(121 days)
The Halo™ Single-Loop Snare Kit is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.
Halo™ Single-Loop Snare Kit contains: (1) Snare, (1) Snare Catheter, (1) Introducer and (1) Torque Handle. The snare is constructed of a flexible and radiopaque loop. The pre-formed snare loop can be introduced through the snare catheter without risk of snare deformation because of the snare's super-elastic construction. The snare catheter is constructed of flexible tubing and contains a radiopaque marker band.
The provided text describes a 510(k) premarket notification for the Halo™ Single-Loop Snare Kit. This documentation is for a medical device (a snare kit), not an AI device or software. Therefore, the questions related to AI device performance, such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance, and training set ground truth establishment, are not applicable to this submission.
The document discusses non-clinical performance tests conducted to demonstrate substantial equivalence to predicate devices. These tests are focused on the physical and material properties of the snare kit.
Here's an analysis based on the provided text, focusing on what is available:
Acceptance Criteria and Reported Device Performance (Non-Clinical):
The document states that "A series of testing was conducted in accordance with protocols based on requirements outlined in guidances and industry standards and the below were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence."
While specific numerical acceptance criteria and exact performance results are not provided in a table format, the document lists the types of tests performed and indicates that the device met the acceptance criteria for each.
| Acceptance Criteria (Test Category) | Reported Device Performance (Met/Not Met) |
|---|---|
| Tensile strength | Met Acceptance Criteria |
| Liquid leakage | Met Acceptance Criteria |
| Air leakage | Met Acceptance Criteria |
| Corrosion Resistance | Met Acceptance Criteria |
| System Tip Flexibility | Met Acceptance Criteria |
| Tip Flexibility – Snare & Catheter | Met Acceptance Criteria |
| Snare Flexing & Fracture Test | Met Acceptance Criteria |
| Catheter Flexural Modulus | Met Acceptance Criteria |
| Catheter Kink Test | Met Acceptance Criteria |
| Marker Band Pull Test | Met Acceptance Criteria |
| Torque Strength Test | Met Acceptance Criteria |
| Simulative Use | Met Acceptance Criteria |
| Radiopacity | Met Acceptance Criteria |
| Particulate | Met Acceptance Criteria |
| Luer Testing | Met Acceptance Criteria |
| Shipping Test | Met Acceptance Criteria |
| Cytotoxicity (ISO 10993-5) | Met Acceptance Criteria |
| Sensitization (ISO 10993-10) | Met Acceptance Criteria |
| Intracutaneous Irritation (ISO 10993-10) | Met Acceptance Criteria |
| Acute Systemic Toxicity (ISO 10993-11) | Met Acceptance Criteria |
| Material Mediated Pyrogen (ISO 10993-11) | Met Acceptance Criteria |
| Hemocompatibility (ISO10993-4) | Met Acceptance Criteria |
| - ASTM Hemolysis Direct and Indirect Contact | Met Acceptance Criteria |
| - Complement Activation, SC5b-9 | Met Acceptance Criteria |
| - Platelet and Leucocyte Counts | Met Acceptance Criteria |
| - Partial Thromboplastin Time (PTT) | Met Acceptance Criteria |
Regarding the AI-specific questions:
The questions provided pertain to the evaluation of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. The document describes a Halo™ Single-Loop Snare Kit, which is a physical device used for retrieving and manipulating foreign objects in the cardiovascular system or hollow viscous. This is a traditional medical device, not an AI/ML software or algorithm.
Therefore, the following questions are not applicable to this specific FDA submission:
- Sample sized used for the test set and the data provenance: Not applicable. This is for a physical device, not an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication of expert annotations is for AI model ground truth.
- 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: Not applicable. MRMC studies are for evaluating AI's impact on human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for an AI model is not relevant here.
- The sample size for the training set: Not applicable. There is no AI model to train.
- How the ground truth for the training set was established: Not applicable. There is no AI model to train.
In summary, the provided FDA document is for a traditional physical medical device, not an AI-powered one, hence most of the detailed questions regarding AI study methodology are not relevant to this specific submission. The performance assessment relied on non-clinical (bench and material) testing to demonstrate substantial equivalence.
