← Product Code [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW) · K960509 # 18 GAUGE TRU-CUT BIOPSY NEEDLE (K960509) _Baxter Healthcare Corp · KNW · Apr 4, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K960509 ## Device Facts - **Applicant:** Baxter Healthcare Corp - **Product Code:** [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW.md) - **Decision Date:** Apr 4, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1075 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The 18 gauge Tru-Cut Biopsy Needle is a device that introduces a cannula into the soft tissue such as breast, lungs, lymph nodes and prostate, etc. for diagnostic evaluation. ## Device Story 18 gauge Tru-Cut Biopsy Needle; consists of cannula and stylet assembly with handle; used for soft tissue biopsy (breast, lung, lymph node, prostate); manual operation by clinician; device facilitates tissue sample collection for diagnostic evaluation. ## Clinical Evidence Bench testing only. Biocompatibility evaluated per ISO 10993-1 including USP Plastics Class VI, Implant, Hemolysis, Tissue Culture, Pyrogenicity, Ocular Irritation, and Guinea Pig Maximization tests. ## Technological Characteristics 18 gauge needle; cannula and stylet assembly; manual operation; materials evaluated per ISO 10993-1 biocompatibility standards. ## 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 14 Gauge Tru-Cut Biopsy Needle ## 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} k960509 APR - 4 1996 Surgical Group Baxter Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA 847.473.1500 FAX: 847.785.2460 A # Baxter APR - 4 1996 # XII. SMDA REQUIREMENTS # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 18 GAUGE TRU-CUT BIOPSY NEEDLE Manufacturer: Baxter Healthcare Corporation Surgical Group 400 East Foster Road Mannford, OK 74044 Regulatory Affairs Contact: Sharon Richter Surgical Group 1500 Waukegan Road MPK McGaw Park, IL 60085 Telephone: (847) 785-3311 Date Summary Prepared: January, 1996 Common Name: 18 Gauge Tru-Cut Biopsy Needle Classification: Class II per 21CFR § 876.1075 Predicate Device: Baxter 14 Gauge Tru-Cut Biopsy Needle Description: The 18 gauge Tru-Cut Biopsy needle is comprised of a cannula and stylet assembly connected to a handle for ease of insertion into the soft tissue. {1} 13 # XII. SMDA REQUIREMENTS (continued) ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ## 18 GAUGE TRU-CUT BIOPSY NEEDLE **Intended Use:** The 18 gauge Tru-Cut Biopsy Needle is a device that introduces a cannula into the soft tissue such as breast, lungs, lymph nodes and prostate, etc. for diagnostic evaluation. **Substantial Equivalence:** The Baxter 18 gauge Tru-Cut Biopsy Needle is substantially equivalent to Baxter’s 14 gauge Tru-Cut Biopsy Needle in that: - the intended use is the same - the performance attributes are the same **Summary of testing:** All materials used in the fabrication of this 18 gauge Tru-Cut Biopsy Needle were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 “Biological Evaluation of Medical Devices”. The biocompatibility tests performed were USP Plastics Class VI, Implant, Hemolysis, Tissue Culture, Pyrogenicity, Ocular Irritation, and Guinea Pig Maximization as required. These materials have met the requirements of the guidance and were found to be acceptable for the intended use. --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K960509](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K960509) **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