EpiZact is intended for use with an epidural needing a loss of resistance, which ads a clinician in verifying needle tip placement in the epidural space.

Device Description

EpiZact is a self-pressurizing piston syringe that uses the same loss of resistance technique used by physicians to detect the epidural space. The device is single use, sterile, hanually powered, and designed to connect to standard epidural Tuohy needles (16-18 gauge) with a standard Luer connector.

EpiZact provides tactile feedback, in addition to visual feedback, when a loss of resistance is detected. The tactile feedback is also designed to help reduce the forward motion of the needle upon detection of loss of resistance. The device is comprised of copolyester plastic, stainless steel springs, silicone Orings, silicone and ABS valve, and polydimethylsiloxane (silicone) lubricant.

AI/ML Overview

The provided text describes the EpiZact device and its substantial equivalence to a predicate device, EpiFaith. However, it does not include detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the format requested.

The document lists performance tests conducted, but it doesn't specify the acceptance criteria for each test or the exact performance results of the EpiZact device against those criteria. It focuses on demonstrating that the EpiZact underwent similar testing as the predicate device and that the differences do not raise new safety or effectiveness concerns.

Therefore, I cannot provide the specific table of acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, or details about MRMC studies as requested, because this information is not present in the provided text.

Based on the available text, here's what can be extracted and what is missing:

Missing Information:

A table of acceptance criteria and the reported device performance.
Sample sizes used for the test set.
Data provenance (country of origin, retrospective/prospective).
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size.
If a standalone (algorithm only) performance study was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the performance benchtop testing.
The sample size for the training set.
How the ground truth for the training set was established.

Information that can be inferred or directly stated from the text:

A table of acceptance criteria and the reported device performance:
- N/A. The document lists types of tests performed (e.g., ISO 7886-1 sections, ISO 80369-7 sections, USP <788>) but does not provide a table with specific acceptance criteria (e.g., "X% pass rate," "Y mm deviation maximum") or the quantitative results for the EpiZact against those criteria. It generally states that "Testing conducted under performance... demonstrate the subject device is substantially equivalent to the predicate device" and that the "conclusions drawn... demonstrate that the proposed device is as safe, as effective, and performs as well or better than the legally marketed predicate device."
Sample sized used for the test set and the data provenance:
- N/A. The document does not specify sample sizes for any of the performance tests. It also does not mention study data provenance like country of origin or whether data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. The document does not describe the establishment of ground truth by experts for the performance tests. The "Performance Benchtop Testing" and "Human Factors Studies" are mentioned, but no details on expert involvement for ground truthing are provided.
Adjudication method for the test set:
- N/A. No information on adjudication methods is provided.
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:
- N/A. This device (EpiZact) is a mechanical piston syringe, not an AI or imaging device with "readers" in the typical sense. Therefore, an MRMC study related to AI assistance for human readers is not applicable and not mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is a mechanical device. The concept of "algorithm only" or "standalone algorithm performance" does not apply. The device's function is to provide tactile and visual feedback to a human clinician during an epidural procedure.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. While "Performance Benchtop Testing" and "Human Factors Studies" were conducted, the specific type of ground truth (e.g., established by expert consensus on successful epidural placement in a simulated environment, or physical measurements against a standard) is not detailed. The tests listed (ISO standards, USP) typically have defined metrics and criteria that act as their own "ground truth" for compliance, rather than relying on external expert consensus in the way an imaging AI might.
The sample size for the training set:
- N/A. This device does not involve machine learning or AI, so there is no "training set" in that context.
How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.

Summary

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November 2, 2023

GuideStar Medical Devices % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K233056

Trade/Device Name: EpiZact Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: October 23, 2023 Received: October 23, 2023

Dear Prithul Bom:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Bradley Q. Quinn -S

Bradley Quinn Assistant 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name EpiZact

Indications for Use (Describe)

EpiZact is intended for use with an epidural needing a loss of resistance, which ads a clinician in verifying needle tip placement in the epidural space.

