(30 days)
The HeartSpan® Steerable Sheath Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The HeartSpan® Steerable Sheath Introducer consists of a dilator, guide wire, and steerable sheath, which are designed for catheter introduction into the cardiac anatomy. The device is provided sterile (ethylene oxide) and intended for single use only. It is for use in hospitals or healthcare facilities. The HeartSpan® Steerable Sheath Introducer has three configurations; Small, Medium, and Large Curl (differing curve radii). The steerable sheath introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The sheath introducer handle includes a rotating knob to enable clockwise and counterclockwise tip deflection ≥180° with a radius of 16.4 - 50 mm nominal (measured at 180° deflection). The steerable sheath introducer also includes distal holes to facilitate aspiration and minimize cavitation, a radiopaque tip marker to improve fluoroscopic visualization, an atraumatic soft tip, and a lubricious coating on the outer surface. The dilator is designed to mate to the inner diameter of the sheath, and has a tapered tip. The guide wire is super-stiff with PTFE coating and J-tip. The guide wire maintains a percutaneous path through the skin and tissue over which the sheath/dilator assembly is tracked. The materials of construction are primarily polymers with the exception of stainless steel braid reinforcement and deflection wires in the sheath introducer shaft that are completely encapsulated in the sheath wall and do not contact the patient or bodily fluids.
The provided text describes a 510(k) premarket notification for a medical device, the HeartSpan® Steerable Sheath Introducer. It details the device's characteristics, indications for use, comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.
However, the document does not contain the specific information required to address the request fully, particularly regarding a study that proves the device meets acceptance criteria in the context of an AI/human-in-the-loop system. The provided text is for a physical medical device (a steerable sheath introducer), not an AI algorithm or an imaging device whose performance is measured in terms of reader improvements or AI standalone performance. Therefore, many of the requested fields are not applicable to the submitted content.
Based on the provided text, I can extract information related to the acceptance criteria and performance of the physical device.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document lists various performance tests conducted on the HeartSpan® Steerable Sheath Introducer, which serve as the acceptance criteria for its physical and functional attributes. The general statement about performance is that "The results of the testing demonstrated that the subject HeartSpan® Steerable Sheath Introducer met the predetermined acceptance criteria applicable to the safety and efficacy of the device." Specific quantitative results are not provided in this summary.
| Acceptance Criteria (Performance Testing - Bench) | Reported Device Performance |
|---|---|
| Sheath & Dilator Tube Radiopacity | Met predetermined criteria |
| Sheath Tube Flexural & Torsional Rigidity | Met predetermined criteria |
| Sheath Tube O.D., I.D. & Free Length | Met predetermined criteria |
| Sheath Curl Diameter | Met predetermined criteria |
| Sheath Hemostasis / Air Leak Resistance | Met predetermined criteria |
| Dilator Extension Length | Met predetermined criteria |
| Sheath Neutral Position Tactile Indicator | Met predetermined criteria |
| Sheath and Dilator Tip Integrity | Met predetermined criteria |
| Sheath Bonded Joints Leak Resistance | Met predetermined criteria |
| Sheath Valve Housing / Sideport Tube Joint Pull Force | Met predetermined criteria |
| Sheath Tube Joint Pull Forces | Met predetermined criteria |
| Dilator Hub & Tip I.D. | Met predetermined criteria |
| Dilator Tip Wall Thickness | Met predetermined criteria |
| Safety & Dilator Free & Overall Length | Met predetermined criteria |
| Transseptal Needle Protrusion from Dilator Tip & from Dilator Hub Performance | Met predetermined criteria |
| Dilator Hub Mark Adherence | Met predetermined criteria |
| Sheath/Dilator Attachment & Detachment Force | Met predetermined criteria |
| Dilator Hub Luer Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, and Resistance to Overriding Dilator Hub Luer Stress Cracking | Met predetermined criteria |
| Dilator Tip Integrity | Met predetermined criteria |
| Dilator Hub/Tube Joint Pull Force | Met predetermined criteria |
| Package Integrity | Met predetermined criteria |
| Sheath, Dilator & Guidewire Visual Appearance after Transit Simulation | Met predetermined criteria |
Biocompatibility Testing:
| Acceptance Criteria (Biocompatibility Testing) | Reported Device Performance |
|---|---|
| Cytotoxicity | Met predetermined criteria |
| Sensitization | Met predetermined criteria |
| Irritation / Intracutaneous | Met predetermined criteria |
| Acute Systemic Toxicity | Met predetermined criteria |
| Pyrogenicity | Met predetermined criteria |
| Hemolysis | Met predetermined criteria |
| Thrombogenicity | Met predetermined criteria |
| Complement Activation | Met predetermined criteria |
2. Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided: The document discusses testing for a physical medical device, not an AI model that uses a "test set" in the context of image analysis. The tests mentioned are bench tests and biocompatibility tests on the device itself. Sample sizes for these types of engineering and biological tests are not specified in this summary document.
