The LIM Precision Steerable TS Transseptal System is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Device Description

The Keystone Heart LIM Precision Steerable TS Transseptal System is a sterile, single use, tridirectional introducer. The system consists of a sheath and a dilator.

The sheath has a handle assembly with a rotating knob and steering lever that deflects the distal end of the sheath. The dilator can be inserted and advanced or retracted through the inner lumen of the sheath. Hemostasis is maintained along the dilator lumen via a hemostatic valve. The dilator lumen is flushable. Once the dilator is generally in the proper position relative to the sheath, an actuator is tightened to secure the dilator to the handle. A knob is then turned to slowly advance the dilator.

AI/ML Overview

The provided text is a 510(k) summary for the Keystone Heart LIM Precision Steerable TS Transseptal System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria for a new device's efficacy or safety. Therefore, the information needed to directly answer many of the questions regarding acceptance criteria, study details, and ground truth is not present in the provided document.

However, I can extract what is present and indicate where the requested information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria and reported device performance in the manner typically used for diagnostic or AI-driven devices with specific quantitative performance metrics like sensitivity, specificity, etc. Instead, performance data is discussed in the context of demonstrating substantial equivalence through various engineering and biocompatibility tests.

Acceptance Criteria Category	Reported Device Performance (Summary)
Functional Performance	Visual Inspection and Dimensional Analysis: Performed
	Primary and Secondary Deflection: Performed
	Insertion and Removal: Performed
	Dilator Lock and Buckle: Performed
	Leak and Flush: Performed
	Femoral and Septal Insertion: Performed
	Torque Test: Performed
	Fluoroscopy and Ultrasound Visualization: Performed
Biocompatibility	Cytotoxicity: Performed
	Sensitization: Performed
	Intracutaneous Reactivity: Performed
	Systemic Toxicity: Performed
	Pyrogenicity: Performed
	ASTM Hemolysis (Direct and Indirect): Performed
	SC5b-9 Complement Activation: Performed
	Partial Thromboplastin Time: Performed
	In Vivo Thrombogenicity: Performed
Usability/Clinical	Not explicitly detailed as acceptance criteria or performance metrics in this summary.
Safety	Not explicitly detailed as acceptance criteria or performance metrics in this summary beyond biocompatibility testing.

Missing Information: Specific quantitative acceptance criteria (e.g., deflection angles must be within X degrees, torque must be at least Y Nm, leakage rate must be less than Z) and the numerical results demonstrating that the device met these criteria are not provided. The document only states that these tests were "performed" to "assure reliable design and performance" and provide "evidence of substantial equivalence."

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

Sample Size: Not specified. The document mentions "in vitro bench testing" but does not detail the number of devices or components tested for each specific test.
Data Provenance: The tests are described as "in vitro bench testing" and "biocompatibility testing." These are laboratory tests, not human or animal studies with clinical data provenance.

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

This question is not applicable to the provided document. The tests performed are engineering and laboratory-based (e.g., deflection, torque, biocompatibility), which do not typically involve human expert establishment of ground truth in the way medical image analysis or diagnostic AI studies do.

4. Adjudication Method for the Test Set

This question is not applicable for the reasons stated above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

No. The document explicitly states: "No animal or human testing was conducted on the Keystone Heart Transseptal System." Therefore, an MRMC study related to human reader performance with or without AI assistance was not performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.

No. The Keystone Heart LIM Precision Steerable TS Transseptal System is a physical medical device (introducer system), not an algorithm or AI software. Therefore, an "algorithm only" performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., expert consensus, pathology, outcomes) is not applicable here. The "ground truth" for the engineering performance tests would be the established engineering specifications and physical properties of the materials and design (e.g., a known force applied, a measured dimension, a defined biocompatibility standard).

8. The Sample Size for the Training Set

No. The device is a physical medical device. This question implies a machine learning or AI training set, which is not relevant to this 510(k) submission.

9. How the ground truth for the training set was established

Not applicable. There is no training set for a physical medical device like this introducer system.

Summary

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December 15, 2020

Keystone Heart, Ltd. % Mike Winegar Principal Winegar Consulting, Inc. 7829 Ithaca Ln N Maple Grove, Minnesota 55311

Re: K202226

Trade/Device Name: Keystone Heart LIM Precision Steerable TS Transseptal System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: November 27, 2020 Received: December 1, 2020

Dear Mr. Winegar:

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.

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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 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 (OS) 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 Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular 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) K202226

Device Name

Keystone Heart LIM Precision Steerable TS Transseptal System

Indications for Use (Describe)

The LIM Precision Steerable TS Transseptal System 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)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Keystone Heart. The logo consists of a stylized red heart shape on the left, with the words "Keystone" and "Heart" written in black to the right of the heart shape. The word "Keystone" is above the word "Heart".

