Cianna Medical SAVI Scout Reflector and SAVI Scout System

K161507 · Cianna Medical, Inc. · PDW · Jul 29, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161507
• Device Name: Cianna Medical SAVI Scout Reflector and SAVI Scout System
• Applicant: Cianna Medical, Inc.
• Product Code: PDW · General, Plastic Surgery
• Decision Date: Jul 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4670
• Device Class: Class 2

Intended Use

The SAVI Scout Reflector is intended to be placed percutaneously in the breast to temporarily mark (<30days) a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound 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 lumpectomy site intended for surgical removal.

Device Story

The SAVI Scout System is a non-imaging localization device used to identify breast lumpectomy sites. The system consists of an implantable reflector and a console/handpiece. The reflector is placed percutaneously into the breast tissue under imaging guidance (ultrasound or radiography) to mark the target site. During surgery, the SAVI Scout System console emits an electromagnetic signal to detect the reflector; the handpiece provides real-time feedback to the surgeon regarding the reflector's location. This allows the surgeon to precisely localize and excise the target tissue. The system is intended for use in a clinical/surgical setting by trained healthcare professionals. It benefits patients by providing a non-radioactive alternative for lesion localization, potentially improving surgical accuracy and workflow compared to traditional wire-guided localization.

Clinical Evidence

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

Technological Characteristics

The system utilizes electromagnetic detection technology to locate an implanted reflector. The reflector is a passive implantable device. The system is non-imaging and operates via a console and handpiece. Connectivity is internal to the system for signal processing. Sterilization is performed for the reflector component.

Indications for Use

Indicated for patients requiring temporary marking (<30 days) of a breast lumpectomy site prior to surgical removal. Used for localization of the target tissue.

Regulatory Classification

Identification

An internal tissue marker is a prescription use device that is intended for use prior to or during general surgical procedures to demarcate selected sites on internal tissues.

Special Controls

In combination with the general controls of the FD&C Act, the Internal Tissue Marker is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided. (2) Performance testing must demonstrate that the device performs as intended to mark the tissue for which it is indicated. (3) Performance data must demonstrate the sterility of the device. (4) Performance data must support the shelf life of the device by demonstrating sterility, package integrity, device functionality, and material stability over the requested shelf life. (5) Labeling must include: (i) A warning that the device must not be used on a non-sterile surface prior to use internally. (ii) An expiration date/shelf life. (iii) Single use only labeling must be labeled directly on the device.

Predicate Devices

• Cianna Medical SAVI Scout Surgical Guidance System (K150556)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 20, 2016

Cianna Medical, Inc. % Mr. Gary Mocnik V.P. Regulatory Affairs and Quality Systems 6 Journev. Suite 125 ALISO VIEJO CA 92656

Re: K161507

Trade/Device Name: SAVI Scout Reflector and SAVI Scout System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: PBY Dated: May 25, 2016 Received: June 1, 2016

Dear Mr. Mocnik.

This letter corrects our substantially equivalent letter of July 29, 2016.

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D'Hara

For

Robert Ochs, Ph.D. Director Office of In Vitro Diagnostics and Radiological Health] Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K161507

Device Name

SAVI Scout Reflector and SAVI Scout System

Indications for Use (Describe)

The SAVI Scout Reflector is intended to be placed percutaneously in the breast to temporarily mark (<30days) a lumpectomy site intended for surgical removal. Using imaging guidance (such as ultrasound 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 lumpectomy site intended for surgical removal.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size: 10pt;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </div> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10pt;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </div> |

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