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June 3, 2020
Argon Medical Devices, Inc. Ana Jimenez-Hughes Sr. Regulatory Affairs Specialist 1445 Flat Creek Road Athens, Texas 75751
Re: K200268
Trade/Device Name: Halo™ Single-Loop Snare Kit Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: April 22, 2020 Received: April 24, 2020
Dear Ms. Jimenez-Hughes:
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post-marketing 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
Gregory O'Connell 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) K200268
Device Name Halo™ Single-Loop Snare Kit
Indications for Use (Describe)
The Halo™ Single-Loop Snare Kit is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| Date Prepared: | January 31, 2020 |
|---|---|
| Company: | Argon Medical Devices, Inc.1445 Flat Creek RoadAthens, Texas 75751 USAFacility Registration number: 1625425 |
| Contact: | Ana Jimenez-HughesSr. Regulatory SpecialistPhone: 903-676-4276Fax: 903-677-9396Email: ana.hughes@argonmedical.com |
| Device Trade Name: | Halo™ Single-Loop Snare Kit |
| Device Common Name: | Percutaneous Retrieval Device |
| Device Classification: | Device, Percutaneous RetrievalProduct code, MMX21 CFR 870.5150Class IIReview Panel: Cardiovascular Devices |
| Predicate Device(s): | Primary: K972511 Amplatz Goose Neck Snare Kit/CatheterReference: K122088 Merit ONE Snare™ Endovascular Snare System |
| Description of theDevice: | Halo™ Single-Loop Snare Kit contains: (1) Snare, (1) Snare Catheter,(1) Introducer and (1) Torque Handle. |
| The snare is constructed of a flexible and radiopaque loop. The pre-formed snare loop can be introduced through the snare catheterwithout risk of snare deformation because of the snare's super-elastic construction. The snare catheter is constructed of flexibletubing and contains a radiopaque marker band. | |
| Indication for Use: | The Halo™ Single-Loop Snare Kit is intended for use in thecardiovascular system or hollow viscous to retrieve and manipulateforeign objects. |
| TechnologicalCharacteristics: | A comparison of the technological characteristics of the subjectdevice and the predicate devices shows the Halo™ Single-Loop SnareKit to be substantially equivalent to the current marketed predicatedevices.Equivalence is based upon the product performance, design andintended use. The Halo™ Single-Loop Snare Kit and the predicatedevices have similar materials of construction, dimensionalspecifications, designs and sterilization process. |
| Performance Tests(Non-Clinical): | No performance standards have been established under section514, performance standards, of the Food, Drug and Cosmetic Act forthese devices. A series of testing was conducted in accordance withprotocols based on requirements outlined in guidances and industrystandards and the below were shown to meet the acceptancecriteria that were determined to demonstrate substantialequivalence.The following tests were performed under the specified testingparameters to support the Halo™ Single-Loop Snare Kit substantialequivalence. |
| Performance Testing, including:● Tensile strength● Liquid leakage● Air leakage● Corrosion Resistance● System Tip Flexibility● Tip Flexibility – Snare & Catheter● Snare Flexing & Fracture Test● Catheter Flexural Modulus● Catheter Kink Test● Marker Band Pull Test● Torque Strength Test● Simulative Use● Radiopacity● Particulate● Luer Testing● Shipping Test |
510(k) Summary
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Biocompatibility Testing, including:
- · Cytotoxicity (ISO 10993-5)
- · Sensitization (ISO 10993-10)
- Intracutaneous Irritation (ISO 10993-10)
- · Acute Systemic Toxicity (ISO 10993-11)
- Material Mediated Pyrogen (ISO 10993-11)
- · Hemocompatibility (ISO10993-4)
- ASTM Hemolysis Direct and Indirect Contact O
- Complement Activation, SC5b-9 O
- O Platelet and Leucocyte Counts
- O Partial Thromboplastin Time (PTT)
Substantial Based on the Indication for Use, design, and safety and performance Equivalence: testing, the Halo™ Single-Loop Snare Kit meets the requirements for its intended use and is substantially equivalent to the predicate devices. Conclusion: The results of all testing demonstrate that the Halo™ Single-Loop Snare Kits are substantially equivalent to the predicate devices.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).