Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a mechanical device (catheter and needle) used for drug delivery under ultrasound guidance. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on the insertion technique and safety profile of the physical device.

Therapeutic

No
The device delivers medication for regional anesthesia and pain management, which makes it a drug delivery device, not a therapeutic device itself.

Diagnostic

No
The device is described as a catheter set for delivery of medication for regional anesthesia and pain management, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a needle, catheter, and hub, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Certa Catheter™ is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Certa Catheter™ Function: The Certa Catheter™ is a device used for the delivery of medication directly into the body for regional anesthesia and pain management. It is an invasive device used for therapeutic purposes, not for analyzing samples outside the body.

The description clearly states its purpose is to deliver medication for nerve blocks, which is a clinical procedure performed directly on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of medication for regional anesthesia and pain management in lower extremity blocks. It may be used by a qualified healthcare professional in a perioperative monitored care setting.

Certa Catheter™ is intended for use in adult patients only. It should always be inserted and placed under ultrasound guidance by a healthcare professional.

The Certa Catheter has not been evaluated for use in upper extremity blocks.

Product codes

BSO

Device Description

Certa Catheter™ is a single patient use, disposable device which is the combination of a needle and catheter, intended for delivery of local anesthetic for continuous peripheral nerve blocks.

Certa Catheter™ is intended to be placed with the use of ultrasound guidance. The procedure is performed using aseptic technique.

Certa Catheter™ consists of a curved needle to which the catheter is attached. The curved needle is available in several radius and lengths. To assist with the control of the needle during insertion, there is a Hub which allows the user to rotate the needle during the insertion and placement along or above the target nerve. The Hub is removed and then the user is able to grab the needle tip and pull the cather through the entry and exit locations. The needle is then cut from the catheter and the user is able to pull the catheter back and forth to locate the eyelets in the proper location along or above the target nerve. The catheter is then fixed on one side to secure its location. The system consists of: Curved needle; Hub – a handle that helps during insertion and is removed afterwards; which has a Luer port; Catheter with single or multiple orifices; and echogenic markings for ultrasound detection.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

ultrasound

Anatomical Site

lower extremity

Indicated Patient Age Range

adult patients only

Intended User / Care Setting

qualified healthcare professional in a perioperative monitored care setting.

The environment of use is hospital, sub-acute and clinic settings.

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)

Performance Testing - Non-clinical:
Comparative bench testing was performed to demonstrate that the subject device performed substantially equivalent to the predicate. The tests included:

Strength of bonds
Tensile strength
Leakage
Luer fitting
Sharpness
Flow rate
Catheter Kinking

Biocompatibility and Materials: evaluated per ISO 10993-1.
Sterility: EO and ECH residuals were evaluated per ISO 10093-7 and LAL endotoxins. The sterilization was validated.
Effects of Aging: Testing related to aging to evaluate the performance of the device post-aging.

Clinical Study Summary:
Results of several clinical trials related to the insertion technique of the Certa Catheter™ were provided. The studies included healthy volunteers where the insertion technique of the Certa Catheter was part of the studies. In addition, a review of the catheter fixation method and any infection at the needle puncture sites were noted. No adverse events were recorded on study days in the two studies.
A review of the Safety and Risk Profile for peripheral nerve block catheters included MAUDE Database search and Literature Search for Nerve damage and Infection.

One study performed on healthy individuals with high level of mobility showed an increased incidence of transient neurologic deficits when the catheter was placed below the nerve [CONTINUOUS ADDUCTOR CANAL BLOCK WITH A SUTURE-METHOD CATHETER - PRIMARY PLACEMENT AND SECONDARY REPOSITIONING; ESRA Academy. Lyngeraa T. Sep 8, 2016; 138581]. As a result, it is recommended that the catheter is placed above or along the nerve (not below or circumferentially around the nerve), with fixation on one side not two, to reduce the risk of nerve injury.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Key metrics mentioned from performance testing:

Strength of bond: Average bond strength between catheter and its luer is 34.91N +/- 4.09
Tensile strength: Average tensile strength of catheter (at its weakest point) is 20.12N +/- 0.75N (1 hole model), 18.43N +/- 0,33N (3 holes model)
Sharpness: Average penetration force is 2.93N +/- 0.33N
Flow rate: Average flow rate 5.24ml/min +/-0.08ml/min (1 hole model), 5.2ml/min +/- 0.1ml/min (3 holes model)
Catheter Kinking: Kink resistant up to at least 1.11mm catheter

Predicate Device(s)

K143164

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.5120 Anesthesia conduction catheter.

(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.

December 18, 2017

Ferrosan Medical Devices SP. Z O.O. % Paul Dryden Consultant ProMedic. LLC 24301 Woodsage Dr. Bonita Springs, Florida 34134-2958

Re: K171193

Trade/Device Name: Certa Catheter Continuous Peripheral Nerve Block Catheter Set Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO Dated: November 15, 2017 Received: November 16, 2017

Dear Paul Dryden:

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

1

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tara A. Ryan -S 2017.12.18 06:04:25 -05'00'

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K171193

Device Name

Certa Catheter Continuous Peripheral Nerve Block Catheter Set

Indications for Use (Describe)

Certa Catheter™ continuous peripheral nerve block catheter set is indicated for delivery of medication for regional anesthesia and pain management in lower extremity blocks. It may be used by a qualified healthcare professional in a perioperative monitored care setting.

