(121 days)
The OptiFix AT Absorbable Fixation System with Articulating Technology is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
The OptiFix™ AT Absorbable Fixation System with Articulating Technology, hereinafter referred to as "OptiFix ""AT", is a sterile (via gamma) single use device that is comprised of a deployment component and an absorbable fastener component. Two different product ordering codes are to be packaged for distribution; each contains the same ergonomically designed deployment device. The variation will be the number of preloaded fasteners; either 15 or 30. The deployment shaft of the OptiFix™ AT device is 37cm in length and designed for use with 5mm trocars. The tip of the shaft can be articulated and the handle of the device can be rotated 360 degrees to facilitate access for fixation during surgery. The fasteners are designed with retention features and are manufactured from Poly (L-lactide-co-glycolide) and are dyed with D & C Violet No. 2 (<0.15% by weight).
The provided text describes the OptiFix™ AT Absorbable Fixation System with Articulating Technology. The document is a 510(k) premarket notification for a medical device seeking substantial equivalence to already marketed predicate devices.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a consolidated table of acceptance criteria with corresponding performance data in a dedicated section. However, it states that "All samples tested met the acceptance criteria" for various performance tests. The performance data is scattered throughout Section VII. PERFORMANCE DATA.
Below is a summary of the performance testing and an inferred "met acceptance criteria" outcome:
| Test Category | Specific Tests / Endpoints Evaluated | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Testing | Cytotoxicity, Sensitization, Intracutaneous (Irritation), Systemic Acute Toxicity, Sub-Chronic Toxicity (13 weeks), Chronic Toxicity (26 weeks), Genotoxicity (Mouse Peripheral Blood Micronucleus, Bacterial Reverse Mutation, Mouse Lymphoma Assay), Implantation (4, 8, 12, 26, 39, 52, 77 weeks), Pyrogenicity | Met established criteria | All samples met criteria |
| Product Testing | Actuation (trigger) Torque, Fastener Deployment, Fastener Gap Height, Ball Burst Testing | Met established criteria | Passed all test requirements and demonstrated substantial equivalence to the primary predicate device |
| Mesh Compatibility Testing | Not specified, but listed as a test conducted. | Met established criteria | Passed all test requirements and demonstrated substantial equivalence to the primary predicate device |
| Fastener Resorption Profile | In-Vitro Degradation, In-Vitro to In-Vivo Correlation | Met established criteria | Passed all test requirements and demonstrated substantial equivalence to the primary predicate device |
| Animal Study (Safety & Feasibility Endpoints) | Mesh contracture, Fastener seating properties, Tissue in-growth (T-peel analysis), Host inflammatory/fibrotic response | Safety and feasibility demonstrated (by comparison to secondary predicate) | The study demonstrated that the OptiFix AT device can safely approximate soft tissue and fixate surgical mesh to tissues during open or laparoscopic surgical procedures. |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Biocompatibility Testing: The document does not specify the sample sizes (number of devices or biological samples) used for each biocompatibility test.
-
Product Testing: The document does not specify the sample sizes for the product tests (Actuation Torque, Fastener Deployment, Fastener Gap Height, Ball Burst Testing, Mesh Compatibility, Resorption Profile).
-
Animal Study: The document does not specify the number of animals used in the study.
-
Data Provenance: The studies are described as "preclinical testing" and were conducted to support the 510(k) submission, implying they were prospective studies. The country of origin of the data is not specified, but the submission is to the U.S. FDA by a company based in Warwick, Rhode Island, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Biocompatibility Testing: Ground truth is established by standardized biological evaluation methods (ISO 10993-1). No specific "experts" for ground truth are mentioned beyond the execution of these standardized tests.
- Product Testing: Ground truth is based on engineering specifications and benchmark performance against the predicate device. No specific "experts" (e.g., engineers with a certain number of years of experience) for ground truth establishment are detailed within the narrative.
- Animal Study: The evaluation included "histological evaluation of the tissue". This would typically involve pathologists, but the number and qualifications of these experts are not provided.
4. Adjudication Method for the Test Set
Not applicable. The tests described are primarily objective, quantitative measurements (e.g., torque, force, gap height, material degradation, histological analysis in the animal study). There is no mention of a human-centric "test set" requiring adjudication or consensus for classification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "Clinical studies were not performed for the submission of this proposed device nor were clinical studies performed for the primary predicate device (OptiFix-K142873)." Therefore, no MRMC study, or any clinical study involving human readers, was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This device is a mechanical surgical fixation system, not a software-based diagnostic algorithm. Therefore, "standalone" performance in the context of AI algorithms is not applicable here. The device itself is the standalone system.
7. The Type of Ground Truth Used
- Biocompatibility: Ground truth is based on the results of standardized biological tests as per ISO 10993-1, indicating biological safety (e.g., non-cytotoxic, non-sensitizing).
- Product Testing: Ground truth is derived from engineering specifications and the established performance characteristics of the primary predicate device, used for equivalence comparison.
