(405 days)
Not Found
No
The summary describes a physical gastric tube and its intended use, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is used for prophylaxis, which means prevention, not treatment or therapy. It prevents pulmonary aspirations (a medical problem) during specific medical procedures.
No
The device, a gastric tube, is intended for prophylaxis (prevention) of pulmonary aspirations, not for diagnosis. Its description focuses on its function as a tool in a medical procedure, not as a means to identify or determine a medical condition.
No
The device description explicitly states "The Aspisafe Gastric Tube is designed to be used...", indicating a physical device (a tube) is the primary component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the prophylaxis of pulmonary aspirations during induction and termination of general anesthesia." This describes a therapeutic or preventative action performed directly on a patient, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Device Description: The description reinforces the intended use as a "Gastric Tube" used for prophylaxis during anesthesia. This is a medical device used in a clinical setting, not a diagnostic test.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
Therefore, the Aspisafe Gastric Tube is a medical device used for a clinical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use is for the prophylaxis of pulmonary aspirations during induction and termination of general anesthesia.
Product codes (comma separated list FDA assigned to the subject device)
78 BSS
Device Description
The Aspisafe Gastric Tube is designed to be used for the prophylaxis of pulmonary aspiration during induction and termination of general anesthesia. The Aspisafe Gastric Tube is composed of materials that have been cested in accordance with Tripartite Guidance for been cested accordingly and determined to be suitable for the intended use of this product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to: physical testing, visual examination (in process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications. The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K961711
1 of 2
II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
1997
April 29, 1996
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610) 691-5400
Mark S. Alsberge, Regulatory Affairs Manager CONTACT:
PRODUCT NAME: Aspisafe Gastric Tube
Nasogastric Tube TRADE NAME:
CLASSIFICATION NAME:
General Hospital Class II, 80 BSS 21 CFR 880.5440
SUBSTANTIAL EQUIVALENCE, TO:
| 510 (k) number | Name | Applicant |
|---|---|---|
| K935688 | Gastric Sump Tubes | Andersen Products |
DEVICE DESCRIPTION:
In accordance with section 510(k) for the Federal Food, In accordance with Bct, B. Braun Medical, Inc. intends to Drug, and Cosmetre commerce Aspisafe Gastric Tube. The Aspisafe Gastric Tube is designed to be used for the prophylaxis of pulmonary aspiration during induction and termination of general anesthesia.
The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an Intended co be a decembiated. One and the Federal Food, Drug, and FDA Tegulatory polices to the fact that the product can be cosmetic not and premarket approval or reclassification. These marketed without premained distinct from a parent point of view. products may be concidered ivalent" is not applicable to and does The CEIM 'Substantially Sqarms related to this product or the technology used to manufacture the product.
MATERIAL :
The Aspisafe Gastric Tube is composed of materials that have The Aspisare Gaocrance with Tripartite Guidance for been cested in accordained to be suitable for the intended use of this product.
Image /page/0/Picture/17 description: The image contains a single digit, specifically the number 5. The number is written in a simple, sans-serif font and is slightly blurred. The digit is black against a white background.
1
SUBSTANTIAL EQUIVALENCE:
The Aspisafe Gastric Tube is identical in materials, form, and intended use to the Gastric Sump Tubes currently and incomes are aroducts. There are no new issues of
safety or effectiveness raised by Aspisafe Gastric Tube.
2012
SAFETY AND EFFECTIVENESS:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited physical testing, visual examination (in process and to: finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 1997
Mr. Mark S. Alsberge Regulatory Affairs Manager B. Braun Medical, Inc. 824 Twelfth Avenue P.O. Box 4027 Bethlehem, Pennsylvania 18018-0027 Re: K961711
Aspisafe Gastric Tube Dated: March 12, 1997 Received: March 13, 1997 Regulatory class: II 21 CFR §876.5980/Product code: 78 BSS
Dear Mr. Alsberge:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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) 594-4616. 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,
William Yi
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
510(k) Number (if known): n 96/7/1
Device Name: Aspisafe Gastric Tube
Indications For Use:
参
The intended use is for the prophylaxis of pulmonary aspirations during induction and termination of general anesthesia.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Salling/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K961711
Prescription Use
(Per 21 CFR 801.109)
:
OR
Over-The-Counter Use
(Optional Format 1-2-96)