EPINAUT Spring Guide Epidural Catheter is constructed of a stainless steel continuous spring. EPINUAT Spring Guide Epidural Catheter offers two types of catheter. The catheter types, L330 & L600 have an uncoated distal tip which is flexible, smooth and rounded with coils slightly spread for maximum flexibility and lateral distribution of injectant. The other catheter types, C310 & C600 have a distal end which is entirely coated by tube for maximum smoothness. There are 16 models in EPINAUT: L33011320, L33013820, L33011315, L33013815, L60011320, L60013820, L60011315, L60013815, C31011320, C31013820, C31011315, C31013815, C60011320, C60013820, C60011315 and C60013815. Each model is characterized by different length of catheter, length and outer diameter of wire, inner diameter of adapter, length and diameter of introducer needle and needle cap.

EPINUAT Spring Guided Epidural Catheter have enhanced tensile/ break strength and restrict longitudinal catheter stretch, while the spring coils make the catheter resistant to kinking and collapsing. Wire is also provided with the device which consists of a stainless steel and a molded plastic hub.

The introducer needle is inserted into the epidural space through the sacral hiatus under intermittent fluoroscopy. After appropriate determination of the epidurogram and target area, the catheter with the wire in it is advanced through the introducer needle to the concerned area as determined by MRI or symptomatology. When the catheter is approached to target site, the wire is removed from the catheter and then the medication can be injected by attaching the adapter to a syringe.

AI/ML Overview

The medical device in question, EPINAUT, is an Anesthesia Conduction Catheter. The provided context does not include information about clinical studies involving human patients or AI-based performance metrics. The information focuses on non-clinical testing to establish substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various non-clinical tests performed to evaluate the performance of EPINAUT and to demonstrate substantial equivalence to the predicate device, the Racz Epidural Catheter. The acceptance criteria are implicitly met if the test results "met the pre-set criteria" or "supported that the subject device is substantially equivalent." Specific numerical acceptance criteria are not explicitly stated for all tests; rather, the successful completion of the test according to a standard often serves as the acceptance.

No.	Test	Acceptance Criteria (Implicit)	Reported Device Performance
1	Visual Inspection (Appearance)	Device appears as intended, free from defects.	Test performed, results met pre-set criteria.
2	Size Measurement	Dimensions conform to specifications.	Test performed, results met pre-set criteria.
3	Leakage Test (Catheter)	No leakage.	Test performed, results met pre-set criteria.
4	Tensile strength (Catheter)	Meets specified tensile strength (e.g., ISO 10555-1 Annex B for catheter, BS 6196:1989 Appendix D for catheter-hub/Stylet/Needle Stylet).	Test performed, results met pre-set criteria. (Also see side-by-side testing results below).
5	Assemble compatibility (Catheter)	Components fit together correctly.	Test performed, results met pre-set criteria.
6	Radiopacity test	Device is visible under fluoroscopy.	Test performed, results met pre-set criteria.
7	Corrosion resistance test	No significant corrosion.	Test performed, results met pre-set criteria.
8	Flexural Rigidity (Catheter introducer and needle)	Meets specified flexibility requirements.	Test performed, results met pre-set criteria.
9	Pulling (Drawing) Test (Catheter introducer and needle)	Meets specified pulling force requirements.	Test performed, results met pre-set criteria.
10	Flexural Rigidity (Wire)	Meets specified flexibility requirements.	Test performed, results met pre-set criteria.
11	EO Gas residue	Residue levels below accepted limits.	Test performed, results met pre-set criteria.
12	Sterility Test	Sterility Assurance Level (SAL) of 10^-6 (in accordance with ISO 11135 and ISO 11737-1, 2).	Test performed, results met pre-set criteria.
13	Endotoxin Test	Endotoxin levels below specified limits.	Test performed, results met pre-set criteria.
14	Particulate Matter Test	Particulate matter levels below specified limits.	Test performed, results met pre-set criteria.
Side-by-Side Comparative Tests with Predicate Device:
1	Tensile strength (Catheter, Catheter-Hub, Stylet, Needle Stylet)	Performance comparable to predicate device, meeting relevant standards (ISO 10555-1 Annex B, BS 6196:1989 Appendix D for various components, BS 6196:1989 Appendix F for Needle Stylet).	"The test results supported that the subject device is substantially equivalent to the predicate devices." Implies comparable or better performance.
2	Dullness test	Performance comparable to predicate device, meeting BS 6196:1989 Appendix G.	"The test results supported that the subject device is substantially equivalent to the predicate devices." Implies comparable or better performance.
3	Fluid pressure of the catheter/adapter connection	Performance comparable to predicate device, meeting ISO 10555-1 Annex G.	"The test results supported that the subject device is substantially equivalent to the predicate devices." Implies comparable or better performance.
4	Flow rate	Performance comparable to predicate device, meeting ISO 10555-1 Annex E.	"The test results supported that the subject device is substantially equivalent to the predicate devices." Implies comparable or better performance.
5	Luminal integrity	Performance comparable to predicate device, meeting ISO 10555-1 Annex C.	"The test results supported that the subject device is substantially equivalent to the predicate devices." Implies comparable or better performance.
Biocompatibility:		Biocompatible as per ISO 10993-4, 5, 10, 11 and USP 39 <151> for External communicating device (tissue/bone/dentin communicating), Limited exposure (<24 hours).	"Biocompatibility tests were performed... and the test results supported that the subject devices are biocompatible."
Shelf Life:		Validated 3-year shelf life using accelerated aging (ASTM F1980).	"The test results validated 3 year shelf life."

