The EpiFinder is intended for use, in between a luer Loss of resistance (LOR) syringe and an epidural needle, to verify the needle tip placement in the epidural space as a secondary indicator adjunctive to the LOR technique.

Device Description

The EpiFinder is intended to be used in conjunction with a standard epidural LOR technique as an independent secondary confirmatory indicator, giving the practitioner a clear visual signal that the needle tip has entered the epidural space. The EpiFinder is a sterile, single-use device that is used during epidural procedures. The device works with a standard loss of resistance (LOR) syringe and an epidural needle (18G) to verify that the needle tip placement is in the epidural space in patients ages 18 or older.

The EpiFinder consists of a blunt tip spring-loaded probe that is installed into a standard epidural needle, and a plastic housing that is composed of a linear actuator, a sensor, and a microcontroller that measures the probe spring's contraction. The EpiFinder is attached to a Tuohy needle that has been inserted into the patient. The device has built in "wings" to help advance the needle, if the practitioner wishes to use them. As the needle advances forward, there are LED indicator lights on the housing that give feedback to the operator as to when the epidural space is entered, as input to the user in conjunction with the standard LOR technique.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the EpiFinder device, based on the provided text:

Important Note: The provided text does not explicitly list acceptance criteria in a quantitative table format with pass/fail metrics. Instead, it describes various performance evaluations and concludes that the device's performance was "appropriate," "effective," and "similar to standard practice." Therefore, the table below will summarize the reported device performance based on the described studies, indicating what was evaluated and the general outcome.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Implied)	Reported Device Performance
Biocompatibility	Conformed to ISO 10993 for externally communicating devices with limited contact. All results (cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity) were acceptable.
Benchtop Performance	Demonstrated LOR channel sealing integrity (per ISO 80369-7), Luer dimensional and functional attributes, acceptable probe penetration force, probe integrity, sensing mechanism function, wings mechanism function, acceptable particulate matter, corrosion resistance, device integrity, and consistent operation.
Electrical Safety & EMC	Conformed to IEC 60601 and other applicable standards for electrical safety and electromagnetic compatibility.
Software Validation	Software verification and validation testing was conducted per IEC 62304:2006+AMD1:2015 and FDA's 2005 guidance. Results were found acceptable for software release.
Safety and Effectiveness (Animal)	Evaluated in a pig study (GLP compliant). Device was found appropriate for its intended use (only one adverse event) and effective in providing a clear visual signal that the epidural needle entered the epidural space.
Human Factors/Usability	Evaluated per IEC 62366-1:2015 and FDA's 2016 guidance. No use-related hazards recorded. Three participants in each group experienced use problems, but these were deemed not to pose any additional risk. Users reported high satisfaction.
Safety and Performance (Clinical)	Evaluated in a single-arm, open-label multicenter trial. Device was found appropriate for use in human subjects. Performance was established, demonstrating its capability to correctly identify the epidural space. Utilization of LOR technique with EpiFinder was similar to standard practice.

