Cianna Medical SAVI Scout Reflector and SAVI Scout System

K171767 · Cianna Medical, Inc. · NEU · Oct 31, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K171767
• Device Name: Cianna Medical SAVI Scout Reflector and SAVI Scout System
• Applicant: Cianna Medical, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Oct 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended 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.

Device Story

SAVI Scout System provides non-imaging detection and localization of an implanted SAVI Scout Reflector. Reflector is placed percutaneously in breast tissue to mark biopsy or lumpectomy sites. System detects reflector via electromagnetic signal; provides real-time guidance to surgeon during excision. Used in clinical settings by physicians to locate target tissue for surgical removal. Benefits include precise localization of non-palpable lesions, potentially improving surgical accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and bench testing.

Technological Characteristics

System utilizes electromagnetic detection technology to locate an implanted reflector. Reflector is a passive implantable device. System consists of a console and handpiece for signal detection. Connectivity is standalone. Sterilization method for the reflector is ethylene oxide.

Indications for Use

Indicated for patients requiring surgical removal of breast tissue (biopsy or lumpectomy sites) where a reflector has been implanted for localization.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Cianna Medical SAVI Scout Surgical Guidance System (K143536)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known)

K171767

#### 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)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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