(168 days)
The ETS 45, ETS-Flex45, and Compact-Flex 45 reprocessed, reloadable Endoscopic Linear Cutters are intended for transection, resection and/or anastomosis. These instruments have applications in open and minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic and pediatric surgery. The ETS Flex 45, ETS 45 and ETS Compact Flex 45 device can be used with staple line or tissue buttressing materials such as bovine pericardium.
The ETS and ETS-Flex (articulating) reprocessed, reloadable Endoscopic Linear Cutters (35mm) have applications in general, gynecologic, urologic, and thoracic surgery for transection, and/or creation of anastomoses.
SterilMed's reprocessed Ethicon ETS Linear Cutter is a sterile, single patient use device. It delivers two double-staggered or two triple-staggered rows of staples while simultaneously dividing the tissue between the rows of staples. An articulation lever on the ETS-Flex Linear Cutter enables bilateral movement of the instrument jaws. These devices are reloadable linear cutters that allow for a maximum of 8 firings in a single surgical procedure.
Note: Only the linear cutter is the subject of this submission, the implantable staple and the staple cartridge are not reprocessed and therefore are not included.
The provided text does not contain detailed acceptance criteria for a device, nor does it describe a specific study that proves the device meets such criteria. Instead, the document is a 510(k) summary for the reprocessing of Ethicon ETS Endoscopic Linear Cutters, demonstrating substantial equivalence to predicate devices. It outlines the device description, intended use, and general functional and safety testing, but lacks the specific performance metrics and study details requested.
Therefore, I cannot provide the requested information in the structured table and numbered points. The document states:
"Representative samples of reprocessed Linear Cutters are tested to demonstrate appropriate functional characteristics. Process validation testing is performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced."
This indicates that testing was performed, but the specifics of acceptance criteria and the results of a study designed to prove these criteria are met are not included in the provided text.
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Ko70.859
I. SUMMARY AND CERTIFICATION
- A. 510(k) Summary
:
| Submitter: | SterilMed, Inc. | SEP 12 2007 |
|---|---|---|
| Contact Person: | Caroline Butterfield11400 73rd Avenue NorthMaple Grove, MN 55369Ph: 888-856-4870Fax: 763-488-3350 | |
| Date Prepared: | March 27, 2007 | |
| Trade Name: | Reprocessed Ethicon ETS Endoscopic Linear Cutters | |
| Classification Name: | Staple, Implantable | |
| Classification Number: | Class II, 21 CFR 878.4750 | |
| Product Code: | NLL |
| PredicateDevices: | The reprocessed Ethicon ETS Linear Cutters are substantially equivalent to the EthiconEndopath ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating LinearCutter (K961390). |
|---|---|
| DeviceDescription: | SterilMed's reprocessed Ethicon ETS Linear Cutter is a sterile, single patient usedevice. It delivers two double-staggered or two triple-staggered rows of staples whilesimultaneously dividing the tissue between the rows of staples. An articulation leveron the ETS-Flex Linear Cutter enables bilateral movement of the instrument jaws.These devices are reloadable linear cutters that allow for a maximum of 8 firings in asingle surgical procedure. |
| Note: Only the linear cutter is the subject of this submission, the implantable staple andthe staple cartridge are not reprocessed and therefore are not included. | |
| Intended Use: | The ETS 45, ETS-Flex 45, and ETS Compact-Flex 45 reprocessed, reloadable EthiconLinear Cutters are intended for transection, resection and/or anastomosis. Theseinstruments have applications in open and minimally invasive general, gynecologic,urologic (including radical prostatectomy), thoracic and pediatric surgery. The ETS-Flex 45, ETS 45 and ETS Compact-Flex 45 device can be used with staple line or tissuebuttressing materials such as bovine pericardium. |
| The ETS, ETS-Flex (articulating) Endoscopic reprocessed, reloadable Linear Cutters(35mm) have applications in general, gynecological, and thoracic surgery fortransection, resection, and/or creation of anastomoses. | |
| Functional andSafety Testing: | Representative samples of reprocessed Linear Cutters are tested to demonstrateappropriate functional characteristics. Process validation testing is performed tovalidate the cleaning and sterilization procedures as well as device packaging. Inaddition, the manufacturing process includes visual and validated functional testing ofall products produced. |
| Conclusion: | The reprocessed ETS Linear Cutters are substantially equivalent to the Endopath ETSEndoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter(K961390, K980023, K002398 and K020079) manufactured by Ethicon. |
| This conclusion is based upon the devices' similarities in functional design (principle ofoperation), materials, indications for use and methods of construction. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The caduceus in the logo is a modern interpretation, featuring a series of curved lines that suggest the wings and staff of the traditional symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2007
SterilMed, Inc. % Mr. Dennis Toussaint Director of Regulatory Affairs 11400 731d Avenue North, Suite 100 Maple Grove, Minnesota 55369
Re: K070859
Trade/Device Name: Reprocessed Ethicon ETS Linear Cutters Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: NLL Dated: August 27, 2007 Received: August 28, 2007
Dear Mr. Toussaint:
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.
