(29 days)
The SorbaFix 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 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.
The proposed SorbaFix Absorbable Fixation System is a sterile single use device that delivers either 15 or 30 synthetic absorbable fasteners. The fasteners are dyed with D & C Violet No. 2 in accordance with 21 CFR 74.1602. The shaft of the SorbaFix Absorbable Fixation System is 36 cm in length, including a piloting tip. The fasteners are 6.7 mm in length and are manufactured from Poly (D, L)-lactide. The fixation instrument shafts have an outer diameter of 5 mm, and may be used in open procedures or with most 5 mm trocars in laparoscopic procedures. The device includes a fastener gauge located on the back of the handpiece for user convenience only. The gauge will move right to left as the fasteners are deployed and indicates the approximate level of fasteners remaining in the device. The proposed PermaFix Fixation System is a sterile single use device that delivers fasteners manufactured from a non-absorbable acetal copolymer material. The other patient contacting components in the delivery system are all made from the same stainless steel as that of the predicates.
This 510(k) summary is for the SorbaFix™ Absorbable Fixation System and PermaFix™ Fixation System, which are implantable staples used for soft tissue approximation and surgical mesh fixation. The application focuses on demonstrating substantial equivalence to previously cleared predicate devices (SorbaFix K082396 and PermaFix K092483).
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify numerical acceptance criteria for specific performance metrics (e.g., tensile strength, deployment force). Instead, it relies on demonstrating that the proposed devices meet the requirements set up in the product performance specifications for their respective predicate devices. The overall "acceptance criterion" is thus substantial equivalence to the predicates, which is shown through design verification and validation testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate devices (K082396, K092483) | - Devices have the same implantable fastener design and similar delivery system design.- Devices have the same materials as the predicate devices.- Devices have the same shelf life.- Devices use the same sterilization method.- Devices are packaged and sterilized using the same materials and processes. |
| Biocompatibility with intended use | Full biocompatibility testing was conducted on the predicate SorbaFix and PermaFix fasteners (long term implants) in accordance with ISO 10993 series requirements. The results of these tests were submitted under K082396 and K092483. No further testing was necessary for the proposed devices as they incorporate the same materials. |
| Functional performance (e.g., fastener deployment, device operation) | "Design verification and validation testing were conducted and demonstrated that the proposed SorbaFix and PermaFix met the requirements set up in the product performance specifications for their respective predicate devices." (Summary of activities in Section 18.0, not provided here). |
| Adherence to intended use statement | The proposed devices are indicated for approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair, which aligns with the predicates. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the design verification and validation testing. It mentions "design verification and validation testing were conducted," but details on the number of devices or components tested are not provided within this summary.
The data provenance is not specified in terms of country of origin. Given it's a 510(k) submission to the US FDA, it can be inferred that the testing and validation were conducted in a manner compliant with US regulatory standards. The testing appears to be retrospective in the sense that it evaluates the performance of the modified devices against established specifications of prior cleared devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the evaluation of mechanical medical devices like fixation systems. The "ground truth" for these devices is typically established through engineering specifications, material properties, and functional performance testing, rather than expert interpretation of data like in diagnostic imaging. Therefore, no number of experts for ground truth establishment is mentioned within this summary.
4. Adjudication Method for the Test Set
Not applicable. The evaluation is based on engineering and material testing, not human-read interpretations requiring adjudication.
5. 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
Not applicable. This is a medical device submission for a physical fixation system, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device submission for a physical fixation system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the test set is established by:
- Engineering Specifications: Defined performance requirements for mechanical properties, material integrity, and functionality established for the predicate devices.
- Material Properties: Chemical and physical characteristics of the materials used.
- Biocompatibility Standards: Adherence to ISO 10993 series requirements for long-term implants.
8. The Sample Size for the Training Set
Not applicable. This is a medical device submission for a physical fixation system, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
MAY 2 4 2011 This 510(k) Summary is provided per the requirements of section 807.92(c).
