(50 days)
Not Found
No
The device description and performance studies focus on a mechanical adjunct for stent positioning, with no mention of AI/ML algorithms, data processing, or training/test sets.
No.
The device is an "adjunct device" to "maneuver endo-vascular stent delivery systems and support their positioning." It does not directly treat a disease or condition.
No
The device description indicates SPAS is an adjunct device used to maneuver and support the positioning of endo-vascular stent delivery systems and coronary stents during Percutaneous Coronary Interventions (PCI). It does not analyze patient data or provide diagnostic information; instead, it aids in a therapeutic procedure.
No
The device description clearly states that SPAS is a "sterile disposable device" made of "biocompatible polycarbonate with an inner polymer sleeve/hub," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- SPAS Function: The description clearly states that 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)". This means it is used within the body during a medical procedure.
- Anatomical Site: The anatomical site is "Coronary," indicating use within the heart's blood vessels.
- Intended User/Care Setting: The intended users are "Cardiologists in coronary stenting procedures," further confirming its use in a clinical procedure setting.
The device's purpose is to assist in the mechanical delivery and positioning of a stent within a blood vessel, not to analyze biological samples.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Clinical performance testing has been performed on the proposed Stent Positioning Assistance System (SPAS) and included the performance of an usability evaluation of the SPAS device in coronary stenting procedures.
The main study objective of this multi-center usability study was to evaluate the 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 stenting procedures. The usability evaluation using a 7-point device usability questionnaire showed that operators were satisfied with the SPAS device. Moreover, no (device-related) adverse events were reported in a wide range of cardiac stenting procedures, from standard to complex.
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
§ 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.
0
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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
1
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)
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
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 Street | |
| Tel Aviv, 67443 | |
| Israel | |
| Primary Contact | |
| Person: | Vladimir Trapeznikov |
| CEO | |
| E-mail: vt@spas-system.com |
| Device: | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Trade Name:Stent Positioning Assistance System (SPAS)Classification Name:Catheter Guide WireClassification | |||||||||||||
| Regulation:21CFR 870.1330Classification Panel:CardiovascularDevice Class:Class IIPrimary Product Code:DQX | Trade Name: | Stent Positioning Assistance System (SPAS) | Classification Name: | Catheter Guide Wire | Classification | ||||||||
| Regulation: | 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 | ||||||||||||
| Classification | |||||||||||||
| Regulation: | 21CFR 870.1330 | ||||||||||||
| Classification Panel: | Cardiovascular | ||||||||||||
| Device Class: | Class II | ||||||||||||
| Primary Product Code: | DQX |
| Primary Predicate
| Device: | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Trade Name:Distal Access Torque Device or Controller | |||||||||||||||||
| (Predict or Spinr)Manufacturer:Distal Access, LLC510(k) Clearance:K141054Classification Name:Catheter Guide WireClassification | |||||||||||||||||
| Regulation: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 | Classification | ||||||||||
| Regulation: | 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 | ||||||||||||||||
| Classification | |||||||||||||||||
| Regulation: | 21CFR §870.1330 | ||||||||||||||||
| Classification Panel: | Cardiovascular | ||||||||||||||||
| Device Class: | Class II | ||||||||||||||||
| Product Code: | DQX |
4
| 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. | |
| Indications for Use: | SPAS is an adjunct device intended to be used to manoeuvre endo-
vascular stent delivery systems and support their positioning in
Percutaneous Coronary Interventions (PCI). SPAS is not intended for use
in neurovascular interventional procedures. | |
| Technological characteristics: | The subject device and the predicates share the same intended use and
compatibility with endovascular procedural devices. The subject device
and the predicate control the movement of the connected devices by
rotatory motions. Both devices share similar technological characteristics
(materials, sterilization method, single use and torque ability) as listed
detail in below table. | |
| | Proposed Device | Predicate Device |
| | SPAS | Distal Access torque
device (Predict or Spinr) |
| Torque | The device can | The Distal Access torque |
| | SPAS | Distal Access torque
device (Predict or Spinr) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Torque
assist
provided
by | The device can
fix/release the coronary
stent delivery system and
move the fixed delivery
system in both forward
and backward directions.
The delivery system is
moved by rotatory
motions of the back of
the device. | The Distal Access torque
device manually rotates
devices between 3 and 5
times clockwise and counter
clockwise as per the labelled
number of rotations.
Rotation is manually
controlled by the user's
finger, thumb and hand. |
| Sterility | Sterile, ethylene oxide
sterilization. Shelf life is
defined. | Sterile, ethylene oxide
sterilization. Shelf life is
defined. |
5
| Material | Polycarbonate (body, cap, traveler, retainer)
Elastomer (insert) | Medical grade polycarbonate (sleeve, grip, body, screw, slider, and cap components)
Stainless steel spring |
| ---------- | --------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
|---|
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-
Clinical
Performance Data: | Non-clinical performance testing has been performed on the proposed
Stent Positioning Assistance System (SPAS) and demonstrates
compliance with the following FDA recognized consensus standards: |
| -------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- . 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.
6
| Summary of
Clinical
Performance Data: | Clinical performance testing has been performed on the proposed Stent
Positioning Assistance System (SPAS) and included the performance of
an usability evaluation of the SPAS device in coronary stenting
procedures. |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The main study objective of this multi-center usability study was to evaluate
the 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 stenting
procedures. The usability evaluation using a 7-point device usability
questionnaire showed that operators were satisfied with the SPAS device.
Moreover, no (device-related) adverse events were reported in a wide
range of cardiac stenting procedures, from standard to complex. |
| Substantial
Equivalence
Conclusion: | The Stent Positioning Assistance System (SPAS) is substantially
equivalent to the currently marketed predicate device Distal Access
Torque Device (K141054) in terms of indications for use,
technological characteristic, and safety and effectiveness. |
| | Additionally, substantial equivalence was demonstrated by non-clinical
performance tests provided in this 510(k) premarket notification. These
tests demonstrate that the device complies with the requirements
specified in the international and FDA-recognized consensus standards
and is as safe and effective as its predicate device without raising any
new safety and/or effectiveness concerns. |