ENTACT SEPTAL STAPLER, MODEL 610-00100

K082750 · Entrigue Surgical, Inc. · OLL · Jan 6, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K082750
• Device Name: ENTACT SEPTAL STAPLER, MODEL 610-00100
• Applicant: Entrigue Surgical, Inc.
• Product Code: OLL · General, Plastic Surgery
• Decision Date: Jan 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENTact™ Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissues during nasal septal surgery.

Device Story

ENTact Septal Stapler is a manual surgical delivery system for resorbable fixation devices; used during nasal septal surgery to approximate mucoperichondrial flaps of nasal septum; staples are preloaded in single-use, disposable stapler; device operated by surgeon in clinical setting; staples connect internal tissues to facilitate healing; provides mechanical approximation of soft tissues.

Technological Characteristics

Manual surgical stapler delivery system; implantable staples composed of absorbable copolymer; single-use, disposable form factor.

Indications for Use

Indicated for patients undergoing nasal septal surgery requiring approximation of soft tissues and connection of internal tissues to aid healing.

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

• Incisive Surgical, INSORB® Absorbable Staple
• Ethicon Inc., Vicryl® Suture

Submission Summary (Full Text)

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# JAN - 6 2009

510(k) Number K082750

## 510(k) SUMMARY

Trade Name:

Sponsor:

ENTact™ Septal Stapler

ENTrigue Surgical, Inc. 12672 Silicon Drive, Suite 150 San Antonio, Texas 78249 Telephone: [phone] Fax: [phone] Contact Person: Gabriele G. Niederauer, Ph.D.

Date Prepared:

January 5, 2009

Product Code and Device Classification Name:

Classification:

Predicate Devices:

Device Description:

Indications for Use:

OLL

Implantable Staple (21 C.F.R. § 878.4750)

Class II

Incisive Surgical, INSORB® Absorbable Staple Ethicon Inc., Vicry|® Suture

The ENTact™ Septal Stapler consists of resorbable fixation devices, which are delivered via an manual surgical stapler delivery system. The ENTact™ implantable septal staples, composed of an absorbable copolymer, may be used during nasal surgery to approximate the mucoperichondrial flaps of the nasal septum and at the completion of surgery. The staples are provided preloaded in a single-use, disposable stapler.

The ENTact™ Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissues during nasal septal surgery.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ENTrigue Surgical, Inc. c/o Gabriele G. Niederauer, Ph.D. Vice-President, Research & Development 12672 Silicon Drive, Suite 150 San Antonio, TX 78249

Re: K082750

Trade/Device Name: ENTact Septal Stapler System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: OLL Dated: December 19, 2008 Received: December 22, 2008

Dear Dr. Niederauer:

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 I ou may ontrols provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JAN - 6 2009

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 or mry with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

-Sincerely yours,

M. B. Egerlins, m.D.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 1082750

### Indications for Use Statement

510(k) Number (if known): KOOQ750

Device Name: ENTact™ Septal Stapler

Indications for Use:

The ENTact™ Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissues during nasal septal surgery.

Prescription Use 区

AND/OR

Over-The-Counter Use O

(Part 21 C.F.R. 801 Subpart D)

(21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Cennon

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number KD82750

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