(83 days)
For diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.
The InstaFlo Bowel Catheter System Kit contains two main parts: the catheter and the collection bag. The insertion end of the catheter contains a retention cuff and the other end of the catheter has a twist lock fitting to attach the collection bag. The retention cuff leads to a drain tube that allows stool to drain directly from the rectum into the bag. There are two catheter connectors attached to the catheter. The Blue connector is used to inflate and deflate the retention cuff. The Clear connector is used only to irrigate the device when needed.
This document does not describe a study to prove a device meets acceptance criteria. Instead, it is a 510(k) summary for the InstaFlo Bowel Catheter System Kit, which is a medical device.
The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device) and does not require premarket approval (PMA). This is typically achieved by demonstrating substantial equivalence to a predicate device, rather than through a clinical study with acceptance criteria in the traditional sense.
Here's how to interpret the document in the context of your request:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for a modification to an existing device (ActiFlo Indwelling Bowel Catheter System Kit), the "acceptance criteria" are implied by demonstrating substantial equivalence. The document highlights changes in technological characteristics and intended use compared to the predicate, and asserts that product evaluation supports acceptability.
| Characteristic / "Acceptance Criteria" Equivalent | Predicate Device (ActiFlo) Performance/Description | Modified Device (InstaFlo) Performance/Description |
|---|---|---|
| Indications for Use | Diversion of fecal matter to minimize external contact... | For diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control. (Key change, narrower indication) |
| Kit Contents | ActiFlo Catheter, 60cc Syringe, 2 Water Soluble Lube, Drainable Collection Bag or 2 Closed Bags, 2 Skin Barriers, Irrigation Bag, Instructions for Use | InstaFlo Catheter, 60cc Syringe, Closed Collection Bag, Instructions for Use, Quick Reference Insertion Guide (Simplified kit) |
| Bowel Retention | External Balloon | External Balloon |
| Bowel Irrigation | Silicone funnel, cath-tip syringe compatible, removable barbed connector | Removing bowel irrigation indications from IFU. Irrigation bag will not be provided in kit. IRRG connection will only be recommended for irrigation of the bowel catheter tubing. |
| Port Access | Sampling / fluid administration | Sampling / fluid administration |
| Drainage Flow Suspension | Intraluminal (ARV) balloon | No Intraluminal (ARV) balloon. |
| Anti-Internal Migration | External silicone retention faceplate with anchor straps | Blue colored collapsible transphincteric zone to be used as a visual indicator |
| Flush / Stool Sampling | Mid-line silicone access port compatible with catheter tip syringe | Mid-line silicone access port compatible with catheter tip syringe |
| Enema / Medication Administration | Silicone funnel that is cath-tip syringe compatible; also comes with removable barbed connector | Removing the instructions for Enema / Medication Administration from IFU to simplify usage of the device. An irrigation bag will not be supplied. |
| Sterility | Non-Sterile | Non-Sterile |
| Biocompatibility | (Implicitly accepted as per existing device) | Performed based on G95-1 and ISO 10993 standards. (Reported as supporting acceptability) |
The "study" that proves the device meets the acceptance criteria (i.e., substantial equivalence):
The document explicitly states: "Biocompatibility testing was performed based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Product evaluation supports acceptability of the device for its intended clinical use."
This indicates that the primary "study" or evaluation performed was biocompatibility testing. The "product evaluation" mentioned likely encompasses a review of the design changes, materials, manufacturing processes, and how they compare to the predicate device to ensure the modified device is as safe and effective.
Detailed answers to your specific questions based on the provided text:
1. A table of acceptance criteria and the reported device performance
See the table above. The "acceptance criteria" are not given as numerical thresholds of performance metrics but rather as demonstration of substantial equivalence through design and material property comparisons, and biocompatibility testing.
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 sample sizes for biocompatibility testing. Biocompatibility testing often involves in vitro and in vivo tests, which have their own sample size considerations, but these are not detailed here.
- Data provenance: Not specified, but standard ISO 10993 testing is generally conducted by accredited labs. It is not indicated if the data is retrospective or prospective, but typical biocompatibility testing would be considered prospective for the specific material/device being tested.
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 in this context. Biocompatibility testing results are generally evaluated against established biological endpoints and acceptance criteria from ISO 10993 standards, rather than requiring expert consensus for a "ground truth" like in clinical image interpretation studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation), not for objective physical or chemical tests like biocompatibility.
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
- No. This is a medical device (catheter system), not an AI/imaging device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility testing, the "ground truth" is defined by the established biological endpoints and thresholds of the ISO 10993 standards and FDA guidance (G95-1). This involves assessing for cytotoxicity, sensitization, irritation, acute systemic toxicity, etc., as per the standards.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no training set.
