The SCOUT MD 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 MD System) the SCOUT MD Reflector is located and surgically removed with the target tissue. The SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

Device Description

The SCOUT MD Delivery System is used to implant the preassembled SCOUT MD Reflector. The needle of the Delivery System is percutaneously advanced into tissue to the site to be marked for biopsy or surgical removal. Needle placement is confirmed under imaging technique (radiographic, ultrasound). The Reflector (tissue marker) is deployed at the target site and the Delivery Device is removed from the patient and discarded. The Reflector, a passive implant, remains in situ and, if surgical removal of the target tissue is necessary, the Reflector is located at the time of surgery (intraoperatively) by the SCOUT MD Surgical Guidance System. The SCOUT MD Guide/Handpiece connected to the SCOUT MD Console is used to detect the SCOUT MD Reflector but it does not contact tissue. SCOUT MD Guides are always used while inside the SCOUT Guide Sheath. When the SCOUT MD System detects the Reflector, the Console emits audible feedback that increases in cadence as the Guide is placed closer to the Reflector. The distance between the distal end of the Guide and the detected Reflector, in millimeters, is displayed on the Console. If necessary, the Reflector is removed from the patient during a subsequent surgical procedure along with the tissue of interest or the Reflector can be left in-situ.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the SCOUT MD Surgical Guidance System. It aims to demonstrate substantial equivalence to a predicate device, the SAVI Scout Reflector and SAVI Scout System.

However, the document does not contain the detailed performance data, acceptance criteria, or study methodologies that would typically be described in a clinical study report for proving a device meets specific acceptance criteria. Instead, it lists the types of tests performed to support substantial equivalence.

Therefore, I cannot extract answers to many of your specific questions regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert roles, and MRMC studies, as this information is not present in the provided text.

The document implicitly "proves" the device meets acceptance criteria by stating that the results of safety and performance tests demonstrate the device is substantially equivalent to the predicate, and that any differences do not raise new questions of safety and effectiveness. This is the core argument for a 510(k) submission.

Here's an attempt to answer what can be inferred or directly stated from the provided text, with clear indications where the information is not available.

Acceptance Criteria and Device Performance (Inferred/Stated)

While explicit numerical acceptance criteria are not detailed, the summary implies that the device performance met the standards for demonstrating substantial equivalence to the predicate. The performance "tests" enumerated are implicitly the method by which acceptance was determined.

Acceptance Criteria Type (Inferred)	Reported Device Performance (Inferred/Stated)
Software Verification and Validation	Performed per IEC 62304 and FDA Guidance; documentation provided.
Integrity (System withstands operating pressures)	Tests performed; results demonstrate substantial equivalence.
Functional Testing (Deployment, detection, accuracy)	Tests performed; results demonstrate substantial equivalence.
Dimensional Inspection and Testing (for each component)	Tests performed; results demonstrate substantial equivalence.
Safety & Functional Testing (for each component and entire system)	Tests performed; results demonstrate substantial equivalence.
Performance Simulated Use (Deployment and detection test)	Tests performed; results demonstrate substantial equivalence.
MR Compatibility Testing	Performed per ASTM F2503; device is MR Unsafe (same as predicate).
Biocompatibility Evaluation	Performed per ISO 10993-1.
Sterilization Validation	Performed per ISO 11135 (SAL 10-6 achieved, same as predicate).
Packaging Validation	Performed per ASTM D4169.
Accelerated Aging	Performed per ASTM F1980.
Electrical Safety & EMC	In accordance with IEC 60601-1 and IEC 60601-1-2.
Overall substantial equivalence to predicate	Demonstrated that the subject device meets its performance specifications and will perform as intended, and that differences do not raise new questions of safety and effectiveness.

Study Details (Information from the Text):

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document lists types of performance tests, but not the sample sizes used for those tests (e.g., number of devices tested, number of simulated deployments, or any human subject data).
- Data Provenance: Not specified. The document does not mention the country of origin of any data or whether the studies were retrospective or prospective. Given the nature of the tests listed (e.g., integrity, functional, electrical safety, biocompatibility, simulated use), these are typically bench or lab-based engineering verification and validation activities, not clinical studies with human subjects in the traditional sense for AI/imaging devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The listed tests are primarily engineering and bench testing, not clinical performance studies requiring expert ground truth establishment in the context of diagnostic accuracy. If "Simulated Use" involved expert assessment, it's not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. This typically refers to clinical image interpretation studies, which are not detailed here.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No evidence of an MRMC study. This device (SCOUT MD Surgical Guidance System) is an implantable marker and a localization system. It does not appear to be an AI-powered diagnostic imaging device that would assist human readers in interpreting images. Its function is to non-imaging detect and localize an implanted reflector.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD Reflector." The functional and performance tests mentioned (deployment, detection, accuracy) would constitute standalone performance evaluation of the algorithm and system components. The specific details of how thoroughly this was tested are not explicitly described beyond listing the types of tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering and functional tests described (e.g., dimensional accuracy, detection range accuracy, material properties), the "ground truth" would be engineering specifications, physical measurements, and established scientific standards (e.g., ISO, ASTM standards for materials, sterilization, electrical safety). There is no mention of expert consensus, pathology, or outcomes data as ground truth, as these tests are not related to diagnostic accuracy.
The sample size for the training set:
- Not applicable / Not provided. The document describes a "Surgical Guidance System" that non-imaging detects an implanted marker. There is no indication that this system uses machine learning or requires a 'training set' in the context of AI model development. The principle of operation is described as measuring the relative strength of RF reflective energy.
How the ground truth for the training set was established:
- Not applicable / Not provided. As there's no mention of a traditional 'training set' for an AI model, this question is not relevant to the information provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 12, 2024

