(144 days)
No
The description focuses on the mechanical function and material properties of a surgical fixation system, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is used for soft tissue approximation and mesh fixation during surgical procedures, which are mechanical actions rather than therapeutic.
No
The device is described as an absorbable fixation system for approximating soft tissue and fixing surgical mesh, indicating it is used for surgical procedures rather than diagnosis.
No
The device description clearly states it is a sterile single-use device that delivers fasteners via a straight shaft, indicating it is a physical hardware device, 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 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 device used in vivo (within the body) for mechanical fixation.
- Device Description: The description details a device that delivers physical fasteners made of an absorbable material. This is consistent with a surgical implant or fixation device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical fixation 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
GDW
Device Description
The OPTIFIX™ Absorbable Fixation System is a sterile single use device that delivers either 15 or 30 synthetic absorbable fasteners via a straight shaft. The shaft of the OPTIFIX™ Absorbable Fixation System is 39 cm in length. The fasteners are designed with a retention feature on the end 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
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 non-clinical tests were completed for the subject and predicate devices. OptiFix™ passed all the test requirements and showed substantial equivalence to the results of the predicate device- SorbaFix™
- . Shear strength testing
- Mass loss determination .
- Dimensional changes .
- Inherent viscosity .
- . Glass transition temperatures
- Residual monomer content .
All samples tested met the acceptance criteria.
Animal Test Summary
- The following Animal in-vivo studies were completed
- Contracture .
- Tissue Ingrowth ●
- Histology o
Ex-vivo Burst Strength on Pig wall
OptiFix™ passed all the test requirements and showed substantial equivalence to the results of the predicate device- SorbaFix™.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
DEC
.
510(k) Summary
| OPTIFIX™ Absorbable Fixation System | 10 July, 2013 | |||
|---|---|---|---|---|
| Submitter | Davol Inc. | |||
| 100 Crossings | ||||
| Boulevard | ||||
| Warwick, RI 02886 | Contact | Radhika Pondicherry | ||
| Senior Regulatory Affairs Specialist | ||||
| radhika.pondicherry@crbard.com | ||||
| (401) 825-8464 | ||||
| (401) 825-8764 (fax) | ||||
| Preparation Date | 10 July, 2013 | |||
| Trade Name | ||||
| Common/Classification | ||||
| Name | OPTIFIX™ Absorbable Fixation System | |||
| Staple Implantable/Implantable Staple | ||||
| Regulatory Class | ||||
| Product Code | Class II per 21 CFR §878.4750 | |||
| GDW | ||||
| Legally Marketed | ||||
| Predicate Device(s) | K082396 Davol Absorbable Fastener System- SorbaFix™ - 02Jan2009 | |||
| Device Description | The OPTIFIX™ Absorbable Fixation System is a sterile single use device | |||
| that delivers either 15 or 30 synthetic absorbable fasteners via a straight | ||||
| shaft. The shaft of the OPTIFIX™ Absorbable Fixation System is 39 cm | ||||
| in length. The fasteners are designed with a retention feature on the end | ||||
| and are manufactured from Poly (D, L)-lactide. | ||||
| 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. | ||||
| Predicate Device | ||||
| Comparison | Device Comparison | |||
| Device Features | OptiFix™ | |||
| (Subject Device) | SorbaFix | |||
| (K082396) | ||||
| Tack Schematic | Image: Tack Schematic for OptiFix | Image: Tack Schematic for SorbaFix | ||
| Indication For use | Identical to predicate | 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 | Identical to predicate | Poly (D,L) Lactide |
PREMARKET NOTIFICATION FOR OPTIFIX™ ABSORBABLE FIXATION SYSTEM
1
| Fastener Violet
| Dye | Identical to predicate | D & C Violet No. 2 |
|---|---|---|
| Fastener Body | ||
| Contact | Identical to predicate | Long term implant (>30 |
| days) contacting tissue | ||
| and/or bone | ||
| Fastener | ||
| Shape/Design | Push Tack with retention | |
| feature on end | Screw | |
| Fastener Quantity | ||
| per Device | 15 & 30 fasteners | 5,15& 30 fasteners |
| Deployment | ||
| component - Shaft | ||
| Length | 39 cm in length | 18cm and 36 cm in length |
| Deployment | ||
| component Handle | ||
| design | Identical to predicate | Pistol/Gun shape |
| Device Sterilization | Identical to predicate | Gamma Irradiation (25 - 40 |
| kGy) |
Non-Clinical Test Summary
"
The following non-clinical tests were completed for the subject and predicate devices. OptiFix™ passed all the test requirements and showed substantial equivalence to the results of the predicate device- SorbaFix™
- . Shear strength testing
- Mass loss determination .
- Dimensional changes .
- Inherent viscosity .
- . Glass transition temperatures
- Residual monomer content .
All samples tested met the acceptance criteria.
Animal Test Summary
- The following Animal in-vivo studies were completed
- Contracture .
- Tissue Ingrowth ●
- Histology o
Ex-vivo Burst Strength on Pig wall
OptiFix™ passed all the test requirements and showed substantial equivalence to the results of the predicate device- SorbaFix™.
PREMARKET NOTIFICATION FOR OPTIFIX™ ABSORBABLE FIXATION SYSTEM
2
Conclusions
V
・デ
The OPTIFIX™ Absorbable Fixation System is substantially equivalent to the predicate device. The device is as safe, as effective, and performs as well as the predicate device.
.
.
PREMARKET NOTIFICATION FOR OPTIFLX™ ABSORBABLE FIXATION SYSTEM
・
· September 1998
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
C.R. Bard Incorporated Radhika Pondicherry Senior Regulatory Affairs Specialist 100 Crossing Boulevard Warwick, Rhode Island 02886
December 2, 2013
Re: K132134
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: October 29, 2013 Received: October 30, 2013
Dear Pondicherry:
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. Ilsting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Radhika Pondicherry
. ........
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/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.goy/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 vours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use-
510{k} Number (if known) K132134
Device Name
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OPTIFIX™ Absorbable Fixation System
: ·
Indications for Use (Describe)
The OPTIFLY™ Absorbable Fixation System is indicated for the approximation 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)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)