(128 days)
A bowel catheter system kit with odor barrier properties for diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.
The InstaFio Bowel Catheter System Kit contains two main parts: the catheter (made with odor barrier film) 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.
The provided text describes a 510(k) summary for the InstaFlo Bowel Catheter System Kit, which details performance testing conclusions but does not contain specific acceptance criteria or an in-depth study report with the detailed information requested.
Therefore, I cannot populate the table and answer all questions with the provided information. However, I can extract what is available.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance to ISO 10993 biocompatibility testing standards and FDA General Program Memorandum #G95-1 | Results indicate compliance to the standard. |
| Odor Barrier Capabilities | (Implied) Verification of odor barrier capabilities compared to predicate | Test results confirmed odor barrier capabilities. |
| Connections and Joints (Bond Strength & Leakage) | Acceptable results (implied by "no impact to product design" and "substantial equivalence") | Acceptable results were obtained, thereby demonstrating substantial equivalence. |
| Functional Parameters | (Not specified) | Testing completed. |
| Structural Parameters | (Not specified) | Testing completed. |
Details not explicitly available in the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The document states "non-clinical testing" was performed, which typically refers to bench testing rather than human clinical trials.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was non-clinical testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as this was non-clinical testing.
- 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. This is a medical device (catheter system), not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (catheter system), not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for non-clinical testing. Ground truth in this context would be adherence to engineering specifications and performance standards.
- The sample size for the training set: Not applicable, as this is non-clinical device testing, not an AI model.
- How the ground truth for the training set was established: Not applicable, as this is non-clinical device testing, not an AI model.
Summary of available information regarding the "study" (non-clinical testing):
- Type of Study: Non-clinical testing for functional and structural parameters, biocompatibility, odor barrier capabilities, and connection/joint integrity (bond strength and leakage).
- Purpose: To demonstrate that the modified InstaFlo Bowel Catheter System Kit is as safe and effective and substantially equivalent to its predicate device (K100273).
- Key Findings:
- Biocompatibility testing met US FDA Office of Device Evaluation General Program Memorandum #G95-1 and ISO 10993 standards.
- Odor testing verified the odor barrier capabilities compared to the predicate.
- Connections and joints tested for bond strength and leakage showed acceptable results, demonstrating no impact from the change in tubing.
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Image /page/0/Picture/0 description: The image shows handwritten text on a white background. The text at the top reads "K123804", which appears to be a reference or identification number. Below this, the text "Pg. 1 of 2" indicates that this is the first page of a two-page document. The handwriting is cursive and legible, with a slight slant.
APR 1 7 2013
Image /page/0/Picture/1 description: The image shows the word "Hollister" in a bold, sans-serif font. To the left of the word is a geometric design that resembles a stylized snowflake or asterisk. The design is composed of intersecting lines and shapes, creating a symmetrical pattern. The overall impression is clean and modern, suggesting a brand identity.
510(k) Summary
510(k) Owner: Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048' Submitted By: Chris Stukel Hollister Incorporated 2000 Hollister Drive Libertyville. IL 60048 847-680-1000 (phone) 847-847-918-3981.
Date Summary Prepared:
December, 7, 2012
Device Name:
Classification Name - Gastrointestinal tube and accessories 21 CFR 876.5980-KNT Common/Usual Name - Rectal Catheter Proprietary Name - InstaFlo Bowel Catheter System Kit
Predicate Device:
Modifications are being made to the following predicate device:
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Device Description:
The InstaFio Bowel Catheter System Kit contains two main parts: the catheter (made with odor barrier film) 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.
Intended Use:
A bowel catheter system kit with odor barrier properties for diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.
Page, 16 of 48.
InstaFlo (Odor Barrier Tube) Traditional 510(k) Submission
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K123804
PG. 2 of 2
Technological Characteristics:
The table below summarizes the technological characteristics of the device as compared to the predicate devices.
| Characteristics | InstaFlo Bowel Catheter System Kit(K100273) | InstaFlo Bowel Catheter System KitMODIFIED DEVICE |
|---|---|---|
| Intended Use | For diversion of liquid orsemi-liquid stool to facilitate thecollection of fecal matter in patientswith little or no bowel control. | A bowel catheter system kit with odorbarrier properties for diversion of liquidor semi-liquid stool to facilitate thecollection of fecal matter in patientswith little or no bowel control. |
| Condition ofUse | Single Use | |
| Kit Contents | (1) Catheter (1) 60cc Syringe (1) Collection Bag (1) Instructions for Use (1) Quick Reference Insertion Guide | (1) Odor Barrier Catheter (1) 60cc Syringe (1) Disposable Collection Bag with Filter (1) Instructions for Use (1) Quick Reference Insertion Guide |
| CatheterMaterial | Silicone | Thermoplastic |
| Catheter OdorBarrierProperties | No | Yes |
| Closed WasteBag | Approximate Volume- 2000 mLSide catheter connector portNo Filter | Approximate Volume- 2500 mLTop catheter connector-portFilter |
Performance Testing Conclusions:
Non-clinical testing of the proposed device for functional and structural parameters has been completed.
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. Results indicate compliance to the standard.
Odor testing was performed compared to the predicate to verify the odor barrier capabilities which the test results confirmed.
Connections and joints affected by the change in tubing were tested for bond strength and leakage to verify no impact to product design. Acceptable results were obtained, thereby demonstrating substantial equivalence.
In conclusion, based on the above information, the proposed device has been shown to be as safe and effective and substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2013
Hollister Incorporated % Ms. Chris Stukel Sr. Global Regulatory Affairs Specialist 2000 Hollister Drive LIBERTYVILLE, IL 60048
Re: K123804
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: April 5, 2013 Received: April 10, 2013
Dear Ms. Stukel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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. 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.
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.
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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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/3/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a bold, sans-serif font. The letters "DA" are stylized with a geometric design, appearing to be interwoven with the rest of the name. The text is horizontally oriented and appears to be a signature or title.
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): K123804
Device Name: InstaFlo Bowel Catheter System Kit
Indications for Use:
A bowel catheter system kit with odor barrier properties 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 ਮ (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)
Benjamin R. Fisher -S 2013.04.17 13:46:20 -04'00'
Page 14 of 48
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123804 510(k) Number _
InstaFlo (Odor Barrier Tube) Traditional 510(k) Submission
§ 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.