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

Z Prescription Use (Part 21 CFR 801 Subpart D) [ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

SUBMITTER 1

Submitter:	GuideStar Medical Devices Inc.
	201-2067 Cadboro Bay Rd.
	Victoria, BC, Canada, V8R 5G4
	604-970-2714

Contact Person: Michael Dolphin, CEO 604-970-2714 mdolphin@guidestarmd.com

Date of Preparation: July 24, 2023

2 DEVICE INFORMATION

Trade Name:	EpiZact
Regulation Number:	21 CFR 880.5860
Regulation Name:	Piston Syringe
Regulatory Class:	Class II
Product Code:	FMF

3 PREDICATE DEVICE

Predicate Trade Name:	EpiFaith Syringe
Premarket Notification:	K192421
Manufacturer:	Flat Medical Co., Ltd
Regulation Number:	21 CFR 880.5860
Regulation Name:	Piston Syringe
Regulatory Class:	Class II
Product Code:	FMF

4 DEVICE DESCRIPTION

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The device is intended to be used in a hospital setting, with sterile medical supplies. The intended user of this device is a clinician who is performing an epidural procedure.

5 INTENDED USE

EpiZact is intended for use with an epidural needle for detecting a loss of resistance, which aids a clinician in verifying needle tip placement in the epidural space.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE б

Characteristics	EpiZact	EpiFaith	Differences
Indications forUse	Intended for use with anepidural needle for detecting aloss of resistance, which aids aclinician in verifying needle tipplacement in the epiduralspace.	Intended for use with anepidural needle for detecting aloss of resistance, which aids aclinician in verifying needle tipplacement in the epiduralspace.	Same
PatientPopulation	Not designed for the treatmentof any specific disease orcondition, nor does it have atarget population.	Not designed for the treatmentof any specific disease orcondition, nor does it have atarget population.	Same
Principle ofoperation	Loss of resistance (LOR)	Loss of resistance (LOR)	Same
Signalmechanism	A visual and tactile signal istriggered when the needle tipenters the epidural space,indicating a clear endpoint forthe advancement of theneedle.	A visual signal is triggeredwhen the needle tip enters theepidural space, indicating aclear endpoint for theadvancement of the needle.	Similar. EpiZact has tactilefeedback in addition to visualfeedback.
Nozzle type	Compatible with 16–18 gaugeepidural needles. One model:Luer slip (as per ISO 80369-7)	Compatible with 16-18-gaugeepidural needles. Two models(two colors):Luer slip (as per ISO80369-7)NRFit™ (as per ISO80369-6)	Luer slip connector (ISO 80369-7) is the same.NRFit™ connector (ISO 80369-6) is not part of this EpiZactapplication.
Materials	Plastic Components:Copolyester and ABSO-Ring/Seal/Valve: SiliconeSprings: Stainless steel	Plastic Components:PolypropyleneO-Ring/Seal: Synthetic andsilicone rubberSpring: Stainless steel	Similar. The materialdifferences between thesubject and predicate devicesdo not alter suitability of theproposed device for itsintended use. Materials weresubject to a biocompatibilityassessment per ISO 10993- 1.
Lubricant	Silicone oil	Silicone oil	Same
Biocompatibility	Biocompatibility Assessmentmeets ISO 10993-1.	Biocompatibility Assessmentmeets ISO 10993-1.	Same
Single use	Yes	Yes	Same
Characteristics	EpiZact	EpiFaith	Differences
Sterilization	E-beam radiation as per ISO11137.Sterile assurance level: 10-6	E.O gas sterilization as per ISO11135.Sterile assurance level: 10-6	Similar. Both sterilizationmethods are recognized asEstablished Category Asterilization methods.Sterilization methodology wasverified through sterilizationvalidation.
Performancestandards	ISO 7886-1ISO 80369-7USP 788 particulatesOperational Bench Tests	ISO 7886-1ISO 80369-7USP 788 particulates	Same, with additional benchtests performed on EpiZact.
Packaging	Tyvek and PET pouch with SBSbacker card.	Tyvek and PET pouch.	Same, with additional SBScardboard backer card inEpiZact packaging.

