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K Number
K051301
Device Name
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
Manufacturer
ETHICON ENDO-SURGERY, INC.
Date Cleared
2005-08-30

(103 days)

Product Code
GDW
Regulation Number
878.4750
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

Device Description

The PROXIMATE PPH Hemorrhoidal Circular Stapler (PPH03) is available in a 33mm diameter size only. The instruments allow surgeon to control tissue compression by varying the height of the closed staple. The instrument has been designed for the procedure for prolapse and hemorrhoids (PPH).

AI/ML Overview

The provided document is a 510(k) summary for the PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance, number and qualifications of experts, or adjudication methods for a test set.
  • Details of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
  • Results of a standalone algorithm-only performance study.
  • Type of ground truth used.
  • Sample size for the training set or how ground truth for the training set was established.

Explanation:

The 510(k) summary explicitly states that the "Technological and Performance Characteristics The technological and performance characteristics of the device remain unchanged." This indicates that the device being submitted is a modification or re-submission of an existing device (or one substantially equivalent to an existing device) and therefore, extensive new clinical performance data to meet specific acceptance criteria is typically not required or presented in this type of submission. The FDA's review in this case focuses on ensuring that the device is as safe and effective as a legally marketed predicate device.

§ 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.