The Spirol® Block Continuous Peripheral Nerve Block Catheter permits placement of catheters next to nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

Device Description

Epimed's Spirol® Block Continuous Peripheral Nerve Block Catheter has the following characteristics:

· 19 Ga. & 20 Ga., 14" to 24" in length.
· Offered in open and closed end distal tip configurations.
· Offered in styletted and non-styletted versions.
· Internal radiopaque, echogenic coiled reinforced wire to allow visibility under fluoroscopy and/or ultrasound.
· Catheters to be provided in sterile kit/set style configurations or as a standalone replacement catheter.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Spirol® Block Continuous Peripheral Nerve Block Catheter." This type of document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving a device meets specific acceptance criteria through a comparative effectiveness study or standalone performance.

As such, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly applicable to this document because it describes a different type of device approval process.

Here's why and what information can be extracted:

No Acceptance Criteria or Performance Metrics: The 510(k) process for this type of device does not typically involve defining specific numerical "acceptance criteria" and then demonstrating the device "meets" them in the way clinical trials for new drugs or AI algorithms might. Instead, the focus is on showing the new device functions similarly and is as safe and effective as a legally marketed predicate device.
No "Study" as such for comparative efficacy: There isn't a "study that proves the device meets acceptance criteria" in the sense of a clinical trial or a performance study with human readers improvement. The "study" here refers to non-clinical testing to confirm technological characteristics and biocompatibility.
No AI Component: This device is a physical catheter, not an AI or algorithm-based device. Therefore, questions related to AI-specific metrics (standalone performance, MRMC studies, human reader improvement with AI) are not relevant.

However, I can extract information about the non-clinical testing performed and the basis for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Demonstrated Equivalence to Predicate)	Reported Device Performance (as demonstrated by testing)
Technological Characteristics:
- Single-use, disposable	- Polymer coated stainless steel spring (identical to P1)
- Polymer coated stainless steel spring	- Available in various lengths (identical to P1)
- Available in various lengths	- Open-ended or closed-ended configurations (identical to P1)
- Open-ended or closed-ended configurations	- Three eyes (injection ports) at distal end for closed-ended (identical to P1)
- Three eyes (injection ports) at distal end	- Styletted or non-styletted versions (identical to P1)
- Styletted or non-styletted versions	- 19 Ga. or 20 Ga. models (identical to P1)
- 19 Ga. or 20 Ga. models	- Insertion by trained physician with introducer needle (identical to P1)
- Catheter placement remains after needle withdrawal	- Connects to standard Luer-lock accessories (identical to P1)
- Conveys anesthetic agents
Functional/Material Performance:
- Resists kinking, collapsing, shearing	- Polymer coated stainless steel spring proven to resist (bench testing)
- Withstands minimum acceptable tensile force	- Proven to withstand (bench testing)
- Materials compatible with PNB drugs	- Tested for compatibility (bench testing)
- Injection ports remain patent	- Designed to remain patent (bench testing)
- Deliver injectants at sufficient flow rate	- Designed to deliver (bench testing)
- Catheter and connector compatibility	- Tested and proven compatible (bench testing)
Biocompatibility (per ISO 10993):
- Cytotoxicity	- Meets necessary biocompatibility requirements
- Sensitization	- Meets necessary biocompatibility requirements
- Irritation or Intracutaneous Reactivity	- Meets necessary biocompatibility requirements
- Acute Systemic Toxicity (catheter only)	- Meets necessary biocompatibility requirements
- Sub-acute / Sub-chronic Toxicity (catheter only)	- Meets necessary biocompatibility requirements
- Genotoxicity (catheter only)	- Meets necessary biocompatibility requirements
- Implantation (catheter only)	- Meets necessary biocompatibility requirements
Non-Clinical Testing:
- Dimensional	- Performed, results demonstrate comparability
- Substance compatibility	- Performed, results demonstrate comparability
- Kink testing	- Performed, results demonstrate comparability
- Stiffness	- Performed, results demonstrate comparability
- Tensile strength	- Performed, results demonstrate comparability
- Connector attachment	- Performed, results demonstrate comparability
- Flow test	- Performed, results demonstrate comparability
- Resistance to leakage during aspiration or vacuum	- Performed, results demonstrate comparability
- Resistance to leakage under pressure	- Performed, results demonstrate comparability
- Corrosion resistance	- Performed, results demonstrate comparability
- Skive testing	- Performed, results demonstrate comparability

