(29 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
The device is described as a measuring device used to determine the length of a stoma prior to placement of a feeding tube, which is a diagnostic/measurement function, not a therapeutic one.
No
This device is used for measuring the length of a stoma, which is a physical measurement, not a diagnosis of a condition or disease.
No
The device description explicitly details physical components like a tubular shaft, inflation valve, and retaining balloon, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure the length of a stoma prior to placement of a feeding tube. This is a measurement of a physical characteristic of the patient's body (the stoma), not an analysis of a biological sample (like blood, urine, or tissue) to diagnose a condition or monitor a disease.
- Device Description: The device is a physical measuring tool with a balloon and graduated scale. It does not involve any reagents, assays, or analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis.
Therefore, the MIC-KEY* SF Over-the-Wire Stoma Measuring Device is a medical device used for a physical measurement procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
MIC-KEY* SF Over-the-Wire Stoma Measuring Device is designed for measuring the length of a stoma prior to placement of a low profile feeding tube. The Stoma Measuring Device comprises a tubular shaft 10 Fr with graduated scale, an inflation valve and retaining balloon. The MIC-KEY* SF Over the Wire Stoma Measuring Device is made of polyurethane tubing, EtO sterilized and for single use. Like the predicate device, it is intended to be use in hospital environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stoma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital environment
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)
Performance testing on the device under submission was conducted to demonstrate the modified device continued to meet performance specification. Results of design verification and validation activities did not raise any new issues of safety or effectiveness. Non-clinical verification was conducted through the risk management process according to ISO 14971:2012. The following verification tests were conducted: Tensile Strength, Head/Tube (Pass), Balloon Concentricity (Pass), Deflated Balloon Outer Diameter (Pass through 4 Fr size larger ring gauge and Pass through 2 Fr size larger ring gauge), Tube Outer Diameter (Pass), Balloon Valve Luer Tip Compatibility (Pass), Printed Ink Durability (Pass), Device Removal Force (Pass), Balloon System Leak Test (Pass), Collar Movement (Pass), System Leak Test, Cap/Head (Pass), Guidewire Insertion (Pass), Device Radiopacity (Pass), Sterile Barrier (Pass). The following biocompatibility tests were also conducted, and all met acceptance criteria: ISO 10993-1, AAMI ANSI ISO 10993-5, ISO 10993-10, ISO 10993-11.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 26, 2018
Halyard Health, Inc. David M. Lee, JD Associate Director, Regulatory Affairs 5405 Windward Parkway Alpharetta, GA 30004
Re: K173955
Trade/Device Name: MIC-KEY* SF Over-the-Wire Stoma Measuring Device Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: December 26, 2017 Received: December 28, 2017
Dear David M. Lee:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173955
Device Name
MIC-KEY* SF Over-the-Wire Stoma Measuring Device
Indications for Use (Describe)
MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY- K173955
Date: January 20, 2018
Applicant's Name, Address, Telephone, Contact Person
Halvard Health. Inc. 5405 Windward Parkway Alpharetta, Georgia 30004
Contact Name: David M. Lee, JD Associate Director, Requlatory Affairs Halvard Health 470 448 5182 (Phone) David.lee@hyh.com
1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification: | Class II, per 21 CFR 876.5980 |
|---|---|
| Classification Name: | Gastrointestinal tube and accessories |
| Common/Usual Name: | Stoma Measuring Device |
| Product Code: | KNT |
| Trade Name: | MIC-KEY* SF Over-the-Wire Stoma Measuring Device |
2. PREDICATE DEVICE
MIC-KEY* SF Over the Wire Stoma Measuring Device cleared under the MIC-KEY*LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES-K122653.
3. INDICATIONS FOR USE
MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube.
4. DESCRIPTION OF DEVICE
MIC-KEY* SF Over-the-Wire Stoma Measuring Device is designed for measuring the length of a stoma prior to placement of a low profile feeding tube. The Stoma Measuring Device comprises a tubular shaft 10 Fr with graduated scale, an inflation valve and retaining balloon. The MIC-KEY* SF Over the Wire Stoma Measuring Device is made of polyurethane tubing, EtO sterilized and for single use. Like the predicate device, it is intended to be use in hospital environment.
5. TECHNOLOGICAL CHARACTERISTICS
The MIC-KEY* SF Over-the-Wire Stoma Measuring Device is substantially equivalent to the predicate device. The following changes from the predicate device were made:
- . the printed device labeling (printed marking was added to the polyurethane molded head indicating the balloon inflation volume)
- minor changes to the geometry of the molded polyurethane head ●
- minor change to the geometry of the molded tethered cap ●
- the ink used for device marking was changed o
There are no other significant differences in the design, materials, performance, and technological characteristics from the predicate device.
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6. SUMMARY OF NONCLINICAL TESTS
Performance testing on the device under submission was conducted to demonstrate the modified device continued to meet performance specification. Results of design verification and validation activities did not raise any new issues of safety or effectiveness. Non-clinical verification was conducted through the risk management process according to ISO 14971:2012. The following verification tests were conducted:
| Test | Acceptance Criterion | Result |
|---|---|---|
| Tensile Strength, Head/Tube | ≥ 15 N per EN 1615:2000 | Pass |
| Balloon Concentricity |