With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits; and
As a stand alone device to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative or percutaneous.

Device Description

The Soaker Catheter is identical to the predicate IntraOp Catheter (K991543). This premarket notification adds an additional model to the Soaker Catheter family of catheters. The Soaker Catheter consists of a Teleflex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries Medical) with the insertion of a hollow fiber membrane in the inner diameter of the distal end of the catheter. The catheter has a closed end tip with multiple holes arranged radially along the lateral surface at the distal end of the device.

AI/ML Overview

The provided text is a 510(k) summary for the "Soaker Catheter." This document focuses on demonstrating substantial equivalence to pre-existing devices, not on proving performance against specific acceptance criteria through a study. Therefore, the information required to answer most of your questions (acceptance criteria table, study details, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth types for test and training sets) is not present in the provided text.

The document is a regulatory submission for a medical device, which typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than conducting new performance studies that would establish acceptance criteria for novel functionalities.

Here's a breakdown of what can be extracted and why other information is missing:

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

Information Not Found: The document does not specify quantitative acceptance criteria or report performance data against such criteria. Its entire premise is based on substantial equivalence to predicate devices.

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

Information Not Found: No mention of a "test set" or any clinical study from which such data would originate. The submission states the device's materials are "identical" to predicate devices and biological testing is in conformance with ISO 10993, but it doesn't describe a specific performance study in humans.

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)

Information Not Found: Not applicable, as there's no described "test set" requiring ground truth establishment by experts for performance evaluation.

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

Information Not Found: Not applicable, as there's no described "test set" requiring 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

Information Not Found: This is a physical catheter, not an AI-powered diagnostic device. MRMC studies are not relevant here.

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

Information Not Found: This is a physical catheter, not an algorithm. Standalone performance as typically understood for AI/software is not applicable.

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

Information Not Found: Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Information Not Found: Not applicable. There is no "training set" in the context of an AI/machine learning model. The device's design is based on existing, legally marketed catheters.

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

Information Not Found: Not applicable.

Summary of what the document does provide regarding device characteristics and regulatory pathway:

Device Name: Soaker Catheter
Common Name: Anesthetic Catheter
Classification Name: Anesthesia Conduction Catheter
Predicate Devices:
1. I-Flow IntraOp 1.1.1 Catheter (K991543)
2. Teleflex Medical (TFX) Epidural Catheter (K840202)
3. B. Braun Perifix Set (K813186)
4. Epimed International FETH-R KATH catheter (K981329)
Key Aspect of Substantial Equivalence: The Soaker Catheter is described as "identical" to the predicate IntraOp Catheter (K991543), with this submission adding an additional model (S1205: 20 GA with 12.5 cm (5.0 in.) infusion segment) to the existing S0605 model (20 GA with 6.5 cm (2.5 in.) infusion segment). The new model is "virtually identical" to the predicate 2.5-inch Soaker Catheter except for the longer infusion segment.
Material Equivalence: "All materials in the catheter are identical in formulation to materials currently being used in other products with the same or similar uses and have a long history of use in those devices." (Section 3.1)
Biological Testing: "Biological testing is in conformance with ISO 10993 Part 1 for fluid path components." (Section 3.2)
Drug Compatibility: No specific drugs are referenced, and no drugs are included with the catheter. (Section 4.1)
Intended Use:
- With I-Flow Corporation's PainBuster, ON-Q, and Nerve Block pain management kits.
- As a stand-alone device to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative or percutaneous. (Section 5.1 & Indication for Use statement)

In essence, this 510(k) asserts that the Soaker Catheter is substantially equivalent to existing, legally marketed devices. It does not present new performance data against specific acceptance criteria, but rather relies on the established safety and effectiveness of its predicate devices and the similarity of its design and materials.

Summary

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MAR - 3 2000

K 994374

Summary of Safety and Effectiveness

Trade Name: Soaker Catheter Common Name: Anesthetic Catheter Classification Name: Anesthesia Conduction Catheter Classification Panel: Anesthesiology

All questions and/or comments concerning this document should be made to:

Stanlev E. Frv Vice President of Regulatory and Quality

I-Flow Corporation 20202 Windrow Drive Lake Forest, CA 92630

Telephone: 949.206.2700 Fax: 949.206.2600

1.0 GENERAL INFORMATION

1.1 Statement of Equivalence

The Soaker Catheter is substantially equivalent to the (1) I-Flow IntraOp 1.1.1 Catheter (K991543), (2) Teleflex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries), (3) B. Braun Perifix Set (K813186) and (4) the Epimed International FETH-R KATH catheter (K981329).
The Soaker Catheter package may include components that are legally 1.1.2 marketed (either pre-amendment devices or devices that have been granted permission to market via premarket notification regulation) such as an introducer needle or dressing.