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

Sample Size: Not specified for any of the non-clinical tests. Medical device bench testing often uses small, representative samples, but specific numbers are not provided in this summary.
Data Provenance: The tests were performed internally by Epimed International, Inc. or by external labs for specific ISO 10993 testing. No country of origin for data is specified beyond the company's location in the USA. All testing described is pre-clinical/bench testing, not human clinical data.

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

This is not applicable. "Ground truth" in the context of expert consensus is typically for diagnostic interpretation tasks (e.g., radiology). For a physical medical device, "ground truth" refers to established engineering specifications, material standards (e.g., ISO 10993), and regulatory requirements. These were assessed through the non-clinical testing listed. While engineers and quality assurance personnel ("experts") would design and oversee these tests, their number and specific qualifications for "establishing ground truth" are not detailed.

4. Adjudication method for the test set:

Not applicable. This concept applies to expert review of clinical cases. The tests described are objective, physical, and chemical tests against defined standards.

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 device is a physical catheter, not an AI or imaging interpretation device, and no human reader studies were performed.

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

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

7. The type of ground truth used:

For technological characteristics and functional performance: Engineering specifications, design inputs, and established performance of the predicate devices.
For biocompatibility: ISO 10993 series of standards.
For non-clinical testing (dimensional, strength, flow, etc.): Industry standards, internal specifications, and performance data from predicate devices.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device. The design validation and non-clinical testing confirm the device meets its intended specifications.

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

Not applicable for the same reason as above.

In summary, the document demonstrates substantial equivalence through:

Comparing the Intended Use and Indications For Use to Predicate Device #2 (K122027).
Comparing the design, manufacture, and material composition to Predicate Device #1 (K981329).
Presenting results from a series of non-clinical bench and laboratory performance tests (dimensional, substance compatibility, kink testing, stiffness, tensile strength, connector attachment, flow test, resistance to leakage, corrosion resistance, and skive testing) to show comparable performance to the predicate devices.
Confirming biocompatibility according to ISO 10993 standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for "Epimed - Designed by Experts for Experts". The logo is in black and white. The word "Epimed" is in a bold, sans-serif font, with a geometric shape to the left of the word. Below the word "Epimed" is the tagline "Designed by Experts for Experts" in a smaller font.

510(k) Summar

Submitter Information:

Name:	Epimed International, Inc.
Address:	141 Sal Landrio DriveCrossroads Business ParkJohnstown, N.Y. 12095
Telephone Number:	(518) 725-0209
Fax Number:	(518) 725-0207
Contact Person:	Preston H. FrasierManager - QA/RA
Telephone Number:	(518) 725-0209 Ext. 1300
Email Address:	prestonf@epimedint.com
Date Prepared:	October 23rd, 2013

Device Name & Classification:

Device Trade Name:	Spirol® Block Continuous Peripheral Nerve Block Catheter
Common Name:	Peripheral Nerve Block Catheter
Classification Name:	Anesthesia Conduction Catheter, BSO (21 CFR 868.5120)

Predicate Device(s) Information:

Predicate Device #1:	Epimed International's "Feth-R-Kath" (K981329)• Catheter later renamed “Spirol®” by Epimed.
Predicate Device #2:	Arrow International's “ARROW FlexBlock ContinuousPeripheral Nerve Block Catheter” (K122027)

Device Description:

Epimed's Spirol® Block Continuous Peripheral Nerve Block Catheter has the following characteristics:

· 19 Ga. & 20 Ga., 14" to 24" in length.
· Offered in open and closed end distal tip configurations.
· Offered in styletted and non-styletted versions.
· Internal radiopaque, echogenic coiled reinforced wire to allow visibility under fluoroscopy and/or ultrasound.
· Catheters to be provided in sterile kit/set style configurations or as a standalone replacement catheter.

