(42 days)
Not Found
No
The document describes a mechanical biopsy system that uses cold temperatures and a cutting cannula. There is no mention of AI, ML, image processing, or any other computational analysis of data that would suggest the use of AI/ML.
No
The device is used to obtain biopsies for diagnostic sampling, not to treat a condition.
Yes
The device is indicated for use in obtaining biopsies and tissue samples for diagnostic sampling and histologic examination of abnormalities, which directly supports diagnosis.
No
The device description clearly outlines physical components like a control unit (Handle), Biopsy Needle Unit (sticking needle and cutting cannula), and sample collection tray, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is used for obtaining biopsies from soft tissues. It is a tool for collecting tissue samples.
- Purpose of the Samples: The samples obtained are intended for histologic examination, which is a laboratory process performed after the sample is collected. The device itself does not perform any diagnostic testing on the sample.
The device is a biopsy device, which is a surgical instrument used to collect tissue. While the collected tissue is used for diagnostic purposes (histology), the device itself is not an IVD.
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 (comma separated list FDA assigned to the subject device)
KNW
Device Description
The Sanarus Cassi II Rotational Core Biopsy System consists of a fully integrated control unit (Handle), Biopsy Needle Unit (comprised of a sticking needle and cutting cannula) and sample collection tray. 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors, breast
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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 II Rotational Core Biopsy System is equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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K051581 pg, 1 of 2
Sanarus Cassi II Rotational Core Biopsy System
JUL 27 2005
Caye 102
Section 2: Summary of Safety and Effectiveness
Contact Information (1)
Trena Depel Director, Requlatory & Clinical Affairs Telephone: (925) 460-5731 FAX: (925) 460-0688 E-mail: tdepel@sanarus.com
Company Information (2)
Sanarus Medical, Inc. 4696 Willow Road Pleasanton, CA 94588 Telephone: (925) 460-6080 FAX: (925) 460-6084
(3) Device Name
Sanarus Cassi™ II Rotational Core Biopsy System
(4) Device Description
The Sanarus Cassi II Rotational Core Biopsy System consists of a fully integrated control unit (Handle), Biopsy Needle Unit (comprised of a sticking needle and cutting cannula) and sample collection tray. 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 (5)
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
1
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.
(6) Name of Predicate or Legally Marketed Device
Sanarus Cassi™ Rotational Core Biopsy System
(7) Substantial Equivalence
The Sanarus Cassi II Rotational Core Biopsy System is substantially equivalent to the Cassi Rotational Core Biopsy System that was determined to be substantially equivalent on Sep 8 2004 (reference K042136).
The Sanarus Cassi II 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 packaging 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 II Rotational Core Biopsy System does not raise significant new questions of safety and effectiveness.
(8) Performance Testing Summary
Performance testing confirms that the quality of samples obtained with the Sanarus Cassi II Rotational Core Biopsy System is equivalent to the predicate device.
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Image /page/2/Picture/2 description: The image shows a black and white logo. The logo features a stylized bird in flight, with three lines representing its wings. The bird is positioned within a circle, and there is some text visible around the circumference of the circle, although the text is not clear enough to read.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050
JUL 2 7 2005
Ms. Trena Depel Director, Regulatory and Clinical Affairs Sanarus Medical, Inc. 4696 Willow Road PLEASANTON CA 94588
Re: K051581 Trade/Device Name: Sanarus Cassi™ II Rotational Core Biopsy System Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II
Product Code: KNW Dated: June 14, 2005 Received: June 15, 2005
Dear Ms. Depel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we ha re reviewed 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 the cholors of to regary ment date of the Medical Device Amendments, or to devices that have been May 20, 1710, and classince 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 do not require approvisions of the Act. The general controls provisions of the Act do froo, subjoct to at to 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 (Premarket It your all to is vascent in to such additional controls. Existing major regulations affecting your Apployali, It the you be begiller 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 I reast of advisou that i Dr. in that your device complies with other requirements of the Act or any I Drives and regulations administered by other Federal agencies. You must comply with all the I cacrates and reguirements, 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) (21 CFR Part 801); 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 5 [0(k) I his letter will anow you to begin marketing your and equivalence of your device to a legally premarket notification. THE PDA multing of bassantial sept revice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your correst on the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Antification the Also, please note the regulation entitled, "Misetanaling on your responsibilities under the Act from the 190 807.97). You may obtain outci general miornation on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number: K051581
Device Name: Sanarus Cassi™ II 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 br. Leggrm
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological De 510(k) Number
Prescription Use: × (Per 21 CFR 801.109)
Sanarus Medical CONFIDENTIAL