- Data Provenance: Not applicable in the context of clinical data for AI, but for the physical device, the tests are performed in a lab setting by the manufacturer (Merit Medical Systems, Inc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This pertains to clinical data labeling for AI models. This document describes a physical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable: This pertains to clinical data labeling for AI models.
5. 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: This is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a physical medical device, not an AI algorithm. Its performance is inherent to its design and material properties, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical device, the "ground truth" for acceptance criteria is based on engineered specifications, validated test methods, and compliance with recognized international standards (e.g., ISO, ASTM, USP, AAMI). For biocompatibility, it's established by the outcomes of standard biological tests.
8. The sample size for the training set:
- Not Applicable: This pertains to AI model training, not a physical device.
9. How the ground truth for the training set was established:
- Not Applicable: This pertains to AI model training.
In summary, the provided document is a 510(k) summary for a physical medical device (HeartSpan® Steerable Sheath Introducer) and outlines the engineering and biological testing performed to demonstrate its safety and effectiveness for substantial equivalence. It does not provide the type of information typically associated with the development and validation of an AI-powered diagnostic or assistive tool.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping and appearing to be connected.
April 5, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Merit Medical Systems, Inc. Alina Stubbs Regulatory Affairs Specialist II 65 Great Vallev Parkway Malvern, Pennsylvania 19355
Re: K170668
Trade/Device Name: Heartspan Steerable Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 3, 2017 Received: March 6, 2017
Dear Alina Stubbs:
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. 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 (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando Aguel
Fernando Aguel -
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4.0 Indications for Use
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017 |
|---|---|
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | K170668 |
|---|---|
| Device Name | HeartSpan® Steerable Sheath Introducer |
Indications for Use (Describe)
The HeartSpan® Steerable Sheath Introducer is indicated for introducing various cardiovascular catheters into the heart,
including the left side of the heart through the interatrial septum.
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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5.0 510(k) Summary
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date of Preparation:Registration Number: | Merit Medical Systems, Inc.65 Great Valley ParkwayMalvern, PA 19335(610) 651-5046(801) 545-4285Alina StubbsMarch 3, 20172529252 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | HeartSpan® Steerable Sheath IntroducerSheath IntroducerIntroducer, CatheterIIDYB870.1340Cardiovascular |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | HeartSpan Steerable Introducer KitIntroducer, CatheterK132164Merit Medical Systems, Inc.This predicate has not been subject to a design-related recall. |
| ReferenceDevice | No reference devices were used in this submission. |
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| DeviceDescription | The HeartSpan® Steerable Sheath Introducer consists of a dilator, guide wire,and steerable sheath, which are designed for catheter introduction into thecardiac anatomy. The device is provided sterile (ethylene oxide) and intendedfor single use only. It is for use in hospitals or healthcare facilities.The HeartSpan® Steerable Sheath Introducer has three configurations; Small,Medium, and Large Curl (differing curve radii). The steerable sheathintroducer contains a hemostasis valve to minimize blood loss during catheterintroduction and/or exchange. A sideport with three-way stopcock is providedfor air or blood aspiration, fluid infusion, blood sampling, and pressuremonitoring. The sheath introducer handle includes a rotating knob to enableclockwise and counterclockwise tip deflection ≥180° with a radius of16.4 - 50 mm nominal (measured at 180° deflection). The steerable sheathintroducer also includes distal holes to facilitate aspiration and minimizecavitation, a radiopaque tip marker to improve fluoroscopic visualization, anatraumatic soft tip, and a lubricious coating on the outer surface. The dilator isdesigned to mate to the inner diameter of the sheath, and has a tapered tip.The guide wire is super-stiff with PTFE coating and J-tip. The guide wiremaintains a percutaneous path through the skin and tissue over which thesheath/dilator assembly is tracked.The materials of construction are primarily polymers with the exception ofstainless steel braid reinforcement and deflection wires in the sheathintroducer shaft that are completely encapsulated in the sheath wall and do notcontact the patient or bodily fluids. |
|---|---|
| Indications forUse | The HeartSpan® Steerable Sheath Introducer is indicated for introducingvarious cardiovascular catheters into the heart, including the left side of theheart through the interatrial septum.There is no change in the Indications for Use Statement from the predicate tothe subject device other than the device trade name. |
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Summary of the key technological characteristics of the device compared to the predicate devices:
| Comparison toPredicateDevice | Key TechnicalCharacteristics | Predicate Device(K132164) | Subject Device |
