SPAS is an adjunct device intended to be used to maneuver endo-vascular stent delivery systems and support their positioning in Percutaneous Coronary Interventions (PCI). SPAS is not intended for use in neurovascular interventional procedures

Device Description

SPAS is a sterile disposable device, which serves as adjunct to compatible coronary stent delivery systems. It interfaces with the coronary stent delivery system and supports the positioning the coronary stent on the delivery system. SPAS is made of biocompatible polycarbonate with an inner polymer sleeve/hub, which interfaces with the distal outer diameter of the catheter of stent delivery systems. It does not interfere with proximal catheter handling until the stent target region is approximated. Then it is slid to the most proximal outer part of the patient's vascular access and fixated with its inner sleeve to the delivery catheter to allow its precise advancement and positioning in the target region.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal / Test)	Reported Device Performance (Result)
Non-Clinical Performance
Biocompatibility	Complies with ISO 10993-1:2018 (Biological evaluation of medical devices).
Sterilization Effectiveness	Complies with ISO 11135-1:2014 (Sterilization of health care products - Ethylene oxide). Device is sterile with defined shelf life.
Packaging Integrity (Sterile Barrier)	Complies with ISO 11607-1:2019 (Packaging for terminally sterilized medical devices - Part 1).
Packaging Process Validation	Complies with ISO 11607-2:2019 (Packaging for terminally sterilized medical devices - Part 2).
Risk Management	Complies with ISO 14971:2019 (Medical devices - Application of risk management).
Torque Ability	Demonstrated by non-clinical verification testing. The device can fix/release the coronary stent delivery system and move it in both forward and backward directions via rotatory motions. (Compared to predicate: manually rotates devices between 3 and 5 times clockwise and counter-clockwise.)
Compatibility	Demonstrated by non-clinical verification testing (compatibility with compatible coronary stent delivery systems).
Usability (Non-clinical)	Demonstrated by non-clinical verification testing.
Clinical Performance
Usability (Clinical)	Operators were satisfied with the SPAS device, as evaluated using a 7-point device usability questionnaire.
Safety / Adverse Events	No (device-related) adverse events were reported in a wide range of cardiac stenting procedures (standard to complex).
Effectiveness / Stent Positioning	The study's main objective was to evaluate the usability of the SPAS device in stent positioning. While "satisfaction" is reported, specific metrics for "effectiveness" in positioning are not explicitly detailed in the provided text beyond the general statement of usability. However, the absence of adverse events suggests it did not hinder the procedure. This is implied to be met through successful procedures and user satisfaction.
Substantial Equivalence	The SPAS is substantially equivalent to the predicate device (K141054) in terms of intended use, technological characteristics, and safety and effectiveness, supported by both non-clinical and clinical data, and meets specified consensus standards without raising new safety/effectiveness concerns.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 55 standard stenting procedures.
Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "multi-center usability study," implying data from multiple medical institutions. It was a usability evaluation with real device use, so it is a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Seven (7) cardiologists.
Qualifications: "Cardiologists." No further specific details like years of experience or sub-specialization are provided.

4. Adjudication Method for the Test Set

The text describes the usability evaluation using a "7-point device usability questionnaire" completed by the operators (cardiologists). It doesn't mention any independent adjudication of the clinical outcomes or the usability scores by external experts. The cardiologists themselves were the evaluators of usability and adverse events. Therefore, there was no external adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study evaluated the usability of the SPAS device itself. It did not compare the effectiveness of human readers (cardiologists) with and without AI assistance (as SPAS is a mechanical device, not an AI-assisted diagnostic tool).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

N/A. The SPAS is described as a "sterile disposable device" that "serves as adjunct to compatible coronary stent delivery systems." It's a physical, mechanical assistance device, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" doesn't apply. The evaluation inherently involves a human operator (the cardiologist).

7. The Type of Ground Truth Used

For the usability criteria, the "ground truth" was established by the subjective evaluation and feedback from the seven cardiologists through a 7-point usability questionnaire.
For safety, the "ground truth" was the absence of reported device-related adverse events during the 55 procedures, which can be considered an outcome-based assessment of safety.
For the non-clinical performance, the ground truth was compliance with recognized international and FDA-recognized consensus standards (e.g., ISO standards for biocompatibility, sterilization, packaging, risk management), and direct verification testing for torque ability and compatibility.

8. The Sample Size for the Training Set

The provided text does not mention a training set as the device is a physical mechanical device, not a machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

As the device is a physical mechanical device and not a machine learning algorithm, there is no training set mentioned, and therefore no ground truth establishment for a training set. Performance was evaluated through non-clinical testing against standards and a clinical usability study.

Summary

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August 19, 2022

Seven Sons Ltd. Nancy Zhang Regulatory Affairs 65 Yigal Alon Street Tel Aviv. 67443 Israel

Re: K221917

Trade/Device Name: Stent Positioning Assistance System (SPAS) Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: June 17, 2022 Received: June 30, 2022

Dear Nancy Zhang:

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

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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 medical devices and radiation-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 Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221917

Device Name

Stent Positioning Assistance System (SPAS)

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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510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared:	August 15, 2021
Manufacturer:	Seven Sons Ltd.,65 Yigal Alon StreetTel Aviv, 67443Israel
Primary ContactPerson:	Vladimir TrapeznikovCEOE-mail: vt@spas-system.com