In summary, the information provided is typical of a 510(k) submission for a device modification, focusing on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and performance (in this case, primarily biocompatibility testing), rather than a clinical study with detailed acceptance criteria and performance metrics.
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K100273
Page 1 of 2
Image /page/0/Picture/1 description: The image shows the word "Hollister" in a serif font next to a geometric symbol. The symbol is a black shape that resembles a stylized snowflake or asterisk. The word "Hollister" is in a bold, black font and is positioned to the right of the symbol. The overall image has a clean and simple design.
510(k) Summary
| Submitted By: | Ben LichtenwalnerHollister Incorporated2000 Hollister DriveLibertyville, IL 60048847-680-1000 | APR 22 2010 |
|---|---|---|
| Date Summary Prepared: | March 5, 2010 | |
| Device Name: | Classification Name - Gastrointestinal Tube and accessoriesCommon/Usual Name - Rectal CatheterProprietary Name - InstaFlo Bowel Catheter System Kit | |
| Predicate Device: | The InstaFlo Bowel Catheter System Kit is a modificationto the following device: | |
| Product | 510(k) | |
| ActiFlo Indwelling Bowel Catheter SystemKit | K083153 | |
| Device Description: | The InstaFlo Bowel Catheter System Kit contains two mainparts: the catheter and the collection bag. The insertion endof the catheter contains a retention cuff and the other end ofthe catheter has a twist lock fitting to attach the collectionbag. The retention cuff leads to a drain tube that allowsstool to drain directly from the rectum into the bag. Thereare two catheter connectors attached to the catheter. TheBlue connector is used to inflate and deflate the retentioncuff. The Clear connector is used only to irrigate thedevice when needed. | |
| Intended Use: | For diversion of liquid or semi-liquid stool to facilitate thecollection of fecal matter in patients with little or no bowelcontrol. |
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Technological Characteristics:
K100273
Page 2 of 2
| FUNCTION | ActiFlo Indwelling BowelCatheter System Kit(Current Device) | InstaFlo Catheter System Kit(Modified Device) |
|---|---|---|
| Indications forUse | Diversion of fecal matter to minimizeexternal contact with the patient, tofacilitate the collection of fecalmatter for patients requiring stoolmanagement, and to provide accessfor colonic irrigation to trigger adefecatory response, andadministration of enema/medications. | For diversion of liquid or semi-liquidstool to facilitate the collection of fecalmatter in patients with little or nobowel control. |
| Kit Contents | • (1) ActiFlo Catheter• (1) 60cc Syringe• (2) 5g Packet Water SolubleLube• (1) Drainable Collection Bag or• (2) Closed Collection Bags• (2) Skin Barriers• (1) Irrigation Bag• (1) Instructions for Use | • (1) InstaFlo Catheter• (1) 60cc Syringe• (1) Closed Collection Bag• (1) Instructions for Use• (1) Quick Reference InsertionGuide |
| BowelRetention | External Balloon | External Balloon |
| BowelIrrigation | Silicone funnel that is cath-tipsyringe compatible; also comes withremovable barbed connector forattachment to Luer-tip syringe. | Removing bowel irrigation indicationsfrom IFU. Irrigation bag will not beprovided in kit. IRRG connection willonly be recommended for irrigation ofthe bowel catheter tubing. |
| Port Access | Sampling / fluid administration | Sampling / fluid administration |
| Drainage FlowSuspension | Intraluminal (ARV) balloon | No Intraluminal (ARV) balloon. |
| Anti-InternalMigration | External silicone retention faceplatewith anchor straps | Blue colored collapsibletransphincteric zone to be used as avisual indicator |
| Flush / StoolSampling | Mid-line silicone access portcompatible with catheter tip syringe | Mid-line silicone access portcompatible with catheter tip syringe |
| Enema /MedicationAdministration | Silicone funnel that is cath-tipsyringe compatible; also comes withremovable barbed connector forattachment to Luer-tip syringe. | Removing the instructions for Enema /Medication Administration from IFUto simplify usage of the device. Anirrigation bag will not be supplied inthe InstaFlo kit. |
| Sterile | Non-Sterile | Non-Sterile |
Performance Testing Conclusions:
Biocompatibility testing was performed based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Product evaluation supports acceptability of the device for its intended clinical use.
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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Mr. Benjamin Lichtenwalner Senior Regulatory Affairs Specialist Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048
APR 22 2010
Re: K100273
Trade/Device Name: InstaFlo Bowel Catheter System Kit Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: March 22, 2010 Received: March 23, 2010
Dear Mr. Lichtenwalner:
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 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). 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 defermined 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.
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Page 2 - Mr. Benjamin Lichtenwalner
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): _ K100273
Device Name: InstaFlo Bowel Catheter System Kit
Indications for Use:
For diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _ K100273
§ 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.