(105 days)
Not Found
No
The description focuses on electromagnetic signature analysis and real-time navigation based on detected signals, with no mention of AI or ML techniques for data processing or decision-making.
No.
The device is a navigation system used to locate markers for surgical removal; it does not treat or prevent a disease or condition.
No
The device's intended use and description state that it detects the presence of an implanted marker and provides navigation for surgical removal of tissue. This is for guidance during a procedure, not for diagnosing a condition or disease.
No
The device description explicitly lists hardware components: Console, Heads Up Display, Patient Pad, and Foot Pedal. It also mentions sterile, non-patient contacting single-use devices (Navigator and Calibration Disk). This indicates it is a system with both hardware and software, not a software-only device.
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 to provide information for diagnosis, monitoring, or screening.
- Device Function: The SmartClip™ Soft Tissue Marker and the EnVisio™ Navigation System are used in vivo (within the body) to mark and locate a specific site for surgical removal. They do not analyze biological samples to provide diagnostic information.
- Intended Use: The intended use is for marking and guiding surgical removal of soft tissue, not for diagnosing a condition based on analysis of a biological sample.
The device is a surgical guidance and marking system, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The SmartClip™ Soft Tissue Marker is intended to be placed percutaneously in soft tissue to permanently mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (EnVisio™ Navigation System) the SmartClip™ is located and surgically removed with the target tissue. The EnVisio™ Navigation System is intended only for the non-imaging detection and localization (by navigation) of the SmartClip™ that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
Product codes (comma separated list FDA assigned to the subject device)
NEU
Device Description
The EnVisio™ Navigation System is a medical device that detects the presence of the SmartClip™ Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery. The EnVisio™ Navigation System acquires and analyzes electromagnetic signatures that display the relative distance, depth, and direction from the tip of the electrosurgical tool to the implanted SmartClips™ within the surgeon's field of view during the procedure. The EnVisio™ Navigation System will be utilized in an operating room where surgical excision of soft tissue is performed. The EnVisio™ system can detect and provide real-time three-dimensional navigation for up to three separate SmartClips™ each programmed to emit a unique electromagnetic signature.
The EnVisio™ Navigation System equipment components are the Console, Heads Up Display, Patient Pad and Foot Pedal. The EnVisio™ Navigation System Navigator and Calibration Disk are sterile, non-patient contacting single use devices which are available separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft Tissue
Indicated Patient Age Range
Adult
Intended User / Care Setting
Intra-operative, guided surgical procedure
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)
Performance testing was conducted to evaluate and characterize the performance of the EnVisio Navigation System. The following performance testing was conducted on the EnVisio Navigation System to support a determination of substantial equivalence to the predicate device.
- System Design Verification
- Navigation Performance Verification
- Navigation Performance Validation
- EMC/Safety Testing
- Packaging/Shelf Life
- Sterilization Validation
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
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 22, 2019
Elucent Medical, Inc Ms. Debra Kridner Vice President of Regulatory and Quality 7480 Flying Cloud Drive, Suite 110 Eden Prairie, Minnesota 55344
Re: K183400
Trade/Device Name: EnVisio Navigation System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: February 20, 2019 Received: February 22, 2019
Dear Ms. Kridner:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by David Krause David Krause -S Date: 2019.03.22 14:41:33 -04'00' 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) K183400
Device Name EnVisio™ Navigation System
Indications for Use (Describe)
The SmartClip Soft Tissue Marker is intended to be placed percutaneously in soft tissue to permanently mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (EnVisio Navigation System); the SmartClip is located and surgically removed with the target tissue. The EnVisio Navigation System is intended only for the non-imaging detection and localization (by navigation) of the SmartClip that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Date Prepared: | March 20, 2019 |
|---|---|
| 1. APPLICANT | Elucent Medical, Inc. |
| 7480 Flying Cloud Drive, Suite 110 | |
| Eden Prairie, MN 55344 USA | |
| Official Correspondent: | Debra Kridner |
| Tel: (844) 417 1700 / Fax: (952) 314-7105 | |
| debra.kridner@elucent.com | |
| 2. DEVICE | |
| Trade Name: | EnVisio™ Navigation System |
| 510(k) | K183400 |
| Common Name: | Implanted, Radiographic, Tissue Marker |
| Classification Number: | 21 CFR 878.4300 |
| Classification Name: | Implantable Clip |
| Device Class: | Class II |
| Product Code: | NEU |
| Review Panel: | General and Plastic Surgery |
3. PREDICATE DEVICE (PRIMARY)
| Trade Name: | Cianna Medical SAVI Scout Reflector and SAVI Scout System |
|---|---|
| 510(k) | K181007 |
| Common Name: | Implanted, Radiographic, Tissue Marker |
| Classification Number: | 21 CFR 878.4300 |
| Classification Name: | Implantable Clip |
| Device Class: | Class II |
| Product Code: | NEU |
| Review Panel: | General and Plastic Surgery |
4. DEVICE DESCRIPTION (for the device subject to this 510(k) notification)
The EnVisio™ Navigation System is a medical device that detects the presence of the SmartClip™ Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery. The EnVisio™ Navigation System acquires and analyzes electromagnetic signatures that display the relative distance, depth, and direction from the tip of the electrosurgical tool to the implanted SmartClips™ within the surgeon's field of view
4
during the procedure. The EnVisio™ Navigation System will be utilized in an operating room where surgical excision of soft tissue is performed. The EnVisio™ system can detect and provide real-time three-dimensional navigation for up to three separate SmartClips™ each programmed to emit a unique electromagnetic signature.