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 comply 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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Page 2 -- Mr. Dennis Toussaint
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page (8-
Indications for Use
510(k) Number (if known): K070859
Device Name: Reprocessed Ethicon ETS Linear Cutters
Indications for Use:
The ETS 45, ETS-Flex45, and Compact-Flex 45 reprocessed, reloadable Endoscopic Linear Cutters are intended for transection, resection and/or anastomosis. These instruments have applications in open and minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic and pediatric surgery. The ETS Flex 45, ETS 45 and ETS Compact Flex 45 device can be used with staple line or tissue buttressing materials such as bovine pericardium.
The ETS and ETS-Flex (articulating) reprocessed, reloadable Endoscopic Linear Cutters (35mm) have applications in general, gynecologic, urologic, and thoracic surgery for transection, and/or creation of anastomoses.
Prescription Use X (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number_ L670859
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| Manufacturer | Base Device | Model # | Description |
|---|---|---|---|
| Ethicon | ETS Flex 45 | ATW45 | ETS-Flex 45mm, 34cm long (no cartridge included) |
| ATB45 | ETS-Flex 45mm, 34cm long (no cartridge included) | ||
| ATG45 | ETS-Flex 45mm, 34cm long (no cartridge included) | ||
| 6TB45 | ETS-Flex 45mm, 34cm long (no cartridge included) | ||
| ETS Flex 35 | ATW35 | ETS-Flex 35mm, 34cm long (no cartridge included) | |
| ATB35 | ETS-Flex 35mm, 34cm long (no cartridge included) | ||
| ETS 45 | TSW45 | ETS Straight 45mm, 34cm long (no cartridge included) | |
| TSB45 | ETS Straight 45mm, 34cm long (no cartridge included) | ||
| TSG45 | ETS Straight 45mm, 34cm long (no cartridge included) | ||
| ETS 35 | TSW35 | ETS Straight 35mm, 34cm long (no cartridge included) | |
| TSB35 | ETS Straight 35mm, 34cm long (no cartridge included) | ||
| ETS FlexCompact 45 | SCW45 Compact | ETS-Flex Compact 45mm, 24cm long (no cartridge included) | |
| SCB45 Compact | ETS-Flex Compact 45mm, 24cm long (no cartridge included) | ||
| 6CB45 Compact | ETS-Flex Compact 45mm, 24cm long (no cartridge included) | ||
| SCG45 Compact | ETS-Flex Compact 45mm, 24cm long (no cartridge included) | ||
| 6SB45 Compact | ETS-Flex Compact 45mm, 24cm long (no cartridge included) |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Table 1 - List of Devices included in this Premarket Notification Submission | |||
|---|---|---|---|
| -- | -- | -- | ------------------------------------------------------------------------------ |
§ 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.