Study Details

Sample sizes used for the test set and the data provenance:
- Animal Study (Pigs): "Numerous test sites" (specific number not given) were randomly divided into two groups: Group 1 (EpiFinder + standard LOR technique) and Group 2 (standard LOR technique alone). The study was conducted in compliance with OECD principles of Good Laboratory Practice (GLP) ENV/MC/CHEM (98)17 (except for blood analysis).
- Human Factors Evaluation: 16 anesthesiologists (physicians) and 10 student resident nurse anesthetists (sRNAs).
- Clinical Evaluation: 31 adult subjects.
- Data Provenance: The animal study was noted as GLP compliant, implying a controlled, prospective design. The human factors and clinical evaluations would also be prospective studies. The country of origin for the animal and clinical studies is not explicitly stated, but the company address is in Israel.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Animal Study: Ground truth was confirmed using X-ray and contrast medium. No specific number of experts or their qualifications are mentioned for interpreting these confirmations.
- Human Factors: The "experts" were the participating 16 anesthesiologists (physicians) and 10 student resident nurse anesthetists (sRNAs) who evaluated usability. Their feedback contributed to assessing safety and usability.
- Clinical Evaluation: Ground truth for epidural space identification during the clinical trial is implied to be clinical assessment by the performing physicians, potentially combined with the standard LOR technique used concurrently. The text mentions "The performance of the device was also established, demonstrating that the device is capable of correctly identifying the epidural space during the injection procedure." No specific number of independent experts or their detailed qualifications for establishing ground truth are explicitly stated beyond the clinical team performing the procedures.
Adjudication method for the test set:
- The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in any of the studies.
- In the animal study, confirmation was via X-ray and contrast medium, which typically involves interpretation by a radiologist or veterinary specialist, but a specific adjudication process isn't detailed.
- In the clinical evaluation, the "correctly identifying the epidural space" implies the clinical judgment of the performing physician was the primary determinant, likely corroborated by the LOR technique.
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:
- No MRMC comparative effectiveness study is described where human readers' performance with and without AI assistance is compared. The EpiFinder is a physical device with an indicator (LEDs) and functions adjunctively to the standard LOR technique, rather than being an AI diagnostic tool primarily interpreted by human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The EpiFinder is designed to be used "in conjunction with a standard epidural LOR technique as an independent secondary confirmatory indicator." It provides a "clear visual signal" via LEDs. Therefore, its performance is inherently "human-in-the-loop" as it provides feedback to the operator. The animal study did evaluate the device's signal in conjunction with the standard LOR technique, and its effectiveness was confirmed against X-ray and contrast.
The type of ground truth used:
- Animal Study: Radiographic confirmation (X-ray and contrast medium).
- Clinical Evaluation: Clinical identification of the epidural space by performing physicians, presumably leveraging the concurrent standard LOR technique. The device's ability to "correctly identify" the space refers to its agreement with this clinical assessment.
The sample size for the training set:
- The document describes performance evaluation studies (validation studies) for the EpiFinder. It does not provide information about a "training set" as this device is a hardware product with a pre-programmed microcontroller/firmware, not a machine learning (AI) algorithm that undergoes a training phase with a distinct dataset. Software verification and validation were performed, but this typically involves testing inputs/outputs against specifications, not learning from a dataset.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a "training set" in the context of an AI/machine learning model. The software is described as "pre-programmed software (firmware)," implying it's deterministic based on its design specifications, not trained on data.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 16, 2023

Omeq Medical Ltd. % Janice Hogan Partner Hogan Lovells, US LLP 1735 Market Street, 23RD Floor Philadelphia, Pennsylvania 19103

Re: K221974

Trade/Device Name: EpiFinder Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: March 17, 2023 Received: March 17, 2023

Dear Janice Hogan:

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

{1}------------------------------------------------

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 mediation-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,

James J. Lee -S

James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below

510(k) Number (if known)

K221974

Device Name

EpiFinder™

Indications for Use (Describe)

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

区 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.gov

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

{3}------------------------------------------------

510(k) Summary Omeq Medical's EpiFinder™ - K221974

510k Owner:	Omeq Medical Ltd.
Address	17 Tchelet (sky) St. Misgav Business ParkM.P. Misgav 2017400, Israel
Contact person:	Lior MargalitOmeq Medical Ltd.Bezalel 4, Ramat Gan, Israel (5252104)TEL: +972-(0)54-4315340Email: lior@omeqmedical.com
Date Prepared:	April 13, 2023
Device Trade Name:	EpiFinder™
Common or Usual Name:	Loss of Resistance (LOR) Device
Classification:	Class II per 21 C.F.R. § 880.5860, Piston Syringe
Product Code:	FMF
Predicate Device:	Exmoor Plastics Limited's Epidrum (K093863)
Reference Device	Mirador Biomedical, Inc.'s Compass Epidural Assist(K112203)

A. INTENDED USE/INDICATION FOR USE

B. DEVICE DESCRIPTION

{4}------------------------------------------------

C. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

Both the subject and predicate devices operate in conjunction with a standard luer LOR syringe and epidural needle to enable detection of when the needle has entered the epidural space. Both devices detect entry into the epidural space via tissue resistance differentiation, which is based on the wellknown and widely used loss of resistance technique. In addition, both are comprised entirely or largely of medical-grade polymers.

