The Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile is a single use, sterile, naso-gastric double balloon tube that can be passed nasally or orally into the stomach suitable for use in the management of bleeding esophageal varices.

Device Description

The Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile consists of a radiopaque (BaSO2) soft red rubber tube which is rounded and sealed at the distal end and belled out to form a funnel at the proximal end. Four elongated eyes are cut in the tube between the distal end and the cuffs. Two SILKOLATEX™ cuffs are inflated via separate color identified funnels using any Luer syringe; pilot balloons are provided to indicate cuff inflation. A fourth lumen is provided for suctioning of saliva from just above the esophageal cuff.

AI/ML Overview

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device (Rüsch Blakemore Tube - 4 Lumen), and it primarily focuses on establishing substantial equivalence to a predicate device. This type of submission, popular prior to the mid-2010s, does not typically include detailed information on acceptance criteria, a standalone study, or the comprehensive data provenance and expert adjudication methods that would be present in a submission for an AI/ML-powered device.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and reported device performance: This document does not specify any performance acceptance criteria or report results of a performance study. Its focus is on demonstrating equivalence based on materials, manufacturing, and intended use.
Sample size and data provenance for the test set: No information on a test set, sample size, or data origin is provided as no performance study is described.
Number of experts and their qualifications for ground truth: No ground truth establishment is described.
Adjudication method for the test set: Not applicable as no test set or adjudication is described.
Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of such a study. This is a traditional medical device, not an AI/ML product where such studies are common.
Standalone algorithm-only performance: The device is a physical tube, not an algorithm.
Type of ground truth used: Not applicable as no ground truth is established or discussed.
Sample size for the training set: Not applicable as no training set is relevant to this device.
How the ground truth for the training set was established: Not applicable as no training set is relevant to this device.

The document is a regulatory submission for a physical medical device, not software or an AI/ML product. The regulatory pathway in 1998 was based on demonstrating substantial equivalence to a predicate device, which did not typically involve the type of performance studies and detailed data analysis commonly required for AI/ML devices today.

Summary

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MAY 1 8 1998

Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108

510 (k) Summary

of 2

Submitter Name, Address, and Date of Submission. 1.

Mr. James R. Whitney Group Requlatory Affairs Associate Willy Rüsch AG Group Tall Pines Park Jaffrey, New Hampshire 03452

(603) 532-7706 Telephone: (603) 532-8211 Facsimile:

Same as above. Contact:

Name of the Device, Common, Proprietary (if known), and 2. Classification.
Classification Name: Tube, Gastrointestinal and Accessories

Common Name: Blakemore Tube

Proprietary Name: Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile

Identification of the legally marketed device to which the 3. submitter claims equivalence.

The Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile is substantially equivalent to the Rüsch Ultra Blakemore Tube - 4 Lumen, sterile - K832672.

4 . Description of the Device.

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funnels using any Luer syringe; pilot balloons are provided to indicate cuff inflation. A fourth lumen is provided for suctioning of saliva from just above the esophageal cuff.

Intended Use of the Device. 5.

6. Summary of Technological Characteristics.

The Rusch Blakemore Tube - 4 Lumen (Minnesota Type), sterile, is manufactured of the same materials and by the same processes as the Rüsch Blakemore Tube - 3 Lumen, non sterile.

The new 4 Lumen tube will have an additional lumen for suctioning saliva from just above the esophageal cuff and will be available sterile.

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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health. The letters "USA" are also visible above the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K973892 Rusch Blakemore Tube - 4 Lumen (Minnesota Type) Dated: February 17, 1998 Received: February 18, 1998 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT

Dear Mr. Whitney:

MAY 1 8 1998

Mr. James R. Whitney

RUSCH® International

Tall Pines Park

Jaffrey, NH 03452

Group Regulatory Affairs Associate

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 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 (OS) 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to vour premarket notification submission does not affect any obligation you might have under sections 542 of 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the programs on the programs 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/odrb/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): __ K 973892_

Device Name:

Indications for Use:

. .

The Rüsch Blakemore Tube - 4 Lumen (Minnesota Type), sterile is a single use, sterile, naso-gastric double balloon tube that can be passed nasally into the stomach suitable for use in the management of bleeding esophageal varices.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Satting

(Division Sign-Off Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

な

Over-The-Counter Use

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.