2. Sample size used for the test set and the data provenance:

The document describes non-clinical bench testing. It does not refer to "test sets" in the context of clinical data, human subjects, or AI performance evaluation. Therefore, information on sample sizes for a clinical test set or data provenance (country of origin, retrospective/prospective) is not applicable or provided. The tests mentioned adhere to international standards (e.g., ISO, ASTM, BS) which typically specify the number of samples required for each test.

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

This information is not applicable. The device is an Anesthesia Conduction Catheter, and its performance evaluation relies on engineering, material, and biocompatibility testing according to established standards, not on expert-adjudicated ground truth from clinical image interpretation or similar AI applications.

4. Adjudication method for the test set:

Not applicable, as there is no "test set" in the context of clinical data requiring expert adjudication.

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. The EPINAUT device is an anesthesia conduction catheter, a physical medical device, not an AI software. There is no mention of AI assistance or MRMC studies.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

For non-clinical performance tests, the "ground truth" is defined by the requirements of the relevant international standards (e.g., ISO, ASTM, BS) and the pre-set internal specifications of the manufacturer. For biocompatibility, the ground truth is established by the results of tests performed according to ISO 10993 and USP standards, demonstrating the material not to be toxic or irritating. For sterilization, the ground truth is a Sterility Assurance Level (SAL) of 10^-6 demonstrated through validated methods according to ISO 11135 and ISO 11737.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI system that requires a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

IMEDICOM Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt, Irvine, California 92620

Re: K173541

Trade/Device Name: EPINAUT Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO Dated: July 12, 2018 Received: July 19, 2018

Dear Priscilla Chung:

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 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

Todd D. Courtney -S

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)

K173541

Device Name EPINAUT

Indications for Use (Describe)

For administration of anesthetic agents into the epidural space to provide epidural or caudal anesthesia.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 12, 2018

1. Applicant / Submitter

IMEDICOM Co., Ltd. #612, 172, LS-ro, Gunpo-si, Gyeonggi-do, 435-824 Republic of Korea Tel:+82-31-479-1156 Fax:+82-31-479-1157

2. Submission Correspondent

Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine CA 92620 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com

3. Device

י Trade Name: EPINAUT
י Common Name: Anesthesia conduction catheter
י Classification Name: Anesthesia conduction catheter
Product Code: BSO
Classification regulation: Class II, 21 CFR 868.5120 י

4. Predicate Device:

י Racz Epidural Catheter by Epimed International. Inc. (K954584)

5. Description:

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rounded with coils slightly spread for maximum flexibility and lateral distribution of injectant. The other catheter types, C310 & C600 have a distal end which is entirely coated by tube for maximum smoothness. There are 16 models in EPINAUT: L33011320, L33013820, L33011315, L33013815, L60011320, L60013820, L60011315, L60013815, C31011320, C31013820, C31011315, C31013815, C60011320, C60013820, C60011315 and C60013815. Each model is characterized by different length of catheter, length and outer diameter of wire, inner diameter of adapter, length and diameter of introducer needle and needle cap.

