(76 days)
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.
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.
This document focuses on the Rabbit breast biopsy instrument, a conventional medical device, rather than an AI-powered system. Therefore, most of the requested information regarding AI-specific criteria (like acceptance criteria for AI performance, MRMC studies, standalone AI performance, or training set details) is not applicable.
Here's an analysis based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a non-AI device relying on substantial equivalence, there are no explicit quantitative "acceptance criteria" for diagnostic performance in the way one would define them for an AI algorithm (e.g., specific sensitivity/specificity thresholds). Instead, the acceptance is based on demonstrating equivalence to predicate devices and meeting general device safety and performance standards.
| Acceptance Criteria Category | Device Performance (Based on Substantial Equivalence Review) |
|---|---|
| Intended Use | Provides breast tissue samples for diagnostic sampling of breast abnormalities for histologic examination. |
| Design | Coaxial breast biopsy system with disposable biopsy device, localization needle, stylet, and hook wire. Includes a circular scalpel and a Garrote wire. |
| Material Safety | Materials conform to ISO Standard # 10993-1. |
| Sterility | Provided sterile for single use only. |
| Substantial Equivalence | Found substantially equivalent to: K983296 (Auto Suture ABBI System), K011575 (SiteSelect Breast Biopsy Device), K003297 (Mammotome). |
| General Controls | Subject to general controls provisions of the Act (registration, listing, GMP, labeling, no misbranding/adulteration). |
2. Sample size used for the test set and the data provenance:
- Not applicable for this type of device. The provided text does not describe a clinical study with a "test set" for diagnostic performance in the context of an AI algorithm. Substantial equivalence for this device relies on demonstrating that its design, materials, and intended use are comparable to legally marketed predicate devices, implying similar safety and effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. As above, there's no diagnostic test set in the AI sense for which ground truth would need to be established by experts for this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is described for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a biopsy instrument, not an AI diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical biopsy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Pathology/Histology: The primary "ground truth" related to the device's function is the histological examination of the tissue samples it retrieves. The device's purpose is to provide these samples, which are then analyzed by pathologists. The K-number does not detail specific studies proving the accuracy of the biopsy in comparison to a gold standard, but rather establishes equivalence to predicate devices that are accepted for providing such samples.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
Summary of Device and 510(k) Process:
The provided documents detail a 510(k) premarket notification for the "Rabbit" breast biopsy instrument. The FDA reviewed this submission and determined the device to be substantially equivalent to three predicate biopsy devices already on the market (Auto Suture ABBI System, SiteSelect Breast Biopsy Device, Mammotome).
For conventional medical devices under a 510(k) pathway, "acceptance criteria" largely revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves comparing:
- Indications for Use: The "Rabbit" is indicated for providing breast tissue samples for diagnostic sampling of breast abnormalities for histologic examination, identical or very similar to predicate devices.
- Technological Characteristics: The device description details its coaxial design, components (scalpel, Garrote wire), and single-use sterile nature. This is compared to the predicate devices.
- Performance Data: While not explicitly detailed as specific diagnostic performance metrics in this summary, the submission would have included verification and validation testing (e.g., mechanical strength, cutting performance, material biocompatibility per ISO 10993-1, sterility) to demonstrate that the device performs as intended and is safe. The FDA's finding of substantial equivalence implies these tests were sufficient.
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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
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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.
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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
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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_________________________________________________________________________________________________________________________________________________________________
§ 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.