(162 days)
No
The summary describes a mechanical fixation system and does not mention any AI or ML components or functionalities.
No.
This device is used for the mechanical fixation of tissue and mesh during surgical procedures, which is a structural function, not a therapeutic treatment of a physiological condition or disease.
No
The OptiFix™ Absorbable Fixation System is explicitly described as a device for "approximation of soft tissue and fixation of surgical mesh to tissues" during surgical procedures. Its components (deployment device and absorbable fasteners) are designed for mechanical fastening, not for obtaining or interpreting physiological data to diagnose a condition.
No
The device description clearly states it is comprised of a deployment component and an absorbable fastener component, which are physical hardware components.
Based on the provided information, the OptiFix™ Absorbable Fixation System is not an IVD (In Vitro Diagnostic) device.
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, such as hernia repair." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a surgical instrument with a deployment component and absorbable fasteners, designed for use in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be used within the body during surgery.
N/A
Intended Use / Indications for Use
The OptiFix™ Absorbable Fixation System 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 (comma separated list FDA assigned to the subject device)
GDW
Device Description
The OptiFix™ Absorbable Fixation System is a sterile (via gamma) single use product that is comprised of a deployment component and an absorbable fastener component. Two product ordering codes are to be packaged for distribution; each contains the same ergonomically designed deployment device. The variation will be the preloaded fasteners; either 15 or 30. The shaft of the OptiFix™ Absorbable Fixation System is 39 cm in length and is designed for use with 5mm trocars. The fasteners are designed with retention features and are manufactured from Poly (D, L)-lactide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open or laparoscopic surgical procedures
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)
Biocompatibility testing: The biocompatibility evaluation for the OptiFix™ Absorbable Fixation System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." May 1, 1995, 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.
Testing for the fastener included Cytotoxicity and the complete biocompatibility profile for the OptiFix fastener has been supported by full biocompatibility testing on the reference device, SorbaFix (K082396) as listed in the following. The fastener materials between the OptiFix and the reference device have been demonstrated to be substantially equivalent.
- Sensitization
- Intracutaneous Reactivity
- Single-dose Systemic Toxicity
- Rabbit Pyrogenicity
- 14-Day Repeat Dose Intravenous Toxicity
- Genotoxicity
- Chronic Toxicity, 13 weeks
- Implantation. 52 weeks
Testing for the new materials within the deployment device included Cytotoxicity, Sensitization, Intracutaneous Reactivity, and Single-dose Systemic Toxicity.
The deployment component of the proposed OptiFix™ Absorbable Fixation System is determined to be tissue contacting for duration of less than 24 hours, while the absorbable fasteners are determined to be permanent implants.
Testing: The following non-clinical tests were completed for the proposed and predicate device. The OptiFix™ Absorbable Fixation System passed all the test requirements and demonstrated substantial equivalence to the test results of the predicate device.
- Performance and Functional testing of the OptiFix™ Absorbable Fixation System-deployment device and fastener
- Actuation (trigger) torque
- Fastener deployment
- Fastener gap height
- Ball burst testing
- Mesh compatibility testing of the OptiFix™ Absorbable Fixation System
- Resorption profile of the fastener
All samples tested met the established acceptance criteria.
Animal Study: Animal studies were not performed on the proposed device for this submission. Based on identical materials and comparable mechanical strengths measured at the bench level, the in vivo safety and performance of the proposed device was evaluated via the animal and histological studies conducted on the reference device, the SorbaFix Fixation Device.