Merit Medical System, Inc. Saboo Sandeep Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095

Re: K231468

Trade/Device Name: SCOUT MD Surgical Guidance System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: May 19, 2023 Received: May 22, 2023

Dear Saboo Sandeep:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Digitally signed by Tek Tek N. N. Lamichhane -S Lamichhane -S Date: 2024.02.12 07:53:58 -05'00' Tek Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231468

Device Name SCOUT MD Surgical Guidance System

Indications for Use (Describe)

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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SCOUT MD Surgical Guidance System

Traditional 510(k) Premarket Notification

510(k) Summary-K231468

GeneralProvisions	Submitter Name:Address:Telephone Number:Contact Person:Date of Preparation:Registration Number:	Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(510) 468-9995Sandeep Saboo02 February 20241721504
SubjectDevice	Trade Name:Common/Usual Name:Classification Name:	SCOUT MD Surgical Guidance SystemImplantable ClipMarker, Radiographic, Implantable
Predicate Device	Trade Name:Classification Name:Premarket Notification: K181007Manufacturer:	SAVI Scout Reflector and SAVI Scout SystemMarker, Radiographic, ImplantableMerit Medical Systems, Inc.Predicate has not been a subject of a design related recall.
Classification	Class:Regulation:FDA Product Code:Review Panel:	Class II21 CFR 878.4300NEUGeneral & Plastic Surgery
IntendedUse/IndicationsFor Use	The SCOUT MD 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 imagingguidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance(SCOUT MD System) the SCOUT MD Reflector is located and surgically removed with thetarget tissue. The SCOUT MD System is intended only for the non-imaging detection andlocalization of the SCOUT MD Reflector that has been implanted in a soft tissue biopsy siteor a soft tissue site intended for surgical removal.

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The SCOUT MD Surgical Guidance System consists of the following components:

. SCOUT MD Delivery System, which includes two components:
- o SCOUT MD Reflector
  - o SCOUT MD Delivery Device
SCOUT MD Guide
SCOUT MD Handpiece
. SCOUT MD Console

Device Description The SCOUT MD Delivery System is used to implant the preassembled SCOUT MD Reflector. The needle of the Delivery System is percutaneously advanced into tissue to the site to be marked for biopsy or surgical removal. Needle placement is confirmed under imaging technique (radiographic, ultrasound). The Reflector (tissue marker) is deployed at the target site and the Delivery Device is removed from the patient and discarded. The Reflector, a passive implant, remains in situ and, if surgical removal of the target tissue is necessary, the Reflector is located at the time of surgery (intraoperatively) by the SCOUT MD Surgical Guidance System. The SCOUT MD Guide/Handpiece connected to the SCOUT MD Console is used to detect the SCOUT MD Reflector but it does not contact tissue. SCOUT MD Guides are always used while inside the SCOUT Guide Sheath. When the SCOUT MD System detects the Reflector, the Console emits audible feedback that increases in cadence as the Guide is placed closer to the Reflector. The distance between the distal end of the Guide and the detected Reflector, in millimeters, is displayed on the Console. If necessary, the Reflector is removed from the patient during a subsequent surgical procedure along with the tissue of interest or the Reflector can be left in-situ.

When compared to the predicate device (SAVI Scout System), the SCOUT MD Surgical Guidance System:

Has the same indications for use;
Has the same intended use;
Has the same mechanism of action and principles of operation.

The fundamental scientific technology, use and materials/design of the subject device, SCOUT MD Surgical Guidance System, are the same as those of the predicate SAVI Scout Comparison to System. The principle of operation and mechanism of action are the same. As with the Predicate predicate device SAVI Scout System, the SCOUT MD Delivery System is used to implant the preassembled SCOUT MD Reflector while the SCOUT MD Guides/Handpieces and the SCOUT MD Console are used to detect the SCOUT MD Reflector.

