(163 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical suture, with no mention of AI or ML technologies.
No
The device is a surgical suture used for approximation and ligation of soft tissue, which is a structural and supportive function, not a therapeutic one aiming to treat or cure a disease or condition.
No
This device is a surgical suture used for approximation and/or ligation of soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical surgical suture made of UHMWPE and collagen, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation and/or ligation." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a surgical suture, designed to be implanted in the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Performance Studies: The performance studies focus on the physical properties of the suture (tensile strength, knot security, resorption profile, biocompatibility) and its performance in surgical applications. IVD performance studies would focus on analytical and clinical performance related to diagnosing a condition (e.g., sensitivity, specificity).
In summary, the ACTIVBRAID™ suture is a surgical device used for physical repair within the body, not a diagnostic tool used to analyze samples for medical information.
N/A
Intended Use / Indications for Use
ACTIVBRAID™ is indicated for use in soft tissue approximation and/or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft tissues are used for repair.
Product codes
GAT
Device Description
ACTIVBRAID is a partially absorbable surgical co-braid suture constructed of nonabsorbable Ultra High Molecular Weight Polyethylene (UHMWPE) and absorbable bovine-derived type I collagen. ACTIVBRAID suture ends are stiffened with cyanoacrylate.
ACTIVBRAID is available in several sizes (sutures meet U.S. Pharmacopeia standards for nonabsorbable sutures, except diameter). Sutures are oversized in diameter. ACTIVBRAID is provided in pre-cut lengths with and without needles. Suture strands that are dyed (Chromium Cobalt-Aluminum Oxide or D&C Black No. 4) are made of UHMWPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
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
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing: The biocompatibility evaluation for the ACTIVBRAID device was conducted in accordance with the FDA guidance 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 battery of testing included the following tests: cytotoxicity, sensitization, systemic toxicity, pyrogenicity, genotoxicity, and implantation.
Non-Clinical Performance Testing: Nonclinical performance testing was performed to demonstrate that ACTIVBRAID meets the current USP Monograph for nonabsorbable surgical sutures, except diameter. Testing was performed in accordance with FDA's guidance document, "Surgical Sutures – Class II Special Controls Guidance Document for Industry and FDA Staff" and included the following tests:
- Nonabsorbable Suture Diameter USP Sutures Diameter
- Nonabsorbable Suture Needle Attachment USP Sutures Needle Attachment
- Nonabsorbable Suture Tensile Strength USP Sutures – Tensile Strength
ACTIVBRAID meets or exceeds USP performance standards for nonabsorbable surgical sutures, except for an oversize in diameter. Bacterial Endotoxin Test (BET) was performed to demonstrate that the subject device meets pyrogen limit specifications.
Additional performance testing was conducted in comparison to the predicate device and included the following tests:
- Abraded Tensile Strength
- Knot Profile
- Knot Security
- Abrasiveness to Tissue
- Physiological Fluid Absorption
ACTIVBRAID performs as well as or better than the predicate device for all performance tests listed. Both the subject and predicate devices have suitable characteristics for their indication for use.
Resorption Profile: ACTIVBRAID is partially absorbable; therefore, resorption profile testing was conducted in accordance with FDA's special controls guidance, "Surgical Sutures – Class II Special Controls Guidance Document for Industry and FDA Staff" to characterize the device's rate of absorption, time to complete absorption, and residual tensile strength over time. The results of implantation studies of ACTIVBRAID in animals indicate that approximately 85% of its original strength remains 16 weeks after implantation and absorption of the collagen component is complete between 8 and 16 weeks post-implantation. The ACTIVBRAID degradation profile combined with the tensile strength retention over time demonstrates the resorption profile is consistent with the intended use of the subject device, for the long-term approximation of soft tissue.
