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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Certa Catheter Continuous Peripheral Nerve Block Catheter Set" (K171193). This document is primarily focused on demonstrating substantial equivalence to a predicate device (Halyard ON-Q QuikBloc Over-the-Needle Catheter set K143164) rather than presenting a detailed clinical study for a novel AI/software medical device.

Therefore, the information required to address your specific questions about acceptance criteria, test set sample size, expert ground truth establishment, MRMC studies, standalone performance, training set details, and adjudication methods for an AI/software medical device is largely not present in this document.

However, I can extract information related to the device's non-clinical performance testing and the clinical studies mentioned, although they are not structured as an AI algorithm performance study.

Here's an attempt to answer your questions based on the available information, noting where details are not provided in the document:

Device Name: Certa Catheter™ Continuous Peripheral Nerve Block Catheter Set (K171193)
Device Type: Anesthesia Conduction Catheter (hardware medical device, not an AI/software medical device)

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for the non-clinical performance tests, but it presents comparative performance data against a predicate device. The implicit acceptance criterion is "substantially equivalent" or "within specifications of the predicate and reference devices."

Non-Clinical Performance Testing Comparison:

Feature	Acceptance Criteria (Predicate/Reference Performance, or Implied)	Reported Device Performance (Certa Catheter™)
Strength of bond	Predicate: Average bond strength between catheter and its luer is $34.64N +/- 2.34N$	Average bond strength between catheter and its luer is $34.91N +/- 4.09N$ (Deemed substantially equivalent)
Tensile strength	Predicate: Average tensile strength of catheter (at its weakest point) is $30.28N +/- 1.66N$. Implied: Comparable to predicate or legally marketed reference device specifications that have been found safe and effective.	1 hole model: Average tensile strength of catheter (at its weakest point) is $20.12N +/- 0.75N$. 3 holes model: Average tensile strength of catheter (at its weakest point) is $18.43N +/- 0.33N$.Discussion: Lower than predicate but higher than a legally marketed reference device with similar indications for use. Deemed not to raise different safety/effectiveness concerns.
Leakage	Tested to EN 1618:1997 Annex B (Implied compliance)	Tested to EN 1618:1997 Annex B (Implied compliance)
Luer fitting	Compliant with ISO 594-2 (Implied compliance)	Tested and compliant with ISO 594-2 (Implied compliance)
Sharpness	Predicate: Average penetration force is $3.7N +/- 0.31N$	Average penetration force is $2.93N +/- 0.33N$ (Deemed substantially equivalent)
Flow rate	Predicate: Average flow rate is $83.91ml/min +/- 2.73ml/min$. Implied: Sufficient for regional anesthesia and pain management.	1 hole model: Average flow rate $5.24ml/min +/- 0.08ml/min$. 3 holes model: Average flow rate $5.2ml/min +/- 0.1ml/min$.Discussion: Lower than predicate but clinician determines effectiveness; allows for slower assessment. Deemed not to alter risk profile.
Catheter Kinking	Predicate: kink resistant up to 0.25" (6.35mm)	Kink resistant up to at least 1.11mm catheter (Deemed substantially equivalent, potentially implying a different resistance metric or superior performance if 1.11mm refers to diameter)
Biocompatibility	All applicable components meet ISO 10993-1 requirements for external communicating, tissue/bone, limited/prolonged duration; surface contact, intact/breached skin, limited/prolonged duration.	All applicable components meet ISO 10993-1 requirements. Results supported materials meet biocompatibility.
Sterility	Validation of EO and ECH residuals per ISO 10093-7 and LAL endotoxins.	Sterilization validated.
Effects of Aging	No adverse effect on device performance post-aging.	Results supported aging does not have an effect on the performance.
Clinical Performance (Safety)	No adverse events in studies regarding insertion technique, catheter fixation, or infection at puncture sites. Safe and effective with proper placement.	No adverse events recorded on study days in the two healthy volunteer studies. Safety and risk profiles deemed substantially equivalent to predicate based on MAUDE database and literature review. Supports safety and substantial equivalence with recommended placement.

Note: The document is a 510(k) submission, not a scientific publication for an AI algorithm. The "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device through comparative bench testing and clinical use (not a comparative clinical trial).

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

Test Set Sample Size:
- Non-clinical (Bench) Tests: The document details performance metrics (mean and standard deviation), implying samples were used for these tests (e.g., for tensile strength, flow rate, sharpness). However, the specific number of samples used for each bench test (e.g., N=10, N=20) is not reported.
- Clinical Studies: The document mentions "several clinical trials related to the insertion technique of the Certa Catheter™," including "healthy volunteers." It states "two studies." The exact number of healthy volunteers in these studies is not specified.
Data Provenance:
- Non-clinical (Bench) Tests: Not specified, but generally conducted by the manufacturer or a contract testing lab.
- Clinical Studies: "One of the studies performed on healthy individuals with a 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]". This suggests at least one study was prospective, potentially conducted in Europe (ESRA Academy). The other mentioned clinical studies' provenance is not detailed beyond being "several clinical trials." It states "No adverse events were recorded on study days in the two studies."

