(139 days)
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No
The summary describes a passive reflector and a system for its non-imaging detection and localization, with no mention of AI/ML terms, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is used for marking and localizing tissue for surgical removal, not for treating a disease or condition.
No
The device is a marker (reflector) designed to locate biopsy or lumpectomy sites for surgical removal, not to diagnose a disease or condition. It aids in surgical planning and execution.
No
The description explicitly mentions a "SAVI Scout Reflector" which is a physical device intended for percutaneous placement, and a "SAVI Scout System" for detection and localization, implying hardware components beyond just software.
Based on the provided information, the SAVI Scout Reflector and the SAVI Scout System are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is typically used for diagnosis, monitoring, or screening.
- SAVI Scout Function: The SAVI Scout Reflector is an implantable marker placed within the breast tissue. The SAVI Scout System is a device used to locate this implanted marker. Neither device is used to analyze a specimen taken from the body.
- Intended Use: The intended use clearly states that the devices are for marking and localizing a site within the breast for surgical removal. This is a surgical guidance and localization tool, not a diagnostic test performed on a sample.
Therefore, the SAVI Scout Reflector and System fall under the category of medical devices used for surgical planning and guidance, not IVDs.
N/A
Intended Use / Indications for Use
The SAVI Scout Reflector is intended to be placed percutaneously in breast tissue to mark (>30 days) a biopsy site or a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a breast biopsy site or a lumpectomy site intended for surgical removal.
Product codes
NEU
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound, MRI, or radiography
Anatomical Site
breast tissue
Indicated Patient Age Range
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Intended User / Care Setting
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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)
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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.
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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
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§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
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October 31, 2017
Cianna Medical, Inc. Mr. Gary Mocnik V.P. Regulatory Affairs and Quality Systems 6 Journev. Suite 125 Aliso Viejo, California 92656
Re: K171767
Trade/Device Name: Cianna Medical SAVI Scout Reflector and SAVI Scout System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: September 27, 2017 Received: September 29, 2017
Dear Mr. Mocnik:
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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Cianna Medical Scout Reflector and Scout System
Indications for Use (Describe)
The SAVI Scout Reflector is intended to be placed percutaneously in breast tissue to mark (>30 days) a biopsy site or a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a breast biopsy site or a lumpectomy site intended for surgical removal.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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