(76 days)
Not Found
No
The description focuses on a mechanical biopsy system and does not mention any software, image analysis, or AI/ML capabilities.
No
The device is described as a biopsy system used for diagnostic sampling of breast abnormalities, not for treatment.
Yes
The device is used to obtain breast tissue samples for "histologic examination," which is a diagnostic process used to determine the nature of breast abnormalities.
No
The device description explicitly states it is a "coaxial breast biopsy system" and includes physical components like a "disposable biopsy device, Localization needle, stylet, and hook wire." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes. The key is that the diagnostic process happens outside the body, using the collected specimen.
- Device function: The Rabbit device is a biopsy system. Its primary function is to retrieve tissue samples from the breast within the body. It is a tool for obtaining the specimen, not for analyzing it.
- Intended Use: The intended use clearly states it provides breast tissue samples for diagnostic sampling and histologic examination. This means the diagnostic process (histologic examination) happens after the tissue is collected, likely in a laboratory setting using other IVD devices or procedures.
The device is a tool for obtaining the sample that will then be used in an in vitro diagnostic process (histologic examination).
N/A
Intended Use / 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.
Product codes
KNW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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_________________________________________________________________________________________________________________________________________________________________