PERMASORB DISPOSABLE FIXATION DEVICE

K123718 · C.R. Bard, Inc. · GDW · Jan 22, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123718
• Device Name: PERMASORB DISPOSABLE FIXATION DEVICE
• Applicant: C.R. Bard, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jan 22, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

PermaSorb™ is a sterile, single-use endoscopic or open surgical stapler; consists of a delivery instrument and resorbable fixation devices. Used by surgeons in OR settings for hernia repair or similar procedures requiring mesh fixation. Device delivers resorbable fasteners to approximate tissue and secure mesh. Surgeon manually operates the delivery instrument to deploy fasteners. Output is the physical fixation of mesh to tissue. Benefits include secure mesh placement and tissue approximation using resorbable materials. Modification adds specific contraindications regarding hemostasis verification and avoidance of underlying structures (nerves, vessels, viscera, bone).

Clinical Evidence

No clinical studies were performed. Bench testing only.

Technological Characteristics

Resorbable fixation device; disposable, sterile, single-use delivery instrument. Class II device per 21 CFR 878.4750. Mechanical delivery system. No software or electronic components.

Indications for Use

Indicated for soft tissue approximation and surgical mesh fixation during open or laparoscopic procedures, including hernia repair. Contraindicated for use where hemostasis cannot be visually verified after application and in the close vicinity of underlying structures such as nerves, vessels, viscera, or bone to avoid inadvertent penetration.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Medchannel EasyTac Anchor (K060494)
• SorbaFix™ Absorbable Fixation and PermaFix™ Fixation System (K111153)

Submission Summary (Full Text)

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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, Inc<br>100 Crossing Boulevard,<br>Warwick, RI 02886 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Radhika Pondicherry<br>Senior Regulatory Affairs<br>(401)-825-8464<br>Fax [phone] |
| 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<br>· K111153 SorbaFix™ Absorbable Fixation and PermaFix™ Fixation System-<br>24May2011 |
| Device Description | PermaSorb™ is endoscopic or open surgical stapler composed of a disposable<br>sterile single use delivery instrument and resorbable fixation devices. |
| Indications for Use | The PERMASORB™ Disposable Fixation Device is indicated for the approximation<br>of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic<br>surgical procedures, such as hernia repair. |
| Device Modification | The ONLY modification is the addition of the following contraindications:<br>1. 'Do not use this device where hemostasis cannot be verified visually after application.'<br>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 [phone] or [phone] 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)

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# David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123718