AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES

K090470 · Covidien · OCW · May 14, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090470
• Device Name: AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES
• Applicant: Covidien
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: May 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Autosuture™ Protack™: The Autosuture™ Protack ™ 5 mm instrument has application in endoscopic surgery procedures for fixation of prosthetic material and approximation of tissue in various surgical specialties, such as the repair of hernial defects. Autosuture™ TACKER™ System: The Autosuture™ TACKER™ System is indicated to affix prosthetic material or approximate tissue in a variety of endoscopic or other surgical procedures. Absorbatack™ Absorbable Fixation Devices: The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.

Device Story

Autosuture™ Protack, TACKER™ System, and Absorbatack™ are surgical fixation devices used to secure prosthetic mesh or approximate soft tissue during endoscopic or open surgeries, such as hernia repair. Protack and TACKER™ systems utilize titanium helical fasteners; Absorbatack™ uses absorbable synthetic polyester copolymer tacks derived from lactic and glycolic acid. Devices are operated by surgeons in OR settings. Protack and TACKER™ are delivered via specialized instruments through trocar sleeves; Absorbatack™ is a single-use delivery device. These devices provide mechanical fixation to stabilize mesh or tissue, facilitating healing and preventing hernia recurrence.

Clinical Evidence

No clinical data. Bench testing only; performance testing not applicable as no changes were made to the device design or function.

Technological Characteristics

Devices utilize mechanical helical fasteners (titanium) or absorbable synthetic polyester copolymer tacks (lactic/glycolic acid). Materials comply with ISO 10993-1. Protack instrument shaft length ~35.5 cm; TACKER™ system includes reusable handle (sterilizable up to 5 times) and single-use delivery components. Devices are manual, non-powered, and standalone.

Indications for Use

Indicated for fixation of prosthetic material or tissue approximation in endoscopic or open surgical procedures, including hernia repair, in patients requiring such surgical intervention.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Autosuture™ Protack™ (K963999)
• Autosuture™ TACKER™ System (K944415)
• Absorbatack™ Absorbable Fixation Devices (K071920)

Submission Summary (Full Text)

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K090470
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### 510(k) Summary of Safety and Effectiveness

1 4 2009 MAY

| SUBMITTER: | Surgical Devices, a global business unit<br>of Tyco Healthcare Group LP (d/b/a Covidien)<br>60 Middletown Avenue<br>North Haven, CT 06473<br>Tel. No.: [phone] | MAY 14 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| CONTACT PERSON: | Jennifer Brennan<br>Manager, Regulatory Affairs | |
| DATE PREPARED: | January 19, 2008 | |
| TRADE/PROPRIETARY NAME: | Autosuture™ Protack, Autosuture™ TACKER™ System, Absorbatack™<br>Absorbable Fixation Devices | |
| COMMON/USUAL NAME: | Surgical Stapler with Implantable Staple | |
| CLASSIFICATION NAME: | Staple, Implantable | |
| PREDICATE DEVICE(S): | Autosuture™ Protack™ (K963999),<br>Autosuture™ TACKER™ System (K944415),<br>Absorbatack™ Absorbable Fixation Devices (K071920) | |
| DEVICE DESCRIPTION: | Autosuture™ Protack™: The Autosuture™ Protack 5 mm instrument<br>contains 30 titanium helical fasteners. The diameter of the fastener measures<br>approximately 4 mm and the length is approximately 3.8 mm. The instrument<br>is designed for introduction and use through an appropriately sized trocar<br>sleeve or larger with the use of a converter. The overall length of the shaft is<br>approximately 35.5 cm.<br><br>Autosuture™ TACKER™ System: The Autosuture™ TACKER™ System<br>is packaged in 4 different product configurations as specified on the product<br>package. The Autosuture™ TACKER™ System contains the following<br>products: The Autosuture™ TACKER™ delivery device, which contains 20<br>titanium helical fasteners and is designed to be used with the Autosuture™<br>TACKER™ reusable handle. The Autosuture™ TACKER™ reusable handle<br>is packaged sterile and may be resterilized four (4) times for a total of five (5)<br>uses. The Autosuture™ STAT TACK™ single use instrument is designed to<br>deliver 15 helical fasteners. The helical fastener size is approximately 3.9 mm<br>in diameter by 4 mm long.<br><br>Autosuture™ Absorbatack™ Absorbable Fixation Devices:<br>The Absorbatack™ Absorbable Fixation Device is a sterile single use device for fixation of<br>prosthetic material, such as mesh, to soft tissue. The tack is constructed of<br>an ausorbable synthetic polyester copolymer derived from lactic and glycolic<br>acid. The device is offered with 5, 10, or 20 absorbable tacks. | |
| INTENDED USE: | Autosuture™ Protack™: The Autosuture™ Protack ™ 5 mm instrument has<br>application in endoscopic surgery procedures for fixation of prosthetic material<br>and approximation of tissue in various surgical specialties, such as the repair<br>of hernial defects.<br><br>Autosuture™ TACKER™ System: The Autosuture™ TACKER™ System is<br>indicated to affix prosthetic material or approximate tissue in a variety of<br>endoscopic or other surgical procedures, | |

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## Autosuture™ Protack, Autosuture™ Tacker™ System, Absorbatack™ Absorbable Fixation Devices

Absorbatack™ Absorbable Fixation Devices: The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.

- TECHNOLOGICAL The Autosuture™ Protack™ is identical to the predicate device. CHARACTERISTICS: The Autosuture™ TACKER™ System is identical to the predicate device. The Absorbatack™ Absorbable Fixation Device is identical to the predicate device.
- The Autosuture™ Protack, Autosufure™ TACKER™ System, Absorbatack™ MATERIALS: Absorbable Fixation Devices are comprised of materials which are in accordance with ISO Standard 10993-1.
- There have been no changes to the Autosuture™ Protack, Autosulure™ PERFORMANCE DATA: System, Absorbatack™ Absorbable Fixation Devices. TACKER™ Performance testing is not applicable to this 510(k) - Changes Being Effected, since only contraindications are being added.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

MAY 14 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Covidien % Ms. Jennifer Brennan Manager Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K090470

Trade/Device Name: Autosuture™ Protack, Autosuture™ TACKER™ System AbsorbatackTM Absorbable Fixation Devices Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW, GDW, GDW Dated: February 4, 2009 Received: February 27, 2009

Dear Ms. Brennan:

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 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.

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Page 2 - Ms. Jennifer Brennan

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biomctrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Mark A. Millican

Mark N. Melkerson 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

K090470 510(k) Number (if known):

#### Autosuture™ Protack, Autosuture™ TACKER™ System Absorbatack™ Device Name: Absorbable Fixation Devices

# Indications For Use .

Autosuture™ Protack: The Auto Suture™ Protack™ 5mm instrument has application in endoscopic surgery procedures for fixation of prosthetic material and approximation of tissue in various surgical specialties, such as the repair of hernial defects.

Autosuture™ TACKER™ System: The Auto Suture™ TACKER™ System is indicated to affix prosthetic material or approximate tissue in a variety of endoscopic or other surgical procedures.

Absorbatack™ Absorbable Fixation Devices: The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Kraure for mxm

Division Sig Division of Surgical, Orthopedic, and Restorative Devi

510(k) Number K090470