← Product Code [KNW](/productcode/KNW) · K040087 # RABBIT (K040087) _Scion International, Inc. · KNW · Apr 1, 2004 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K040087 ## Device Facts - **Applicant:** Scion International, Inc. - **Product Code:** [KNW](/productcode/KNW.md) - **Decision Date:** Apr 1, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1075 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The Rabbit is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. The extent of removal of the imaged evidence of an abnomality does not predict the extent of removal of a histologic abnormality (e.g. malignancy). When the sampled abnormality is and heine standed benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. ## Device Story The Rabbit is a coaxial breast biopsy system used to retrieve tissue samples for histological analysis. The system comprises a disposable biopsy device, localization needle, stylet, and hook wire. It utilizes a circular scalpel and a Garrote wire to transect tissue specimens. The device is provided sterile for single-use only. It is intended for use by clinicians to obtain tissue for histologic examination of breast abnormalities. The device aids in the partial or complete removal of imaged abnormalities, though it does not predict the extent of malignancy removal. Clinicians must perform standard surgical procedures to examine tissue margins if the sampled abnormality is not histologically benign. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Coaxial breast biopsy system. Components: disposable biopsy device, localization needle, stylet, hook wire. Mechanism: circular scalpel and Garrote wire for tissue transection. Materials: compliant with ISO 10993-1. Sterilization: provided sterile for single use. ## 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 - Auto Suture ABBI System ([K983296](/device/K983296.md)) - SiteSelect Breast Biopsy Device ([K011575](/device/K011575.md)) - Mammotome ([K003297](/device/K003297.md)) ## 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}------------------------------------------------ APR = 1 2004 KO40087 Scion International Inc. Submitter: 12415 SW 136 Ave. Unit 2 Miami.Fl. 33186 Contact Person; C.Kenneth French 254-435-2306 ckennethfrench a scionvalley.com Establishment Registration Number: We are registered with the Food and Drug Administration as Establishment Number 1055542 Date Prepared: 12-23-03 Name of Device: Common name: Biopsy Instrument Trade name: Rabbit Classification name: Instrument, Biopsy Devices to which substantial equivalence is claimed: | 510(K) # | Device | Manufacture | |----------|---------------------------------|---------------------------| | K983296 | Auto Suture ABBI System | U.S. Surgical Corporation | | K011575 | SiteSelect Breast Biopsy Device | Imagyn Surgical | | K003297 | Mammotome | Ethicon | Device Description: The Candidate Device is a coaxial breast biopsy system, which is intended to retrieve tissue samples from the breast for histological analysis .The device is provided sterile for single use only. The system includes a disposable biopsy device, Localization needle, stylet, and hook wire. The biopsy device includes a circular scalpel and a Garrote wire to transect the specimen. ## Rabbit 510 {k} Notification ## CONFIDENTIAL The Rabbit is indicated to provide breast tissue samples for diagnostic sampling of breast Intended use: abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. The extent of removal of the imaged evidence of an abnomality does not predict the extent of removal of a histologic abnormality (e.g. malignancy). When the sampled abnormality is and heine standed benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. Materials: All of the materials used to produce the Rabbit are in accordance with ISO Standard # 10993-1. - end of summary {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or waves. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR = 1 2004 Scion International, Inc. c/o Mr. C. Kenneth French QA/QC Scion Valley, Inc. 7930 Highway 22 Meridian, Texas 76665 Re: K040087 Trade/Device Name: Rabbit Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy istrument Regulatory Class: II Product Code: KNW Dated: January 15, 2004 Received: January 20, 2004 Dear Mr. French: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ Page 2 - Mr. C. Kenneth French This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriane C. Provost Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K040087 Device Name: Rabbit Indications For Use: The Rabbit is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use ____ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Provost (Division Sign-Off) Division of General, Restorative, and Neurological Devices Page 1 of ____ 510(k) Number_________________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda-staging.innolitics.com/device/K040087](https://fda-staging.innolitics.com/device/K040087) **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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