(49 days)
The PERMASORB™ Disposable Fixation Device 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.
PermaSorb™ is endoscopic or open surgical stapler composed of a disposable sterile single use delivery instrument and resorbable fixation devices.
The provided text is a 510(k) summary for the PERMASORB™ Disposable Fixation Device. It describes the device, its indications for use, and a comparison to predicate devices, but it explicitly states that "No clinical studies were performed."
Therefore, based on the provided text, there is no information available to construct a table of acceptance criteria or describe a study that proves the device meets those criteria. The submission relies solely on non-clinical testing summary (which states "No changes to product design specifications were made") and substantial equivalence to predicate devices (K060494 and K111153) to demonstrate safety and effectiveness.
Key takeaway from the document: The device approval is based on substantial equivalence, not a new study demonstrating performance against specific acceptance criteria.
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K123718 Page 1/1
510(k) Summary
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PERMASORB™ Disposable Fixation Device
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03 December, 2012
JAN 2 2 2 2013
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| Submitter | Davol Inc. Subsidiary of C.R Bard, Inc100 Crossing Boulevard,Warwick, RI 02886 |
|---|---|
| Contact | Radhika PondicherrySenior Regulatory Affairs(401)-825-8464Fax (401)825-8764 |
| Preparation Date | 03 December, 2012 |
| Device Name | PermaSorb™ Disposable Fixation Device |
| Trade Name | Staple, Implantable |
| Common/Classification Name | |
| Regulatory Class | Class II per 21 CFR §878.4750 |
| Product Code | GDW |
| Legally Marketed Predicate Device(s) | K060494 Medchannel EasyTac Anchor- 03Jul2006· K111153 SorbaFix™ Absorbable Fixation and PermaFix™ Fixation System-24May2011 |
| Device Description | PermaSorb™ is endoscopic or open surgical stapler composed of a disposablesterile single use delivery instrument and resorbable fixation devices. |
| Indications for Use | The PERMASORB™ Disposable Fixation Device is indicated for the approximationof soft tissue and fixation of surgical mesh to tissues during open or laparoscopicsurgical procedures, such as hernia repair. |
| Device Modification | The ONLY modification is the addition of the following contraindications:1. 'Do not use this device where hemostasis cannot be verified visually after application.'2. 'Carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as nerves, vessels, viscera or bone. Use of the PERMASORB™ Disposable Fixation Device in the close vicinity of such underlying structures is contraindicated. For reference, the total length of the fastener (including the head) is 6.4mm.' |
| Predicate Comparison | The PermaSorb™ Disposable Fixation Device is substantially equivalent to the predicate device cleared in K060494, with respect to indications for use, operating principles, materials, basic design, shelf life, packaging and sterilization. The Permasorb Disposable Fixation Device contains similar contraindications referenced in K111153. |
| Non-Clinical Test Summary | No changes to product design specifications were made. |
| Clinical Test Summary | No clinical studies were performed. |
| Conclusions | PermaSorb™ Disposable Fixation Device is substantially equivalent to the predicate devices. |
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 22, 2013
C.R. Bard, Inc. % Davol Inc. Ms. Radhika Pondicherry 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K123718
Trade/Device Name: PermaSorb™ Disposable Fixation Device Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: January 04, 2013 Received: January 07, 2013
Dear Ms. Pondicherry:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your socured the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered pror to May 2017/03/11 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 The general connous proving 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 your device 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 f icaso be actives and itermination that your device complies with other requirements of the Act that I Dri has made a dolor administered by other Federal agencies. You must or any I editare and the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Radhika Pondicherry
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of it Fart 607), accember (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 forth in the qualify by covisions (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 11 you desire specific adviaboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mep.//www.radesond Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part now the regulations 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 Tou may oount only general methonal 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.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K123718
Device Name: PermaSorb™ Disposable Fixation Device
The PERMASORB™ Disposable Fixation Device is indicated for the approximation of soft tissue and fixation of
ten in the may be and seen and sever in writes are such as hernia The PERMASORB™ Disposable Fixation Device is macerca for the appear of the appear.
surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia re
x Prescription Use __ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please do not write Below this line-continue on another page if needed)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
David Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123718
§ 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.