Indicated Patient Age Range
adults, adolescents and children
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Confirmatory clinical data from the BEAR III Study (IDE #G170156) and the BRIDGE Registry (post-market study) demonstrated that the BEAR Implant subject of this 510(k) is as safe and effective as the predicate device in patients less than 14 years of age and in patients with partial ACL tears.
The BEAR III Study was a prospective multicenter single-arm cohort study of the BEAR Implant that enrolled 151 subjects at 7 U.S. investigational sites. The study eligibility criteria included subjects ≥12 years of age and with partial or complete ACL tears. The two primary outcomes were the IKDC Subjective Knee Evaluation score and IKDC Objective Physical Exam score at post-operative year 2. Safety endpoints included the rate of adverse events (AE), serious adverse events (SAE), UADEs and device-related AEs and SAEs.
The ongoing BRIDGE Registry is a real-world observational registry, with prospective arms, of patients receiving the BEAR Implant at up to 30 U.S. sites. The two primary effectiveness endpoints are IKDC Subjective Knee Evaluation score at year 2 and Lachman knee laxity at 1 year. Secondary endpoints include 7 patient-reported outcomes (PRO) and knee-related adverse events.
For purposes of this 510(k) submission, safety and effectiveness data for BEAR Implant patients under age 14 were compared to those ≥14 years from the pooled BEAR III and BRIDGE studies were analyzed; safety and effectiveness data for patients with partial ACL tears were compared to complete ACL tears using the BEAR III dataset alone.
Subject Accountability by Age Group:
- Visit Completed, Subjects ≥ 14 Years Old, BEAR III: Baseline 167, Surgery 148, 1 Year 136, 2 Years 89
- Visit Completed, Subjects
§ 888.3044 Resorbable implant for anterior cruciate ligament (ACL) repair.
(a)
Identification. A resorbable implant for anterior cruciate ligament (ACL) repair is a degradable material that allows for healing of a torn ACL that is biomechanically stabilized by traditional suturing procedures. The device is intended to protect the biological healing process from the surrounding intraarticular environment and not intended to replace biomechanical fixation via suturing. This classification includes devices that bridge or surround the torn ends of a ruptured ACL.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Post-operative evaluation of knee pain and function; and
(ii) Durability as assessed by re-tear or re-operation rate.
(2) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Device performance characteristics, including resorption and ligament healing at repair site; and
(ii) Adverse effects as assessed by gross necropsy and histopathology.
(3) Non-clinical testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Characterization of materials, including chemical composition, resorption profile, and mechanical properties; and
(ii) Simulated use testing, including device preparation, device handling, compatibility with other ACL repair instrumentation, and user interface.
(4) The device must be demonstrated to be biocompatible.
(5) Performance data must demonstrate the device to be sterile and non-pyrogenic.
(6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(7) Labeling must include the following:
(i) Identification of device materials and specifications;
(ii) A summary of the clinical performance testing conducted with the device;
(iii) Instructions for use, including compatibility with other ACL repair instrumentation or devices;
(iv) Warnings regarding post-operative rehabilitation requirements; and
(v) A shelf life.
0
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March 6, 2025
Miach Orthopaedics, Inc. % Julie Broderick Regulatory Consultant Broderick Regulatory Consulting, LLC 7 Kendall Street Winchester, Massachusetts 01890
Re: K243578
Trade/Device Name: BEAR® (Bridge-Enhanced ACL Restoration) Implant Regulation Number: 21 CFR 888.3044 Regulation Name: Resorbable Implant For Anterior Cruciate Ligament (ACL) Repair Regulatory Class: Class II Product Code: QNI Dated: February 5, 2025 Received: February 5, 2025
Dear Julie Broderick:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
CHRISTOPHER EERREIRA -S
Christopher Ferreira, MS 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
3
Indications for Use
Submission Number (if known)
Device Name
BEAR® (Bridge-Enhanced ACL Restoration) Implant
Indications for Use (Describe)
The BEAR® (Bridge-Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagenbased implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for adults, adolescents and children with a complete or partial rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair. Children with open physes must have sufficient bone in the femoral and tibial epiphyses on either side of the intended tunnel locations to avoid disruption of the growth plates.