Key Metrics
Not Found
Predicate Device(s)
Arthrex Bio-Suture, K112899
Reference Device(s)
Arthrex BioWire, K091018, ORTHOCORD® Braided Composite Suture, K040004
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
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June 2, 2023
Embody, Inc. Brianna Schehr Vice President, Quality, Regulatory & Clinical Affairs 4211 Monarch Way, Suite 500 Norfolk, Virginia 23508
Re: K223822
Trade/Device Name: ActivbraidTM Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable polyethylene terephthalate surgical suture Regulatory Class: Class II Product Code: GAT Dated: December 21, 2022 Received: December 21, 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
1
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 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,
Cynthia Chang -S
Cynthia J. Chang, Ph.D. Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223822
Device Name ACTIVBRAID™
Indications for Use (Describe)
ACTIVBRAID™ is indicated for use in soft tissue approximation and/or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft tissues are used for repair.
| 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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510(k) Summary - K223822
SUBMITTER l.
| Owner/Submitter: | Embody, Inc.
4211 Monarch Way
Suite 500
Norfolk, VA 23508 |
|-----------------------|--------------------------------------------------------------------------|
| Phone: | 236-994-7912 |
| Contact Person: | Brianna Schehr
Vice President, Quality, Regulatory & Clinical Affairs |
| Date Prepared: | May 24, 2023 |
| II. DEVICE | |
| Name of Device: | ACTIVBRAID™ |
| Common or Usual Name: | Suture |
| Classification Name: | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Regulation Number: | 21 CFR 878.5000 |
| Regulatory Class: | Class II |
| Product Code: | GAT |
lll. PREDICATE DEVICE
Medical Specialty:
Arthrex Bio-Suture, K112899. This predicate has not been subject to a design-related recall.
General & Plastic Surgery
Reference Devices: Arthrex BioWire, K091018 ORTHOCORD® Braided Composite Suture, K040004
IV. DEVICE DESCRIPTION
ACTIVBRAID is a partially absorbable surgical co-braid suture constructed of nonabsorbable Ultra High Molecular Weight Polyethylene (UHMWPE) and absorbable bovine-derived type I collagen. ACTIVBRAID suture ends are stiffened with cyanoacrylate.
ACTIVBRAID is available in several sizes (sutures meet U.S. Pharmacopeia standards for nonabsorbable sutures, except diameter). Sutures are oversized in diameter. ACTIVBRAID is provided in pre-cut lengths with and without needles. Suture strands that are dyed (Chromium Cobalt-Aluminum Oxide or D&C Black No. 4) are made of UHMWPE.
V. INDICATION FOR USE
ACTIVBRAID is indicated for use in soft tissue approximation and/or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
ACTIVBRAID is substantially equivalent in terms of indication for use, technological characteristics, and performance characteristics to the predicate device. Both the subject and predicate devices meet the USP Monograph for nonabsorbable surgical sutures, except diameter.
The following technological differences exist between the subject and predicate devices:
- The subject device is composed of nonabsorbable UHMWPE fiber braided with . absorbable bovine type I collagen fiber, whereas the predicate device is composed of nonabsorbable UHMWPE fiber braided with polyester fibers coated with absorbable type I bovine collagen, and
- The subject device is available in sizes 2-0, 2, 1.5mm tape, and 2.5mm tape, whereas . the predicate device is available in sizes 2 and 2mm tape.
The differences between the subject and predicate device are considered minor and do not raise questions concerning safety and effectiveness. Biocompatibility and nonclinical performance testing data demonstrate that ACTIVBRAID is as safe, as effective, and performs as well as or better than the predicate device, K112899.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the ACTIVBRAID device was conducted in accordance with the FDA guidance 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 battery of testing included the following tests: cytotoxicity, sensitization, systemic toxicity, pyrogenicity, genotoxicity, and implantation.
Non-Clinical Performance Testing
Nonclinical performance testing was performed to demonstrate that ACTIVBRAID meets the current USP Monograph for nonabsorbable surgical sutures, except diameter. Testing was performed in accordance with FDA's guidance document, "Surgical Sutures – Class II Special Controls Guidance Document for Industry and FDA Staff" and included the following tests:
- Nonabsorbable Suture Diameter USP Sutures Diameter .
- Nonabsorbable Suture Needle Attachment USP Sutures Needle Attachment .
- . Nonabsorbable Suture Tensile Strength USP Sutures – Tensile Strength
ACTIVBRAID meets or exceeds USP performance standards for nonabsorbable surgical sutures, except for an oversize in diameter. Bacterial Endotoxin Test (BET) was performed to demonstrate that the subject device meets pyrogen limit specifications.
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Additional performance testing was conducted in comparison to the predicate device and included the following tests:
- Abraded Tensile Strength .
