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.
Autosuture™ Protack™: The Autosuture™ Protack 5 mm instrument contains 30 titanium helical fasteners. The diameter of the fastener measures approximately 4 mm and the length is approximately 3.8 mm. The instrument is designed for introduction and use through an appropriately sized trocar sleeve or larger with the use of a converter. The overall length of the shaft is approximately 35.5 cm.
Autosuture™ TACKER™ System: The Autosuture™ TACKER™ System is packaged in 4 different product configurations as specified on the product package. The Autosuture™ TACKER™ System contains the following products: The Autosuture™ TACKER™ delivery device, which contains 20 titanium helical fasteners and is designed to be used with the Autosuture™ TACKER™ reusable handle. The Autosuture™ TACKER™ reusable handle is packaged sterile and may be resterilized four (4) times for a total of five (5) uses. The Autosuture™ STAT TACK™ single use instrument is designed to deliver 15 helical fasteners. The helical fastener size is approximately 3.9 mm in diameter by 4 mm long.
Autosuture™ Absorbatack™ Absorbable Fixation Devices: The Absorbatack™ Absorbable Fixation Device is a sterile single use device for fixation of prosthetic material, such as mesh, to soft tissue. The tack is constructed of an ausorbable synthetic polyester copolymer derived from lactic and glycolic acid. The device is offered with 5, 10, or 20 absorbable tacks.
This 510(k) summary for the Autosuture™ Protack, Autosuture™ TACKER™ System, and Absorbatack™ Absorbable Fixation Devices states that no performance testing was conducted for this specific 510(k) submission (K090470). The submission is a "Changes Being Effected" amendment where only contraindications are being added, and the devices themselves are stated to be identical to their predicate devices.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from the provided text for this specific submission. The document explicitly states:
"PERFORMANCE DATA: There have been no changes to the Autosuture™ Protack, Autosufure™ TACKER™ System, Absorbatack™ Absorbable Fixation Devices. TACKER™ Performance testing is not applicable to this 510(k) - Changes Being Effected, since only contraindications are being added."
This means that for K090470, the device's performance was not re-evaluated as it was considered to be unchanged from previously cleared predicate devices. The substantial equivalence relies on the performance data of those predicate devices. Without access to the predicate device 510(k) summaries (K963999, K944415, and K071920), we cannot provide the details of acceptance criteria or performance studies.
{0}------------------------------------------------
K090470
page 1/2
ﻪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
で
510(k) Summary of Safety and Effectiveness
1 4 2009 MAY
| SUBMITTER: | Surgical Devices, a global business unitof Tyco Healthcare Group LP (d/b/a Covidien)60 Middletown AvenueNorth Haven, CT 06473Tel. No.: (203) 492-6060 | MAY 14 |
|---|---|---|
| CONTACT PERSON: | Jennifer BrennanManager, Regulatory Affairs | |
| DATE PREPARED: | January 19, 2008 | |
| TRADE/PROPRIETARY NAME: | Autosuture™ Protack, Autosuture™ TACKER™ System, Absorbatack™Absorbable Fixation Devices | |
| COMMON/USUAL NAME: | Surgical Stapler with Implantable Staple | |
| CLASSIFICATION NAME: | Staple, Implantable | |
| PREDICATE DEVICE(S): | Autosuture™ Protack™ (K963999),Autosuture™ TACKER™ System (K944415),Absorbatack™ Absorbable Fixation Devices (K071920) | |
| DEVICE DESCRIPTION: | Autosuture™ Protack™: The Autosuture™ Protack 5 mm instrumentcontains 30 titanium helical fasteners. The diameter of the fastener measuresapproximately 4 mm and the length is approximately 3.8 mm. The instrumentis designed for introduction and use through an appropriately sized trocarsleeve or larger with the use of a converter. The overall length of the shaft isapproximately 35.5 cm.Autosuture™ TACKER™ System: The Autosuture™ TACKER™ Systemis packaged in 4 different product configurations as specified on the productpackage. The Autosuture™ TACKER™ System contains the followingproducts: The Autosuture™ TACKER™ delivery device, which contains 20titanium helical fasteners and is designed to be used with the Autosuture™TACKER™ reusable handle. The Autosuture™ TACKER™ reusable handleis packaged sterile and may be resterilized four (4) times for a total of five (5)uses. The Autosuture™ STAT TACK™ single use instrument is designed todeliver 15 helical fasteners. The helical fastener size is approximately 3.9 mmin diameter by 4 mm long.Autosuture™ Absorbatack™ Absorbable Fixation Devices:The Absorbatack™ Absorbable Fixation Device is a sterile single use device for fixation ofprosthetic material, such as mesh, to soft tissue. The tack is constructed ofan ausorbable synthetic polyester copolymer derived from lactic and glycolicacid. The device is offered with 5, 10, or 20 absorbable tacks. | |
| INTENDED USE: | Autosuture™ Protack™: The Autosuture™ Protack ™ 5 mm instrument hasapplication in endoscopic surgery procedures for fixation of prosthetic materialand approximation of tissue in various surgical specialties, such as the repairof hernial defects.Autosuture™ TACKER™ System: The Autosuture™ TACKER™ System isindicated to affix prosthetic material or approximate tissue in a variety ofendoscopic or other surgical procedures, |
{1}------------------------------------------------
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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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 (240) 276-0115. 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 (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
{4}------------------------------------------------
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
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.