(127 days)
Not Found
No
The description focuses on a mechanical fastener delivery system and does not mention any AI/ML components or functionalities.
No
The device is designed for the mechanical approximation of soft tissue and fixation of surgical mesh, not for treating a disease or condition therapeutically.
No
This device is used for soft tissue approximation and fixation of surgical mesh, such as in hernia repair, which are therapeutic and procedural actions, not diagnostic ones.
No
The device description clearly outlines a physical, disposable, single-use system with an ergonomic handle, trigger, shaft, penetrating tip, and preloaded fasteners. This is a 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 mechanical approximation of soft tissue and fixation of surgical mesh during surgical procedures. This is a direct surgical intervention, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is a fastener delivery system designed to physically implant fasteners into tissue or prosthesis. This is a surgical tool, not a diagnostic instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Bard PermaFix 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 Bard PermaFix 1M Fixation System is disposable, single-use system designed to deliver a permanent fastener into tissue or prosthesis during general surgery procedures such as hernia repair. The fastener delivery system consists of an ergonomic handle with trigger, shaft and penetrating tip. The shaft is available in either a 36 cm length for laparoscopic use or a 20 cm length for open surgical procedures. The device is preloaded with 15 or 30 permanent fasteners. Each permanent fastener contains threads for mesh and tissue delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, surgical mesh to tissues
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility test results show that the material used in the design and manufacture of the components of the proposed device are compatible with biological tissues consistent with its intended use. In addition, a material characterization has been performed to demonstrate that this material is similar in composition to other implantable medical devices. This material is well characterized and has been used for several years in the medical device industry.
The Bard PermaFix fasteners were tested in vitro in a hernia repair model to confirm the mechanical strength of the repair as compared to the predicate device.
All test results demonstrate that the material chosen, the manufacturing process, and the design used for the Bard PermaFix Fixation System met the established specifications necessary for consistent performance for its intended use.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
02
DEC 1 8 2009
SECTION 7.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter Information A.
Submitter's Name: Address:
Telephone: Fax: Contact Person: Date of Preparation:
Davol Inc. Subsidiary of C. R. Bard, Inc. 100 Crossing Boulevard Warwick, RI 02886 (401) 825-8588 (401) 825-8765 Kevin G. Stevens August 12, 2009
B. Device Name
Trade Name: Common/Usual Name: Classification Name:
Bard PermaFix Fixation System Staple, Implantable Staple, Implantable.
C. Predicate Device Name
Trade name:
Davol Absorbable Fastener System (K082396)
D., Device Description
The Bard PermaFix 1M Fixation System is disposable, single-use system designed to deliver a permanent fastener into tissue or prosthesis during general surgery procedures such as hernia repair. The fastener delivery system consists of an ergonomic handle with trigger, shaft and penetrating tip. The shaft is available in either a 36 cm length for laparoscopic use or a 20 cm length for open surgical procedures. The device is preloaded with 15 or 30 permanent fasteners. Each permanent fastener contains threads for mesh and tissue delivery.
Intended Use E.
The Bard PermaFix 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.
PREMARKE I NOTIFICATION FOR THE BARD PERMAFIX™ FIXA IION SYSTEM
1
K09 2483
pg 2 of 2
Summary of Similarities and Differences in Technological Characteristics, F. Performance and Intended Use
The Bard PermaFix Fixation System and the currently marketed Davol SorbaFix Fastener System (Predicate Device) are both indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair
In addition, both products are similar in technological characteristics and performance. Indeed, both devices are the same design and have fasteners that are the same shape and configuration. Both devices use the same fixation technology to deliver the fasteners by compressing a trigger. The salient difference between the SorbaFix Fastener System and the PermaFix Fastener System is the choice of material used in the fastener. The PermaFix uses a permanent, biocompatible material versus the absorbable poly (D,L) lactide material used in the SorbaFix Absorbable Fastener System.
G. Performance Data
The biocompatibility test results show that the material used in the design and manufacture of the components of the proposed device are compatible with biological tissues consistent with its intended use. In addition, a material characterization has been performed to demonstrate that this material is similar in composition to other implantable medical devices. This material is well characterized and has been used for several years in the medical device industry.
The Bard PermaFix fasteners were tested in vitro in a hernia repair model to confirm the mechanical strength of the repair as compared to the predicate device.
All test results demonstrate that the material chosen, the manufacturing process, and the design used for the Bard PermaFix Fixation System met the established specifications necessary for consistent performance for its intended use.
PREMARKE I NOTIFICATION FOR THE BARD PERMAFIX™ FIXATION SYSTEM
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its head turned to the right, symbolizing vigilance and strength. The eagle is surrounded by a circular border containing the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters. The seal represents the HHS's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 1 8 2009
C.R. Bard, Inc. % Davol. Inc. Mr. Kevin Stevens 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K092483
Trade/Device Name: BARD PERMAFIX FIXATION SYSTEM Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: December 11, 2009 Received: December 14, 2009
Dear Mr. Stevens:
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.
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
3
Page 2 - Mr. Kevin Stevens
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K0924f3
Indications for Use Statement
510(k) Number (if known):
Device Name:
BARD PERMAFIX FIXATION SYSTEM
Indications for Use:
The BARD PERMAFIX FIXA IION 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krone Van Mlyen
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092483