(100 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CASSI™ II Rotational Core Biopsy System, addressing your requested points:
The provided document is a 510(k) summary for a medical device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, this 510(k) submission is for an updated branding and packaging configuration, along with minor modifications, of an already cleared predicate device (Sanarus CASSI™ II Rotational Core Biopsy System K051581). Therefore, the regulatory decision is based on substantial equivalence to that predicate device, not on new performance studies establishing new acceptance criteria.
The core argument in this 510(k) is that the modified device "do[es] 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." This implies that the original predicate device would have had studies and acceptance criteria to demonstrate its safety and efficacy, but those details are not present in this document.
Therefore, I cannot populate most of your requested information based on the provided text. However, I can explain why for each point:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. The submission relies on substantial equivalence to a predicate device. | Not specified in this document. The submission relies on substantial equivalence to a predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable. No new performance study data is described in this 510(k) summary.
- Data provenance: Not applicable. No new performance study data is described in this 510(k) summary.
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. No new performance study requiring ground truth establishment is described in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new performance study requiring adjudication is described in this 510(k) summary.
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
- No MRMC study was done. This device is a biopsy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a biopsy system, not an algorithm, and the submission does not describe a standalone performance study.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No new performance study requiring ground truth is described in this 510(k) summary.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this is not an AI/algorithmic device and no new performance study data is presented.
9. How the ground truth for the training set was established
- Not applicable. No training set or associated ground truth establishment is mentioned.
Summary of what the document does indicate:
- Device: CASSI™ II Rotational Core Biopsy System with the CASSI QuadPoint™ Disposable
- Purpose of Submission: Seek clearance for updated branding and packaging, and summarize minor modifications to the predicate device (Sanarus CASSI™ II Rotational Core Biopsy System, K051581).
- Conclusion: The manufacturer believes the modified device is substantially equivalent to the predicate and does not raise new safety or efficacy questions.
- Indications for Use: Obtaining biopsies from soft tissues (liver, kidney, prostate, spleen, lymph nodes, various soft tissue tumors, and breast abnormalities). Not intended for use in bone.
- Classification: Class II, 21 CFR 876.1075 (Gastroenterology-urology biopsy instrument).
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K123606
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MAR 1 2013
| 510(k) Summary | |
|---|---|
| Submitter'sName andAddress: | Scion Medical Technologies, LLC90 Oak StreetNewton, MA 02464U.S.A. |
| Contact Nameand Information: | Joseph OstendorfRegulatory Affairs ConsultantScion Medical TechnologiesAddress: 23879 Blue Spruce RoadSauk Centre, MN 56378U.S.A.Telephone: (503) 784-6756Fax: (888) 582 - 6211E-mail: jeostendorf@gmail.com |
| Date Prepared: | 20 November 2012 |
| ProprietaryName(s): | CASSI™ II Rotational Core Biopsy System, with theCASSI QuadPoint™ Disposable |
| Common Name: | Biopsy instruments and accessories |
| Product Code: | KNW |
| Classification ofDevice: | Class II, 21 CFR 876.1075 |
| PredicateDevice: | Sanarus CASSI™ IIRotational Core BiopsySystem K051581 July 27, 2005 |
| DeviceDescription: | The proposed CASSI II Rotational Core Biopsy System consistsof the following primary components: a fully integrated control unithandle (the CASSI II handle), a valve block, battery, cryogen, abiopsy needle (CASSI QuadPoint comprised of a sticking needleand cutting cannula/piston assembly), and a sample collectiontray. The sticking needle is operated by the control unit and usescold temperatures at its tip to engage the tissue to be sampled.The cutting cannula is coaxially mounted around the stickingneedle and is used to core the tissue specimen. The cutting |
| Indications forUse: | The device is indicated for use in obtaining biopsies from softtissues such as liver, kidney, prostate, spleen, lymph nodes andvarious soft tissue tumors. It is not intended for use in bone. |
| The device is also indicated to provide breast tissue samples fordiagnostic sampling of breast abnormalities. It is designed toprovide breast tissue for histologic examination with partial orcomplete removal of the imaged abnormality. The extent ofhistologic abnormality cannot be reliably determined from itsmammographic appearance. Therefore, the extent of removal ofthe imaged evidence of an abnormality does not predict the extentof removal of a histologic abnormality (e.g., malignancy). Whenthe sampled abnormality is not histologically benign, it is essentialthat the tissue margins be examined for completeness of removalusing standard surgical procedures. | |
| TechnologicalCharacteristics: | The purpose of this premarket notification is to seek clearance foran updated branding and packaging configuration to the SanarusCASSI II Rotational Core Biopsy System (K051581) and tosummarize minor modifications made to the device since the lastsubmission. The modified device will be marketed under thetrade names CASSI II Rotational Core Biopsy System and theCASSI QuadPoint disposables. |
| Conclusion: | In summary, Scion Medical Technologies, LLC believes that theproposed CASSI II Rotational Core Biopsy System and theCASSI QuadPoint disposables, as described in this submission,do not raise any new or significant questions of safety andefficacy and are substantially equivalent to the predicate SanarusCASSI II Rotational Core Biopsy System, which was determinedto 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.
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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
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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
Page 1 of 1
luctive, Gastr
§ 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.