Device:
	Trade Name:Stent Positioning Assistance System (SPAS)Classification Name:Catheter Guide WireClassificationRegulation:21CFR 870.1330Classification Panel:CardiovascularDevice Class:Class IIPrimary Product Code:DQX	Trade Name:	Stent Positioning Assistance System (SPAS)	Classification Name:	Catheter Guide Wire	ClassificationRegulation:	21CFR 870.1330	Classification Panel:	Cardiovascular	Device Class:	Class II	Primary Product Code:	DQX
Trade Name:	Stent Positioning Assistance System (SPAS)
Classification Name:	Catheter Guide Wire
ClassificationRegulation:	21CFR 870.1330
Classification Panel:	Cardiovascular
Device Class:	Class II
Primary Product Code:	DQX

Primary PredicateDevice:
	Trade Name:Distal Access Torque Device or Controller(Predict or Spinr)Manufacturer:Distal Access, LLC510(k) Clearance:K141054Classification Name:Catheter Guide WireClassificationRegulation:21CFR §870.1330Classification Panel:CardiovascularDevice Class:Class IIProduct Code:DQX	Trade Name:	Distal Access Torque Device or Controller(Predict or Spinr)	Manufacturer:	Distal Access, LLC	510(k) Clearance:	K141054	Classification Name:	Catheter Guide Wire	ClassificationRegulation:	21CFR §870.1330	Classification Panel:	Cardiovascular	Device Class:	Class II	Product Code:	DQX
Trade Name:	Distal Access Torque Device or Controller(Predict or Spinr)
Manufacturer:	Distal Access, LLC
510(k) Clearance:	K141054
Classification Name:	Catheter Guide Wire
ClassificationRegulation:	21CFR §870.1330
Classification Panel:	Cardiovascular
Device Class:	Class II
Product Code:	DQX

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Device description:	SPAS is a sterile disposable device, which serves as adjunct tocompatible coronary stent delivery systems. It interfaces with thecoronary stent delivery system and supports the positioning the coronarystent on the delivery system.
	SPAS is made of biocompatible polycarbonate with an inner polymersleeve/hub, which interfaces with the distal outer diameter of the catheterof stent delivery systems. It does not interfere with proximal catheterhandling until the stent target region is approximated. Then it is slid tothe most proximal outer part of the patient's vascular access and fixatedwith its inner sleeve to the delivery catheter to allow its preciseadvancement and positioning in the target region.
Indications for Use:	SPAS is an adjunct device intended to be used to manoeuvre endo-vascular stent delivery systems and support their positioning inPercutaneous Coronary Interventions (PCI). SPAS is not intended for usein neurovascular interventional procedures.
Technological characteristics:	The subject device and the predicates share the same intended use andcompatibility with endovascular procedural devices. The subject deviceand the predicate control the movement of the connected devices byrotatory motions. Both devices share similar technological characteristics(materials, sterilization method, single use and torque ability) as listeddetail in below table.
	Proposed Device	Predicate Device
	SPAS	Distal Access torquedevice (Predict or Spinr)
Torque	The device can	The Distal Access torque

	SPAS	Distal Access torquedevice (Predict or Spinr)
Torqueassistprovidedby	The device canfix/release the coronarystent delivery system andmove the fixed deliverysystem in both forwardand backward directions.The delivery system ismoved by rotatorymotions of the back ofthe device.	The Distal Access torquedevice manually rotatesdevices between 3 and 5times clockwise and counterclockwise as per the labellednumber of rotations.Rotation is manuallycontrolled by the user'sfinger, thumb and hand.
Sterility	Sterile, ethylene oxidesterilization. Shelf life isdefined.	Sterile, ethylene oxidesterilization. Shelf life isdefined.

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Material	Polycarbonate (body, cap, traveler, retainer)Elastomer (insert)	Medical grade polycarbonate (sleeve, grip, body, screw, slider, and cap components)Stainless steel spring
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The SPAS device is substantially equivalent to the predicate devices with regards to its intended use, design function, materials and sterilization method.

Summary of Non-ClinicalPerformance Data:	Non-clinical performance testing has been performed on the proposedStent Positioning Assistance System (SPAS) and demonstratescompliance with the following FDA recognized consensus standards:
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. ISO 10993-1:2018. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 11135-1:2014, Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
ISO 11607-1: 2019. Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
. ISO 11607-2: 2019, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 14971: 2019 Medical devices - Application of risk management to medical devices

Non-clinical verification testing has been performed to demonstrate the torque ability, compatibility and usability of the proposed device.

All these tests were used to support substantial equivalence of the subject device and demonstrate that Stent Positioning Assistance System (SPAS)

. complies with the aforementioned international and FDA-recognized consensus standards, and
meets the acceptance criteria and is adequate for its intended use.

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Summary ofClinicalPerformance Data:	Clinical performance testing has been performed on the proposed StentPositioning Assistance System (SPAS) and included the performance ofan usability evaluation of the SPAS device in coronary stentingprocedures.
	The main study objective of this multi-center usability study was to evaluatethe usability of the SPAS device in stent positioning. In addition,device-related adverse events and serious adverse events were investigated.
	The SPAS device was deployed by seven cardiologists in 55 standard stentingprocedures. The usability evaluation using a 7-point device usabilityquestionnaire showed that operators were satisfied with the SPAS device.Moreover, no (device-related) adverse events were reported in a widerange of cardiac stenting procedures, from standard to complex.
SubstantialEquivalenceConclusion:	The Stent Positioning Assistance System (SPAS) is substantiallyequivalent to the currently marketed predicate device Distal AccessTorque Device (K141054) in terms of indications for use,technological characteristic, and safety and effectiveness.
	Additionally, substantial equivalence was demonstrated by non-clinicalperformance tests provided in this 510(k) premarket notification. Thesetests demonstrate that the device complies with the requirementsspecified in the international and FDA-recognized consensus standardsand is as safe and effective as its predicate device without raising anynew safety and/or effectiveness concerns.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.