The principles of operation and technology incorporated in the Tubing are equivalent to other standard surgical tubing that acts as a pathway between the operative site and either an aspiration or irrigation source for fluid or soft tissue removal and fluid delivery.

AI/ML Overview

This document, K974295, describes a 510(k) submission for the Byron Medical Aspiration and Infiltration/Irrigation Tubing. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not applicable or not provided in this type of regulatory submission.

Here's a breakdown of what can be gleaned from the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

Not Applicable. This 510(k) submission does not present specific acceptance criteria or performance data for the Byron Medical Tubing. Its primary goal is to establish "substantial equivalence" to existing, legally marketed devices. This means that instead of proving specific performance metrics, the device is asserted to be safe and effective because its operational principles, technology, and intended use are similar to predicate devices that have already been cleared by the FDA.

Study Details

Since this is a substantial equivalence claim, it does not involve the type of clinical or performance study you are asking about. Therefore, the following information is not provided in the document:

Sample size used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no test set requiring ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of Substantial Equivalence Claim

The document explicitly states:

Device Description: "The principles of operation and technology incorporated in the Tubing are equivalent to other standard surgical tubing that acts as a pathway between the operative site and either an aspiration or irrigation source for fluid or soft tissue removal and fluid delivery."
Substantial Equivalence Claim: "The principles of operation and technology incorporated in the Tubing are similar to other tubing devices with the function to deliver fluids or remove soft tissue and general aspirate which the FDA has founded to be substantially equivalent to pre-amendment devices..."

The submission lists several predicate devices to which the Byron Medical Tubing claims substantial equivalence:

VCI Suction and Irrigation Tubing Sets (Vital Concepts, K93482, 01 February 1994)
Irrigation and Aspiration Tubing (ARMM. Inc., K923201, Substantial Equivalence Date: Unknown)
Ackrad Fluid Connecting Set (Ackrad Laboratories, Inc., K820937, 26 April 1982)
Disposable Tubing (Wells Johnson Company., 510(k) Number: Unknown, Substantial Equivalence Date: Unknown)

Conclusion:

This 510(k) submission for the Byron Medical Aspiration and Infiltration/Irrigation Tubing relies on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance data against pre-defined acceptance criteria from a specific study. Therefore, the detailed information requested about study design, sample sizes, ground truth establishment, and expert involvement is not present in this document, as it is generally not required for this type of regulatory pathway.

Summary

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Byron Medical Confidential - TRADE SECRET

FEB 10 1998

510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

The assigned 510(k) number is: ك 97429 ك

Submitted by:

Steve Bollinger V.P. Research and Development Byron Medical, Inc. 3280 East Hemisphere Loop Tucson, AZ 85706

Telephone #: (520) 573-0857 Facsimile #: (520) 746-1757

Date Prepared:

ત્વપ્ર

12 November 1997

Establishment Registration Number: Byron Medical is located at 3280 East Hemisphere Loop, Tucson, AZ 85706. We are registered with the Food and Drug Administration as Establishment Number 2025576.

Classification Name:

Catheter, Irrigation 21 CFR § 878.4200 (1997)

Tubing, Non-Invasive 21 CFR § 884.1720 (1997)

Common/Usual Name:

Aspiration and Irrigation Tubing

Byron Medical Aspiration (HI-VAC) and Infiltration / Irrigation (LAM)Tubing

Indication for Use:

Proprietary Name:

General surgical aspiration and fluid irrigation/ infiltration.

000000025

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Byron Medical Confidential - TRADE SECRET

510(k) SUMMARY (cont.)

Device Description:

Substantial Equivalence Claim:

The principles of operation and technology incorporated in the Tubing are similar to other tubing devices with the function to deliver fluids or remove soft tissue and general aspirate which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined below.

VCI Suction and Irrigation Tubing Sets Product: Vital Concepts Manufacturer: 510(k) Number: K93482 Substantial Equivalence Date: 01 February 1994

Irrigation and Aspiration Tubing Product: Manufacturer: ARMM. Inc. K923201 510(k) Number: Substantial Equivalence Date: Unknown

Ackrad Fluid Connecting Set Product: Ackrad Laboratories, Inc. Manufacturer: 510(k) Number: K820937 Substantial Equivalence Date: 26 April 1982 Substantial Equivalence Letter is presented as Exhibit N.

Disposable Tubing Product: Wells Johnson Company. Manufacturer: Unknown 510(k) Number: Substantial Equivalence Date: Unknown

00000000006

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steve Bollinger Vice President Research and Development Byron Medical, Incorporated 3280 East Hemisphere Loop Tucson, Arizona 85706

FEB 1 0 1998

Re: K974295 Trade Name: Byron Medical Aspiration and Infiltration/Irrigation Tubing Regulatory Class: II Product Code: KGZ Dated: November 12, 1997 Received: November 14, 1997

Dear Mr. Bollinger:

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 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 (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 the Act for

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Page 2 - Mr. Bollinger

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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/dsmamain.html".

Sincerely yours.

tocoell

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K974295 510(k) Number (if known): _

Device Name: Byron Medical Aspiration and Infiltration/IrrigationTubing

Indications for Use:

The Tubing Indications for use are general surgical fluid, exudate, rne Tubing me aspiration and general surgical fluid irrigation/infiltration.

(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 Sign-OM)
Division of General Restorative Devices K4 74245
510(k) Number

Prescription Use
(Per 21 CFR 801.109

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

000000011

Regulation Number and Section

§ 878.4200 Introduction/drainage catheter and accessories.

(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.