The Rüsch Blakemore Tube - 3 Lumen, Sterile, is a single use, naso-gastric double balloon tube that can be passed nasally into the stomach suitable for use in management of bleeding esophageal varcis.

Device Description

The Rusch Blakemore Tube - 3 Lumen, sterile, consists of a radiopaque (BaSQ4), three lumen, soft red rubber, graduated, 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 rounded distal (patient) 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. The Rüsch Blakemore Tube - 3 Lumen, sterile, will be available in three (3) sizes designated by outside diameters Ch 14, 16, 18(14, 16, 18 Fr) and three unique part numbers that are yet to be determined. The device will be sold sterile, individually packed in a paper-film pack. Two devices will be packaged in a cardboard box, with one set of instructions for use, and designated as a naso-gastric, double balloon tube that can be passed nasally into the stomach suitable for use in the management of bleeding esophageal varices. The tube works in the principle of applying pressure or tamponade via a latex balloon to the bleeding varix.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a medical device, the Rüsch Blakemore Tube - 3 Lumen, sterile. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with detailed acceptance criteria for software performance.

Based on the content, none of the requested information regarding acceptance criteria or specific study details for device performance (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set ground truth) is present.

The document states:

Acceptance Criteria and Device Performance: Not applicable in this context. The submission is for substantial equivalence, not a new performance evaluation with specific acceptance criteria.
Study Details: No study is described that proves the device meets specific acceptance criteria in the manner typically expected for AI/software-driven medical devices. The submission indicates the device is substantially equivalent to the Rüsch Blakemore Tube - 3 Lumen, non-sterile. This implies that its performance characteristics are considered the same as the predicate device.
Sample Size for Test Set and Data Provenance: Not applicable.
Number of Experts and Qualifications: Not applicable.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
Standalone Performance: Not applicable.
Type of Ground Truth Used: Not applicable.
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set was Established: Not applicable.

Summary of the document's relevance to the request:

The document describes a medical device (a Sengstaken-Blakemore tube for managing bleeding esophageal varices) and its intended use. It is a Class II medical device (21 CFR 876.5980) and the submission seeks to market a sterile version of an already legally marketed non-sterile version of the same device. The core of the 510(k) is to demonstrate substantial equivalence to the predicate device, not to establish new performance criteria through a study. Therefore, the detailed questions about acceptance criteria and study methodologies common for AI/software devices are not addressed in this type of regulatory submission.

Summary

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16981203 1 of 2

2 1338 JUN

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

510(k) Summary

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

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

(603) 532-7706 Telephone: (603) 532-8211 Facsimile: jrwhitney@compuserve.com E-Mail:

Contact: Same as above

Name of the Device, Common, Proprietary (if Known), and 2 . Classification.

Classification Name: Tube, Gastrointestinal and Accessories

Common Name: Sengstaken Blakemore Tube

Proprietary Name: Rüsch Blakemore Tube - 3 Lumen, sterile

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

The Rüsch Blakemore Tube - 3 Lumen, sterile is substantially equivalent to the Rüsch Blakemore Tube - 3 Lumen, non sterile.

Description of the Device. 4 .

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in three (3) sizes designated by outside diameters Ch 14, 16, 18(14, 16, 18 Fr) and three unique part numbers that are yet to be determined.

The device will be sold sterile, individually packed in a paper-film pack. Two devices will be packaged in a cardboard box, with one set of instructions for use, and designated as a naso-gastric, double balloon tube that can be passed nasally into the stomach suitable for use in the management of bleeding esophageal varices. The tube works in the principle of applying pressure or tamponade via a latex balloon to the bleeding varix.

5. Intended Use of the Device.

6. Summary of Technological Characteristics.

The Rüsch Blakemore Tube - 3 Lumen Sterile was developed from the Rüsch Blakemore Tube - 3 Lumen non-sterile which is The provision of a sterile currently in interstate commerce. product is thought to warrant this premarket notification. The Rüsch Blakemore Tube - 3 Lumen will be available sterile and non-sterile in sizes 14, 16, and 18 Fr.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle's head, composed of three overlapping profiles facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle's head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1998 II IN

Mr. James R. Whitney Group Regulatory Affairs Associate RUSCH International Tall Pines Park Jaffrey, NH 03452

Re: K981203 Rusch Blakemore Tube - 3 Lumen Dated: March 30, 1998 Received: April 2, 1998 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT

Dear Mr. Whitney:

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 (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 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 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 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/dsmaldsmam.html".

Sincerely yours

Lillian Yin, Ph.D.

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

Enclosure

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11481203

Page 1 of 1

510(k) Number (if known):_

Device Name: Rüsch Blakemore Tube - 3 Lumen, sterile

Indications for Use:

The Rüsch Blakemore Tube - 3 Lumen, Sterile, is a single use, naso-gastric double balloon tube that can be passed nasally into the stomach suitable for use chac can be passed na esophageal varcis

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Polar R. Ratliff

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 981203 510(k) Number

Prescription Use_ (Per 21 CFR 801.109)

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.