Provided in the table below is a comparison of the subject and the predicate devices. Based on the comparison, the intended/indications for use and technological characteristics of the SCOUT MD Surgical Guidance System are substantially equivalent to the predicate device (SAVI Scout Reflector and SAVI SCOUT System cleared per K181007).

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SCOUT MD Surgical Guidance System

Traditional 510(k) Premarket Notification

Device Type →	SUBJECT Device (K231468)	PREDICATE Device (K181007)
Manufacturer →	Merit Medical Systems, Inc.	Merit Medical Systems, Inc.
Device Name →	SCOUT MD Surgical Guidance System	SAVI Scout Reflector andSAVI SCOUT System	Result ofComparison
Class	II	II	No Difference
RegulationName	Implantable Clip	Implantable Clip	No Difference
RegulationNumber	878.4300	878.4300	No Difference
Product Code	NEU	NEU	No Difference
Product CodeDescription	Marker, Radiographic, Implantable	Marker, Radiographic, Implantable	No Difference
Indications forUse:	The SCOUT MD Reflector is intendedto be placed percutaneously in softtissue to mark (>30 days) a biopsy siteor a soft tissue site intended forsurgical removal. Using imagingguidance (such as ultrasound, MRI, orradiography) or aided by non-imagingguidance (SCOUT MD System) theSCOUT MD Reflector is located andsurgically removed with the targettissue. The SCOUT MD System isintended only for the non-imagingdetection and localization of theSCOUT MD Reflector that has beenimplanted in a soft tissue biopsy site ora soft tissue site intended for surgicalremoval.	The SAVI Scout Reflector is intended tobe placed percutaneously in soft tissueto mark (>30 days) a biopsy site or asoft tissue site intended for surgicalremoval. Using imaging guidance (suchas ultrasound, MRI, or radiography) oraided by non-imaging guidance (SAVIScout System) the SAVI Scout Reflectoris located and surgically removed withthe target tissue. The SAVI ScoutSystem is intended only for the non-imaging detection and localization ofthe SAVI Scout Reflector that has beenimplanted in a soft tissue biopsy site ora soft tissue site intended for surgicalremoval.	No Difference(other thanproduct name)
		SYSTEM COMPARISON
Procedure(s)Used	Used in guided surgical removal ofsoft tissue (e.g. breast tumor andrelated tissue).	Used in guided surgical removal ofsoft tissue (e.g. breast tumor andrelated tissue).	No Difference
Useenvironment	Intra-operative, guided surgicalprocedure	Intra-operative, guided surgicalprocedure	No Difference
Patientpopulation	Adult patient diagnosed withcarcinoma who are medically eligiblefor tumor resection	Adult patient diagnosed withcarcinoma who are medically eligiblefor tumor resection	No Difference
Tissue Type	Soft tissue, including breast	Soft tissue, including breast	No Difference
Principle ofOperation(localizationtechnique)	Implantable reflector (marker) usedin conjunction with proprietarylocation detection system whichmeasures relative strength of RFreflective energy and providesproximity/location and distanceinformation to the user	Implantable reflector (marker) usedin conjunction with proprietarylocation detection system whichmeasures relative strength of RFreflective energy and providesproximity/location information tothe user	MinorDifference
Systemcomponents	• Reflector (marker)• Reflector Delivery System• Guide (handpiece)• Console	• Reflector (marker)• Reflector Delivery System• Guide (handpiece)• Console	No Difference
REFLECTOR COMPARISON(Reflector is a component of the Delivery System)
How provided	Sterile, assembled within the DeliverySystem	Sterile, assembled within the DeliverySystem	No Difference
SAL	SAL 10-6	SAL 10-6	No Difference
ImplantDuration	> 30 days	> 30 days	No Difference
Reflector body	• 4mm (length) x 1.3.mm (dia),• Loctite 3922 (Fully encaseselectronics)	• 4mm (length) x 1.3.mm (dia),• Loctite 3922 (Fully encaseselectronics)	No Difference
Reflector length(end to end)	Two Length Options• 12mm• 8mm	12mm	Similar:A smallerReflector isavailable tomeet clinicianneeds.
Reflectortissuecontactingmaterials	• Nitinol SE508, light oxide [ASTMF2063-D]• Loctite 3922	• Nitinol SE508, light oxide [ASTMF2063-D]• Loctite 3922	No Difference
Reflectorshapes	Four (4)	One (1)	Similar:4 uniqueshapes allowclinicians todistinguishwhen multiplemarker(s) areimplanted
Reflectoractivity	Responsive (in presence of IR light)marker; passive marker (in absenceof IR light)	Responsive (in presence of IR light)marker; passive marker (in absenceof IR light)	No Difference
Reflectorvisibility	Visible under radiography, MR andultrasound	Visible under radiography, MR andultrasound	No Difference
DELIVERY SYSTEM COMPARISON(see above for comparison of Reflector, a component of the Delivery System)
How providedUse	Sterile (SAL ≥ 10-6)Single-use	Sterile (SAL ≥ 10-6)Single-use	No DifferenceNo Difference
SterilizationMethod	EO	EO	No Difference
MRCompatibility	MR Unsafe	MR Unsafe	No Difference
Delivery ofReflector	Needle delivery system forpercutaneous placement of Reflector(marker)	Needle delivery system forpercutaneous placement of Reflector(marker)	No Difference
WorkingLength	5cm, 7.5cm and 10cm	5cm, 7.5cm and 10cm	No Difference
	GUIDE/HANDPIECE COMPARISON
How provided	Non-sterile for Reuse and Sterile,Single-Use Configurations	Non-sterile for Reuse and Sterile,Single-Use Configurations	No Difference
Primaryfunctions	• Receives micro impulse radar signal(RF electromagnetic wave signals)from Console.• Delivers RF electromagnetic wavesignal and infrared light pulses tosoft tissue.• Receives reflected signal back fromthe detected Reflector andtransmits data to the connectedConsole.	• Receives micro impulse radar signal(RF electromagnetic wave signals)from Console.• Delivers RF electromagnetic wavesignal and infrared light pulses tosoft tissue.• Receives reflected signal back fromthe detected Reflector andtransmits data to the connectedConsole.	No Difference
GuideHandpieceLength	Handpiece Length: 140 mm length	Handpiece Length: 140 mm length	No Difference
Guide/Consoleinterface	Cable	Cable	No Difference
Cables	• Flexible, instant signal processing• Tether probe to surgical Field	• Flexible, instant signal processing• Tether probe to surgical Field	No Difference
	CONSOLE COMPARISON
Consolecalibration	At Factory	At Factory	No Difference
ReflectorLocalization	• Delivers micro impulse radar signal (RFelectromagnetic wave signals) to Guide.• Provides power to the Guide to enableGuide to output infrared light.• Receives reflected RF electromagneticwave signal from the Reflector throughthe Guide.• The time delay between thetransmitted signal and the truereflected signal is used to determine thedistance between the distal surface ofthe Guide Handpiece and the Reflector.	• Delivers micro impulse radar signal (RFelectromagnetic wave signals) to Guide.• Provides power to the Guide to enableGuide to output infrared light.• Receives reflected RF electromagneticwave signal from the Reflector throughthe Guide.• The time delay between thetransmitted signal and the truereflected signal is used to determine thedistance between the distal surface ofthe Guide Handpiece and the Reflector.	No Difference
User interface	Touchscreen Display with volumecontrol, start/stop, mode selection	LCD Display. Separate buttons forvolume control, start/stop	MinorDifference
Audiblelocationinformation(Cadence)	Higher click rate = closer proximity tosite of Reflector (marker)	Higher click rate = closer proximity tosite of Reflector (marker)	No Difference
DistinctAudiblelocationinformation(Tone)	Provides for all compatible Reflectors(up to four) unique click tones	Provides for a single-compatibleReflector a unique click tone.	No Difference

