(28 days)
The SurgASSIST® Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
The SurgASSIST® Circular Stapler Digital Loading Units® (DLUs) offer computer mediated steering and stapling. The DLUs contain implantable, titanium staples and integral cutting blades. The DLUs are used to anastomose tubular structures by applying a double staggered circular row of staples through the tissue. The staples form to controlled closed conditions to secure the layers of tissue together. The DLUs also cut away the excess tissue at a controlled diameter inside the ring of staples. The Circular Stapler DLUs are available in the following four sizes: 21 mm, 25 mm, 29 mm, and 33 mm. The DLU is supplied sterile and ready for use upon removal from its packaging. The purpose of this submission is to clear the modifications to the 29 mm Circular Stapler DLU only.
The provided text describes a Special 510(k) submission for modifications to a medical device, the SurgASSIST® Circular Stapler Digital Loading Units® - 29 mm. It focuses on the device's design changes to address a previous recall issue related to latching mechanism failure. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions regarding study design. The text primarily focuses on regulatory approval for design modifications rather than reporting on a new performance study to meet specific metrics.
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040024 (p.1042)
Section E Special 510(k) - Corrective Action Being Effected Summary
In Accordance with 21 CFR section 807.92 Power Medical Interventions. Inc., is submitting the following 510(k) Summary:
- Submitter Information;
Power Medical Interventions, Inc. 1 10 Union Square Drive New Hope, PA 18938 267-775-8151 Ph 267-775-8123 Fax
Applicant: Barbara J. Whitman
Date of Notification: January 6, 2004
-
- Name of Device:
| Trade Name: | SurgASSIST®Circular Stapler DLUs - 29 mm |
|---|---|
| Common Name: | Circular Stapler with ImplantableStaples |
| Classification Name: | Staple, Implantable, GDW |
4) Device Description:
The SurgASSIST® Circular Stapler Digital Loading Units® (DLUs) offer computer mediated steering and stapling. The DLUs contain implantable, titanium staples and integral cutting blades. The DLUs are used to anastomose tubular structures by applying a double staggered
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K040024 (P.2 of 2)
circular row of staples through the tissue. The staples form to controlled closed conditions to secure the layers of tissue together. The DLUs also cut away the excess tissue at a controlled diameter inside the ring of staples. The Circular Stapler DLUs are available in the following four sizes: 21 mm, 25 mm, 29 mm, and 33 mm. The DLU is supplied sterile and ready for use upon removal from its packaging. The purpose of this submission is to clear the modifications to the 29 mm Circular Stapler DLU only.
-
- Device Modification
Modifications were made to the predicate SurgASSIST® Circular Stapler Digital Loading Units® - 29 mm (originally cleared under K003277) to address the root cause of the voluntary recall, which was a potential for latching mechanism failure. In order to minimize the risk of Iatching mechanism failure, addition of vent holes, heptagon design added to the trocar tip, modification to the housing, coating of the lead screws, modification of anvil stems and an addition of a latch finger spline were the design changes made to improve engagement of the latch fingers. Further details of this modification can be found in Section H of this submission, under the "Device Modification" heading,
- Device Modification
-
- Indications For Use
The SurgASSIST® Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
- Indications For Use
-
- Comparison to Predicate Devices
The modified Circular Stapler Digital Loading Unit® - 29 mm maintains the same fundamental scientific technology as the predicate device, The primary change to the device is the increased strength and reliability of the latching mechanism. Details of the modifications ana be found in Section H of this submission, under the "Device Modification" heading,
- Comparison to Predicate Devices
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines that curve upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 4 2004
Ms. Barbara J. Whitman Regulatory Affairs Manager Power Medical Interventions, Inc. 110 Union Square Drive New Hope, Pennsylvania 18938
Re: K040024
Trade/Device Name: SurgAssist® Circular Staplcr Digital Loading Units® - 29 mm Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: January 6, 2004 Received: January 7, 2004
Dear Ms. Whitman:
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. Drue, 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 adultcration.
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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Barbara J. Whitman
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 (301) 594-4659. Also, please note the regulation catitled. "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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C Provost
to Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Power Medical Interventions, Inc. SurgASSIST® Circular Stapler Digital Loading Unit® 29 mm (CS29) Special 510(k) - Corrective Action Being Effected - January 6, 2004
Section D Indications for Use
Power Medical Interventions, Inc. New Hope, PA 18938
510(k) Number (if known):
Device Name: SurgASSIST® Circular Stapler Digital Loading Units® - 29 mm
Indications For Use:
The SurgASSIST® Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
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)
Miriam C. Provost
ivision Sign-Off) Division of General, Restorative and Neurological Devices
Page 1 of
§ 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.