← Product Code [KNT](/productcode/KNT) · K981203 # RUSCH BLAKEMORE 3 LUMEN, STERILE (K981203) _Rusch Intl. · KNT · Jun 5, 1998 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K981203 ## Device Facts - **Applicant:** Rusch Intl. - **Product Code:** [KNT](/productcode/KNT.md) - **Decision Date:** Jun 5, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5980 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## 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 in management of bleeding esophageal varcis. ## Device Story The Rüsch Blakemore Tube is a 3-lumen, radiopaque, soft red rubber naso-gastric tube featuring two SILKOLATEX™ cuffs. It is designed for clinical use by healthcare professionals to manage bleeding esophageal varices. The device is passed nasally into the stomach; the cuffs are inflated via Luer syringes to apply mechanical pressure (tamponade) to the bleeding varix. Pilot balloons indicate cuff inflation status. The device is provided sterile for single use. ## Clinical Evidence Bench testing only. ## Technological Characteristics Radiopaque (BaSO4) soft red rubber tube; 3-lumen design; two SILKOLATEX™ cuffs; sizes 14, 16, 18 Fr; sterile, single-use; paper-film packaging. ## Regulatory 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). ## Special Controls *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. ## Predicate Devices - Rüsch Blakemore Tube - 3 Lumen, non sterile ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 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 . 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 {1}------------------------------------------------ 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. 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. ### 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ 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) OR Over-The-Counter Use_ --- **Source:** [https://fda-staging.innolitics.com/device/K981203](https://fda-staging.innolitics.com/device/K981203) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com