Clinical Studies: Clinical studies were not performed for the submission of this device nor were clinical studies performed for the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2015
Davol Incorporated Ms. Christine Lloyd Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K142873
Trade/Device Name: OptiFix™ Absorbable Fixation System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: February 6, 2015 Received: February 9, 2015
Dear Ms. Lloyd:
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 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 (reporting of medical
1
device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
for
Sincerely yours,
David Krause -S
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
2
Indications for Use
510(k) Number (if known) K142873
Device Name OptiFix™ Absorbable Fixation System
Indications for Use (Describe)
The OptiFix™ Absorbable Fixation System 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 Sub |
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
I. SUBMITTER
Davol Inc. 100 Crossings Boulevard Warwick, RI 02886
| Contact Person: | Christine Lloyd |
|---|---|
| Regulatory Affairs Specialist | |
| Phone: | (401) 825-8447 |
| Fax: | (401) 825-8753 |
| E-mail: | Christine.Lloyd@crbard.com |
Date Prepared: March 12 2015
II. DEVICE
| Name of Device: | OptiFix™ Absorbable Fixation System [product ordering codes 0113126 (deployment device contains 30 fasteners) and 0113127 (deployment device contains 15 fasteners)] |
|---|---|
| Common or Usual Name: | Staple Implantable/Implantable Staple |
| Classification Name: | Implantable staple (21 CFR §878.4750) |
| Regulatory Class: | II |
| Product Code: | GDW |
III. PREDICATE DEVICE
OptiFixTM Absorbable Fastener System, K132134; marketed by Davol, Inc., This predicate has not been subject to a design-related recall.
The reference device Davol Absorbable Fastem - SorbaFix™ (K082396) is used in this submission.
IV. DEVICE DESCRIPTION
The OptiFix™ Absorbable Fixation System is a sterile (via gamma) single use product that is comprised of a deployment component and an absorbable fastener component. Two product ordering codes are to be packaged for distribution; each contains the same ergonomically designed deployment device. The variation will be the preloaded fasteners; either 15 or 30. The shaft of the OptiFix™ Absorbable Fixation System is 39 cm in length and is designed for use with 5mm trocars. The fasteners are designed with retention features and are manufactured from Poly (D, L)-lactide.
SECTION 7
4
V. INDICATIONS FOR USE
The OptiFix™ Absorbable Fixation System 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 the predicate device. Both the subject and predicate devices have the same intended use for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair using the mechanical actuation (trigger) force to guide the fastener and launch the implant is the principle for both the proposed and predicate devices.
At a high level, the proposed and predicate devices are based on the following same elements:
- Deployment component mechanical component used to guide the fastener into tissue ●
- Use of a mechanical component for positioning and launching the implant ●
- User-controlled mechanical trigger to guide the fastener (implant) ●
- Fastener component - absorbable component based on the same material used to fixate surgical mesh to tissue
At a high level, the following differences exist between the proposed and predicate devices:
- The proposed deployment device has a resistive trigger and the predicate has a rotating ● trigger.
- The proposed fastener component has slight differences in geometry than the predicate.
VII. PERFORMANCE DATA
The following performance data were 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.
5
Biocompatibility testing
The biocompatibility evaluation for the OptiFix™ Absorbable Fixation System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." May 1, 1995, 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.
Testing for the fastener included Cytotoxicity and the complete biocompatibility profile for the OptiFix fastener has been supported by full biocompatibility testing on the reference device, SorbaFix (K082396) as listed in the following. The fastener materials between the OptiFix and the reference device have been demonstrated to be substantially equivalent.
- Sensitization ●
- Intracutaneous Reactivity
- Single-dose Systemic Toxicity ●
- Rabbit Pyrogenicity
- 14-Day Repeat Dose Intravenous Toxicity
- Genotoxicity ●
- Chronic Toxicity, 13 weeks
- . Implantation. 52 weeks
Testing for the new materials within the deployment device included Cytotoxicity, Sensitization, Intracutaneous Reactivity, and Single-dose Systemic Toxicity.
The deployment component of the proposed OptiFix™ Absorbable Fixation System is determined to be tissue contacting for duration of less than 24 hours, while the absorbable fasteners are determined to be permanent implants.
Testing
The following non-clinical tests were completed for the proposed and predicate device. The OptiFix™ Absorbable Fixation System passed all the test requirements and demonstrated substantial equivalence to the test results of the predicate device.