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
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.
Submitter Information l.
- Company: Miach Orthopaedics, Inc. 69 Milk Street, Suite 100 Westborough, MA 01581 USA Phone No.: 800-590-6995 Fax No.: 508-986-9625
- Contact: Rita Paparazzo VP, Regulatory, Clinical Operations, Quality and Medical Education Miach Orthopaedics, Inc. Phone No.: 800-590-6995 Email: rpaparazzo@miachortho.com
Date Prepared: 5 February 2025
II. Name of Device
Device Trade Name: | BEAR® (Bridge-Enhanced ACL Restoration) Implant |
---|---|
Classification Name: | Resorbable implant for anterior cruciate ligament (ACL) repair |
Product Code: | QNI |
Regulation Number: | 21 CFR 888.3044 |
Device Class: | II |
Panel Identification: | Orthopedics |
III. Predicate Device
Predicate Manufacturer: | Miach Orthopaedics, Inc. |
---|---|
Predicate Trade Name: | BEAR® (Bridge-Enhanced ACL Restoration) Implant |
Predicate 510(k) No.: | DEN200035 |
IV. Device Description
The BEAR® Implant (nominal 22 mm in diameter and 44 mm in length) is cylindrical in shape and comprised of collagen and extracellular matrix derived from bovine connective tissue, which has been cleaned, disinfected and processed by a proprietary manufacturing method. The implant has been terminally sterilized by electron-beam irradiation and is intended to be used with up to 10 ml of autologous blood drawn during the surgical implantation procedure. The BEAR® Implant stabilizes the blood in the gap between the tom ligament ends. The BEAR® Implant is resorbed within 8 weeks and replaced with a fibrovascular repair tissue.
Children with open physes must have sufficient bone in the femoral and tibial epiphyses to accommodate a 2.4 mm cannulated drill pin with at least 2-3 mm of bone on either side of the intended tunnel locations to avoid disruption of the growth plates.
V. Indications for Use
The BEAR® (Bridge-Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for adults,
5
adolescents and children with a complete or partial rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair. Children with open physes must have sufficient bone in the femoral and tibial epiphyses on either side of the intended tunnel locations to avoid disruption of the growth plates.
| Characteristic | New Device
BEAR Implant | Predicate Device*
BEAR Implant
DEN200035 | Comparison |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Miach Orthopaedics, Inc. | Miach Orthopaedics, Inc. | Same |
| Regulation No. | 21 CFR 888.3044 | 21 CFR 888.3044 | Same |
| Regulation Name | Resorbable implant for anterior
cruciate ligament (ACL) repair | Resorbable implant for anterior
cruciate ligament (ACL) repair | Same |
| Regulatory Class | Class II | Class II | Same |
| Product Classification Code | QNI | QNI | Same |
| Intended Use / Indications for
Use | The BEAR® (Bridge-Enhanced ACL
Restoration) Implant is a bovine
extracellular matrix collagen-based
implant for treatment of anterior
cruciate ligament (ACL) injuries.
The BEAR® Implant is indicated for
adults, adolescents and children
with a complete or partial rupture
of the ACL, as confirmed by MRI.