2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS

2.1 Description of the Soaker Catheter

The Soaker Catheter is identical to the predicate IntraOp Catheter 2.1.1 (K991543). This premarket notification adds an additional model to the Soaker Catheter family of catheters.
2.1.2 The Soaker Catheter consists of a Teleflex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries Medical) with the insertion of a hollow fiber membrane in the inner diameter of the distal end of the catheter.
- 2.1.2.1 The catheter has a closed end tip with multiple holes arranged radially along the lateral surface at the distal end of the device.

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2.2 Product Configuration

The following Soaker Catheter models will be available: 2.2.1
- S0605: 20 GA with 6.5 cm (2.5 in.) infusion segment (K991543). 2.2.1.1
- S1205: 20 GA with 12.5 cm (5.0 in.) infusion segment. 2.2.1.2
- 2.2.1.3 Each of the catheter sizes will be available as a separate catheter with a currently marketed catheter connector (a Touhy Borst type is an example of any acceptable connector) or an attached luer lock connector. The connectors will meet the ANSI specifications conical connectors.
2.2.2 The Soaker Catheter may consist of a kit that includes components that are legally marketed (either pre-amendment devices or devices that have been granted permission to market via premarket notification regulation).
- 2.2.2.1 Examples of the kit components include the following:
  - Teleflex Medical (TFX) "T" peel catheter over needle 2.2.2.1.1 18 GA X 2 ½" - 3 ½" or
  - 2.2.2.1.2 Johnson & Johnson Bioclusive dressing.
The Soaker Catheter may be used in I-Flow's Pain Management Systems 2.2.3 such as K982946 and K984502.

3.0 BIOLOGICAL SPECIFICATIONS

3.1 All materials in the catheter are identical in formulation to materials currently being used in other products with the same or similar uses and have a long history of use in those devices.
3.2 Biological testing is in conformance with ISO 10993 Part 1 for fluid path components.

4.0 CHEMICAL AND DRUG SPECIFICATIONS

4.1 Drug Compatibility and Stability
- 4.1.1 There are no specific drugs referenced in the labeling for the Soaker Catheter.
- 4.1.2 There are no drugs included in the Soaker Catheter.

5.0 INTENDED USE

5.1 The Soaker Catheter is intended to be used as follows:
- 5.1.1 With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits: and
- 5.1.2 As a stand alone device to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative or percutaneous.
5.2 The catheter is single patient use only.

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LABELS AND LABELING 6.0

I-Flow Corporation believes the proposed labels and labeling, where appropriate, 6.1 meets the requirements of 21 CFR Part 801 as it relates to a determination of intended use and adequate directions for use.

STANDARDS 7.0

There are currently no standards established for anesthetic catheters. 7.1

PACKAGING 8.0

The catheter is packaged in either a Tyvek pouch or a form/fill/seal tray. 8.1

COMPARISON TO LEGALLY MARKETED DEVICES 9.0

The Soaker Catheter is substantially equivalent to the (1) I-Flow IntraOp Catheter 9.1 submitted in K991543, (2) Teleflex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries) (3) the B. Braun Perifix Set (K813186) and (4) the Epimed International FETH-R KATH catheter.
9.2 Device Descriptions
- 9.2.1 Comparisons
  - 9.2.1.1 This submission is intended to notify the Federal Food and Drug Administration that I-Flow Corporation intends to add an additional model to the family of Soaker Catheters formerly referred to as the IntraOp Catheter (K991543). The new model is virtually identical to the predicate 2.5 inch Soaker Catheter except that the new model will have a 5.0 inch infusion segment.
  - 9.2.1.2 All the catheters provide a catheter connector device similar to a Touhy Borst connector or a molded luer lock connector.
- 9.2.2 Based upon the data presented in this section. I-Flow Corporation has determined that the Soaker Catheter is substantially equivalent to the named predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2000

Mr. Stanley E. Fry Vice President of Regulatory and Quality I-Flow Coproration 20202 Windrow Drive Lake Forest, California 92630

K994374 Re : Trade Name: Soaker Catheter Regulatory Class: II Product Code: FRN October 23, 1999 Dated: Received: December 27, 1999

Dear Mr. Fry:

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 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 The general controls provisions of the Act 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory 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

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Page 2 - Mr. Fry

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K994374 Soaker Catheter Device Name: Indications for Use:

The Soaker Catheter is intended to be used as follows:

1. With I-Flow Corporation's PainBuster, ON-Q and Nerve Block pain management kits; and
1. As a stand alone device to provide continuous or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative or percutaneous.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUED ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Patricio Cucurella

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .

(Optional Format 1-2-96)

Page III

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).