- Performance and Functional testing of the OptiFix™ Absorbable Fixation System-● deployment device and fastener
- Actuation (trigger) torque .
- . Fastener deployment
- . Fastener gap height
- . Ball burst testing
- Mesh compatibility testing of the OptiFix™ Absorbable Fixation System
- Resorption profile of the fastener
All samples tested met the established acceptance criteria.
SECTION 7
6
Animal Study
Animal studies were not performed on the proposed device for this submission. Based on identical materials and comparable mechanical strengths measured at the bench level, the in vivo safety and performance of the proposed device was evaluated via the animal and histological studies conducted on the reference device, the SorbaFix Fixation Device.
Clinical Studies
Clinical studies were not performed for the submission of this device nor were clinical studies performed for the predicate device.
| Device Features | Proposed device
OptiFix™ | Predicate device
OptiFix™ (K132134) |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Soft tissue fixation | Soft tissue fixation |
| Indication For use | Indicated for the approximation
of soft tissue and fixation of
surgical mesh to tissues during
open or laparoscopic surgical
procedures, such as hernia repair. | Indicated for the approximation of
soft tissue and fixation of surgical
mesh to tissues during open or
laparoscopic surgical procedures,
such as hernia repair. |
| Fastener Material | Poly (D,L) Lactide | Poly (D,L) Lactide |
| Fastener Violet Dye | D & C Violet No. 2
conforms to 21 CFR §74.3602 | D & C Violet No. 2
conforms to 21 CFR §74.3602 |
| Fastener Body
Contact | Long term implant (>30 days)
contacting tissue and/or bone | Long term implant (>30 days)
contacting tissue and/or bone |
| Fastener
Shape/Design | Push Tack with retention features
on end | Push Tack with retention features
on end |
| Fastener Dimensions | 6.7 mm overall fastener length
Fastener head: 3.7 mm length; 3.5
mm thickness | 6.7 mm overall fastener length
Fastener head: 3.7 mm length; 3.5
mm thickness |
| Fastener
Manufacturing
Method | Injection-Molded | Injection-Molded |
| Fastener Absorption
Time | 360 days | 360 days |
| Fastener Quantity
per Device | 15 & 30 fasteners | 15 & 30 fasteners |
Table 7-1: Device Substantial Equivalence – General Characteristics
Premarket Notification for OptiFix™ Absorbable Fixation System
7
| Device Features | Proposed device
OptiFix™ | Predicate device
OptiFix™ (K132134) |
|----------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Fastener Delivery
System | Push - Impact tube pushes
fasteners forward over a straight
guidewire | Push – Impact tube pushes
fasteners forward over a straight
guidewire |
| Deployment Device
Handle design | Pistol/Gun shape | Pistol/Gun shape |
| Deployment Device
Shaft Nominal
Length | 39 cm in length | 39 cm in length |
| Deployment Device
Trigger | Resistive trigger | Rotating trigger |
| Deployment Device
Trigger Stroke | Swift and full | Slow and progressive |
| Deployment Device
Guidewire | Moveable | Stationary |
| Device Sterilization | Gamma Irradiation
(25 - 40 kGy) | Gamma Irradiation
(25 - 40 kGy) |
VIII. CONCLUSIONS
The OptiFix™ Absorbable Fixation System is substantially equivalent to the legally marketed predicate device for the following reasons:
- A) The same intended use and indications for use as the predicate device.
- B) Both devices use a similar fixation technology to deliver the fasteners by compressing a trigger.
- C) Both devices house similar synthetic absorbable fastener with retention head design.
- D) Identical materials with long history of biocompatible use in medical instrumentation and implantation.
- E) Identical technological characteristics to the predicate devices such as: Fastener dimensions trigger handle, penetration depth, and shaft length.
- F) Same principle of operation.
The comparative analysis as well as the bench and preclinical testing results demonstrated that the OptiFix™ Absorbable Fixation System should perform as safe, and as effective, as the predicate device that is currently marketed for the same intended use.