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SCOUT MD Surgical Guidance System

Traditional 510(k) Premarket Notification

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SCOUT MD Surgical Guidance System

Traditional 510(k) Premarket Notification

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SCOUT MD Surgical Guidance System

Traditional 510(k) Premarket Notification

The following performance data have been provided in support of the substantial equivalence determination. • Software Verification and Validation Testing performed per IEC 62304 and documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." · Other Tests were performed per approved test protocols which included: Integrity: System withstands operating pressures O O Functional Testing: Deployment, detection, accuracy Dimensional Inspection and Testing: For each component of the system O Safety & Functional Testing for each component of the system and the entire system O Performance Simulated Use: Deployment and detection test O Tests MR Compatibility Testing per ASTM F2503 O O Biocompatibility Evaluation per ISO 10993-1 Sterilization Validation per ISO 11135 O Packaging Validation per ASTM D4169 O Accelerated Aging per ASTM F1980 O O Electrical Safety & EMC: In accordance with IEC 60601-1 and IEC 60601-1-2 The results of safety and performance tests demonstrate that the SCOUT MD Surgical Guidance System (subject device) is substantially equivalent to the predicate device (SAVI Scout Reflector and SAVI Scout System cleared per K181007). Based on the comparison of intended/indications for use and technological characteristics, the subject device is substantially equivalent to the predicate device. The performance tests for each system component and the hardware and software Summary of verification and validation testing demonstrate that the subject device meets its Substantial performance specifications and will perform as intended in the specified use Equivalence conditions and that any differences between the subject device and predicate device do not raise new questions of safety and effectiveness. Therefore, the subject device can be found to be substantially equivalent to the predicate device (SAVI Scout Reflector and SAVI Scout System cleared per K181007).

Regulation Number and Section

§ 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.