510(k) SUMMARY

Applicant	Keystone Heart, Ltd.15 Halamish St., PO 3170Caesarea, Israel 3088900
Contact Person	Mike WinegarPrincipalWinegar Consulting, Inc.763-639-0700mwinegar@comcast.net
Summary Date	August 6, 2020
Proprietary Name	KeystoneHeart LIMPrecisionTransseptal System	SteerableTS
Classification	Class II
Classification Name	Introducer, Catheter
Regulation Number	21 CFR 870.1340
Product Code	DYB
Predicate Device	The Keystone Heart LIM Precision Steerable TSTransseptal System is substantially equivalent to thecurrently marketed BioCardiaAvance™8.5FSteerable Introducer (K190941)
Reference Device	Agilis NxTTM Steerable Introducer (K110450)
Keystone Heart 510(k)	CONFIDENTIAL	Page 18 of 53

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Device Description:

The Keystone Heart LIM Precision Steerable TS Transseptal System is a sterile, single use, tridirectional introducer. The system consists of a sheath and a dilator.

Intended Use:

The Keystone Heart Transseptal System is intended to provide a dilator and sheath through which other medical devices can be delivered to targeted locations within the cardiac anatomy. The Keystone Heart Transseptal System is intended to be introduced into the body through the venous system. The distal end of the sheath may be advanced across the interatrial septum of the heart into the left atrium. The Keystone Heart Transseptal System is intended to be delivered to the targeted location using echocardiographic and/or radiographic/fluoroscopic image guidance.

Indications for Use:

The LIM Precision Steerable TS Transseptal System is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum

Summary of Technical Characteristics as Compared to the Predicate Device:

The proposed device is substantially equivalent to the design and materials in the predicate device. The Keystone Heart Transseptal System has the same intended use and fundamental scientific technology as the predicate device. All technological characteristics of the Keystone Heart Transseptal System are substantially equivalent to the predicate device, including packaging, biocompatibility, sterilization, and labeling. Where dimensional differences exist between the subject device and the predicate device, performance testing demonstrates that these differences do not adversely affect safety and effectiveness. The introducer acts as a functioning guide/platform for introduction of other diagnostic and therapeutic devices.

The Keystone Heart Transseptal System is substantially equivalent to currently marketed devices intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum, specifically the BioCardia 8.5F Avance® Steerable Introducer, K190941. Keystone Heart is utilizing a reference device, the St. Jude Medical Agilis NxT™ Steerable Introducer, K110450. This reference device has the same basic design and indications as both the predicate and subject device, but also has a guidewire supplied with the device. The predicate and subject devices are not supplied with a guidewire.

Keystone Heart 510(k)

CONFIDENTIAL

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	Predicate DeviceBioCardia 8.5 FAvance Steerable	Reference DeviceSt. Jude Medical AgilisNxTTM Steerable	Subject DeviceKeystone HeartTransseptal System
Regulation No.	870.1340	870.1340	870.1340
Product Code	DYB	DYB	DYB
510(k) No.	K190941	K110450	TBD
Indications forUse	The BioCardia 8.5 FAvance SteerableIntroducer is intendedfor introducing variouscardiovascular cathetersinto the heart, includingthe left side of the heartthrough the interatrialseptum	The 82cm Agilis NxT™ Steerable Introducer isindicated when introducingvarious cardiovascularcatheters into the heart viathe venous anatomy,including the left side ofthe heart through theinteratrial septum	The Keystone HeartTransseptal System isindicated forintroducing variouscardiovascularcatheters into theheart, including theleft side of the heartthrough the interatrialseptum
Internal Diameter	8.5 F		8.5 F
Effective Length(cm)	71		71
Total Length	88.5		84.5
Curve Diameter(mm)	20, 30, 50		Dynamic
Guidewire	Not Included	Included	Not Included
MaximumGuidewire	0.038"		0.032"
MaximumDeflection	180°Bi-directional		180° Primary+/-45° Secondary
ShaftDeflection	Two pull wireswrapped helicallyaround catheter shaft		3 pull wires. One forprimary deflection andtwo for secondarylateral.
DeflectionMechanism	Levers on handle		Primary-Rotating knobon handleSecondary-Lever
Radiopaque Tip	Yes		Yes
Hemostasis	Rotating valve		Static valve
Sterilization	Ethylene Oxide		Ethylene Oxide

Summary of Technical Characteristics as Compared to Predicate

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Performance Data:

The technical characteristics between the subject device and the predicate device have been evaluated through design, material and dimensional comparison, bench, and biocompatibility tests to provide evidence of substantial equivalence. The Keystone Heart Transseptal System is substantially equivalent to the predicate devices based on comparison of the devices functionality, compatibility, technological characteristics and indications for use.

In vitro bench testing was performed on the Keystone Heart Transseptal System to assure reliable design and performance. The non-clinical tests performed include Visual Inspection and Dimensional Analysis, Primary and Secondary Deflection, Insertion and Removal, Dilator Lock and Buckle, Leak and Flush, Femoral and Septal Insertion, Torque Test, and Fluoroscopy and Ultrasound Visualization.

Biocompatibility testing consisted of Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Pyrogenicity, ASTM Hemolysis (Direct and Indirect), SC5b-9 Complement Activation, Partial Thromboplastin Time, and In Vivo Thrombogenicity.

No animal or human testing was conducted on the Keystone Heart Transseptal System.

Conclusion:

Keystone Heart believes the proposed Keystone Heart Transseptal System is substantially equivalent to the legally marketed predicate device. The indications for use, methods of operation, design and materials used are either identical or substantially equivalent to the existing legally marketed predicate product.

Regulation Number and Section

§ 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).