(30 days)
No
The description focuses on the mechanical and thermal aspects of the biopsy system and does not mention any AI/ML components or image processing capabilities.
No
The device is used to obtain tissue samples for diagnostic purposes and is not described as treating any disease or condition.
Yes
The device is indicated for use in obtaining biopsies and tissue samples for "diagnostic sampling of breast abnormalities" and "histologic examination," which are diagnostic procedures.
No
The device description clearly outlines physical components like a sticking needle, cutting cannula, control unit, and specimen container, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device is a biopsy system used to obtain tissue samples from the body. It is a tool for collecting the specimen, not for analyzing it.
- The description focuses on the mechanical process of obtaining the biopsy (sticking needle, cutting cannula, cold temperatures).
- The intended use is to provide tissue samples for histologic examination, which is the in vitro diagnostic process that would be performed after the sample is obtained by this device.
In summary, this device is a surgical/biopsy device used to collect samples, which are then sent for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
The device is also 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
78 KNW
Device Description
The Sanarus Cassi Rotational Core Biopsy System consists of a sticking needle, cutting cannula, fully integrated control unit and specimen container. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several gauge sizes and lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors, breast tissue
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)
Performance testing confirms that the quality of samples obtained with the Sanarus Cassi Rotational Core Biopsy System is equivalent to the predicate device.
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
Premarket Submission: Special 510k
Sanarus Cassi Rotational Core E
Appendix A: 510k Summary of Safety and Effectiveness
CONTACT INFORMATION
Trena Depel Director, Regulatory and Clinical Affairs Telephone: (925) 460-6080, x-6715 FAX: (925) 460-0688 e-mail: tdepel@sanarus.com
COMPANY INFORMATION
Sanarus Medical, Inc. 5880 W. Las Positas Blvd., Suite 52 Pleasanton, CA 94588 Telephone: (925) 460-6080 FAX: (925) 460-0688
DEVICE NAME
Sanarus Cassi™ Rotational Core Biopsy System
DEVICE DESCRIPTION
The Sanarus Cassi Rotational Core Biopsy System consists of a sticking needle, cutting cannula, fully integrated control unit and specimen container. The sticking needle is operated by the control unit and uses cold temperatures at its tip to engage the tissue to be sampled. The cutting cannula is coaxially mounted around the sticking needle and is used to core the tissue specimen. The cutting cannula will be available in several gauge sizes and lengths.
INDICATIONS FOR USE
The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
The device is also 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.
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K042i36
Premarket Submission: Special 510k
Sanarus Cassi Rotational Core Biopsy
Page 2 of 2
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
Sanarus Centrica™ II Rotational Core Biopsy System
SUBSTANTIAL EQUIVALENCE
The Sanarus Cassi Rotational Core Biopsy System is substantially equivalent to the Centrica Rotational Core Biopsy System that was determined to be substantially equivalent on Oct 9, 2003 (reference K032506).
The Sanarus Cassi Rotational Core Biopsy System has the same indications for use and technological characteristics as the predicate device. The patient contact components and component materials for obtaining core biopsy samples in both the new and predicate device are the same. The packaqing materials, packaging configurations, sterilization methods and sterility assurance level are also equivalent.
Based on the indications for use, technological characteristics and performance testing results, the Sanarus Cassi Rotational Core Biopsy System does not raise significant new questions of safety and effectiveness.
PERFORMANCE TESTING SUMMARY
Performance testing confirms that the quality of samples obtained with the Sanarus Cassi Rotational Core Biopsy System is equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, topped by a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Ms. Trena Depel Director, Regulatory and Clinical Affairs Medical, Inc. Sanarus 5880 W. Las Positas Blvd. Suite 52 PLEASANTON CA 94588
Re: K042136
Ro42130
Trade/Device Name: Sanarus Cassi™ Rotational Core Biopsy System Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: 78 KNW Dated: August 6, 2004 Received: August 9, 2004
Dear Ms. Depel:
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 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mating of substantial equivalence of your device to a legally prematication. The Pice and 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 If you desire specific advise to your are of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on any prosse note the regulation entitled, "Misbranding Other of Onliphallos at (301) 21 11:53 Part 807.97) you may obtain. Other general by reletence to premarked nonmoution (er the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Section: http://www.fda.gov/cdch/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
l'age 2
4
Sanarus Cassi Rotational Core Biopsy System
APPENDIX B: INDICATIONS FOR USE
510(k) Number: _ K042136
Device Name: Sanarus Cassi™ Rotational Core Biopsy System
Indications for Use: The device is indicated for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
The device is also 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.
Concurrence of CDRH, Office of Device Evaluation (ODE):
David A. Legum
(Division Sign-Off) Division of Reproductive Ahrinminal and Radiological Devices 510(k) Number ___
Prescription Use: × (Per 21 CFR 801.109)