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K Number
K220525
Device Name
RESPONDER Polysaccharide Hemostat
Manufacturer
Starch Medical, Inc.
Date Cleared
2023-12-04

(649 days)

Product Code
QSY
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K061079
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

RESPONDER® Polysaccharide Hemostat Rx is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding.

RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.

Device Description

RESPONDER® Polysaccharide Hemostat (RESPONDER®) is a medical device composed of absorbable modified polymer (AMP®) particles. AMP® particles are biocompatible, non-pyrogenic and derived from plant starch. The device contains no human or animal components.

AI/ML Overview

The provided text is a 510(k) summary for the RESPONDER® Polysaccharide Hemostat. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific, pre-defined acceptance criteria through a clinical or algorithmic performance study in the way one might for an AI/ML medical device.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, specifically:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods for ground truth.
  • Details of MRMC or standalone performance studies, if done.
  • Ground truth types (expert consensus, pathology, outcomes data).
  • Sample size for training sets or how ground truth for training was established.

Instead, the document focuses on:

  • Device Description: RESPONDER® Polysaccharide Hemostat is composed of absorbable modified polymer (AMP®) particles derived from plant starch.
  • Intended Use/Indications for Use:
    • Rx: Temporary control of severe topical bleeding in emergency situations.
    • OTC: Local management of bleeding from minor lacerations, minor cuts, and minor abrasions.
  • Predicate Device: CELOX Topical Hemostatic Granules (K061079).
  • Technological Characteristics: Claims similar physical structure (granules), packaging (foil pouch), shelf life, and mechanism of action (forming a gel barrier) to the predicate.
  • Performance (Demonstration of Equivalence, not specific acceptance criteria):
    • Biocompatibility: Tests (ISO10993-5, -6, -10, -11, ASTM F756-17, USP41 NF36) indicated it is biocompatible and safe.
    • Sterility: Achieves a Sterility Assurance Level (SAL) of 10⁻⁶, despite a different sterilization method than the predicate.
    • Animal Studies: Conducted to validate efficacy and safety compared to the predicate, with results demonstrating the proposed device is "as safe as" the predicate device. Specific performance metrics from these animal studies are not detailed in this summary, nor are "acceptance criteria" for these metrics provided.

In summary, this document is not a clinical study report or an AI/ML device performance study. It's a 510(k) summary demonstrating substantial equivalence to a commercially available predicate device based on technological characteristics, biocompatibility, sterility, and general safety/efficacy in animal models, not on specific, quantitatively defined acceptance criteria for human performance or algorithmic output.

N/A