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The subject device (EpiZact) has the same indications for use, use environment, patient population, and principle of operation as the predicate device (EpiFaith). Both the subject and predicate use the same lubricant and are single use. The nozzle type (Luer) is identical to one of the two models of the predicate. The technical characteristics that are not identical are as follows:

Signal Mechanism - EpiZact provides tactile feedback in addition to visual feedback when a loss of resistance is detected. The tactile feedback is also designed to help reduce the forward motion of the needle. This adds no new concerns for safety or efficacy, and ultimately adds a margin of safety by providing additional feedback to the user and reduced needle motion.

Materials - The plastic components of EpiFaith are made from polypropylene, whereas the plastic components of EpiZact are made from copolyester and ABS. All EpiZact materials are medical grade and of similar properties to the materials of EpiFaith. The entire EpiZact assembly was validated through a biocompatibility assessment per ISO 10993.

Sterilization - EpiZact is sterilized by E-beam. EpiFaith is sterilized by E.O. gas. Both methods of sterilization are "Established Category A" methods, with equivalent sterilization method for EpiZact was validated through sterilization testing per ISO 11137.

Performance Testing - EpiZact completed all the same performance tests as EpiFaith, with the addition of benchtop performance tests. These custom tests were added to assess operational performance of the device.

Packaging - EpiZact and EpiFaith both utilize Tyvek and PET (polyethylene terephthalate). EpiZact packaging contains an additional backer made from SBS (solid bleached sulfate). The packaging configuration for EpiZact was validated with distribution conditioning, environmental conditioning, and sterile package integrity. Biocompatibility testing conducted on packaged devices verify that this packaging presents no new concerns for safety.

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7 PERFORMANCE DATA

The following tests were performed on EpiZact in support of the substantial equivalence determination:

Performance Tests

ISO 7886-1:2017 – Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

. Section 6.1 – Extraneous Matter (Visual Inspection)
. Section 6.2, Annex A - Limits for Acidity
. Section 6.3, Annex A – Limits for Extractable Metals
Section 7 - Lubricant (Visual Inspection)
. Section 12.2 – Position of Nozzle on End of Barrel (Visual Inspection)
Section 12.3 – Nozzle Lumen (Visual Inspection)
. Section 13.2, Annex B – Freedom from Air Leakage Past Plunger Stopper
Section 13.4 Fit of Plunger/Stopper in Barrel .

ISO 80369-7:2021 – Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications

. Section 5 - Dimensioning
Section 6.2, Annex D Sub-Atmospheric Pressure Air Leakage .
. Section 6.1.3, Annex C - Falling Drop Positive Pressure Liquid Leakage
. Section 6.4, Annex F – Resistance to Separation from Axial Load
. Section 6.5, Annex G - Resistance to Separation from Unscrewing
Section 6.6, Annex H Resistance to Overriding ●
Section 6.3, Annex E Stress Cracking ●

USP <788> – Particulate Matter in Injections

Biocompatibility Tests

ISO 10993-4:2017 – Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

Hemolysis Test ●
ISO 10993-5:2009 – Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
Cytotoxicity Evaluation ●
ISO 10993-10:2021 – Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Dermal Sensitization
ISO 10993-11:2017 – Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Acute Systemic Toxicity
ISO 10993-23:2021 – Biological evaluation of medical devices — Part 23: Tests for irritation
. Intracutaneous Test

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Sterile Barrier Package Testing

ASTM F1980-21 – Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ASTM D4332-14 Standard Practice for Conditioning Containers, Packaging Components for Testing
ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Leak)
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

Sterilization Testing

ISO 11137-1:2006/(R)2015 & A1:2013 & A2:2019 – Device Sterilization ISO 11137-2:2013/(R)2019 - Sterility Verification ISO 11137-3:2017 - Dose Mapping ISO 11737-1:2018 & A1:2021 — Bioburden USP <85> – Bacterial Endotoxins

Performance Benchtop Testing

Production Benchtop Testing Human Factors Studies

8 CONCLUSION

Testing conducted under performance, biocompatibility, sterile barrier packaging, and sterilization demonstrate the subject device is substantially equivalent to the predicate device. The differences between the devices do not raise any new questions of safety or effectiveness.

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well or better than the legally marketed predicate device.

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).