The intended population of the device is the patient with chronic low back pain and contained disc herniations.

6. Indication for use:

For administration of anesthetic agents into the epidural space to provide epidural or caudal anesthesia.

7. Basis for Substantial Equivalence

EPINAUT is substantially equivalent to the Racz Epidural Catheter (K954584) made by Epimed International, Inc.

There are no significant differences between the subject devices and the predicate device. The subject devices have the same intended use as the identified predicate device and they are similar in fundamental scientific technology, design, and size, and they are sterilized via Ethylene Oxide gas.

The materials used in the subject devices might be different from the predicate device; however, the biocompatibility testing results of the subject device support that the subject devices are biocompatible and the performance testing results show that the subject device would perform as well as the predicate device.

	Subject Device	Predicate Device
Device Name	EPINAUT	Racz Epidural Catheter
510(k) Number	-	K954584

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Product Code		BSO	BSO
Manufacturer		IMEDICOM Co., Ltd.	Epimed International, Inc.
Indications for Use		For administration of anestheticagents into the epidural space toprovide epidural or caudalanesthesia.	For administration of anestheticagents into the epidural space toprovide continuous epidural orcaudal anesthesia.
Device	Diameter(O.D.) ofCatheter	19~20G	19~21G
	Length of Catheter	31~60cm	30~84.5cm
	Material	Stainless Steel, Teflon, ABS	Stainless Steel, FEP, ABS
	Tip type	Coil Spring Type	Coil Spring Type
	Single use	Yes	Yes
	Components	Catheter, Adapter,Introducer Needle	Catheter, Adapter,Introducer Needle
	Biocompatibility	Biocompatible	Biocompatible
Endoscope capable		Incapable	Incapable
Sterilization		Ethylene Oxide Gas Sterilization	Ethylene Oxide Gas Sterilization

8. Non-Clinical Testing

· Sterilization validating testing has been performed in accordance with ISO 11135 and ISO 11737-1, 2 to verify the sterility assurance level (10th).
The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 3 year shelf life.
. The epidural catheter, wire, adapter, introducer needle, and needle cap are the patient contacting components and they are categorized as External communicating device (tissue/bone/dentin communicating), Limited exposure (<24 hours). Biocompatibility tests were performed in accordance with ISO 10993-4, 5, 10, 11 and USP 39 <151>, and the test results supported that the subject devices are biocompatible.
. Various bench tests were performed to evaluate the performance of the subject devices and the test results met the pre-set criteria. Below is the list of the tests performed.

No.	Test
1	Visual Inspection (Appearance)
2	Size Measurement
3	Leakage Test (Catheter)
4	Tensile strength (Catheter)

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5	Assemble compatibility (Catheter)
6	Radiopacity test
7	Corrosion resistance test
8	Flexural Rigidity (Catheter introducer and the needle)
9	Pulling (Drawing) Test (Catheter introducer and the needle)
10	Flexural Rigidity (Wire)
11	EO Gas residue
12	Sterility Test
13	Endotoxin Test
14	Particulate Matter Test

We also performed side by side testing to compare performance of the subject device and the predicate device as below.

No	Test Item	Standard
1	Tensile strengthCatheter	ISO 10555-1 Annex B
	Catheter-Hub	BS 6196:1989 Appendix D
	Stylet	BS 6196:1989 Appendix D
	Needle Stylet	BS 6196:1989 Appendix F
2	Dullness test	BS 6196:1989 Appendix G
3	Fluid pressure of thecatheter/ adapter connection	ISO 10555-1 Annex G
4	Flow rate	ISO 10555-1 Annex E
5	Luminal integrity	ISO 10555-1 Annex C

The test results supported that the subject device is substantially equivalent to the predicate devices.

9. Conclusion

Based on the similarities, we conclude that the EPINAUT is substantially equivalent to the predicate devices.

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).