(405 days)
The intended use is for the prophylaxis of pulmonary aspirations during induction and termination of general anesthesia.
The Aspisafe Gastric Tube is designed to be used for the prophylaxis of pulmonary aspiration during induction and termination of general anesthesia.
The provided text describes a 510(k) premarket notification for the Aspisafe Gastric Tube. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data or detailed performance studies with acceptance criteria in the way a novel therapeutic device might.
Based on the provided text, the device Aspisafe Gastric Tube is a Class II medical device intended for the prophylaxis of pulmonary aspiration during induction and termination of general anesthesia. The submission seeks to prove substantial equivalence to Gastric Sump Tubes (K935688) by Andersen Products.
Here's an analysis of the provided information against your requested points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Material Composition | "Composed of materials that have been tested in accordance with Tripartite Guidance for biocompatibility and determined to be suitable for the intended use of this product." |
| Physical Performance | "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 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." |
| Intended Use | "Identical... to the Gastric Sump Tubes currently... There are no new issues of safety or effectiveness raised by Aspisafe Gastric Tube." (Demonstration of substantial equivalence to predicate) |
| Safety and Effectiveness | "NO new issues of safety or effectiveness raised by Aspisafe Gastric Tube" (vs. predicate) |
Note: The document does not provide specific numerical acceptance criteria (e.g., tensile strength minimums, flow rate ranges, specific biocompatibility thresholds) or quantitative performance data. Instead, it refers to internal quality control procedures and adherence to existing guidance documents, which is common for 510(k) submissions focusing on substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for any test set or provide details on data provenance (country of origin, retrospective/prospective). The "testing" mentioned refers to internal manufacturing quality control and material biocompatibility, not clinical or comparative performance studies in a "test set" in the sense of a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The submission is for a medical device (a gastric tube), not an AI or diagnostic algorithm requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document, as no clinical test set adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided in the document. The device is a physical medical device (gastric tube), not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the document, as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided in the document. The concept of "ground truth" as used in algorithm validation is not relevant to this type of device submission. The "truth" here is compliance with material safety, manufacturing specifications, and functional equivalence to the predicate device.
8. The sample size for the training set
This information is not applicable and not provided in the document. There is no mention of a "training set" as this is not an AI/algorithm submission.
9. How the ground truth for the training set was established
This information is not applicable and not provided in the document, as there is no training set described.
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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.
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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.
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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
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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)
§ 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.