Patients must have an ACL stump
attached to the tibia to construct
the repair. Children with open
physes must have sufficient bone
in the femoral and tibial epiphyses
on either side of the intended
tunnel locations to avoid
disruption of the growth plates. | The BEAR® (Bridge-Enhanced
ACL Restoration) Implant is a
bovine extracellular matrix
collagen-based implant for
treatment of anterior cruciate
ligament (ACL) injuries. The
BEAR® Implant is indicated for
skeletally-mature patients at
least 14 years of age with a
complete rupture of the ACL, as
confirmed by MRI. Patients
must have an ACL stump
attached to the tibia to
construct the repair. | Same except for changes in
Indications:
Remove age limitation
(≥14 years)
Remove requirement for
patient to be skeletally
mature
Replace both with "adults,
adolescents and children"
Add requirement for
epiphyseal bone in
children to avoid
disruption of growth
plates
Add partial rupture of ACL
Same Intended Use; both new
and predicate devices are
intended for use in treating
ACL injuries. |
| Device Description | The BEAR Implant (22 mm in
diameter and 44mm in length) is
cylindrical in shape and comprised
of collagen and extracellular
matrix derived from bovine
connective tissue, which has been
cleaned, disinfected and processed
by a proprietary manufacturing
method. The implant is intended
to be used with up to 10 ml of
autologous blood drawn during | The BEAR Implant (22 mm in
diameter and 44mm in length) is
cylindrical in shape and
comprised of collagen and
extracellular matrix derived
from bovine connective tissue,
which has been cleaned,
disinfected and processed by a
proprietary manufacturing
method. The implant is intended
to be used with up to 10 ml of | Same |
| Characteristic | New Device
BEAR Implant | Predicate Device*
BEAR Implant
DEN200035 | Comparison |
| | the surgical implantation
procedure. | autologous blood drawn during
the surgical implantation
procedure. | |
| Operating Principle | The BEAR Implant stabilizes the
blood in the gap between the torn
ligament ends, facilitating
restoration of the ACL. The BEAR
Implant is resorbed within 8 weeks
and replaced with a fibrovascular
repair tissue. | The BEAR Implant stabilizes the
blood in the gap between the
torn ligament ends, facilitating
restoration of the ACL. The
BEAR Implant is resorbed within
8 weeks and replaced with a
fibrovascular repair tissue. | Same |
| Materials | Bovine-derived Type 1 collagen
and extracellular matrix | Bovine-derived Type 1 collagen
and extracellular matrix | Same - no changes |
| Biocompatibility | No new testing required | Testing completed per ISO
10993-1 and FDA guidance | Same - no changes |
| Technical Specifications | No new testing required | As approved in DEN200035 | Same - no changes |
| In Vivo Animal Testing | No new animal testing required | Completed as described in
DEN200035 | Changes to Indications did not
require new animal testing to
validate. |
| Human Clinical Testing | Confirmatory clinical data
presented in eSTAR Section:
Performance Testing | BEAR II Study (see DEN200035) | De Novo approval based on
BEAR II study data; this 510(k)
includes confirmatory clinical
data from the BEAR III study
(G170156) and the BRIDGE
Registry (post-market study). |
VI. Comparison of Technological Characteristics
6
VII. Performance or Clinical Testing
No non-clinical or animal performance testing was required to support this 510(k), as the change was limited to the indications for use.
Confirmatory clinical data from the BEAR III Study (IDE #G170156) and the BRIDGE Registry (post-market study) demonstrated that the BEAR Implant subject of this 510(k) is as safe and effective as the predicate device in patients less than 14 years of age and in patients with partial ACL tears.
The BEAR III Study was a prospective multicenter single-arm cohort study of the BEAR Implant that enrolled 151 subjects at 7 U.S. investigational sites. The study eligibility criteria included subjects ≥12 years of age and with partial or complete ACL tears. The two primary outcomes were the IKDC Subjective Knee Evaluation score and IKDC Objective Physical Exam score at post-operative year 2. Safety endpoints included the rate of adverse events (AE), serious adverse events (SAE), UADEs and device-related AEs and SAEs.
The ongoing BRIDGE Registry is a real-world observational registry, with prospective arms, of patients receiving the BEAR Implant at up to 30 U.S. sites. The two primary effectiveness endpoints are
7
IKDC Subjective Knee Evaluation score at year 2 and Lachman knee laxity at 1 year. Secondary endpoints include 7 patient-reported outcomes (PRO) and knee-related adverse events.
For purposes of this 510(k) submission, safety and effectiveness data for BEAR Implant patients under age 14 were compared to those ≥14 years from the pooled BEAR III and BRIDGE studies were analyzed; safety and effectiveness data for patients with partial ACL tears were compared to complete ACL tears using the BEAR III dataset alone. Refer to Table 1 for subject accountability by age group and Table 2 for subject accountability by tear type.
Baseline | Surgery | 1 Year | 2 Years | |
---|---|---|---|---|
Visit Completed, Subjects | ||||
≥ 14 Years Old, BEAR III | 167 | 148 | 136 | 89 |
Visit Completed, Subjects |