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

Not applicable. This is a hardware device submission, not an AI/software device requiring subjective expert labeling for ground truth. The "ground truth" for the clinical evaluation was observed events (e.g., adverse events, transient neurological deficits) in healthy volunteers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a hardware device submission, not an AI/software device requiring subjective expert labeling for ground truth.

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 is a hardware device submission. No MRMC study involving AI assistance was performed or reported.

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

Not applicable. This is a hardware device submission. There is no AI algorithm.

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

For the human clinical studies mentioned, the "ground truth" was observational clinical outcomes, specifically:

Occurrence of adverse events.
Incidence of transient neurologic deficits (linked to catheter placement location relative to the nerve).
Catheter fixation method outcomes.
Infection at puncture sites.

For the bench testing, the "ground truth" or reference was the measured performance of the predicate device and established engineering standards (e.g., ISO 594-2, EN 1618:1997, ISO 10993-1).

8. The sample size for the training set

Not applicable. This is a hardware device submission. There is no AI algorithm or training set.

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

Not applicable. This is a hardware device submission. There is no AI algorithm or training set.

Summary

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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

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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

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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™ 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)

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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 QuikBlocOver-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.

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. -

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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	PredicateHalyard, On-Q (K143164)	ProposedCerta
Indications for use	The On-Q* QuikBloc* Over-the-NeedleCatheter set is indicated for delivery ofmedication for regional anesthesia and painmanagement. Route of administration may beintraoperative, percutaneous, or perineural	Certa CatheterTM continuous peripheral nerveblock catheter set is indicated for delivery ofmedication for regional anesthesia and painmanagement in lower extremity blocks. It maybe used by a qualified healthcare professionalin a perioperative monitored care setting.Certa CatheterTM is intended for use in adultpatients only. It should always be inserted andplaced under ultrasound guidance by ahealthcare professional.The Certa Catheter has not been evaluated foruse 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 andanesthesia
Contraindications	Not indicated for epidural or intravasculardelivery	Not indicated for epidural or intravasculardelivery.Moreover, not indicated for intraneural,intrapleural or intrathecal.To be placed along or above target nerve.
Principle of Operation	Insertion of a catheter near the nerve site andinfusion of drug	Insertion of a catheter near the nerve site andinfusion of drug
Technique of CatheterPlacement	Over the needle catheter insertion	Through to through needle is attached tocatheter and upon exit of needle the catheteris then pull through
Echogenic properties forultrasound guidance	YesOn needle	YesOn the catheter
Insertion method	Over-the-needleCatheter is fitted over the needle thenneedle inserted	Catheter is attached to end of needle
Sizes of catheter	Inner diameter: $Ø$ 1mm (measured)Outer diameter: $Ø$ 1.6mm (measured)	Inner diameter: $Ø$ 0,6mm on nominalOuter diameter: $Ø$ 1,2mm on nominal
Features	Predicate	Proposed
	Halyard, On-Q (K143164)	Certa
Length of catheter	Full length:76mm (from product description)Length to first dosing hole: 71mm (measured)	Full length: 600mm on nominalLength to first dosing hole: 400mm on nominal
Number of holes	3 side holes and 1 front hole	1 hole variant: 1 thru hole, so 2 side holes3 holes variant: 3 thru holes, so 6 side holes
Needle configurations	Straight of different lengths and gauges	Curvature Radius – 50, 75, 120 mmLength – 100 and 160 mmGauge - 19
Components of CatheterSet	Multiple needle sizes and lengthCatheterExtension set for needleExtension set for catheter	Multiple needle sizes and lengthCatheter
Maximum time left inplace	< 30 days	< 30 days
Disposable	Single patient, disposable	Single patient, disposable
Sterile	Yes	Yes
Shelf-life	Greater than 1 year	3 years
BiocompatibilityISO 10993-1	ISO 10993-1 considers the components as:Externally communicating, Tissue/bone,Limited and Prolonged duration of useandSurface Contact, Intact Skin and Breached orcomprised surfaces, Limited and Prolongedduration of use.	ISO 10993-1 considers the components as:Externally communicating, Tissue/bone,Limited and Prolonged duration of useandSurface Contact, Intact Skin and Breached orcomprised surfaces, Limited and Prolongedduration of use.
Performance Testing - Non-clinical
Strength of bond	Average bond strength between catheter andits luer is $34.64N +/- 2.34N$	Average bond strength between catheter andits luer is $34.91N +/- 4.09$
Tensile strength	Tested and compared to subject device theaverage tensile strength of catheter (at itsweakest point) is $30.28N +/- 1.66N$	Tested and compared to predicate the averagetensile strength of catheter (at its weakestpoint) is $20.12N +/- 0.75N$3 holes model Average tensile strength ofcatheter (at its weakest point) is $18.43N +/- 0,33N$
Leakage	Tested to EN 1618:1997 Annex B	Tested to EN 1618:1997 Annex B
Luer fitting	Compliant with ISO 594-2	Tested and compliant with ISO 594-2
Sharpness	Average penetration force is $3.7N +/- 0.31N$	Average penetration force is $2.93N +/- 0.33N$
Flow rate	Average flow rate is $83.91ml/min +/- 2.73ml/mi$	Average flow rate $5.24ml/min +/-0.08ml/min$3 holes model average flow rate $5.2ml/min +/- 0.1ml/min$
Catheter Kinking	Reported kink resistant up to 0.25" (6.35mm)	Kink resistant up to at least 1.11mm catheter