- Animal Study: Ground truth involved histological evaluation of tissue (pathology/histology) and objective measurements of mesh contracture, fastener seating, and tissue in-growth in an animal model.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical system, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2017
C.R. Bard Incorporated Ms. Katherine Earle Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K170278
Trade/Device Name: Optifix AT Absorbable Fixation System With Articulating Technology - 30 Fasteners, Optifix AT Absorbable Fixation System With Articulating Technology - 15 Fasteners
Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: April 28, 2017 Received: May 1, 2017
Dear Ms. Earle:
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. 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
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170278
Device Name
OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
Indications for Use (Describe)
The OptiFix AT Absorbable Fixation System with Articulating Technology is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia 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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510(k) Summary
I. SUBMITTER Davol Inc. 100 Crossings Boulevard Warwick, RI 02886
| Contact Person: | Katherine Earle |
|---|---|
| Regulatory Affairs Specialist | |
| Phone: | (401) 825-8450 |
| Fax: | (401) 825-8765 |
| E-mail: |
Date Prepared: May 30, 2017
II. DEVICE
| 510(k) Number: | K170278 |
|---|---|
| Name of Device: | OptiFix TM AT Absorbable Fixation System with Articulating Technology |
| Common or Usual Name: | Implantable Staple |
| Classification Name: | Implantable Staple (21 CFR §878.4750) |
| Regulatory Class: | II |
| Product Code: | GDW |
III. PREDICATE DEVICE
The primary predicate device for this submission is the OptiFix" Absorbable Fixation System (K142873), cleared March 12, 2015; marketed by Davol, Inc. The primary predicate, hereinafter referred to as "the predicate" throughout the remainder of the submission, has not been subject to a design-related recall.
The secondary predicate device for this submission is the Medtronic Covidien AbsorbaTack™ Absorbable Fastener System (K123109), cleared January 27, 2012.
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IV. DEVICE DESCRIPTION
The OptiFix™ AT Absorbable Fixation System with Articulating Technology, hereinafter referred to as "OptiFix ""AT", is a sterile (via gamma) single use device that is comprised of a deployment component and an absorbable fastener component. Two different product ordering codes are to be packaged for distribution; each contains the same ergonomically designed deployment device. The variation will be the number of preloaded fasteners; either 15 or 30. The deployment shaft of the OptiFix™ AT device is 37cm in length and designed for use with 5mm trocars. The tip of the shaft can be articulated and the handle of the device can be rotated 360 degrees to facilitate access for fixation during surgery. The fasteners are designed with retention features and are manufactured from Poly (L-lactide-co-glycolide) and are dyed with D & C Violet No. 2 (<0.15% by weight).
V. INDICATIONS FOR USE
The OptiFix™ AT Absorbable Fixation System with Articulating Technology is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
The Indications for Use statement for the subject device is identical to that of the primary predicate device (OptiFix "-K142873), and similar to that of the secondary predicate device (AbsorbaTack"-K123109). The proposed and predicate devices are all intended for the fixation of surgical mesh/prosthetic to tissue during open or laparoscopic surgical procedures, such as hernia repair.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The fixation of surgical mesh/prosthetic to tissue during open or laparoscopic surgical procedures, such as hernia repair, using a mechanical actuation force to guide and launch the fastener implant is the operating principle for the proposed and predicate devices.
The proposed and predicate devices are based on the following similar elements:
- Deployment component - mechanical component used to position and launch the fastener (implant) into tissue
- Fastener component -absorbable component composed of well-characterized absorbable polymer, used to fixate surgical mesh to tissue.
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The following differences exist between the proposed and predicate devices:
- The handle configuration of the proposed device can be rotated 360° and the deployment ● shaft articulated to facilitate fixation, unlike the predicate devices which have no articulation in the deployment shaft and a static handle.
- The deployment shaft of the proposed device is shorter in length (37 cm) compared to the deployment shaft of the primary predicate device (39cm).
- The proposed absorbable fastener has minor geometric differences and is composed of a different material (Poly(L-lactide-co-glycolide)) than the primary predicate absorbable fastener (Poly(D,L)-lactide).
VII. PERFORMANCE DATA
The following performance data is provided in support of the substantial equivalence determination.
Performance standards
No performance standards have been established for this device under Section 514 of the Federal Food, Drug, and Cosmetic Act.
Biocompatibility testing
The biocompatibility evaluation for the OptiFix™ AT device was conducted in accordance with FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". June 16, 2016; and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
The proposed device is supported by the biocompatibility testing listed below.
- Cytotoxicity
- Sensitization ●
- Intracutaneous (Irritation)
- Systemic Acute Toxicity
- Sub-Chronic Toxicity (13 weeks)
- Chronic Toxicity (26 weeks)
- Genotoxicity - Mouse Peripheral Blood Micronucleus Study
- Genotoxicity - Bacterial Reverse Mutation Study
- Genotoxicity - Mouse Lymphoma Assay
- Implantation - 4, 8, 12, 26, 39, 52, 77 weeks
- Pyrogenicity
All samples tested met the acceptance criteria and the proposed OptiFix™ AT device is biocompatible for its intended use.