The primary technological difference between the subject and predicate devices is that the predicate device incorporates an expandable membrane which deflates while the needle tip enters the epidural space and does not enable utilization of loss of resistance (LOR) technique by using the syringe, (though the reference device does). In contrast, the subject device enables a standard LOR technique (primary indicator) and a secondary indicator that uses a spring-loaded probe which expands while the needle tip enters the epidural space. The subject device provides a secondary indicator as to when the epidural space is entered while the predicate device replaces the LOR technique with its own indicator (membrane deflation).

A table comparing the key features of the subject, predicate, and reference devices is provided below.

Characteristic	EpiFinder(Subject device)	Epidrum(predicate device) (K093863)	Compass Epidural Assist(reference device) (K112203)
Classification	(Primary) 21 C.F.R. §880.5860, Piston Syringe(Product Code FMF);(Secondary) 21 C.F.R. §870.2850, Transducer,BloodPressure, Extravascular(Product Code DRS)	21 C.F.R. § 880.5860, PistonSyringe (Product Code FMF)	(Primary) 21 C.F.R. §870.2850, Transducer,BloodPressure,Extravascular(Product Code DRS)(Secondary) 21 C.F.R. §870.1435, Computer,Diagnostic, Pre-Programmed,Single-Function (ProductCode DXG)
Intended use /Indications forUse	The EpiFinder is intendedfor use, in between a luerLoss of resistance syringeand an epidural needle, toverify the needle tipplacement in the epiduralspace as a secondaryindicator adjunctive to theLOR technique.	Intended Use: The Epidrum isintended for use in epiduralprocedures between a luersyringe and an epiduralneedleto give a clear visual signalthat the needle tip hasentered the epidural space.Indications for Use: TheEpidrum is intended for use,in conjunction with an epiduralneedle, to verify the needle tipplacement in the epiduralspace.	The Compass EpiduralAssist disposable pressuretransducer with integrateddigital display is intended fordirect measurement ofphysiological pressure.
Intended patientpopulation	18 years of age and older	Adults	Information not available
Characteristic	EpiFinder(Subject device)	Epidrum(predicate device) (K093863)	Compass Epidural Assist(reference device) (K112203)
Single /multiuse	Single Use	Single Use	Single Use
Rx / OTC	Rx	Rx	Rx
Shelf life	12 months	Information not available	Information not available
Sterilitymethod	EtO sterile	EtO sterile	sterile
Enabling theoperatorutilizemanual LORtechnique byusing a syringe	Enabled	Not enabled*The loss of resistance isindicated by the deflatedmembrane	Enabled
Principle ofoperation	The Epifinder is attachedbetween a standard 18 Gepidural needle and a LORsyringe to allow a standardLOR technique (Primaryindicator) and simultaneouslya secondary indicator theuses a spring-loaded probethat is compressed orexpands in accordance to theresistance at the needle tip.	A small chamber, featuring anexpandable membrane,which deflates as the needletip enters the epidural space.	The compass is attacheddistally to an inserted needle/ catheter to measurepressure via an embeddedpressure sensor.
SensingTechnology	Force acting on spring loadedprobe	Pressure acting onextendable membrane	Pressure acting on pressuretransducer
Indicator ofchange (Displaytype)	LEDs	Subjective visual indication(membrane)	LCD
Attachmentmechanism	Attached to standardepidural needle and syringe	Attached to standardepidural needle and syringe	Attached to standardepidural needle and syringe
EpiduralNeedle SizeCompatibility	18G	16G-18G	Information not available
Source ofEnergy	Battery	Mechanical device	Battery
Software	Pre-programmed software(firmware)	Mechanical device	Pre-programmed software(firmware)
Materials	Medical grade polymersand medical grade stainlesssteel	Unidentified medical gradepolymer(s) with a siliconediaphragm	Unidentified medical gradepolymer(s)

Substantial Equivalence Table

{5}------------------------------------------------

D. PERFORMANCE DATA

Final verification/validation testing of the EpiFinder device is summarized below. The results were supportive of the device's safety and effectiveness for the proposed indications.

