SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe

K220981 · Fehling Surgical Instruments, Inc. · DWP · Apr 20, 2023 · Cardiovascular

Device Facts

• Record ID: K220981
• Device Name: SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
• Applicant: Fehling Surgical Instruments, Inc.
• Product Code: DWP · Cardiovascular
• Decision Date: Apr 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4475
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Manual, non-electrical surgical instrument; used by surgeons during coronary artery bypass and angioplasty procedures. Device functions as a probe to locate orifices, trace abnormal vessels, and dilate/measure vessel diameters. Features malleable shaft; available in various lengths and diameters. Operated by physician in clinical/OR setting. Provides tactile feedback to surgeon during vessel manipulation; assists in surgical decision-making regarding vessel patency and sizing. Benefits patient by facilitating precise vessel preparation and calibration during cardiac surgery.

Clinical Evidence

Bench testing only. Included mechanical tensile testing to failure, dimensional verification, and simulated use testing to determine removal forces. Validated end-user automated cleaning, steam sterilization, and drying procedures per FDA guidance. Biocompatibility testing performed for cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, and pyrogenicity per ISO 10993-1.

Technological Characteristics

Manual, non-electrical, reusable surgical instrument. Materials: Titanium (handle), Titanium Alloy (tip) per ISO 5832, Nitinol (shaft) per ASTM F2063. Malleable shaft design. Dimensions: 8cm-21cm length, 0.5-5mm tip sizes. Patient contact: blood vessels, transient (<15 min). Sterilization: steam sterilized by user facility.

Indications for Use

Indicated for use in patients undergoing coronary artery bypass and angioplasty procedures requiring vessel enlargement, calibration, orifice location, tracing of abnormal vessels, or measurement of annulus and lumen diameters.

Regulatory Classification

Identification

A surgical vessel dilator is a device used to enlarge or calibrate a vessel.

Predicate Devices

• Geomed Vascular Dilators (K183438)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-size:12px">☑</span> 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.<br>1690 Stone Village Lane STE 721<br>Kennesaw, GA 30152 |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Date: | April 18, 2023 |
| Contact Person:<br>Contact Telephone:<br>Contact Fax: | Jennifer Palinchik, President, JALEX Medical<br>[phone]<br>[phone] |
| Device Trade Name: | SUPERPLAST Probes<br>SUPERPLAST Double-Occluder<br>SUPERPLAST 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)<br>The predicate device has never been subject to a recall |

## Device Description:

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.

### Indications for Use:

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.

### 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 | Fehling<br>SUPERPLAST<br>Probe | Geomed Vascular<br>Dilators |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used to enlarge or<br>calibrate vessels<br>during coronary<br>artery bypass and<br>angioplasty<br>procedures. They are<br>designed to locate<br>orifices, to trace the<br>course of abnormal<br>vessels and to<br>perform various<br>maneuvers of<br>dilation and<br>measurement of<br>annulus and lumen<br>diameters. | Used to enlarge or<br>calibrate vessels<br>during coronary<br>artery bypass and<br>angioplasty<br>procedures. They are<br>designed to locate<br>orifices, to trace the<br>course of abnormal<br>vessels and to<br>perform various<br>maneuvers of dilation<br>and measurement of<br>annulus and lumen<br>diameters. |
| Sterility | Provided Non-sterile | Provided Non-sterile |
| Reusable | Yes; single re-use | Yes; multiple re-use |
| Sterilization | Steam sterilized by<br>user facility per<br>validated procedure | Steam sterilized by<br>user facility per<br>validated procedure |
| Description | Reusable surgical<br>instrument used to<br>enlarge or calibrate<br>vessels | Reusable surgical<br>instrument used to<br>enlarge or calibrate<br>vessels |
| Materials | Titanium (handle)<br>and Titanium Alloy<br>(tip) conforming to<br>ISO 5832, Nitinol<br>(shaft) conforming<br>to ASTM F2063 | Stainless Steel |
| Design<br>Features | Manual, non-<br>electrical, non-<br>sterile, reusable,<br>malleable shaft | Manual, non-<br>electrical, non-sterile,<br>reusable, non-<br>malleable |
| Patient contact | Blood vessels,<br>transient (<15 min) | Blood vessels,<br>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.