The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters. The coronary probe is available in different lengths and diameters to accommodate the needs of various surgical procedures and vessel anatomies. The probe is constructed of Titanium Alloy (TiAl6V4), Nitinol, and Titanium (Grade 2). Coronary probes are supplied non-sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Fehling Surgical Instruments, Inc.'s SUPERPLAST Double-Occluder and SUPERPLAST Vascular Probe. It focuses on demonstrating substantial equivalence to a predicate device through technological characteristics, performance testing, and biocompatibility testing.

However, the document does not provide the specific details requested regarding acceptance criteria and the study proving the device meets them as would be expected for a product involving AI or complex performance metrics. The information is geared towards demonstrating substantial equivalence for a Class II surgical instrument, not an AI/ML powered device. Therefore, many of the requested fields cannot be populated from the given text.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in a table format with specific numerical acceptance criteria. The performance testing focuses on demonstrating mechanical integrity and successful reprocessing.

Performance Metric	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Mechanical Testing	Probes withstand clinical forces and do not break prematurely.	"Probes can handle the forces clinically required" and tested "to the point of failure on the worst-case configuration."
Tensile Strength	(Not explicitly defined with a numerical value)	Demonstrated ability to withstand tension; tested to failure.
Force to Remove from Vessel	(Not explicitly defined with a numerical value)	Preliminary data collected to determine this force.
Dimensional Verification	(Not explicitly defined with a numerical range)	"Probes are dimensionally verified."
Reprocessing (Cleaning & Sterilization)	Device is effectively cleaned and sterilized according to standards.	"Validation of the end user automated cleaning procedures, end user steam sterilization process, and drying time after sterilization was conducted." Conducted per FDA Guidance Document.
Biocompatibility	No cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, or pyrogenicity.	Passed testing for "cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, and pyrogenicity" per ISO 10993-1.

2. Sample size used for the test set and the data provenance

Sample size: Not explicitly stated for performance testing. It mentions "Devices were tested to the point of failure on the worst-case configuration," implying a selection of probes, but no specific number. For preliminary data on force to remove a probe, it's also not specified.
Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is unlikely to be relevant for mechanical and biocompatibility testing of a physical probe.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as this is a physical medical device (vascular dilator) and the testing described is mechanical and biological, not related to expert interpretation for ground truth establishment.

4. Adjudication method for the test set

Not applicable for mechanical and biocompatibility testing of a physical medical device.

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

Not applicable. This device is a surgical instrument (vascular dilator), not an AI/ML-powered diagnostic or assistive tool for human readers.

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

Not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used

For mechanical testing, the "ground truth" would be the physical properties and failure points of the material and device design. For biocompatibility, it's compliance with ISO 10993-1 standards (absence of adverse biological reactions). For reprocessing, it's demonstrating effective cleaning and sterilization. These are established through standardized testing methodologies, not "expert consensus, pathology, or outcomes data" in the typical sense for an AI/ML context.

8. The sample size for the training set

Not applicable. This is not an AI/ML-powered device with a training set.

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

Not applicable. This is not an AI/ML-powered device with a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 20, 2023

Fehling Surgical Instruments, Inc. % Jennifer Palinchik President Jalex Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145

Re: K220981

Trade/Device Name: SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe Regulation Number: 21 CFR 870.4475 Regulation Name: Surgical vessel dilator Regulatory Class: Class II Product Code: DWP Dated: March 24, 2023 Received: March 24, 2023

Dear Jennifer Palinchik:

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

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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 (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,

Carmen G. Johnson -S

Carmen Gacchina Johnson, PhD 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) K220981

Device Name SUPERPLAST Double-Occluder SUPERPLAST Vascular Probe

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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Image /page/3/Picture/0 description: The image shows the logo for FEHLING SURGICAL INSTRUMENTS. The logo is black and white, with a red accent. The word "FEHLING" is in large, bold letters, with the words "SURGICAL INSTRUMENTS" in smaller letters below. To the left of the word "FEHLING" is a red and black swoosh design. To the right of the word "FEHLING" is a spine.

