(210 days)
No reference devices were used in this submission.
No
The summary describes a physical device (reflector and delivery system) and a guidance system that uses non-imaging detection to locate the reflector. There is no mention of AI, ML, or image processing being used for analysis or decision-making.
No
The device is described as a guidance system for surgical removal of tissue, not for treating a disease or condition.
No.
The device is intended for marking a biopsy site or soft tissue site for surgical removal and guiding its surgical excision, not for diagnosing a condition or disease. It is a localization and guidance system.
No
The device description explicitly mentions hardware components like the SCOUT Reflector, delivery system, SCOUT Handpiece, and SCOUT Console, and the performance studies include testing of physical properties and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to mark a biopsy site or soft tissue site for surgical removal and to guide the surgeon in the excision of tissue. This is a surgical guidance and marking device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The device is a delivery system for a reflector that is implanted in the body. It works in conjunction with a console and handpiece to locate the reflector. This is a physical implant and guidance system, not a diagnostic test performed on biological samples.
- Lack of Diagnostic Function: The device's function is to aid in the physical location and removal of tissue, not to analyze biological samples or provide diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information for medical diagnosis. This device's purpose is entirely focused on surgical guidance and localization within the body.
N/A
Intended Use / Indications for Use
Using SCOUT Bx Delivery System, the SCOUT Reflector is intended to be placed percutaneously in soft tissue (>30 days) to 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 (SCOUT System) the SCOUT Reflector is located and surgically removed with the target tissue. The SCOUT System is intended only for the non-imaging detection and localization of the SCOUT Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
Product codes
NEU
Device Description
The SCOUT Bx Delivery System (including the SCOUT Reflector) is a sterile, single use device composed of a SCOUT Reflector preloaded in a delivery system. The SCOUT Reflector, when used in conjunction with the SCOUT Handpiece and SCOUT Console, can be used as a guide for the surgeon to follow in the excision of tissue. The SCOUT Reflector is visible using ultrasound and radiography. The SCOUT® Console, SCOUT Handpiece and SCOUT Reflector are components of the SCOUT Surgical Guidance System. The SCOUT Bx Delivery System is intended to be used with compatible Hologic® Biopsy Devices (Eviva® 0913-20, Eviva 1213-20, BREV09 (20mm aperture) and ATEC® ILS 0914-20).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, MRI, or radiography
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
April 8, 2022
Merit Medical Systems, Inc. Sari Stevens Senior Regulatory Affairs Specialist 1600 W Merit Parkway South Jordan, Utah 84095
Re: K212882
Trade/Device Name: SCOUT BX Delivery System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: September 8, 2021 Received: September 10, 2021
Dear Sari Stevens:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212882
Device Name SCOUT Bx Delivery System
Indications for Use (Describe)
Using SCOUT Bx Delivery System, the SCOUT Reflector is intended to be placed percutaneously in soft tissue (>30 days) to 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 (SCOUT Reflector is located and surgically removed with the target tissue. The SCOUT System is intended only for the non-imaging detection and localization of the SCOUT Reflector that has been implanted in 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 208-4674
Sandeep Saboo
04/01/2022
1721504 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | SCOUT Bx™ Delivery System
Implantable Chip
Marker, Radiographic, Implantable
2
NEU
878.4300
General & Plastic Surgery |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | SCOUT Surgical Guidance System
Marker, Radiographic, Implantable
K181007
Merit Medical Systems, Inc. |
| Reference
Device | | No reference devices were used in this submission. |
| Device
Description | The SCOUT Bx Delivery System (including the SCOUT Reflector) is a
sterile, single use device composed of a SCOUT Reflector preloaded in
a delivery system. The SCOUT Reflector, when used in conjunction
with the SCOUT Handpiece and SCOUT Console, can be used as a
guide for the surgeon to follow in the excision of tissue. The SCOUT
Reflector is visible using ultrasound and radiography. The SCOUT®
Console, SCOUT Handpiece and SCOUT Reflector are components of
the SCOUT Surgical Guidance System. The SCOUT Bx Delivery
System is intended to be used with compatible Hologic® Biopsy
Devices (Eviva® 0913-20, Eviva 1213-20, BREV09 (20mm aperture)
and ATEC® ILS 0914-20). | |
| Indications for
Use | Using SCOUT Bx Delivery System, the SCOUT Reflector is intended to
be placed percutaneously in soft tissue (>30 days) to 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 (SCOUT System) the SCOUT Reflector is located
and surgically removed with the target tissue. The SCOUT System is
intended only for the non-imaging detection and localization of the
SCOUT Reflector that has been implanted in a soft tissue biopsy site or
a soft tissue site intended for surgical removal. | |
| Comparison to
Predicate
Device | | The SCOUT Bx Delivery Device has the similar design and
technological characteristics as the predicate SCOUT Delivery Device.
