(216 days)
No
The 510(k) summary describes a mechanical device (a tube with balloons) and makes no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is used for "management of bleeding esophageal varices," which is a medical treatment.
No.
The device is described as a treatment device (naso-gastric double balloon tube) used in the management of bleeding esophageal varices. It does not mention any function related to diagnosing a condition.
No
The device description clearly details a physical tube with lumens, balloons, and other hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Rüsch Blakemore Tube is a physical device inserted into the body (nasally or orally) to manage bleeding esophageal varices. It's a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly states it's for the "management of bleeding esophageal varices," which is a treatment or intervention, not a diagnostic test.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 or orally into the stomach suitable for use in the management of bleeding esophageal varices.
Product codes
78 KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach, esophageal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
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
1
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.
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.
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.
2
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
3
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
OR
Over-The-Counter Use