141 Sal Landrio Drive • Crossroads Business Park • Johnstown • NY • 12095 • USA 1-800-866-3342 = 1-518-725-0209 · Fax: 1-518-725-0207 · Website: www.epimedpain.com · cserve@epimedint.com

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Image /page/1/Picture/0 description: The image shows the logo for "Epimed", with the tagline "Designed by Experts for Experts" underneath. The logo features a stylized letter "A" to the left of the word "Epimed". The text and logo are in black against a white background.

Statement of Intended Use:

The catheter is designed to deliver anesthesia to manage perioperative pain and/or alleviate postoperative analgesia.

Statement of Indications For Use:

Technological Characteristics and Substantial Equivalence:

Epimed's Spirol Block Continuous Peripheral Nerve Block Catheter has identical Intended Use and Indications For Use as that of the Predicate Device #2 (K122027). The catheter itself is identical in design, manufacture and material composition to Predicate Device #1 (K981329).

The catheter is a single-use, disposable device consisting of a polymer coated stainless steel spring. The catheter is available in various lengths, as well as open-ended or closed-ended configurations; the closed-ended models having three eyes (injection ports) at the distal end. The Spirol® Block is also available in styletted or non-styletted versions, as well as 19 Ga. or 20 Ga. models. This catheter is identical in design, manufacture, and material composition to Predicate Device #1; the only difference being an expansion to the Intended Use / Indications For Use.

The catheter functions by being inserted by a trained physician into a patient by way of an introducer needle (17 Ga. needles recommended to be used to place 19 Ga. catheters. 18 Ga. needles recommended to be used to place 20 Ga. catheters). After placement to the desired peripheral nerve group, the introducer needle is withdrawn, leaving the catheter in place. An Epimed catheter connector (K051171), which is packaged with the device, can then be connected to the catheter which then allows for a standard Luer-lock connection point for a bacterial filter and/ or extension set and/or syringe/pump. Upon successful connection to the desired accessories, anesthetic agents may be delivered continuously or by bolus injection to the intended peripheral nerve group.

As the device is simple in design, there are few scientific concepts that apply; the catheter simply provides a conduit to deliver anesthesia. The polymer coated stainless steel spring has been proven to resist kinking, collapsing and shearing, and has the ability to withstand a minimum acceptable tensile force. The materials used to construct the device have been tested for compatibility with drugs used for performing peripheral nerve blocks. The catheter injection ports have been designed to remain patent and deliver injectants at a flow rate sufficient for the intended use. Lastly, the catheter and the connector with which it is packaged have been tested and proven to be compatible with each other.

141 Sal Landrio Drive . Crossroads Business Park . Johnstown . NY . 12095 . USA 1-800-866-3342 • 1-518-725-0209 • Fax: 1-518-725-0207 • Website: www.epimedpain.com • cserve@epimedint.com

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Image /page/2/Picture/0 description: The image shows the logo for "Epimed", with the tagline "Designed by Experts for Experts" underneath. The logo features a stylized letter "E" with a triangle shape attached to the left side. The word "Epimed" is written in bold, sans-serif font. The tagline is written in a smaller, italicized font.

There are no technological differences among the subject and predicate devices as the subject device, as well as both predicates, are:

Single-use, disposable devices consisting of a polymer coated stainless . steel spring.
Available in various lengths, as well as open-ended or closed-ended . configurations; the closed-ended models having three eyes (injection ports) at the distal end.
Available in styletted or non-styletted versions. .
Available in 19 Ga. or 20 Ga. models. .