Certa Catheter™ is intended for use in adult patients only. It should always be inserted and placed under ultrasound guidance by a healthcare professional.

The Certa Catheter has not been evaluated for use in upper extremity blocks.

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

3

510(k) Summary Certa Catheter

	December 15, 2017
Official Contact:	Elzbieta Porebska-Guillemant, QA Manager
Proprietary or Trade Name:	Certa Catheter ™ Continuous Peripheral Nerve Block Catheter Set
Common/Usual Name:	Catheter, Anesthetic
Classification Name:	BSO, Anesthesia conduction catheter, CFR Title 21, 868.5120, Class II
Predicate Device:	K143164 — Halyard ON-Q QuikBloc
Over-the-Needle Catheter set

Device Description:

Certa Catheter™ is a single patient use, disposable device which is the combination of a needle and catheter, intended for delivery of local anesthetic for continuous peripheral nerve blocks.

Certa Catheter™ is intended to be placed with the use of ultrasound guidance. The procedure is performed using aseptic technique.

Certa Catheter™ consists of a curved needle to which the catheter is attached. The curved needle is available in several radius and lengths. To assist with the control of the needle during insertion, there is a Hub which allows the user to rotate the needle during the insertion and placement along or above the target nerve. The Hub is removed and then the user is able to grab the needle tip and pull the cather through the entry and exit locations. The needle is then cut from the catheter and the user is able to pull the catheter back and forth to locate the eyelets in the proper location along or above the target nerve. The catheter is then fixed on one side to secure its location. The system consists of: Curved needle; Hub – a handle that helps during insertion and is removed afterwards; which has a Luer port; Catheter with single or multiple orifices; and echogenic markings for ultrasound detection.

Indications for Use

Certa Catheter™ continuous peripheral nerve block catheter set is indication for regional anesthesia and pain management in lower extremity blocks. It may be used by a qualified healthcare professional in a perioperative monitored care setting.

Certa Catheter™ is intended for use in adult patients only. It should always be inserted and placed under ultrasound guidance by a healthcare professional.

The Certa Catheter has not been evaluated for use in upper extremity blocks.

Contraindications and Lessons Learned

Certa Catheter™ is contraindicated for all

intraneural -
intravascular
" intrapleural
epidural
intrathecal placement
-Always use Certa Catheter™ under ultrasound guidance.
-Do not use Certa Catheter™ in patients with coagulopathies.
-Do not use Certa Catheter™ in patients with pre-existing neurological diseases.
-Do not use Certa Catheter™ in patients with severe hepatic and/or renal insufficiency where the clearance of local anesthetic may be delayed. Please refer to the Prescribing Information for the local anesthetic used.
-Do not use Certa Catheter™ in patients at risk of developing acute compartment syndrome as local anesthetic may mask the hallmark sign of acute compartment syndrome.
Do not use Certa Catheter™ with local anesthetic if the patient is allergic to local anesthetic. Always consult the -Prescribing Information for the local anesthetic used.
Do not use Certa Catheter™ in patients with infection or inflammation at the insertion and/or exit sites. .
Do not use Certa Catheter™ in patients with known allergies to one or more of the materials used. -

4

Before placing a continuous peripheral nerve block always assess the patient for any risk factors that may contribute to perioperative nerve injury including patient risk factors (e.g. pre-existing neurologic disorders, pre-existing diabetes or extremes of body habitus). This may also include if patient has excessive anxiety that may lead to inability to respond to interventions and inability to tolerate positioning.
Place the catheter above or along the nerve to reduce the risk of transient neurologic deficits. -
It is recommended to use single hard fixation to avoid discomfort and transient neurologic deficits. -

Environments of Use and Patient Population

The environment of use is hospital, sub-acute and clinic settings. For use with adults.

Predicate Device Comparison
Features	Predicate
Halyard, On-Q (K143164)	Proposed
Certa
Indications for use	The On-Q* QuikBloc* Over-the-Needle
Catheter set is indicated for delivery of
medication for regional anesthesia and pain
management. Route of administration may be
intraoperative, percutaneous, or perineural	Certa CatheterTM continuous peripheral nerve
block catheter set is indicated for delivery of
medication for regional anesthesia and pain
management in lower extremity blocks. It may
be used by a qualified healthcare professional
in a perioperative monitored care setting.

Certa CatheterTM is intended for use in adult
patients only. It should always be inserted and
placed under ultrasound guidance by a
healthcare professional.

The Certa Catheter has not been evaluated for
use in upper extremity blocks. |
| Environment of Use | Hospital, sub-acute and clinic settings | Hospital, sub-acute and clinic settings |
| Patient Population | Patients for regional analgesia and anesthesia | Adult patients for regional analgesia and
anesthesia |
| Contraindications | Not indicated for epidural or intravascular
delivery | Not indicated for epidural or intravascular
delivery.

Moreover, not indicated for intraneural,
intrapleural or intrathecal.