510(k) Summary

Submitted By:	Fehling Surgical Instruments, Inc.1690 Stone Village Lane STE 721Kennesaw, GA 30152
Date:	April 18, 2023
Contact Person:Contact Telephone:Contact Fax:	Jennifer Palinchik, President, JALEX Medical(440) 935-3282(440) 933-7839
Device Trade Name:	SUPERPLAST ProbesSUPERPLAST Double-OccluderSUPERPLAST Vascular Probe
Common Name:	Vascular Dilator
Device Classification Name:	Dilator, Vessel, Surgical
CFR Section:	870.4475
Device Classification:	Class II
Reviewing Panel:	Cardiovascular
Product Code:	DWP
Predicate Device:	Geomed Vascular Dilators (K183438)The predicate device has never been subject to a recall

Device Description:

Indications for Use:

Summary of Technological Characteristics:

The Fehling SUPERPLAST Probes and the predicate have the same intended use and fundamental scientific technology. Both devices are similar in technological characteristics as noted in the table below.

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Image /page/4/Picture/0 description: The image is a logo for FEHLING SURGICAL INSTRUMENTS. The logo features the word "FEHLING" in large, bold, black letters. To the left of the word is a stylized graphic with red and black curved lines. To the right of the word is a black and white image of a spine.

Item	FehlingSUPERPLASTProbe	Geomed VascularDilators
Intended Use	Used to enlarge orcalibrate vesselsduring coronaryartery bypass andangioplastyprocedures. They aredesigned to locateorifices, to trace thecourse of abnormalvessels and toperform variousmaneuvers ofdilation andmeasurement ofannulus and lumendiameters.	Used to enlarge orcalibrate vesselsduring coronaryartery bypass andangioplastyprocedures. They aredesigned to locateorifices, to trace thecourse of abnormalvessels and toperform variousmaneuvers of dilationand measurement ofannulus and lumendiameters.
Sterility	Provided Non-sterile	Provided Non-sterile
Reusable	Yes; single re-use	Yes; multiple re-use
Sterilization	Steam sterilized byuser facility pervalidated procedure	Steam sterilized byuser facility pervalidated procedure
Description	Reusable surgicalinstrument used toenlarge or calibratevessels	Reusable surgicalinstrument used toenlarge or calibratevessels
Materials	Titanium (handle)and Titanium Alloy(tip) conforming toISO 5832, Nitinol(shaft) conformingto ASTM F2063	Stainless Steel
DesignFeatures	Manual, non-electrical, non-sterile, reusable,malleable shaft	Manual, non-electrical, non-sterile,reusable, non-malleable
Patient contact	Blood vessels,transient (<15 min)	Blood vessels,transient (<15 min)
Tip Sizes	0.5-5mm	1.0-10mm
Lengths	8cm-21cm	14cm-19cm

Performance Testing:

Substantial equivalence is supported by the results of mechanical testing including tensile testing and simulated use testing. Preliminary data was collected to determine the force required to remove a probe

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Image /page/5/Picture/0 description: The image is a logo for FEHLING SURGICAL INSTRUMENTS. The logo features the word "FEHLING" in large, bold, black letters. To the left of the word is a stylized graphic with red and black curved lines. To the right of the word is a graphic of a spine.

from a blood vessel. Tensile testing was conducted to demonstrate that the probes can handle the forces clinically required, and to determine at what point the probes break. Devices were tested to the point of failure on the worst-case configuration of the Fehling probes. In addition, probes are dimensionally verified.

Validation of the end user automated cleaning procedures, end user steam sterilization process, and drying time after sterilization was conducted. Cleaning and sterilization testing was conducted in accordance with the recommendations outline in FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (3/17/2015)"

Biocompatibility Testing:

Biocompatibility testing per ISO 10993-1 was performed for the following endpoints: cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, and pyrogenicity.

Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.

Regulation Number and Section

§ 870.4475 Surgical vessel dilator.

(a)
Identification. A surgical vessel dilator is a device used to enlarge or calibrate a vessel.(b)
Classification. Class II (performance standards).