(113 days)
Not Found
No
The device description and performance studies focus on mechanical function and tissue interaction, with no mention of AI/ML terms or data processing.
No
The device is used for surgical treatment of hemorrhoidal disease, which is a treatment method rather than a therapeutic device in itself.
No
The device is a surgical stapler used for treating hemorrhoidal disease, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists physical components such as a reusable handle, disposable reload (containing anvil, knife, washer, and staples), and an accessory set (containing dilator, anoscope, introducer, and suture threader). This indicates it is 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 is to perform surgical treatment of hemorrhoidal disease throughout the anal canal. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical stapler and accessory set used for a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
Product codes
GDW
Device Description
The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set consists of a reusable circular stapler handle, a disposable reload (containing the anvil, knife, washer, and staples), and accessory set (consisting of the circular anal dilator, pursestring anoscope, anal introducer, and suture threader).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal canal
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)
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 anastomotic stoma created in porcine colon. Testing results demonstrated that staple lines created by the stapler device met the leak pressure acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories (cleared under K051301)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K103672 page 1/2
510(k) Premarket Notification (Traditional) for Reusable PPH Circular Stapler, Disposable Reload & Accessory
510(k) Summary
APR - 8 2011
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 Fax: (513) 337-2134 Email: dhahn1@its.jnj.com
Date Prepared: December 16, 2010
Device Name: Reusable PPH Circular Stapler, Disposable Reload & Accessory Set
Common or Usual Name: Circular Stapler
Classification Name: Staple, Implantable
Predicate Device: PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories (cleared under K051301)
Device Description: The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set consists of a reusable circular stapler handle, a disposable reload (containing the anvil, knife, washer, and staples), and accessory set (consisting of the circular anal dilator, pursestring anoscope, anal introducer, and suture threader).
Indications for Use: The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
Contraindications for use:
- . Do not use where the combined compressed tissue thickness is less than 0.75 mm or greater than 1.5 mm, or where the internal diameter of the rectum will not accommodate the instrument and accessories. If the instrument is used on tissue less than 0.75mm or greater than 1.5 mm in thickness, an inadequate mucosal repair and inadequate hemostasis could result.
- Do not use the instrument on ischemic or necrotic tissue. .
- Do not use the instrument for full rectal wall thickness resection. ●
- Do not use the instrument for the Stapled Transanal Rectal Resection (STARR). ●
1
K103672 page 2/2
510(k) Premarket Notification (Traditional) for Reusable PPH Circular Stapler, Disposable Reload & Accessory Set
Technological Characteristics: The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set consists of three components: the reusable handle, the disposable reload, and the accessory set. The handle can be used for 200 applications. An adjustable knob on the handle adjusts the device for use on compressed tissue from 0.75 mm to 1.5 mm. The reload, which is designed for a single use, is made up of an anvil head with a diameter of 32.5 mm and two staggered rows of staples. Contained within the same sterile packaging as the reload, the disposable accessory set consists of a circular anal dilator, purse-string anoscope, anal introducer, and suture threader.
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 anastomotic stoma created in porcine colon. Testing results demonstrated that staple lines created by the stapler device met the leak pressure acceptance criteria.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Mr. Dennis Hahn, RAC 4545 Creek Road Cincinnati, Ohio 45242
APR - 8 2011
Re: K103672
Trade/Device Name: Reusable PPH Circular Stapler, Disposable Reload & Accessory Set Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: April 6, 2011 Received: April 7, 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 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
3
Page 2 - Mr. Dennis Hahn, RAC
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.
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 faor the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Alo, 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.htm 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.
Aing B. De. ter
for
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): K103672
Device Name: Reusable PPH Circular Stapler, Disposable Reload & Accessory Set
Indications for Use: The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
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)
David Moore for MKM
Page 1 of 1
(Division Sig Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103672