(127 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device and does not contain information about an AI/ML powered device, therefore, many of the requested details are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through material characterization and mechanical performance testing.
Here's a breakdown of the information that is available and a note on what is not:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility of materials consistent with intended use. | "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." |
| Material composition similar to other implantable medical devices. | "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." |
| Mechanical strength of the repair in a hernia repair model comparable to the predicate device. | "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." |
| Overall achievement of established specifications for consistent performance for intended use. | "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." |
Details Not Applicable to This Device (as it is not an AI/ML device)
The document describes a Bard PermaFix Fixation System, which is a physical medical device (a stapler for hernia repair) and not an AI/ML powered device. Therefore, the following information fields are not applicable and cannot be extracted from the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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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
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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
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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
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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
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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
§ 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.