The EnVisio™ Navigation System equipment components are the Console, Heads Up Display, Patient Pad and Foot Pedal. The EnVisio™ Navigation System Navigator and Calibration Disk are sterile, non-patient contacting single use devices which are available separately.
5. INDICATIONS FOR USE (for the Device Subject to this 510(k) Notification)
The SmartClip™ Soft Tissue Marker is intended to be placed percutaneously in soft tissue to permanently mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (EnVisio™ Navigation System) the SmartClip™ is located and surgically removed with the target tissue. The EnVisio™ Navigation System is intended only for the non-imaging detection and localization (by navigation) of the SmartClip™ that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
| Comparison of
Subject Device
to Predicate
Device | Subject Device
EnVisio™ Navigation System
(K183400) | Predicate Device:
Cianna Medical SAVI Scout Reflector
and SAVI Scout System (K181007) |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The SmartClip™ Soft Tissue Marker is
intended to be placed percutaneously in
soft tissue to permanently mark a biopsy
site or a soft tissue site intended for
surgical removal. Using imaging guidance
(such as ultrasound, MRI, or radiography)
or aided by non-imaging guidance
(EnVisio™ Navigation System) the
SmartClip™ is located and surgically
removed with the target tissue. The
EnVisio™ Navigation System is intended
only for the non-imaging detection and
localization (by navigation) of the
SmartClip™ that has been implanted in a
soft tissue biopsy site or a soft tissue site
intended for surgical removal. | The SAVI Scout Reflector is intended to be
placed percutaneously in soft tissue to mark
(>30 days) a biopsy site or a soft tissue 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 soft tissue biopsy site or a soft
tissue site intended for surgical removal. |
| Intended Use | Detect and Navigate to the implanted
SmartClip - Soft Tissue Marker | Detect and Navigate to the implanted
Reflector - Soft Tissue Marker |
| Use
Environment | Intra-operative, guided surgical procedure | Intra-operative, guided surgical procedure |
| Anatomical Site | Soft Tissue | Soft Tissue |
| Patient
Population | Adult | Adult |
| Comparison of Subject
Device to Predicate
Device | Subject Device
EnVisio™ Navigation System
(K183400) | Predicate Device:
Cianna Medical SAVI Scout
Reflector and SAVI Scout System
(K181007) |
| Manufacturer | Elucent Medical, Inc. | Cianna Medical, Inc. |
| Device Name | EnVisio™ Navigation System | SAVI Scout Reflector and Scout System |
| 510(k) Number | K183400 | K181007 |
| Principles of Operation | Electromagnetic wave technology to
detect and navigate to the soft tissue
marker | Electromagnetic wave technology to
detect and navigate to the soft tissue
marker |
| Intraoperative
Localization Energy | Electromagnetic, passive marker | Electromagnetic, passive marker |
| Audible Location
Indication | Yes | Yes |
| Visual Location
Indication | Yes | Yes |
| Visualization
Compatibility | Using imaging guidance (such as
ultrasound, MRI, or radiography) or
aided by non-imaging guidance
(EnVisio Navigation System) | Using imaging guidance (such as
ultrasound, MRI, or radiography) or
aided by non-imaging guidance (SAVI
Scout System) |
| System Components
(Equipment) | Console
• Heads-Up Display
• Patient Pad
• Foot Pedal (optional)
• Cart | • Console |
| System Components
(Sterile) | Navigator
• Calibration Disk | • Hand piece
• Sterile Sheath applied to
nonsterile Handpiece |
| Sterilization Method | Ethylene oxide | Ethylene oxide |
| Implanted Soft Tissue
Marker | Yes - SmartClip | Yes - Reflector |
| Biocompatibility | Not applicable for Navigator and
Calibration Disk - no direct or
indirect patient contact | Yes -Handpiece has direct patient
contact |
Indications for Use Comparison:
5
6. TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS COMPARISON
Performance Testing:
Performance testing was conducted to evaluate and characterize the performance of the EnVisio Navigation System. The following performance testing was conducted on the EnVisio Navigation System to support a determination of substantial equivalence to the predicate device.
- System Design Verification
- Navigation Performance Verification ●
- Navigation Performance Validation ●
6
- EMC/Safety Testing ●
- Packaging/Shelf Life ●
- . Sterilization Validation
Conclusion:
The EnVisio Navigation System met all specified criteria and did not raise new safety or performance questions.
Basis for Determination of Substantial Equivalence:
The Indications for Use, Intended Use, Fundamental Scientific Technology and Principles of Operation for the EnVisio Navigation System are the same as those described for the predicate device.
In summary, the EnVisio Navigation System has the following similarities to the predicate device which has previously received 510(k) clearance:
- Has substantially equivalent indications for use ●
- Has substantially equivalent intended use ●
- Used in substantially equivalent anatomical sites ●
- Uses substantially equivalent technological characteristics ●
- Uses substantially equivalent principles of operation
- Uses substantially equivalent sterilization methodology ●
Therefore, the conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device predicate. The EnVisio Navigation System is substantially equivalent to the predicate device.