(100 days)
Not Found
No
The document describes a mechanical biopsy system and does not mention any AI or ML components or functions.
No.
The device is used for obtaining biopsies and tissue samples for diagnostic purposes, which is a diagnostic procedure, not a therapeutic one.
Yes
Explanation: The device is used to obtain tissue samples for diagnostic sampling of abnormalities, and specifically mentions providing breast tissue for "histologic examination," which is a diagnostic process.
No
The device description clearly outlines multiple hardware components including a control unit handle, valve block, battery, cryogen, biopsy needle, and sample collection tray. This indicates it is a physical medical 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The description clearly states the device is used for obtaining biopsies from soft tissues and breast tissue. This is a procedure performed on the patient's body to collect a tissue sample.
- Purpose: The purpose of the device is to acquire the tissue sample, which is then sent for histologic examination (analysis of the tissue structure). The device itself does not perform the diagnostic test on the sample.
The device is a biopsy system, which is a surgical or interventional device used to collect tissue for subsequent diagnostic testing (which would be an in vitro diagnostic test performed in a lab).
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.q., 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 proposed CASSI II Rotational Core Biopsy System consists of the following primary components: a fully integrated control unit handle (the CASSI II handle), a valve block, battery, cryogen, a biopsy needle (CASSI QuadPoint comprised of a sticking needle and cutting cannula/piston assembly), and a 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
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
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): 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.
Not Found
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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K123606
Page 1 of 2
MAR 1 2013
| 510(k) Summary | |
|---|---|
| Submitter's | |
| Name and | |
| Address: | Scion Medical Technologies, LLC |
| 90 Oak Street | |
| Newton, MA 02464 | |
| U.S.A. | |
| Contact Name | |
| and Information: | Joseph Ostendorf |
| Regulatory Affairs Consultant | |
| Scion Medical Technologies |
Address: 23879 Blue Spruce Road
Sauk Centre, MN 56378
U.S.A.
Telephone: (503) 784-6756
Fax: (888) 582 - 6211
E-mail: jeostendorf@gmail.com |
| Date Prepared: | 20 November 2012 |
| Proprietary
Name(s): | CASSI™ II Rotational Core Biopsy System, with the
CASSI QuadPoint™ Disposable |
| Common Name: | Biopsy instruments and accessories |
| Product Code: | KNW |
| Classification of
Device: | Class II, 21 CFR 876.1075 |
| Predicate
Device: | Sanarus CASSI™ II
Rotational Core Biopsy
System K051581 July 27, 2005 |
| Device
Description: | The proposed CASSI II Rotational Core Biopsy System consists
of the following primary components: a fully integrated control unit
handle (the CASSI II handle), a valve block, battery, cryogen, a
biopsy needle (CASSI QuadPoint comprised of a sticking needle
and cutting cannula/piston assembly), and a 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 |
| 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. |
| Technological
Characteristics: | The purpose of this premarket notification is to seek clearance for
an updated branding and packaging configuration to the Sanarus
CASSI II Rotational Core Biopsy System (K051581) and to
summarize minor modifications made to the device since the last
submission. The modified device will be marketed under the
trade names CASSI II Rotational Core Biopsy System and the
CASSI QuadPoint disposables. |
| Conclusion: | In summary, Scion Medical Technologies, LLC believes that the
proposed CASSI II Rotational Core Biopsy System and the
CASSI QuadPoint disposables, as described in this submission,
do not raise any new or significant questions of safety and
efficacy and are substantially equivalent to the predicate Sanarus
CASSI II Rotational Core Biopsy System, which was determined
to be substantially equivalent and cleared on July 27, 2005
(K051581). |
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K123606
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Image /page/2/Picture/1 description: The image contains a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1. 2013
Scion Medical Technologies, LLC % Mr. Joseph Ostendorf Regulatory Affairs Consultant Ostendorf Consulting 23879 Blue Spruce Road SAUK CENTRE MN 56378
Re: K123606
Trade/Device Name: CASSI™ II Rotational Core Biopsy System with the CASSI QuadPoint™ Disposable Regulation Number: 21 CFR& 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: January 25, 2013 Received: January 31, 2013
Dear Mr. Ostendorf:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
CASSI™ II Rotational Core Biopsy System with the CASSI QuadPoint™ Disposable
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.q., 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S
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