|---|---|---|---|
| Hemostasis valve provided | Yes | Yes | |
| Dilator to Guide WireCompatibility | up to 0.038" | up to 0.032" | |
| Guide wire Design /Dimensions | Super-Stiffwith PTFE0.032" x 180cm | Super-Stiffwith PTFE0.032" x 180cm | |
| Compatibility with StandardTransseptal Needle | Yes | Yes | |
| Length | 74 cm | 74 cm | |
| Labeled French size | 8.6F | 8.5F | |
| Bi-Directional Curving | Yes≥180° in bothdirectionsradius: 10 – 56 mmnominal (measuredat 180° deflection) | Yes≥180° in bothdirectionsradius: 16.4 – 50 mmnominal (measured at180° deflection) | |
| One-Handed Operation ofCurving Mechanism | Yes | Yes | |
| Wire braid reinforcementcompletely encapsulated | Yes | Yes | |
| Radiopaque tip or marker | Yes | Yes | Yes |
| Soft Atraumatic Tip | Yes | Yes | Yes |
| Sheath neutral positionindicator | molded visibleindicators onsteering knob andhandle | addition of tactileneutral positionindicator | |
| Side port for infusion andcontrast injection | Yes | Yes | |
| Orientation of side portassembly | 90° relative tosheath steeringplane | parallel to sheathsteering plane | |
| Dilator Hub CurveOrientation Indicator | None | Printed raised arrow | |
| Dilator Length | 95cm | 94cm | |
| Labeled Dilator French Size | 8.6F | 8.5F | |
| Dilator Curve | 55° | 55° |
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The HeartSpan® Steerable Sheath Introducer has been thoroughly tested through verification of product specifications and user requirements. The following quality assurance measures were applied during the development of the HeartSpan® Steerable Sheath Introducer: Performance Testing-Bench ● Sheath & Dilator Tube Radiopacity o Sheath Tube Flexural & Torsional Rigidity O Sheath Tube O.D., I.D. & Free Length O Sheath Curl Diameter O Sheath Hemostasis / Air Leak Resistance o Dilator Extension Length O Sheath Neutral Position Tactile Indicator O O Sheath and Dilator Tip Integrity O Sheath Bonded Joints Leak Resistance Sheath Valve Housing / Sideport Tube Joint Pull Force O Sheath Tube Joint Pull Forces O Dilator Hub & Tip I.D. O Dilator Tip Wall Thickness O Safety & Dilator Free & Overall Length o Transseptal Needle Protrusion from Dilator Tip & from Dilator Hub Performance O Dilator Hub Mark Adherence O Tests Sheath/Dilator Attachment & Detachment Force O Dilator Hub Luer Liquid Leakage, Air Leakage, Separation Force, O Unscrewing Torque, Ease of Assembly, and Resistance to Overriding Dilator Hub Luer Stress Cracking O O Dilator Tip Integrity Dilator Hub/Tube Joint Pull Force O Package Integrity O o Sheath, Dilator & Guidewire Visual Appearance after Transit Simulation Biocompatibility Testing Cytotoxicity O Sensitization O Irritation / Intracutaneous O Acute Systemic Toxicity O Pyrogenicity O Hemolysis o Thrombogenicity o Complement Activation O No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject HeartSpan® Steerable Sheath Introducer was conducted based on the risk analysis and based on the requirements of the following international standard: AAMI/ANSI ST72:2011, Bacterial Endotoxins - Test methods, routine Safety & ● monitoring, and alternatives to batch testing Performance AAMI TIR28:2009, Product adoption and process equivalence for ethylene ● Tests cont. oxide sterilization ASTM D4169-09, Packaging Distribution Testing ● ASTM F756-13, Standard Practice for Assessment of Hemolytic Properties ● of Materials. 2013 . ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA
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| guidance Required Biocompatibility Training and Toxicology Profiles forEvaluation of Medical Devices, May 1, 1995• ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical devices- Part 4: Selection of tests for interaction with blood• ISO 10993-5:2009, Biological evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity• ISO 10993-7: 2008, Biological Evaluation of Medical Devices Part-7Ethylene Oxide Sterilization Residuals• ISO 10993-10:2010, Biological evaluation of medical devices - Part 10:Tests for irritation and delayed type hypersensitivity• ISO 10993-11:2006, Biological evaluation of medical devices - Part 11:Tests for systemic toxicity• ISO 11070:2014 Sterile single-use intravascular catheter introducers• ISO 11135-1: 2007 Sterilization of health care products - routine control ofa sterilization process for medical devices• ISO 14971:2012, Medical devices - Application of risk management tomedical devices• ISO 15223-1: 2012, Medical Devices - Symbols to be used with medicaldevice labels, labeling and information to be supplied - Part 1: GeneralRequirements• ISO 11607-1: 2006, Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packagingsystems• ISO 2233:2000, Packaging -- Complete, filled transport packages and unitloads -- Conditioning for testing• ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes,needles and certain other medical equipment - Part 1: Generalrequirements• ISO 594-2:1998, Conical fittings with a 6% (Luer) taper for syringes,needles and certain other medical equipment - Part 2: Lock fittings• USP 39-NF 34 <151>, United States Pharmacopeia 39, NationalFormulary 34, 2016 <151> Pyrogen TestThe results of the testing demonstrated that the subject HeartSpan® SteerableSheath Introducer met the predetermined acceptance criteria applicable to thesafety and efficacy of the device. | |
|---|---|
| Summary ofSubstantialEquivalence | Based on the indications for use, design, safety and performance testing, thesubject HeartSpan® Steerable Sheath Introducer meets the requirements thatare considered essential for its intended use and is substantially equivalent tothe predicate device, the HeartSpan Steerable Introducer Kit, K132164manufactured by Merit Medical Systems, Inc. |
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).