(381 days)
Not Found
No
The device description and performance studies focus on mechanical properties and sterilization, with no mention of AI or ML.
Yes
The device is used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures, which are therapeutic interventions.
No
Explanation: The device is described as a surgical tool used to enlarge, calibrate, locate, trace, dilate, and measure vessels. It performs physical manipulations and measurements rather than diagnosing medical conditions.
No
The device description explicitly states the probes are constructed of Titanium Alloy, Nitinol, and Titanium, indicating a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Fehling SUPERPLAST Probes are surgical instruments used directly on blood vessels during procedures like coronary artery bypass and angioplasty. They are used for physical manipulation (enlarging, calibrating, locating, tracing, dilating, measuring) of the vessels.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It is used for direct intervention within the body.
The description clearly indicates a device used for surgical procedures and physical manipulation of anatomical structures, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
DWP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 per ISO 10993-1 was performed for the following endpoints: cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, and pyrogenicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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)
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) | |
|---|---|
| ☑ 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 721
Kennesaw, 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 Probes
SUPERPLAST Double-Occluder
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)
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
SUPERPLAST
Probe | Geomed Vascular
Dilators |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | 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. |
| Sterility | Provided Non-sterile | Provided Non-sterile |
| Reusable | Yes; single re-use | Yes; multiple re-use |
| Sterilization | Steam sterilized by
user facility per
validated procedure | Steam sterilized by
user facility per
validated procedure |
| Description | Reusable surgical
instrument used to
enlarge or calibrate
vessels | Reusable surgical
instrument used to
enlarge or calibrate
vessels |
| Materials | Titanium (handle)
and Titanium Alloy
(tip) conforming to
ISO 5832, Nitinol
(shaft) conforming
to ASTM F2063 | Stainless Steel |
| Design
Features | Manual, non-
electrical, non-
sterile, reusable,
malleable shaft | Manual, non-
electrical, non-sterile,
reusable, non-
malleable |
| Patient contact | Blood vessels,
transient (