{6}------------------------------------------------

. Biocompatibility: Testing per ISO 10993 evaluated the relevant endpoints for an externally communicating device with limited contact with tissue: cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity and material-mediated pyrogenicity. All results were acceptable.
Benchtop tests: LOR channel sealing integrity, LOR channel sealing integrity per ISO 80369-. 7, Luer dimensional and functional attributes verification, probe penetration force, probe integrity, sensing mechanism, wings mechanism, particulate matter, corrosion resistance, device integrity, device operation time under load, torques on Front Luer and Housing interface point, Sensing mechanism consistency throughout shelf-life and LOR channel resistance.
Electrical Safety and Electromagnetic Compatibility (EMC): The EpiFinder was determined to ● be in conformance with IEC 60601 and other applicable standards for electrical safety and EMC.
. Software: Software verification and validation testing was conducted, and results were found acceptable for software release per IEC 62304:2006+AMD1:2015 and FDA's 2005 quidance document.
. Animal Study: A study in pigs was conducted to evaluate the safety and effectiveness of using the EpiFinder device in epidural procedures in accordance with the proposed indications for use. The study was conducted in compliance with the OECD principles of Good Laboratory Practice (GLP) ENV/MC/CHEM (98)17 (except for the blood analysis). The study evaluated numerous test sites which were randomly divided into two groups: Group 1 (where the EpiFinder was used in conjunction with standard LOR technique) and Group 2 (where standard LOR technique alone was used). Needle advancement was halted when the epidural space was identified either by the EpiFinder's LEDs or by standard LOR technique, and the finding was confirmed using X-ray and contrast medium (if needed). Results demonstrated that the device is appropriate for its intended use (only one adverse event) and effective in providing a clear visual signal that the epidural needle had entered the epidural space.
Human Factors Evaluation: Usability studies have been conducted with the EpiFinder per IEC . 62366-1:2015 and FDA's corresponding 2016 guidance document. The study was conducted with 16 anesthesiologists (physicians) and 10 student resident nurse anesthetists (sRNAs) to evaluate the safe use, any usability concerns, and clear readability of the IFU/labeling of the Epifinder. No use-related hazards were recorded. Three participants in each group experiences use problems, but these were deemed not to pose any additional risk. Additionally, users reported a high level of satisfaction with the device's design and ergonomic attributes.
Clinical Evaluation: The EpiFinder was evaluated in a single arm, open label multicenter trial. The purpose of the trial was to assess the safety and performance of the EpiFinder in 31 adult subjects with clinical indication for a lumbar epidural steroid injection. The EpiFinder was found to be appropriate for use in human subjects. The performance of the device was also established, demonstrating that the device is capable of correctly identifying the epidural space during the injection procedure. In addition, the data from this trial demonstrate that the utilization of LOR technique with the EpiFinder is similar to the standard practice and that the device can be incorporated into clinical practice. All injections were performed on the lumbar region (21 injections in the L5-S1 interspace, 9 injections in the L4-L5 and one injection in L2-L3) while patients were in the prone position. 2 users conducted LOR technique with air as the medium while 1 user conducted it with saline as the medium.

{7}------------------------------------------------

E. CONCLUSION

The EpiFinder is as safe and effective as the Epidrum predicate device (K093863). The EpiFinder has the same intended use and similar indications for use, and technological characteristics and principles of operation, as the predicate device. The minor technological differences between the EpiFinder and its predicate device raise no new issues of safety or effectiveness, and the reference device -Compass Epidural Assist (K112203) – further supports these elements of the EpiFinder technology. Performance data demonstrate that the minor technological differences do not adversely impact the subject device's performance as intended. Thus, the EpiFinder is substantially equivalent.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).