FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The PFR95TM Particulate Filter Respirator and Surgical Masks are intended for use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

Device Description

Respirator consisting of nonwoven inter facing, filter media(s), and an outer facing. It covers the nose and mouth of the wearer, and is held in place with two synthetic elastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece.

AI/ML Overview

The provided 510(k) summary for the Tecnol PFR95™ Particulate Filter Respirator and Surgical Mask (K974068) describes the device, its intended use, and performance data from non-clinical tests. Since this is a submission for a physical medical device (particulate filter respirator/surgical mask) and not a software-as-a-medical-device (SaMD), many of the requested criteria (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or typically reported for this type of submission. The information provided focuses on material properties and physical performance rather than AI/algorithm performance.

Here's an analysis of the available information based on the prompt's request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Requirements/Standards)	Reported Device Performance
Filtration Efficiency:
- Meet NIOSH required sodium chloride test	Met NIOSH required sodium chloride test with 0.3 micron particles.
- Filtration efficiency not drop below 95%	At no time did the filtration efficiency drop below 95%.
Fluid Resistance:
- Resist splash and splatter of blood and body fluids	Subject device samples were challenged with 2cc of synthetic blood at a speed simulating release of blood from an artery. (Implied successful resistance, as no failure is reported and a conclusion of "safe and effective" is made).
Face Fit:
- Not explicitly stated quantitative criteria, but implicitly requires acceptable fit for protection.	Subject device samples were tested using a qualitative fit test. (Implied successful fit, as no failure is reported and a conclusion of "safe and effective" is made).
Ease of Breathing (Airflow Resistance):
- NIOSH airflow resistance test requirement: Initial resistance (inhalation) less than 35mm H2O.	Subject device samples met the requirements of the NIOSH airflow resistance test, with initial resistance (inhalation) less than 35mm H2O.
Biocompatibility:
- Meet requirements of ISO-10993, Part 1: Evaluation and Testing.	Subject device meets the requirements of ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document refers to "Subject device samples" for each test. For physical device testing like this, the sample size would typically be defined by the relevant standards (e.g., NIOSH, ISO).
Data Provenance: Not specified. This would be laboratory testing conducted on the manufactured device, not data from human subjects or clinical records.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. The "ground truth" for this type of device is established through performance against objective, standardized physical and chemical tests (e.g., NIOSH standards for filtration, ISO standards for biocompatibility). There is no human expert consensus for defining ground truth in this context.

4. Adjudication Method for the Test Set

Not Applicable. As ground truth relies on objective laboratory measurements against defined standards, there is no need for an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic imaging or similar scenarios where human readers interpret medical data, often with and without AI assistance. This is a physical device, so such a study is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not a software algorithm; it is a physical medical device. Therefore, a "standalone algorithm performance" study is not applicable. The performance described is the standalone performance of the physical device itself.

7. The Type of Ground Truth Used

Standardized Test Results/Compliance with Regulatory Standards. The "ground truth" is adherence to established national and international standards (e.g., NIOSH for filtration, airflow resistance, and fluid resistance; ISO-10993 for biocompatibility). These standards define objective, measurable pass/fail criteria.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. This is not an AI/ML device that requires a training set.

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K Number

K970448

Device Name

PCM 2000; ISOLAIR APR MODEL 2735

Manufacturer

TECNOL MEDICAL PRODUCTS, INC.

Date Cleared

1997-04-30

(83 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

Meets the CDC guidelines for TB exposure control. Has a filter efficiency level of 95% against solid particulate aerosols free of oil (Type N95 respirator). Designed to be fluid resistant to splash and spatter of blood and body fluids.

Device Description

Respirator consisting of nonwoven inter facing, filter media(s), a fluid barrier film, and an outer facing. It covers the nose and mouth of the wearer, and is held in place with two synthetic clastic headbands, conforming to the curvature of the wearer's nose with a malleable nosepiece.

AI/ML Overview

This document is a 510(k) Premarket Notification for a respirator and surgical mask. It primarily focuses on demonstrating equivalence to a predicate device through performance testing. Therefore, it does not involve the type of study design or criteria typically used for AI-driven medical devices, which the provided questions are geared towards.

Here's an analysis based on the information provided, highlighting why many questions are not directly applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Filtration Efficiency ≥ 95% for 0.3 micron particles (NIOSH standard)	Met NIOSH required sodium chloride test; no filtration efficiency drop below 95%.
No fluid penetration with 2cc synthetic blood at arterial speed	No fluid penetration observed.
Qualitative Face Fit test passed	Samples tested successfully.
Initial inhalation resistance

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K Number

K963559

Device Name

WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)

Manufacturer

TECNOL MEDICAL PRODUCTS, INC.

Date Cleared

1996-11-22

(78 days)

Product Code