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Electrical safety and electromagnetic compatibility (EMC)
The proposed OptiFix™ AT device is not an electro-mechanical medical device nor is it a medical system, therefore this section does not apply.
Software Verification and Validation Testing
The proposed OptiFix " AT device does not contain software; therefore this section does not apply.
Product Testing
The following non-clinical tests were completed for the proposed and primary predicate device. The proposed OptiFix™ AT device passed all the test requirements and demonstrated substantial equivalence to the test results of the primary predicate device.
- · Performance and Functional testing of the OptiFix™ AT device
- Actuation (trigger) Torque ●
- Fastener Deployment ●
- Fastener Gap Height
- Ball Burst Testing
- · Mesh compatibility testing of the OptiFix " AT device
- · Resorption Profile of the fastener
- In-Vitro Degradation ●
- In-Vitro to In-Vivo Correlation
All samples tested met the established acceptance criteria.
Animal Study
The safety and feasibility of the OptiFix™ AT device was evaluated by animal and histological evaluation of the tissue in the treatment fixated areas. The evaluation used the secondary predicate, AbsorbaTack™ (K123109), as a control since the fastener is composed of the same material, Poly (L-lactide-co-glycolide) in an 82%/18% molar ratio, and has the same intended use as the OptiFix" AT device. The study demonstrated that the OptiFix AT device can safely, approximate soft tissue and fixate surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair. The following endpoints were evaluated:
- Mesh contracture
- · Fastener seating properties
- · Tissue in-growth (T-peel analysis)
- · Host inflammatory/fibrotic response
Clinical Studies
Clinical studies were not performed for the submission of this proposed device nor were clinical studies performed for the primary predicate device (OptiFix-K142873).
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VIII. CONCLUSIONS
The proposed OptiFix™ AT device is substantially equivalent to the legally marketed primary predicate device for the following reasons:
- A) The same intended use as the primary predicate device.
- B) Similar technological characteristics as the primary predicate device such as: Fastener shape/design, trigger handle, penetration depth, and shaft length. The differences in technology do not adversely impact the safety and performance of the device.
- C) Identical principle of operation to deliver fasteners perpendicular to the tissue plane.
The comparative analysis, see Table 5-1 below, as well as the bench and preclinical testing results demonstrate that the proposed OptiFix™ AT device performs as intended and is substantially equivalent to the primary predicate device that is currently marketed for the same intended use.
| Device Features | Proposed deviceOptiFix™ AT | Predicate deviceOptiFix™ (K142873) |
|---|---|---|
| Intended Use | Identical to predicate | Soft tissue fixation |
| Indication ForUse | Identical to predicate | Indicated for the approximation ofsoft tissue and fixation of surgicalmesh to tissues during open orlaparoscopic surgical procedures,such as hernia repair. |
| Fastener Material | Resorbable PolymerPoly(L-lactide-co-glycolide)(PLG) | Resorbable PolymerPoly (D,L) Lactide |
| Fastener VioletDye | Identical to predicate | D & C Violet No. 2(<0.15% by weight)conforms to 21 CFR §74.1602 |
| Fastener BodyContact | Identical to predicate | Long term implant (>30 days)contacting tissue and/or bone |
| FastenerShape/Design | Push Tack with retention featureson end; nested tipImage: [purple fastener] | Push Tack with retention featureson endImage: [purple fastener] |
| Device Features | Proposed deviceOptiFix™ AT | Predicate deviceOptiFix™ (K142873) |
| FastenerDimensions | 7.1 mm overall fastener lengthFastener head: 3.5 mm diameter | 6.7 mm overall fastener lengthFastener head: 3.7 mm diameter |
| FastenerManufacturingMethod | Identical to predicate | Injection-Molded |
| FastenerAbsorption Time | Identical to predicate | 360 days |
| Fastener Quantityper Device | Identical to predicate | 15 & 30 fasteners |
| Fastener DeliverySystem | Identical to predicate | Push – Impact tube pushesfasteners forward over aguidewire |
| DeploymentComponentHandle design | Pistol/Gun shape with 360 degreerotation option | Pistol/Gun shape with no rotation |
| DeploymentComponent Shaft | 37 cm in length, 6 cm ofarticulation | 39 cm in length, no articulation |
| DeploymentComponentConfiguration | Image: OptiFix AT Deployment Component Configuration | Image: OptiFix (K142873) Deployment Component Configuration |
| DeploymentComponent BodyContact | Identical to predicate | Transient use - Less than 24 hourduration |
| DeviceSterilization | Identical to predicate | Gamma Irradiation(25 - 40 kGy) |
| DevicePackaging | Identical to predicate | Device is placed into an SBScardboard insert which is insertedinto a foil pouch, sealed and thenplaced into an SBS paperboardprinted shelf carton. |
Table 5-1: Device Substantial Equivalence - General Characteristics
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§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.