Submitter Information
| Submitter's Name: | Davol, Inc., Subsidiary of C. R. Bard, Inc. |
|---|---|
| Address: | 100 Crossings BoulevardWarwick, RI 02886 |
| Contact Person: | Zheng LiuRegulatory Affairs Project ManagerTel: (401) 825-8671Fax: (401) 825-8765Email: jane.liu@crbard.com |
| Device Name | |
| Trade Name: | SorbaFix™ Absorbable Fixation SystemPermaFix™ Fixation System |
| Device Common Name: | Staple, Implantable |
| Classification Code: | Class II, §878.4750, Product Code GDW |
Predicate Device Names
- K082396 Davol Absorbable Fastener System, cleared on January 02, 2009 - K092483 PermaFix Fixation System, cleared on December 18, 2009
Device Description
The proposed SorbaFix Absorbable Fixation System is a sterile single use device that delivers either 15 or 30 synthetic absorbable fasteners. The fasteners are dyed with D & C Violet No. 2 in accordance with 21 CFR 74.1602. The shaft of the SorbaFix Absorbable Fixation System is 36 cm in length, including a piloting tip. The fasteners are 6.7 mm in length and are manufactured from Poly (D, L)-lactide. The fixation instrument shafts have an outer diameter of 5 mm, and may be used in open procedures or with most 5 mm trocars in laparoscopic procedures. The device includes a fastener gauge located on the back of the handpiece for user convenience only. The gauge will move right to left as the fasteners are deployed and indicates the approximate level of fasteners remaining in the device.
The proposed PermaFix Fixation System is a sterile single use device that delivers
PREMARKET NOTIFICATION FOR THE SORBAFIX™ ABSORBABLE FIXATION SYSTEM AND PERMAFIXTM FIXATION SYSTEM
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- have the same implantable fastener design and similar delivery system design:
- have the same materials as the predicate device:
- have the same shelf life;
- use the same sterilization method; and
- are packaged and sterilized using the same materials and processes.
The contraindication statement was expanded to the proposed SorbaFix and PermaFix IFU's as a remedial action taken following the internal investigation of the medical device reports from one incidence on one patient during one procedure. The proposed SorbaFix Absorbable Fixation System and PermaFix Fixation System are made from materials identical to their respective predicates (SorbaFix K082396 and PermaFix K092483). The SorbaFix fasteners are composed of an absorbable polymer material, i.e. poly (D, L) lactide, dyed with D&C Violet No. 2 in accordance with 21 CFR 74.1602. The PermaFix fasteners are manufactured from a non-absorbable acetal copolymer material. The other patient contacting components in the delivery system are all made from the same stainless steel as that of the predicates.
Full biocompatibility testing was conducted on both the predicate SorbaFix and PermaFix fasteners, the long term implants, in accordance with the ISO 10993 series requirements. The results of these tests were submitted under K082396 (Davol Absorbable Fastener System) and K092483 (PermaFix Fixation System) respectively. The biocompatibility data has ensured that the devices are safe for their intended use.
No further biocompatibility testing is necessary because the proposed devices incorporate the same materials as their respective predicates.
Other modifications covered under this Special 510(k) include:
- labeling changes to remove the word "laparoscopic" from the 36 cm shaft devices for clarity purposes;
- Modification of component dimensional specifications in the delivery system by removing the location of the clutch component from the end of the drive train towards the trigger to improve the drive mechanism:
- Addition of a fastener gauge to the back of the ergonomic handle for user convenience.
Tables summarizing the similarities and differences between the proposed devices and their respective predicates are provided in Section 15.0.
Substantial Equivalence:
Design verification and validation testing were conducted and demonstrated that the proposed SorbaFix and PermaFix met the requirements set up in the product performance specifications for their respective predicate devices (SorbaFix K082396 and
PREMARKET NOTIFICATION FOR THE SORBAFIX™ ABSORBABLE FIXATION SYSTEM AND PERMAFIXTM FIXATION SYSTEM
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PermaFix K092483). A summary of the design control activities are provided in Section 18.0 of this Premarket Notification.
In summary, based on the performance data and the substantial equivalence comparison tables (reference Section 15.0), Davol Inc. believes that the proposed SorbaFix Absorbable Fixation System and PermaFix Fixation System are substantially equivalent to their respective predicates (SorbaFix K082396 and PermaFix K092483).
PREMARKET NOTIFICATION FOR THE SORBAFIX™ ABSORBABLE FIXATION SYSTEM AND PERMAFIXTM FIXATION SYSTEM
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 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 image of an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
C. R. Bard, Inc. % Davol, Inc. Ms. Zheng Liu Regulatory Affairs Project Manager 100 Crossings Boulevard Warwick, Rhode Island 02886
MAY 2 4 2011
Re: K111153
Trade/Device Name: SorbaFix™ and PermaFix™ Absorbable Fixation Systems Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: April 22, 2011 Received: April 25, 2011
Dear Ms. Liu:
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.
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Page 2 - Ms. Zheng Liu
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 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/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 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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
SorbaFix™ Absorbable Fixation System Device Name: The SorbaFix Absorbable Fixation System is indicated for Indications for Use: the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair. PermaFix™ Fixation System Device Name: The PermaFix Fixation System is indicated for the Indications for Use: 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)
Daniel Kacor for MXM
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111153
§ 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.