(113 days)
The Andersen® Nasogastric Tube is indicated in those situations where the physician desires to keep the stomach continuously and completely evacuated of swallowed air, swallowed saliva, gastric secretions or fresh blood in a fasting patient for a prolonged period, such as pancreatitis. cholecyctitis, post-operative ileus and non-operative management of peptic ulcer. It is also indicated to keep the stomach evacuated of fresh blood once clots have been removed.
Sterile, disposable, bilumenal, medical grade vinyl nasogastric tube with radiopaque vent tube, 24 round aspirating ports, and anti-reflux filter. Includes a lubricated polyethylene stylet. The tubes are marked to aid in positioning the tube during passage.
The provided text describes a 510(k) summary for the Andersen® Nasogastric Tube with Stylet, which is a medical device. This document is a regulatory submission for premarket notification to the FDA. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results in the way one might expect for a software or AI-driven device.
Therefore, many of the requested points related to AI performance, sample sizes for training/test sets, expert adjudication, and ground truth establishment are not applicable to this type of device and submission.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| New Risks Added | "No new risks were added by the modification." (This is more a statement of compliance with safety, rather than a quantifiable performance criterion.) |
| Safety and Effectiveness | "Based on the indications for use and comparison to its predicate device, the Andersen® Nasogastric Tube with Stylet has been shown to be safe and effective for its intended use." (This is a conclusion based on substantial equivalence claim, not specific performance metrics.) |
| Design Control Compliance | "Andersen Products, Inc. has provided a declaration of conformity to 21 CFR § 820.30 Design Control requirements." (This is a regulatory compliance criterion, not a performance metric.) |
| Substantial Equivalence | The device was found substantially equivalent to the predicate device Andersen® Nasogastric Tube with Stylet (AN 10S), K935688. This is the primary "acceptance criterion" for a 510(k). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a traditional medical device (nasogastric tube), not a device that processes data or uses AI. The submission relies on a comparison to a predicate device and a declaration of conformity to design controls, not on a clinical test set with associated data.
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)
Not applicable, as no test set data requiring ground truth establishment by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable, as there is no AI component involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as there is no algorithm or AI component involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no ground truth data is established or used in this type of submission for this device. The regulatory pathway is based on substantial equivalence to a legally marketed predicate, meaning it asserts that the new device is as safe and effective as the existing one.
8. The sample size for the training set
Not applicable, as there is no AI component requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no AI component and therefore no training set with ground truth.
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AUG 3 0 2002
י
510 (k) Summary
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
| Trade Name | Andersen® Nasogastric Tube with Stylet (AN 11S, 13S, 14S and18S) |
|---|---|
| Manufacturer | Andersen Products, Inc. 3202 Caroline Drive Haw River, NC 27258 |
| Device GenericName | Nasogastric tube |
| Classification | Nasogastric tubes have been classified as Class II. No performancestandards have been established under Section 514 of the Food, Drugand Cosmetic Act for gastrointestinal tubes. |
| PredicateDevice | Andersen® Nasogastric Tube with Stylet (AN 10S), K935688 |
| DeviceDescription | Sterile, disposable, bilumenal, medical grade vinyl nasogastric tubewith radiopaque vent tube, 24 round aspirating ports, and anti-refluxfilter. Includes a lubricated polyethylene stylet. The tubes aremarked to aid in positioning the tube during passage. |
| Indications forUse | The Andersen® Nasogastric Tube is indicated in those situationswhere the physician desires to keep the stomach continuously andcompletely evacuated of swallowed air, swallowed saliva, gastricsecretions or fresh blood in a fasting patient for a prolonged period,such as pancreatitis, cholecystitis, post-operative ileus and non-operative management of peptic ulcer. It is also indicated to keep thestomach evacuated of fresh blood once clots have been removed. |
| Safety andPerformance | No new risks were added by the modification. In support of thisSpecial 510(k), Andersen Products, Inc. has provided a declaration ofconformity to 21 CFR § 820.30 Design Control requirements. |
| Conclusion | Based on the indications for use and comparison to its predicatedevice, the Andersen® Nasogastric Tube with Stylet has been shownto be safe and effective for its intended use. |
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
AUG 3 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Wendy Hedrick Director Quality Assurance/Regulatory Affairs Andersen Products. Inc. Health Science Park 3202 Caroline Drive HAW RIVER NC 27258
Re: K021493 Trade/Device Name: Andersen Nasogastric Tube with Stylet (AN 11S, 13S, 14S and 18S) Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II
Dated: July 29, 2002 Received: July 31, 2002
Product Code: 78 KNT
Dear Ms. Hedrick:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
MP
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
.
| 510(k) Number | K021493 |
|---|---|
| Device Name | Andersen® Nasogastric Tube with Stylet (AN 11S, 13S, 14S and 18S) |
| Indications for Use | The Andersen® Nasogastric Tube is indicated in those situations where the physician desires to keep the stomach continuously and completely evacuated of swallowed air, swallowed saliva, gastric secretions or fresh blood in a fasting patient for a prolonged period, such as pancreatitis. cholecyctitis, post-operative ileus and non-operative management of peptic ulcer. It is also indicated to keep the stomach evacuated of fresh blood once clots have been removed. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR § 801. 109) |
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
| 510(k) Number | K021493 |
|---|---|
| --------------- | --------------------------------------------------------- |
§ 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.