(112 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a bioabsorbable implant, with no mention of AI or ML.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is an anchor used for the fixation of soft tissue grafts, which is a structural or supportive function rather than a direct therapeutic one.
No
The device is an implant for tissue fixation, not for diagnosing conditions. Its purpose is to provide mechanical support during surgical procedures rather than to identify or assess medical conditions.
No
The device description clearly states it is an "absorbable implant device" composed of physical materials (polydioxanone) and provided with a "disposable anchor inserter instrument." This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of soft tissue grafts in various minimally invasive and open orthopedic surgical procedures in shoulder." This describes a surgical implant used directly on the patient's body during a procedure.
- Device Description: The description details an "absorbable implant device" made of PDO, designed to provide "fixation of a prosthetic material to soft tissue and/or bone." This further confirms it's an implant for surgical use.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such tests on samples.
- Performance Studies: The performance studies described (Biocompatibility, Non-Clinical Performance Testing, In vitro hydrolytic degradation, Absorption Profile) are typical for surgical implants, focusing on material properties, mechanical strength, and degradation within the body. They do not involve testing patient samples.
Therefore, the Bioabsorbable Anchor is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bioabsorbable Anchor is indicated for the fixation of soft tissue grafts in various minimally invasive and open orthopedic surgical procedures in shoulder.
Product codes
MAI
Device Description
The Bioabsorbable Anchor is an absorbable implant device that is intended to provide fixation of a prosthetic material to soft tissue and/or bone. The Bioabsorbable Anchor is composed of polydioxanone (PDO) dyed with D&C Violet No. 2. Two Bioabsorbable Anchors are provided sterile for single use only, packaged preloaded in a disposable anchor inserter instrument, the Dual Anchor Inserter. The preloaded Dual Anchor Inserter is provided in a dual sterile pouch confiquration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder
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
Biocompatibility Testing: The biocompatibility evaluation for the Bioabsorbable Anchor device was conducted in accordance with the FDA quidance document "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" dated September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation Testing Within a Risk Management Process," as recognized by FDA. The finished device met the requirements of the standards for the following battery of tests; cytotoxicity, sensitization, acute systemic toxicity, systemic toxicity (material-mediated pyrogenicity), bacterial endotoxin testing, genotoxicity, and implantation. Chemical characterization in accordance with ISO 10993-18 and a toxicological risk assessment in accordance with ISO 10993-17 confirmed the Bioabsorbable Anchor is considered safe for its intended use.
Non-Clinical Performance Testing: The Bioabsorbable Anchor was evaluated in comparison to the predicate device when applicable in accordance with the FDA guidance document "Bone Anchors—Premarket Notification (510(k)) Submissions" and included the following tests: Insertion Testing, Pullout Testing, Fatigue Testing. Both the subject and predicate devices had suitable characteristics for their indication for use.
Absorption Profile: A sixteen-week in vitro hydrolytic degradation study guided by ASTM F1635-16 "Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants" was also performed. This study provided characterization of the degradation profile via mass loss. The Bioabsorbable Anchor is hydrolytically degraded in tissues and demonstrated expected local tissue response, histological observations, and degradation after 13 weeks in both intramuscular and femoral condyle implantation. The degradation products are subsequently absorbed by tissues and excreted from the body.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
April 8, 2022
Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Embody, Inc. Brianna Schehr Director of Quality, Regulatory & Clinical Affairs 4211 Monarch Way, Suite 500 Norfolk, Virginia 23508
Re: K213958
Trade/Device Name: Bioabsorbable Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI Dated: March 10, 2022 Received: March 10, 2022
Dear Brianna Schehr:
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 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
1
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.
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
2
Indications for Use
510(k) Number (if known) K213958
Device Name Bioabsorbable Anchor
Indications for Use (Describe)
The Bioabsorbable Anchor is indicated for the fixation of soft tissue grafts in various minimally invasive and open orthopedic surgical procedures in shoulder.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K213958 - 510(k) Summary
SUBMITTER l.
| Owner/Submitter: | Embody, Inc.
