(121 days)
No
The description focuses on the mechanical and material properties of a surgical fixation system and does not mention any computational or data-driven components indicative of AI/ML.
No.
The device is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues, which serves a mechanical support function during surgery, rather than a therapeutic function that cures or rehabilitates a condition.
No
The device is used for soft tissue approximation and surgical mesh fixation during procedures like hernia repair, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines a physical, sterile, single-use device comprised of a deployment component and absorbable fasteners, indicating it is a hardware-based medical device.
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 approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures. This is a surgical device used in vivo (within the body) for mechanical fixation.
- Device Description: The description details a surgical instrument (deployment component) and absorbable fasteners. This aligns with a surgical fixation system, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical fixation during surgery.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
GDW
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 (
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.
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 (30 days)
contacting tissue and/or bone |
| Fastener
Shape/Design | Push Tack with retention features
on end; nested tip
Image: [purple fastener] | Push Tack with retention features
on end
Image: [purple fastener] |
| Device Features | Proposed device
OptiFix™ AT | Predicate device
OptiFix™ (K142873) |
| Fastener
Dimensions | 7.1 mm overall fastener length
Fastener head: 3.5 mm diameter | 6.7 mm overall fastener length
Fastener head: 3.7 mm diameter |
| Fastener
Manufacturing
Method | Identical to predicate | Injection-Molded |
| Fastener
Absorption Time | Identical to predicate | 360 days |
| Fastener Quantity
per Device | Identical to predicate | 15 & 30 fasteners |
| Fastener Delivery
System | Identical to predicate | Push – Impact tube pushes
fasteners forward over a
guidewire |
| Deployment
Component
Handle design | Pistol/Gun shape with 360 degree
rotation option | Pistol/Gun shape with no rotation |
| Deployment
Component Shaft | 37 cm in length, 6 cm of
articulation | 39 cm in length, no articulation |
| Deployment
Component
Configuration | Image: OptiFix AT Deployment Component Configuration | Image: OptiFix (K142873) Deployment Component Configuration |
| Deployment
Component Body
Contact | Identical to predicate | Transient use - Less than 24 hour
duration |
| Device
Sterilization | Identical to predicate | Gamma Irradiation
(25 - 40 kGy) |
| Device
Packaging | Identical to predicate | Device is placed into an SBS
cardboard insert which is inserted
into a foil pouch, sealed and then
placed into an SBS paperboard
printed shelf carton. |
Table 5-1: Device Substantial Equivalence - General Characteristics
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