EpiFinder

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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) 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. 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 Park<br>M.P. Misgav 2017400, Israel | | Contact person: | Lior Margalit<br>Omeq Medical Ltd.<br>Bezalel 4, Ramat Gan, Israel (5252104)<br>TEL: +972-(0)54-4315340<br>Email: 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<br>(K112203) | ## A. INTENDED USE/INDICATION FOR USE 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. ## B. 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. {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<br>(Subject device) | Epidrum<br>(predicate device) (K093863) | Compass Epidural Assist<br>(reference device) (K112203) | |--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification | (Primary) 21 C.F.R. §<br>880.5860, Piston Syringe<br>(Product Code FMF);<br>(Secondary) 21 C.F.R. §<br>870.2850, Transducer,<br>BloodPressure, Extravascular<br>(Product Code DRS) | 21 C.F.R. § 880.5860, Piston<br>Syringe (Product Code FMF) | (Primary) 21 C.F.R. §<br>870.2850, Transducer,<br>BloodPressure,<br>Extravascular<br>(Product Code DRS)<br>(Secondary) 21 C.F.R. §<br>870.1435, Computer,<br>Diagnostic, Pre-<br>Programmed,<br>Single-Function (Product<br>Code DXG) | | Intended use /<br>Indications for<br>Use | The EpiFinder is intended<br>for use, in between a luer<br>Loss of resistance syringe<br>and an epidural needle, to<br>verify the needle tip<br>placement in the epidural<br>space as a secondary<br>indicator adjunctive to the<br>LOR technique. | Intended Use: The Epidrum is<br>intended for use in epidural<br>procedures between a luer<br>syringe and an epidural<br>needle<br>to give a clear visual signal<br>that the needle tip has<br>entered the epidural space.<br>Indications for Use: The<br>Epidrum is intended for use,<br>in conjunction with an epidural<br>needle, to verify the needle tip<br>placement in the epidural<br>space. | The Compass Epidural<br>Assist disposable pressure<br>transducer with integrated<br>digital display is intended for<br>direct measurement of<br>physiological pressure. | | Intended patient<br>population | 18 years of age and older | Adults | Information not available | | Characteristic | EpiFinder<br>(Subject device) | Epidrum<br>(predicate device) (K093863) | Compass Epidural Assist<br>(reference device) (K112203) | | Single /multi<br>use | Single Use | Single Use | Single Use | | Rx / OTC | Rx | Rx | Rx | | Shelf life | 12 months | Information not available | Information not available | | Sterility<br>method | EtO sterile | EtO sterile | sterile | | Enabling the<br>operator<br>utilize<br>manual LOR<br>technique by<br>using a syringe | Enabled | Not enabled<br>*The loss of resistance is<br>indicated by the deflated<br>membrane | Enabled | | Principle of<br>operation | The Epifinder is attached<br>between a standard 18 G<br>epidural needle and a LOR<br>syringe to allow a standard<br>LOR technique (Primary<br>indicator) and simultaneously<br>a secondary indicator the<br>uses a spring-loaded probe<br>that is compressed or<br>expands in accordance to the<br>resistance at the needle tip. | A small chamber, featuring an<br>expandable membrane,<br>which deflates as the needle<br>tip enters the epidural space. | The compass is attached<br>distally to an inserted needle<br>/ catheter to measure<br>pressure via an embedded<br>pressure sensor. | | Sensing<br>Technology | Force acting on spring loaded<br>probe | Pressure acting on<br>extendable membrane | Pressure acting on pressure<br>transducer | | Indicator of<br>change (Display<br>type) | LEDs | Subjective visual indication<br>(membrane) | LCD | | Attachment<br>mechanism | Attached to standard<br>epidural needle and syringe | Attached to standard<br>epidural needle and syringe | Attached to standard<br>epidural needle and syringe | | Epidural<br>Needle Size<br>Compatibility | 18G | 16G-18G | Information not available | | Source of<br>Energy | Battery | Mechanical device | Battery | | Software | Pre-programmed software<br>(firmware) | Mechanical device | Pre-programmed software<br>(firmware) | | Materials | Medical grade polymers<br>and medical grade stainless<br>steel | Unidentified medical grade<br>polymer(s) with a silicone<br>diaphragm | Unidentified medical grade<br>polymer(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.