4211 Monarch Way
Suite 500
Norfolk, VA 23508 |
|------------------|----------------------------------------------------------------------|
| Phone: | 236-994-7912 |
| Contact Person: | Brianna Schehr
Director of Quality, Regulatory & Clinical Affairs |
| Date Prepared: | April 8, 2022 |
ll. DEVICE
| Name of Device: | Bioabsorbable Anchor |
|---|---|
| Common or Usual Name: | Bone Anchor |
| Classification Name: | Fastener, fixation, biodegradable, soft tissue |
| Regulation Number: | 21 CFR 888.3030 |
| Regulatory Class: | Class II |
| Product Code: | MAI |
| Medical Specialty: | Orthopedic |
PREDICATE DEVICE lll.
Rotation Medical Bone Staple (RMB Staple), K131635. This predicate has not been subject to a design-related recall.
ORTHOSORB Resorbable Pins, K111077, is being referenced as a device made of polydioxanone. Therefore, the use of polydioxanone as a fixation material is not new.
DEVICE DESCRIPTION IV.
The Bioabsorbable Anchor is an absorbable implant device that is intended to provide fixation of a prosthetic material to soft tissue and/or bone. The Bioabsorbable Anchor is composed of polydioxanone (PDO) dyed with D&C Violet No. 2. Two Bioabsorbable Anchors are provided sterile for single use only, packaged preloaded in a disposable anchor inserter instrument, the Dual Anchor Inserter. The preloaded Dual Anchor Inserter is provided in a dual sterile pouch confiquration.
V. INDICATION FOR USE
The Bioabsorbable Anchor is indicated for the fixation of soft tissue grafts in various minimally invasive and open orthopedic surgical procedures in shoulder.
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Image /page/4/Picture/1 description: The image shows the word "EMBODY" in a stylized font. The letters are dark blue, except for the "O", which is inside an orange square with rounded corners. Inside the orange square, there are several diagonal white lines.
Both the subject and predicate devices have the same intended use for the fixation of a prosthetic material.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Bioabsorbable Anchor is substantially equivalent in terms of indications for use, technological characteristics, and performance characteristics to the predicate device. Fixation is the technological principle for both the subject and predicate devices and is based on the use of a permanent implant in a U-shape polymer strap design with barbed ends, to directly affix a prosthetic material. The Bioabsorbable Anchor is substantially equivalent to the reference device in terms of material composition of an absorbable fixation device.
The following technological differences exist between the subject and predicate devices:
- The subject device is composed of an absorbable polymer (polydioxanone), whereas the . predicate device is a nonabsorbable polymer (PEEK), and
- The subject device is optimized for fixation to both soft tissue and bone, whereas the . predicate device is optimized only for fixation to bone.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility Testing
The biocompatibility evaluation for the Bioabsorbable Anchor device was conducted in accordance with the FDA quidance document "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" dated September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation Testing Within a Risk Management Process," as recognized by FDA. The finished device met the requirements of the standards for the following battery of tests; cytotoxicity, sensitization, acute systemic toxicity, systemic toxicity (material-mediated pyrogenicity), bacterial endotoxin testing, genotoxicity, and implantation. Chemical characterization in accordance with ISO 10993-18 and a toxicological risk assessment in accordance with ISO 10993-17 confirmed the Bioabsorbable Anchor is considered safe for its intended use.
The Bioabsorbable Anchor is considered a permanent implant device in contact with tissue/bone, while the anchor inserter instrument is considered tissue/bone contacting for a duration of less than 24 hours.
Non-Clinical Performance Testing
The Bioabsorbable Anchor was evaluated in comparison to the predicate device when applicable in accordance with the FDA guidance document "Bone Anchors—Premarket Notification (510(k)) Submissions" and included the following tests:
- Insertion Testing .
- Pullout Testing .
- Fatigue Testing o
Both the subject and predicate devices had suitable characteristics for their indication for use.
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A sixteen-week in vitro hydrolytic degradation study guided by ASTM F1635-16 "Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants" was also performed. This study provided characterization of the degradation profile via mass loss.
Absorption Profile
The Bioabsorbable Anchor is hydrolytically degraded in tissues and demonstrated expected local tissue response, histological observations, and degradation after 13 weeks in both intramuscular and femoral condyle implantation. The degradation products are subsequently absorbed by tissues and excreted from the body.
VIII. CONCLUSIONS
Results of the biocompatibility testing and non-clinical performance testing demonstrate that the Bioabsorbable Anchor is as safe and as effective, and substantially equivalent to the predicate device for its intended use.