Who is the manufacturer of MEDI-VAC FLEXI-CLEAR SUCTION HANDLE?

Allegiance Healthcare Corp. filed the 510(k) submission for MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (K964127).

What is the FDA product code for MEDI-VAC FLEXI-CLEAR SUCTION HANDLE?

GCX. It is classified under 21 CFR 880.6740 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for MEDI-VAC FLEXI-CLEAR SUCTION HANDLE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MEDI-VAC FLEXI-CLEAR SUCTION HANDLE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MEDI-VAC FLEXI-CLEAR SUCTION HANDLE

Q: What are the predicate devices for MEDI-VAC FLEXI-CLEAR SUCTION HANDLE?

Argyle® Yankauer Suction Tube.

K964127 · Allegiance Healthcare Corp. · GCX · Dec 31, 1996 · General Hospital

Device Facts

Record ID	K964127
Device Name	MEDI-VAC FLEXI-CLEAR SUCTION HANDLE
Applicant	Allegiance Healthcare Corp.
Product Code	GCX · General Hospital
Decision Date	Dec 31, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6740
Device Class	Class 2

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 Story

Medi-Vac Flexi-Clear™ Suction Handles; rigid suction tips; polyvinyl chloride construction; sterile; single-patient use. Connects to vacuum-powered suction apparatus; enables aspiration/removal/sampling of body fluids from surgical wounds or body orifices. Used in clinical settings by healthcare providers. Benefits patient by facilitating fluid removal during procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed: Cytotoxicity (non-toxic), Intracutaneous Reactivity (no reactivity), Hemocompatibility (no lysis), Systemic Toxicity (no irritation), and Sensitization (no irritation).

Technological Characteristics

Rigid suction tip; material: polyvinyl chloride; sterile; single-patient use; vacuum-powered operation.

Indications for Use

Indicated for patients requiring aspiration, removal, or sampling of body fluids from surgical wounds or body orifices via vacuum-powered suction apparatus.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

Argyle® Yankauer Suction Tube

Related Devices

K961880 — MEDCARE SUCTION CONNECTING TUBING · Medcare Medical Group, Inc. · Jul 19, 1996
K982891 — CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS · California Medical Laboratories, Inc. · Sep 30, 1998
K060277 — BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM · Boehringer Laboratories · Mar 3, 2006
K972074 — SUCTION INSTRUMENTATION · Walter Lorenz Surgical, Inc. · Jul 25, 1997
K093479 — DISPOSABLE SUCTION AND IRRIGATION SYSTEM · Modern Medical Equipment Mfg., Ltd. · May 19, 2010

Submission Summary (Full Text)

{0} DEC 31 1996 K964/27 # XI. SUMMARY OF SAFETY AND EFFECTIVENESS ## 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. 13 {1} Page 2 ## 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: | Test | Result | | --- | --- | | 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. | 14