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K Number
K200325
Device Name
Orbit Subretinal Delivery System
Manufacturer
Orbit Biomedical
Date Cleared
2020-07-14

(155 days)

Product Code
FMF,HMX
Regulation Number
880.5860
Type
Traditional
Panel
OP
Reference & Predicate Devices
K182274
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.

Device Description

The Orbit Subretinal Delivery System (SDS) is comprised of 3 primary component sets including the Subretinal Injection Device Set, the Tubing Set, and the Dosing Set. Each Orbit SDS Set contains sterile single-use only components. The Subretinal Injection Device set includes the magnetic pad, ophthalmic marker, and subretinal injection device (SID). The Tubing Set includes the components for priming the BSS line and pneumatic BSS control via a vitreoretinal surgical console. The Dosing Set includes the syringe for delivery of a precise dose of Balanced Salt Solution (BSS) or BSS PLUS® infusate.

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary for a medical device called the "Orbit Subretinal Delivery System." This document focuses on demonstrating substantial equivalence to a predicate device and outlines various performance tests conducted.

However, it does not contain the specific information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML powered device. Specifically, it lacks:

  1. A table of acceptance criteria and reported device performance for an AI/ML component.
  2. Sample size used for the test set and data provenance.
  3. Number of experts used to establish ground truth and their qualifications.
  4. Adjudication method for the test set.
  5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
  6. Details about a standalone (algorithm only) performance study.
  7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
  8. Sample size for the training set for an AI/ML model.
  9. How the ground truth for the training set was established for an AI/ML model.

The document describes performance data related to biocompatibility, sterilization, packaging, shelf life, and simulated use for a physical medical delivery system, not an AI/ML algorithm.

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).