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The InteliPORT® Occluding Device is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching or foreign body sensations which can be relieved by occluding the lacrimal drainage system in order to increase tear volume.

The InteliPORT® Occluding Device may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases.

Other patients that may benefit are: patients with arthritis, patients taking systemic or topical medications known to produce dry eyes, contact wearers who experience dry eye related problems, and patients who live in dry climates, or spend extended periods of time in low humidity environments (such as air conditioning). Topical eye drops may be more effective with punctal occlusion because tear drainage will be retarded, and tear breakup time extended.

The InteliPORT® Occluding Device is designed to deliver a custom fit plug through the punctal opening to block tear drainage. The self-forming plug (Intelimer Occluding Material*) is heated and inserted through the punctal opening into the proximal canaliculus as a melted viscous liquid. It rapidly solidifies to conform to the shape of the ampulla and canaliculus. The InteliPORT® Occluding Device is composed of a transitional and continuous block of Intelimer Occluding Material (matrix) which is adequate for delivering two doses in a single patient use applicator and is provided in a sealed, sterilized package. The Intelimer Occluding Material is liquefied in the applicator by warming it a few degrees above body temperature via an internal 1.5 volt battery and a heating coil. The narrow applicator tip is then inserted into the punctal opening and the plunger is pushed to deliver the Intelimer Occluding Material. Once inside the duct, the material cools to form a customized plug that conforms to the shape of the individual's ampulla and canaliculus. The volume of material delivered, approximately 4-7 micro liters, is controlled so as to flow into the common ampulla and canaliculus. Restoration of patency may be accomplished by irrigation with warm sterile saline.

The provided text is for a 510(k) premarket notification for a medical device (InteliPORT® Occluding Device), not an AI/ML device. Therefore, the questions about acceptance criteria, study design for AI evaluation (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth) are not applicable.

The document describes the safety and effectiveness of the InteliPORT® Occluding Device based on non-clinical and clinical data, comparing it to a predicate device for substantial equivalence.

Here's an overview of the safety and effectiveness information provided, structured to best fit the spirit of the request, acknowledging the non-AI nature of the device:

Acceptance Criteria and Device Performance (Interpreted for a non-AI medical device submission)

For a device like the InteliPORT® Occluding Device, "acceptance criteria" are not framed as statistical thresholds for AI metrics. Instead, they are implicitly defined by the demonstration of safety, biocompatibility, and clinical effectiveness similar to a legally marketed predicate device, with an acceptable risk profile for its intended use. The "reported device performance" refers to the findings from the non-clinical and clinical studies that support these claims.

Table: Summary of Safety and Effectiveness Findings (Non-AI Device)

• Non-cytotoxic, non-hemolytic, non-pyrogenic for Intelimer Occluding Material/extracts.
• Non-mutagenic in Ames Salmonella and chromosomal aberration assays. |
  | Applicator Safety | Safe for user, no hazard. | - Plastic applicator determined safe in standard USP plastics testing. |
  | MR Compatibility | Safe for patients undergoing MR imaging, no interference with image quality. | - Safe and compatible with static magnetic resonance fields up to 1.5 Tesla, no safety hazard, no interference with MR image quality. |
  | Thermal Safety | No unacceptable histological effects at operational temperatures. | - No unacceptable or marginal histological effects at 75°C (highest temperature evaluated). Specification for maximum temperature of 70°C considered safe. |
  | Removal Techniques | Restoration of patency without adverse effects on the nasolacrimal duct. | - Mineral oil-based ophthalmic lubricant with or without warm saline (less than 50°C) and warm compress restored duct patency for 100% of rabbits, with no adverse effects. |
  | Chronic Irritation (Animal) | No significant chronic irritation or adverse effects on nasolacrimal duct. | - Evaluated in rabbits for 182 days. Minimal conjunctival redness observed sporadically in both eyes, not indicative of ocular irritation.
• 2/30 rabbits had discharge/conjunctivitis in right eye, resolved with topical antibiotics; attributed to subclinical infection facilitated by occlusion. No signs in rabbits implanted for 180 days. Average histopathology scores

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