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Discussion of substantial equivalence

The Certa Catheter™ is viewed as substantially equivalent to the predicate device because:

Indications for Use – The proposed indications for use are similar that is for delivery of medication for regional anesthesia and pain management. Route of administration is in a perioperative monitored care setting. Discussion - The Certa Catheter is limited to lower extremity blocks which are a subset of the predicate.

Patient Population - The patient population is adults. Discussion - There are no differences in the patient population.

Environment of Use – The proposed environments of use are the same. Discussion - There are no differences in the environments of use.

Technology – The technology for insertion with a needle and inserting a catheter with holes of infusion of the medication is similar. The use of echogenic markings to assist with visualization under ultrasound guidance is also similar.

Discussion of Differences – The technology of using a curved needle to insert the catheter via a through to through technique vs. over the needle catheter insertion and placement technician to be able to move the catheter and the drug orifices to the desired location by pulling the catheter from either end whereas the over the needle technique does not allow one to adjust the catheter drug orifice as easily. In the end the insertion technique and catheter placement was shown in the clinical studies to be substantially equivalent for blocks in lower extremities. In addition, comparative performance testing demonstrated that the specifications of the needle and catheter were substantially equivalent to the predicate or reference device.

Differences – The difference is the catheter insertion and placement technique and the device involves both the use of needle inserted near the nerve and then the placement of a catheter. Having a curved needle, the catheter attached to the needle, single or multiple orifices in the catheter, physical specifications, and method of catheter fixation do not raise new or different safety or effective concerns.

Performance Testing - Non-clinical

Biocompatibility and Materials – The materials have been evaluated per ISO 10993-1. They are characterized as:

External Communicating, Tissue / Bone / Dentin communicating
Surface Contact, Intact Skin and Breached
Duration of Use Limited and Prolonged (> 24 hours < 30 days) ●

Discussion - We tested the all applicable components according to ISO 10993-1 and the results supported the materials as meeting the biocompatibility requirements.

Differences – Any differences in materials were evaluated with the testing which demonstrated that the proposed meets the ISO 10993 requirements and the proposed materials have not raised different questions of safety and effectiveness.

Sterility – We performed sterilization. EO and ECH residuals were evaluated per ISO 10093-7 and LAL endotoxins. The sterilization was validated.

Effects of Aging – We performed testing related to aging to evaluate the performance of the device post-aging. The results supported that aging does not have an effect on the performance of the subject device.

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Comparative Performance - 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

Discussion – There were some differences in the comparative performance.

Tensile strength while lower when compared to the predicate comparison to a legally marketed reference device demonstrated that the subject device had higher tensile when compared to the reference device which had the similar indications for use. The results demonstrated that the tensile strength of the various bonds and connections were within the specifications of the predicate and reference devices which have been found to be safe and effective for the similar indications. The differences do not raise different concerns of safety and effectiveness.
-Flow rate is lower than the predicate but the clinician determines the effectiveness of a block after injection of the anesthetics and the subject does allows for a slower flow rate and allows the clinician time to assess the level of block vs. a higher flow rate device. The quality of a nerve block is a clinical decision under the control of the clinician. This lower flow rate does not alter the risk of safety profile.
-There were no significant differences between the subject device and the predicate which would raise different concerns of safety and effectiveness.

Clinical Study Summary - We provided the results of several clinical trials related to the insertion technique of the Certa Catheter™. 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.

In addition, a review of the Safety and Risk Profile for peripheral nerve block catheters included MAUDE Database search, Literature Search for Nerve damage and Infection supported that the Certa Catheter™ and the predicate had substantially equivalent safety and risk profiles.

One of the studies performed on healthy individuals with a 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]

Discussion - As a result of the Lyngeraa study, 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.

The studies that used this insertion technique support the safety and substantial equivalence of the Certa Catheter.

Substantial Equivalence Conclusion

Based upon the comparison of the indications for use, patient population, environment of use, technology or principle of operation, and performance the subject device can be found substantially equivalent to the predicate.

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).