(97 days)
Not Found
No
The summary describes a mechanical surgical stapler and its components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies described are bench and animal testing, not studies evaluating AI/ML performance metrics.
No.
The device is a surgical stapler used for anastomoses, which is a structural connection of tissues, not a device intended to treat or cure a disease or condition.
No
Explanation: The device is a surgical stapler used for creating anastomoses in the alimentary tract, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines physical components: a reusable circular stapler handle and disposable reloads containing an anvil, knife, washer, and staples. This indicates a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure performed on the patient (creating anastomoses in the alimentary tract). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The device is a surgical stapler, a tool used directly in surgery. IVDs are typically laboratory instruments or test kits.
- Anatomical Site: The device is used on the alimentary tract, which is part of the patient's body. IVDs analyze samples taken from the body.
The description clearly indicates a surgical device used for creating connections within the digestive system, which falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ValuTrus™ Reusable Circular Stapler and Disposable Reloads have application throughout the alimentary tract for end-to-end, end-to-side, and side-toside anastomoses.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The ValuTrus™ Reusable Circular Stapler and Disposable Reloads consists of a reusable circular stapler handle and disposable reloads (containing the anvil, knife, washer, and staples) in three sizes (25.5, 28.5, and 32.5 mm).
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
Prescription Use
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)
Bench testing was conducted to demonstrate and verify the performance of the disposable reload and the reusable handle after 200 simulated uses. Test results demonstrated the bench testing acceptance criteria were met.
Animal (tissue) testing was conducted to evaluate the pressure tolerance of an anasotomic stoma created in porcine colon. Testing results demonstrated that staple lines created by the circular stapler device met the leak pressure acceptance criteria.
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
K111195 page 1/2
510(k) Premarket Notification (Traditional) for ValuTrus™ Reusable Circular Stapler and Disposable Reloads
AUG - 3 2011
510(k) Summary
- Ethicon Endo-Surgery, LLC Company: 475 Calle C Guaynabo, PR 00969
- Contact: Dennis Hahn, RAC Director, Regulatory Strategic Initiatives Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3134 (513) 337-2134 Fax: Email: dhahn l @its.jnj.com
Date Prepared: April 27, 2011
Device Name: ValuTrus™ Reusable Circular Stapler and Disposable Reloads Common or Usual Name: Circular Stapler Classification Name: Staple, Implantable
Predicate Device: PROXIMATE® ILS Curved and Straight Intraluminal Staplers (cleared under K983536 cleared on December 18, 1998)
Device Description: The ValuTrus™ Reusable Circular Stapler and Disposable Reloads consists of a reusable circular stapler handle and disposable reloads (containing the anvil, knife, washer, and staples) in three sizes (25.5, 28.5, and 32.5 mm).
Indications for Use: The ValuTrus™ Reusable Circular Stapler and Disposable Reloads have application throughout the alimentary tract for end-to-end, end-to-side, and side-toside anastomoses.
Contraindications for use:
- Do not use where the combined tissue thickness is less than 1.0 mm or greater than 2.5 . mm or where the internal diameter of the structure is less than 25.5 mm. If the instrument is used on tissue less than 1.0 mm or greater than 2.5 mm in thickness, an inadequate anastomosis could be formed resulting in leakage, inadequate hemostasis or improper healing.
1
Technological Characteristics: The ValuTrus™ Reusable Circular Stapler and Disposable Reloads consists of two components: the reusable handle and disposable reloads. The handle can be used for 200 applications. An adjustable knob on the handle adjusts the device for use on compressed tissue from 1.0 to 2.5 mm. The sterile reloads, which are designed for a single use, are made up of an anvil head and two staggered rows of staples. The reloads are available in three sizes: 25.5 mm, 28.5 mm, and 32.5 mm.
Performance Data: Bench testing was conducted to demonstrate and verify the performance of the disposable reload and the reusable handle after 200 simulated uses. Test results demonstrated the bench testing acceptance criteria were met.
Animal (tissue) testing was conducted to evaluate the pressure tolerance of an anasotomic stoma created in porcine colon. Testing results demonstrated that staple lines created by the circular stapler device met the leak pressure acceptance criteria.
2
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 eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, LLC % Mr. Dennis Hahn, RAC Director, Regulatory Strategic Initiatives 4545 Creek Road Cincinnati, Ohio 45242
AUG - 3 2011
Re: K111195
Trade/Device Name: ValuTrus™ Reusable Circular Stapler and Disposable Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: June 15, 2011 Received: July 18, 2011
Dear Mr. Hahn:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Mr. Dennis Hahn, RAC
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 syste:ns (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.hun for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K111195
Device Name: ValuTrus™ Reusable Circular Stapler and Disposable Reloads
Indications for Use: The ValuTrus™ Reusable Circular Stapler and Disposable Reloads have application throughout the alimentary tract for end-to-end, end-to-side, and side-toside anastomoses.
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 Evaluation (ODE)
Page 1 of 1
Daniel Krenek MEM
Division Sig Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111195