Each catheter functions by being inserted by a trained physician into a patient by way of an introducer needle. After placement to the desired location, the introducer needle is withdrawn, leaving the catheter in place. A catheter connector can then be connected to the catheter which then allows for a standard Luer-lock connection point for a bacterial filter and/ or extension set and/or syringe/pump. Upon successful connection to the desired accessories, anesthetic agents may be delivered continuously or by bolus injection to the intended peripheral nerve group.

As the technologic characteristics across all of the referenced devices are identical, there is no effect on substantial equivalence.

Nonclinical Testing:

The results of the performance testing performed, i.e. dimensional, substance compatibility, kink testing, stiffness, tensile strength, connector attachment, flow test, resistance to leakage during aspiration or vacuum, resistance to leakage under pressure, corrosion resistance and skive testing, demonstrate that the Spirol® Block Continuous Peripheral Nerve Block Catheter performs comparably to, and is substantially equivalent to Predicate Device #1 (K981329) and Predicate Device #2 (K122027).

Pre-Clinical Design Validation studies have been performed on the Spirol® Block Continuous Peripheral Nerve Block Catheter. Based on the evaluation results, the Spirol® Block has been proven to conform to physician's needs, is suitable for its intended use, meeting the requirements of the Design Inputs.

In accordance with the applicable sections of ISO 10993, the relevant patient contacting components have been shown to meet the necessary biocompatibility requirements. The biocompatibility of the materials used to manufacture the Spirol® Block have been proven substantially equivalent through laboratory testing performed and documented in the Spirol® Catheter Biocompatibility Assessment. The biocompatibility testing which has been performed includes the following:

Cytotoxicity (per ISO 10993-5) .
. Sensitization (per ISO 10993-10)
Irritation or Intracutaneous Reactivity (per ISO 10993-10) .
Acute Systemic Toxicity (per ISO 10993-11) catheter only .
Sub-acute / Sub-chronic Toxicity (per ISO 10993-11) catheter only .
. Genotoxicity (per ISO 10993-3) catheter only
Implantation (per ISO 10993-6) catheter only .

141 Sal Landrio Drive . Crossroads Business Park . Johnstown . NY . 12095 . USA 1-800-866-3342 • 1-518-725-0209 • Fax: 1-518-725-0207 • Website: www.epimedpain.com • cserve@epimedint.com

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Image /page/3/Picture/0 description: The image shows the logo for "Epimed", with the tagline "Designed by Experts for Experts" underneath. The logo is in bold, black font and has a horizontal line on either side. The "E" in Epimed is stylized with a triangle shape on the left side.

Lastly, in accordance with ISO 10993-18 Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials) Annex C (Principles for Judging Toxicological Equivalency) part c) The materials comprising the Spirol® Block have already been established in a more invasive exposure (Epidural applications) than this less invasive proposed application (Peripheral applications).

Conclusions:

The results of bench and laboratory testing demonstrate that Epimed's Spirol® Block Continuous Peripheral Nerve Block Catheter is substantially equivalent to the cited predicate devices.

Pestur ferin

Preston H. Frasier Manager - QA/RA Epimed International, Inc. prestonf@epimedint.com

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

May 28, 2014

Epimed International, Inc. Preston Frasier Manager - QA/RA 141 Sal Landrio Dr. Crossroads Business Park Johnstown, NY 12095

Re: K133316

Trade/Device Name: Spirol Block Continuous Peripheral Nerve Block Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO Dated: April 21, 2014 Received: April 28, 2014

Dear Mr. Frasier:

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.

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Page 2 - Mr. Frasier

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Safetw/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

Sincerely yours,

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
ADAGRID/ODE/CDRII FOR

Erin I. Keith, M.S. 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) K133316

Device Name

The Spirol® Block Continuous Peripheral Nerve Block Catheter

Indications for Use (Describe)

The Spirol® Block Continuous Peripheral Nerve Block Catheter permits placement of catheters next to nerve plexuses for coninuous nerve block anesthesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع المو . " Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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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).