← Product Code [GCX](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX) · K964127 # MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (K964127) _Allegiance Healthcare Corp. · GCX · Dec 31, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX/K964127 ## Device Facts - **Applicant:** Allegiance Healthcare Corp. - **Product Code:** [GCX](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX.md) - **Decision Date:** Dec 31, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6740 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for 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. ## Regulatory 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 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX/K964127](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/GCX/K964127) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com