(28 days)
Not Found
No
The summary describes a mechanical surgical stapler and does not mention any AI or ML components or functionalities.
No
The device is a surgical stapler used to create anastomoses, which is a structural connection, not for treating or alleviating disease or condition.
No
The device is a surgical stapler used to create anastomoses, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical surgical stapler, which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the autosuture™ Circular EEA™ Staplers are surgical instruments used to create anastomoses (connections between two structures) within the alimentary tract during open and laparoscopic surgeries. They are used on the patient's body during a surgical procedure, not to test samples from the body.
- Lack of IVD Indicators: The document does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
Therefore, this device falls under the category of a surgical instrument or medical device used in vivo (within a living organism), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The autosuture™ Circular EEA™ Staplers have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
The autosuture™ Circular EEA™ family of staplers place a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. They are indicated for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-vitro and in-vivo tests were performed to verify that the modified autosuture™ EEA™ stapler is substantially equivalent to the predicate device for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K062850 page 1/1
510(k) Summary of Safety and Effectiveness
SUBMITTER:
United States Surgical, a division of Tyco Healthcare Group LP 150 Glover Avenue Norwalk, CT 06856 Tel. No .: (203) 845-1000
CONTACT PERSON: Frank Gianelli Senior Associate, Regulatory Affairs
DATE PREPARED: September 21, 2006
TRADE/PROPRIETARY NAME: autosuture™ Circular EEA™ surgical staplers
COMMON/USUAL NAME: Implantable Staple
CLASSIFICATION NAME: Implantable Staple
PREDICATE DEVICE(S): autosuture™ Premium Plus CEEA™ Disposable Stapler (K024275)
DEVICE DESCRIPTION: The autosuture™ Circular EEA™ family of staplers place a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. They are indicated for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries.
INTENDED USE: The autosuture™ Circular EEA™ Staplers have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
TECHNOLOGICAL The autosuture™ EEA™ stapler is identical to the predicate CHARACTERISTICS: device in terms of intended use and it operates in a similar manner as the predicate device. The only difference is a modification of the wire gauge diameter of the titanium staple.
MATERIALS: All components of the autosuture™ EEA™ stapler are comprised of materials which are in accordance with ISO Standard 10993-1.
PERFORMANCE DATA: In-vitro and in-vivo tests were performed to verify that the modified autosuture™ EEA™ stapler is substantially equivalent to the predicate device for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three abstract human profiles facing right. The profiles are arranged in a stacked formation, creating a sense of depth and unity. Encircling the caduceus is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
United States Surgical a division of Tyco Healthcare Group, LP % Mr. Frank Gianelli Senior Associate, Regulatory Affairs 195 McDermott Road North Haven, Connecticut 06473
OCT 2 3 2006
Re: K062850
Trade/Device Name: autosuture™ EEA" Surgical Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: September 22, 2006 Received: September 26, 2006
Dear Mr. Gianelli:
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.
2
Page 2 - Mr. Frank Gianelli
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,
elkerson
Mark N. Melker Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(k) Number (if known): K0628SO
Device Name: autosuture™ EEA™ Surgical Stapler
Indications For Use:
The autosuture™ Circular EEA™ Staplers have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device
Division of General, Restorative. and Neurological Devices
510(k) Number L062850
United States Surgical Premarket Notification
Page 19 ™Trademark