← Product Code [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW) · K962907 # SKINNY,FRANSEEN,WESCOTT NEEDLES (K962907) _Baxter Healthcare Corp · KNW · Oct 23, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K962907 ## Device Facts - **Applicant:** Baxter Healthcare Corp - **Product Code:** [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW.md) - **Decision Date:** Oct 23, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1075 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use FNA needles are devices that are used to obtain samples through the aspiration of fluid (containing cells) from soft tissues such as breast, liver, kidney, pancreas and lung, etc. to analyze size, shape and structure of cells for diagnostic evaluation or monitor treatment. ## Device Story Fine needle aspiration (FNA) needle consists of cannula and stylet assembly with handle; used for manual insertion into soft tissues (breast, liver, kidney, pancreas, lung); facilitates aspiration of fluid containing cells for diagnostic analysis or treatment monitoring; operated by clinicians in clinical settings. ## Clinical Evidence Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, hemolysis, and pyrogenicity. Materials found acceptable. ## Technological Characteristics Cannula and stylet assembly with handle. Materials evaluated per ISO 10993-1 for biocompatibility. Manual operation. ## Regulatory Identification A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Predicate Devices - Baxter Skinny Chiba Needle - Hart Enterprises, Inc. Soft Tissue Needles ## 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} K962907 Surgical Group OCT 23 1996 Baxter Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA 847.473.1500 FAX: 847.785.2460 # Baxter ## XII. SMDA REQUIREMENTS ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ### FINE NEEDLE ASPIRATION NEEDLE **Manufacturer:** Baxter Healthcare Corporation Surgical Group 400 East Foster Road Mannford, OK 74044 **Regulatory Affairs Contact:** Sharon Robbins Surgical Group 1500 Waukegan Road MPK McGaw Park, IL 60085 **Telephone:** (847) 785-3311 **Date Summary Prepared:** July, 1996 **Common Name:** Fine Needle Aspiration Needle **Classification:** Class II per 21CFR § 876.1075 **Predicate Devices:** Baxter Skinny Chiba Needle Hart Enterprises, Inc. Soft Tissue Needles **Description:** The FNA needles are comprised of a cannula and stylet assembly connected to a handle for ease of insertion into soft tissues of the body. 19 {1} X962907 Surgical Group Baxter Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA 847.473.1500 FAX: 847.785.2460 # Baxter ## XII. SMDA REQUIREMENTS (continued) ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FINE NEEDLE ASPIRATION NEEDLE **Intended Use:** FNA needles are devices that are used to obtain samples through the aspiration of fluid (containing cells) from soft tissues such as breast, liver, kidney, pancreas and lung, etc. to analyze size, shape and structure of cells for diagnostic evaluation or monitor treatment. **Substantial Equivalence:** The Baxter FNA Needles are substantially equivalent to Baxter’s Skinny Chiba Needles and to the Hart Enterprises Soft Tissue Biopsy Needle in that: - the intended use is the same - the performance attributes are the same **Summary of testing:** The materials used in the fabrication of the FNA needles are evaluated through biological qualification safety tests as outlined ISO 10993, Part 1 - “Biological Evaluation of Medical Devices”. The biocompatibility tests performed were Cytotoxicity, Sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, Hemolysis, and Pyrogenicity as required. These materials meet the requirements of the guidance and found to be acceptable for the intended use. --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K962907](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K962907) **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. 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