- . Knot Profile
- Knot Security .
- Abrasiveness to Tissue .
- Physiological Fluid Absorption .
ACTIVBRAID performs as well as or better than the predicate device for all performance tests listed. Both the subject and predicate devices have suitable characteristics for their indication for use.
Resorption Profile
ACTIVBRAID is partially absorbable; therefore, resorption profile testing was conducted in accordance with FDA's special controls guidance, "Surgical Sutures – Class II Special Controls Guidance Document for Industry and FDA Staff" to characterize the device's rate of absorption, time to complete absorption, and residual tensile strength over time. The results of implantation studies of ACTIVBRAID in animals indicate that approximately 85% of its original strength remains 16 weeks after implantation and absorption of the collagen component is complete between 8 and 16 weeks post-implantation. The ACTIVBRAID degradation profile combined with the tensile strength retention over time demonstrates the resorption profile is consistent with the intended use of the subject device, for the long-term approximation of soft tissue.
| Characteristic | Subject Device | Predicate Device
Arthrex Bio-Suture
(K112899) | Comparison |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Product Code | GAT | GAT | Same |
| Regulation | 21 CFR 878.5000 | 21 CFR 878.5000 | Same |
| Classification
Name | Suture, Nonabsorbable,
Synthetic, Polyethylene | Suture, Nonabsorbable,
Synthetic, Polyethylene | Same |
| Intended Use | Long-term approximation of soft
tissue | Long-term approximation of soft
tissue | Same |
| Indications for
Use | For use in soft tissue
approximation and/or ligation.
These sutures may be
incorporated, as components,
into surgeries where constructs
including those with allograft or
autograft tissues are used for
repair. | For use in soft tissue
approximation and/or ligation.
These sutures may be
incorporated, as components,
into surgeries where constructs
including those with allograft or
autograft tissues are used for
repair. | Same |
| Prescription Use | Yes | Yes | Same |
| Material(s) of
Composition | UHMWPE, bovine-derived type I
collagen | UHMWPE, polyester, bovine-
derived type I collagen | Similar, no
new issues of
safety or
efficacy |
| Resorbable | Partially absorbable (i.e.,
nonabsorbable UHMWPE fiber
and absorbable collagen fiber
co-braid) | Nonabsorbable (i.e.,
nonabsorbable braided
UHMWPE and polyester fibers
coated with absorbable type I
bovine collagen) | Similar, no
new issues of
safety or
efficacy |
Substantial Equivalence
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| Characteristic | Subject Device | Predicate Device
Arthrex Bio-Suture
(K112899) | Comparison |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Suture
Configuration(s) | Configured as multifilament
braided strands of multiple sizes
(per USP size system)
ACTIVBRAID suture:
• Size 2-0 (blue) w/ tapered
needle
• Size 2 (blue) w/ tapered
needle
• Size 2 (white/black) w/ tapered
needle
ACTIVBRAID suture tape:
• Flat, tape-style suture, 1.5mm
(white/black) w/ tapered
needle
• Flat, tape-style suture, 1.5mm
(blue) w/ tapered needle
• Flat, tape-style suture, 2.5mm
(white/black)
• Flat, tape-style suture, 2.5mm
(blue) | Configured as multifilament
braided strands of multiple sizes
(per USP size system)
Bio-FiberWire:
• Size 2 (blue) w/ tapered
needle
Bio-FiberTape:
• Flat, tape-style suture, 2mm
(blue) | Similar, no
new issues of
safety or
efficacy |
| Residual Tensile
Strength Over
Time | 85% of original strength remains
16 weeks after implantation | Not known to have significant
change in tensile strength in vivo | Similar, no
new issues of
safety or
efficacy |
| Technological
Principle | Long-term approximation of soft
tissue | Long-term approximation of soft
tissue | Same |
| Operating
Principles | Standard surgical technique | Standard surgical technique | Same |
| How Supplied | Sterile, single use only, with or
without needles attached | Sterile, single use only, with or
without needles attached | Same |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Same |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| Single Use | Single Use | Single Use | Same |
VIII. CONCLUSIONS
Results of the biocompatibility testing and nonclinical performance testing demonstrate that ACTIVBRAID is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K112899.