Both devices are used with the SCOUT Surgical Guidance System to
implant the SCOUT Reflector to the target tissue. The subject device
differs from the predicate device in.
• Blunt cannula compared to the sharp cannula |
4
- No depth marks on the blunt cannula ●
- Compatible with legally marketed 3rd party biopsy devices ●
- Plunger for deplovment instead of a trigger ●
- . Allows for Stereotactic (X-ray) and MRI deployment imaging instead of X-ray and ultrasound imaging
- Longer Length
- Change in grade of stainless steel for tube and plunger ●
- Change in non-patient contacting materials in device handle
- . 15G instead of 16G
- . Indications for Use statement has minor updates due to updated branding and readability; removal of word "SAVI", capitalization of "SCOUT", moved "(>30 days)" from after word "mark" to after "tissue"
The comparison between the subject and reference devices is based on the following:
- Same intended use ●
- Same Indications for Use ●
- Same sterilization methods
- Same fundamental technology/principle of operation between ● the subject and predicate devices
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject SCOUT Bx Delivery System was conducted based on the risk analysis and based on the requirements of the following international standard:
- . ISO 7864 Fourth edition 2016-08-01, Sterile hypodermic needles for single use - Requirements and test methods
- ISO 9626:2016. Stainless steel needle tubing for the manufacture of . medical devices - Requirements and test methods
- JIS T 3228, Biopsy needles for single use ●
- ISO 10993-1:2018, Biological Evaluation of Medical Devices Part ● 1: Evaluation and testing within a risk management process
- . ISO 10993-5:2009. Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Data
- . ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2017, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
- USP 43-NF38:2020 Pyrogen Test
- ISO 11607-1: 2019, Packaging for terminally sterilized medical ● devices
- ASTM D4169-16, Standard Practice for Performance Testing of ● Shipping Containers and Systems
- EN ISO 2233: 2001 Packaging Complete, Filled Transport ● Packages and Unit Loads - Conditioning for Testing
- ISO 11135 Second edition 2014-07-15 Sterilization of health-care . products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
Performance
5
- ISO 10993-7:2008, Biological Evaluation of Medical Devices Part ● 7: Ethylene Oxide Sterilization Residuals.
- ASTM F88-15, Standard Test Method for Seal Strength of Flexible • Barrier Materials
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the SCOUT Bx Delivery System was conducted in accordance with ISO 10993-1:2018. The battery of testing included the following tests:
- Cytotoxicity ●
- Sensitization ●
- Irritation ●
- Acute Systemic Toxicity ●
- Pyrogenicity .
The SCOUT Bx Delivery System is considered tissue contacting for a duration of less than 24 hours.
| Performance Testing-Bench | |
|---|---|
| Compatibility with legally marketed 3rd party Biopsy Device Deployment Accuracy Cannula Effective Length & OD Plunger to Handle Tensile Plunger to Rod Tensile Handle to Cannula Tensile Resistance to Corrosion Design Validation Packaging Qualification | |
| Performance | |
| Data cont. | No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of the device. |
| Summary of | |
| Substantial | |
| Equivalence |