K Number
K964127
Device Name
MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
Date Cleared
1996-12-31

(77 days)

Product Code
Regulation Number
880.6740
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These suction handles are used in conjunction with a vacuum-powered, single patient, body fluid suction apparatus. The handles provide a means to aspirate, remove or sample body fluids from a surgical wound or body orifice via vacuum.
Device Description
The Medi-Vac Flexi-Clear™ Suction Handles are made of polyvinyl chloride in a variety of sizes and are offered sterile.
More Information

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No
The description focuses on the physical characteristics and intended use of a simple suction handle, with no mention of AI/ML terms or functionalities.

No
The device is used to remove or sample body fluids, which is a diagnostic or procedural function, not a therapeutic one (i.e., it does not aim to cure or treat a disease).

No

Explanation: The device is used to aspirate, remove, or sample body fluids, which are actions related to treatment or collection rather than diagnosis. The performance studies also focus on biocompatibility and safety of the device itself, not on its ability to diagnose medical conditions.

No

The device description explicitly states the suction handles are made of polyvinyl chloride, indicating a physical hardware component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "aspirate, remove or sample body fluids from a surgical wound or body orifice via vacuum." This describes a process of physically removing fluids from the body.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information about a person's health.
  • Device Function: The suction handles are tools for collecting fluids, not for analyzing them or performing diagnostic tests on them.

The device is a surgical instrument used for fluid management during procedures, not a diagnostic test.

N/A

Intended Use / Indications for Use

These suction handles are used in conjunction with a vacm-powered, single patient, body fluid suction apparatus. The handles provide a means to aspirate, remove or sample body fluids from a surgical wound or body orifice via vacuum.

Product codes (comma separated list FDA assigned to the subject device)

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Device Description

The Medi-Vac Flexi-Clear™ Suction Handles are made of polyvinyl chloride in a variety of sizes and are offered sterile.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Summary of Testing:
Cytotoxicity Test: Suction handle does not elicit any toxic reactions to acute application.
Intracutaneous Reactivity: No reactivity was observed.
Hemocompatibility: Suction handles are hemocompatible exhibiting no lysis.
Systemic Toxicity: Suction handle does not display potential for irritation.
Sensitization: Suction handle does not display any potential for irritation.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Argyle® Yankauer Suction Tube

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 880.6740 Vacuum-powered body fluid suction apparatus.

(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

0

DEC 31 1996

SUMMARY OF SAFETY AND EFFECTIVENESS XI.

Image /page/0/Picture/3 description: The image shows the word "Allegiance" in a stylized font. The word is written in black and appears to be a logo or brand name. To the left of the word is a symbol that resembles a plus sign made up of small dots.

| 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Medi-Vac Flexi-Clear™ Suction Handles
Manufacturer:Allegiance Healthcare Corporation
Productos Urologos de Mexico S.A. de C.V.
Calle Norte Lote 1
Parque Industrial III
Mexicali-Baja Cal. Mexico 21210
Regulatory Affairs Contact:Ingrid M. Hoos
1500 Waukegan Road, Bldg. K
McGaw Park, IL 60085
Telephone:(847) 785-3312
Date Summary Prepared:October, 1996
Product Trade Name:Medi-Vac Flexi-Clear™ Suction Handles
Common Name:Suction Handle
Classification:Tip, Suction, Rigid
Predicate Devices:Argyle® Yankauer Suction Tube
Description:The Medi-Vac Flexi-Clear™ Suction Handles are made of polyvinyl
chloride in a variety of sizes and are offered sterile.
Intended Use:These suction handles are used in conjunction with a vacuum-
powered, single patient, body fluid suction apparatus. The handles
provide a means to aspirate, remove or sample body fluids from a
surgical wound or body orifice via vacuum.

1

Substantial Equivalence: The Medi-Vac Flexi-Clear™ Suction Handles are substantially equivalent to Argyle® Yankauer Suction Tube in that they provide the following characteristics: - intended use - size, configuration, packaging

  • made of polyvinyl chloride
  • physical properties

Summary of Testing:

TestResult
Cytotoxicity TestSuction handle does not elicit any toxic reactions to acute application.
Intracutaneous ReactivityNo reactivity was observed.
HemocompatibilitySuction handles are hemocompatible exhibiting no lysis.
Systemic ToxicitySuction handle does not display potential for irritation.
SensitizationSuction handle does not display any potential for irritation.