The Spring-Wound Epidiral Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. Micor recommends that the catheter be removed or replaced every 72 hours.

Device Description

This catheter exhibits the same design and performance as the cited predicates. Its external sheath (patient-contact) material is identical to that used in the Preferred Medical predicate.

AI/ML Overview

The provided text is a 510(k) summary for a medical device: the Micor® Spring-Wound Epidural Catheter. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a clinical trial with specific performance metrics and acceptance criteria as might be expected for novel devices.

Therefore, many of the typical elements requested in your prompt (like specific acceptance criteria based on numerical performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance) are not applicable or not present in this type of regulatory document.

However, I can extract information related to the demonstration of equivalence, which functions as the "study" for this type of submission.

Here's a breakdown of the information based on your request, explaining why certain sections are not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: For a 510(k) submission, the "acceptance criteria" are demonstrating substantial equivalence to a predicate device. This is primarily established by showing that the subject device has the same intended use, similar technological characteristics, and similar materials to legally marketed predicate devices, and that no new issues of safety or effectiveness are raised. There are no explicit numerical performance criteria (e.g., sensitivity, specificity, accuracy) defined or measured for this type of device in this document.
Reported Device Performance: The document states:
- "This catheter exhibits the same design and performance characteristics as the legally marketed predicates."
- "The subject device will function the same as the predicate devices."
- "The technological characteristics of Micor's Spring-Wound Epidural Catheter, as compared to those of the Arrow and Epimed predicates, are essentially the same."
- "The materials incorporated in the subject device are identical to ones contained in the legally-marketed predicates..."
- "The intended use of the subject device is equivalent to that of all three predicate devices."
- "Conclusion No new issues of safety or effectiveness are raised by the design of this device. Micor's Spring-Wound Epidural Catheter is equivalent to the cited predicate devices in its material, technology, and intended use."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission is based on a comparison of design, materials, and intended use to existing predicate devices, not on a clinical "test set" of patient data. There are no test sets or data provenance mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As there is no test set in the clinical sense, there is no expert ground truth established for patient data. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their long-term use and regulatory clearance. The FDA's review committee (Division of Cardiovascular, Respiratory, and Neurological Devices) acts as the expert body reviewing the comparison.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set, no adjudication method.

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 is not an AI/Software as a Medical Device (SaMD) and no MRMC study was conducted.

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

Not Applicable. This is a hardware medical device (catheter), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate devices (Arrow International, Inc. FlexTip Plus® Epidural Catheter, Epimed International, Inc. Feth-R-Kath® Epidural Catheters (K981329), and Preferred Medical Products Epidural Catheter (K885278)). The substantial equivalence argument relies on the premise that if the new device is sufficiently similar to these legally marketed devices, it can be considered safe and effective for its intended use.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of device development for a 510(k) submission like this.

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

Not Applicable. See point 8.

Summary

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K991879

OCT 28 1999

Summary of Safety and Effectiveness

Micor®, Inc. Spring-Wound Epidural Catheter

Micor Contact 1.0

Charles W. Eslep Vice President Micor, Inc. 2855 Oxford Boulevard Allison Park, Pennsylvania 15101 Telephone: (412)487-1113 (412)487-1747 Facsimile:

Device Name 2.0

Trade Name 2.1

Spring-Wound Epidural Catheter

2.2 Classification Name

Device Name:	Catheter, Conduction, Anesthetic
Speciality:	Anesthesiology
Product Code:	73 BSO
Device Class:	2
Regulation No.:	21 CFR 868.5120

3.0 Predicate Device

Arrow International, Inc. FlexTip Plus® Epidural Catheter 3.1
Epimed International, Inc. Feth-R-Kath® Epidural Catheters (K981329) 3.2
Preferred Medical Products Epidural Catheter (K885278) 3.3

Product Description/Function 4.0

Description This catheter exhibits the same design and performance 4.1 Desemption Trilo Sumotor Shinned predicates. Its external sheath (patient-contact) material is identical to that used in the Preferred Medical predicate.
Function The subject device will function the same as the predicate 4.2 devices.

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Comparison of the Subject Device and Predicate Devices for Equivalence 5.0

General Catheters incorporating an internal spiral-wound spring, and 5.1 being used for the delivery of anesthetic agents, have been on the U.S. market for over 10 years. These include catheters built and legallymarketed by Arrow International and Epimed International.
Technological Characteristics The technological characteristics of 5.2 Micor's Spring-Wound Epidural Catheter, as compared to those of the Arrow and Epimed predicates, are essentially the same.
5.3 Materials The materials incorporated in the subject device are identical to ones contained in the legally-marketed predicates, Arrow's FlexTip Plus, Epimed's Feth-R-Cath, and Preferred Medical's epidural catheter.
5.4 Intended Use The intended use of the subject device is equivalent to that of all three predicate devices.
Conclusion No new issues of safety or effectiveness are raised by the 5.5 design of this device. Micor's Spring-Wound Epidural Catheter is equivalent to the cited predicate devices in its material, technology, and intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 1999

Mr. Charles W. Eslep Micor, Inc. 2855 Oxford Boulevard Allison Park, PA 15101

Re : K991879 Micor Spring Wound Catheter (part# CS **-0217) Regulatory Class: II (twc) ... . . : Product Code: 73 BSO Dated: September 23, 1999 Received: September 28, 1999

Dear Mr. Eslep:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Charles W. Eslep

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

feanor AU Westerhausen

Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

K99/87 9

510(k) Number (if known)

Spring-Wound Epidural Catheter Device Name

Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K991879

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter__

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).