The intended use of the subject device is for the administration of local anesthetics into intra-operative sites for post-operative pain management and for regional anesthesia outside of the epidural space. Routes of administration may be intra-operative, subcutaneous or percutaneous.
The intended use of the subject device is equivalent to the predicates K003966 and K003611

Device Description

The subject device is available as a closed end with multiple holes, fenestrated area, located radially along the lateral surface at the distal end of the device.
The subject device is radiopaque and is available in 19g and 20g sizes.

AI/ML Overview

This document is a 510(k) premarket notification for a Conduction Catheter. It indicates substantial equivalence to predicate devices rather than presenting a study demonstrating it meets specific acceptance criteria based on performance. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in this document.

Here's what can be extracted based on the provided text:

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

This document does not present specific quantitative acceptance criteria or reported device performance in terms of clinical metrics. The basis for clearance is substantial equivalence to existing predicate devices. The document states:

"No new issues of safety and effectiveness are raised by the design of the subject device."
"The subject device is substantially equivalent in its performance to predicate K003966 and in its intended use to predicates K003966 and K003611."
"The design, performance, materials, intended use and safety and effectiveness of the subject device is substantially equivalent to the cited predicate devices."

Therefore, the "acceptance criteria" are implicitly met by demonstrating this substantial equivalence through comparison of technological characteristics, materials, and intended use to previously cleared devices.

Acceptance Criteria (Implied)	Reported Device Performance
Substantially equivalent in design to predicate devices	Verified as substantially equivalent to K991879 and K003966
Substantially equivalent in performance to predicate K003966	Verified as substantially equivalent to K003966
Substantially equivalent in materials to predicate devices	Verified as substantially equivalent to K991879 and K003966
Substantially equivalent in intended use to predicate K003961 and K003611	Verified as substantially equivalent to K003961 and K003611
No new issues of safety and effectiveness	Stated that no new issues are raised by the design of the device

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

This document describes a 510(k) submission based on substantial equivalence, not a clinical study with a test set of patient data. Therefore, this information is not applicable and not provided.

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 no clinical study with a test set of patient data requiring expert-established ground truth is presented.

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

Not applicable, as no clinical study with a test set of patient data requiring adjudication is presented.

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 a medical device for drug delivery, not an AI-assisted diagnostic device where MRMC studies would typically be performed.

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

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

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

Not applicable, as no clinical study with a ground truth is presented. The "ground truth" for this 510(k) submission is the pre-existing FDA clearance of predicate devices, against which the new device's characteristics are compared for substantial equivalence.

8. The sample size for the training set

Not applicable, as no algorithm requiring a training set is involved.

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

Not applicable, as no algorithm requiring a training set is involved.

Summary

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K031600

AUG 1 3 2003

MICOR, INC CONFIDENTIAL

Summary of Safety and Effectiveness 21 CFR 807.92(a)(6)

Date of preparation of Summary: May 21, 2003

MICOR Contact:

Susan Forgrave 1.
MICOR, INC 2. 2855 Oxford Boulevard Allison Park, PA 15101
Telephone: 412-487-1113 3. Facsimile: 412-487-1747 E-mail: sforgrave@micorinc.com

Device Name:

Common name Conduction Catheter 1.
Trade name not applicable at this time 2.
Classification Name: 3.
- Device name: Conduction catheter a.
- Speciality: Anesthesiology b.
- Product code: FRN C.
- Device class: 2 d.
- e. Regulation: 21 CFR 880.5725

Predicate Devices:

K991879 MICOR EpiFlex Epidural Catheter 1.
K001717 MICOR Epidural Conduction Catheter 2.
K003966 MICOR Conduction Catheter 3.
K003611 Pain Care Multi-Port Catheter 4.

Product Description/Function:

1. Description:
- The subject device is available as a closed end with multiple holes, fenestrated area, a. located radially along the lateral surface at the distal end of the device.
- The subject device is radiopaque and is available in 19g and 20g sizes. b.
1. Function:
- The fenestrated area provides the distribution of anesthetic over the surgical wound 2. sites.
- The stainless steel coil increases the flexibility and kink resistance of the catheter. ს.

Technological Characteristics:

Technological Characteristics of the subject device are substantially equivalent to the 】. predicate devices K991879 and K003966 manufactured by MICOR, INC.

Materials:

The polyamide co-polymer, stainless steel coil and black ink used in the subject device is ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ substantially equivelent to the materials used in the predicate devices K991879 and K003966 manufactured by MICOR, INC.
Section 7 Page 1 of 2

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$()31600

MICOR, INC CONFIDENTIAL

Intended Use:

The intended use of the subject device is for the administration of local anesthetics into intra-1. operative sites for post-operative pain management and for regional anesthesia outside of the epidural space. Routes of administration may be intra-operative, subcutaneous or percutaneous.
1. The intended use of the subject device is equivalent to the predicates K003966 and K003611

Safety and Effectiveness:

No new issues of safety and effectiveness are raised by the design of the subject device. 』。
The subject device is substantially equivalent in its performance to predicate K003966 and in 2. its intended use to predicates K003966 and K003611

Conclusion:

The design, performance, materials, intended use and safety and effectiveness of the subject 1. device is substantially equivalent to the cited predicate devices.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

AUG 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan Forgrave Quality Assurance & Regulatory Manager Micor Incorporated 2855 Oxford Boulevard Allison Park, Pennsylvania 15101

Re: K031600

Trade/Device Name: Conduction Catheter Regulation Number: 880. 5725 Regulation Name: Accessary to Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 20, 2003 Received: June 3, 2003

Dear Ms. Forgrave:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Forgrave

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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

Susan Quarles

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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MICOR, INC CONFIDENTIAL

Indications For Use Statement 21 · I R 807.92(a)(5)

K031600 SIO(k) number(if known)

Device name: Conduction Catheter

Indications for use:

to a viet of the Cenduction Catheter is intestitution intration of local anesthetics ﻟﻠﻘﻀﺎﺀ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ comments winters openative sites for post-operative pain management and for · regional anesthesia outside of the epidural space.

·············································································································································································· percutaneous.

. The Conduction Catheris and intended for intravenous or intra-muscular 115€.

officase domot write below this line - soutinue on another page if needed

Concurrence of CDRH Office, Office of Device Evaluation (ODE)

Prescription use

OR Over-the-Counter

Sultana Cucerant

(Division Sign-Off) Divisor of Anesthesiology Infection Control. Dent

510(k) Number: K051600

So. re: re:

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).