(89 days)
The Peristeen™ Anal Irrigation (PAI) System is intended to instill water into the colon through a rectal catheter-which incorporates an inflatable balloon-inserted into the rectum to promote revacuation of the contents of the lower colon. The PAI System is indicated for use by Children (2 years - < 12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.
The Peristeen™ Anal Irrigation system consists of a single-use irrigation catheter with a balloon for retention; a control unit with a manual switch to add pressure to the water bag, inflate and deflate the balloon on the catheter; a bag with a lid to hold water or isotonic saline solution, leg straps that may be used to fasten the control unit and tubing to the thigh, and tubes with connectors. The system may be purchased with a carrying case (toilet bag). The rectal catheter is single-use, but the other components may be used multiple times. Accessory kits are available for the components. The PAI system does not contain natural rubber latex components.
The provided text is a 510(k) summary for the Peristeen™ Anal Irrigation System, which is a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical performance study with statistical metrics.
The document states that the Peristeen™ Anal Irrigation System is substantially equivalent to a previously cleared device (K083770). The equivalence is supported by a comparison of design, materials, intended use, and acceptable results from functional performance and biocompatibility testing. This indicates that the "acceptance criteria" here are likely related to engineering specifications, safety standards, and material compatibility, rather than clinical performance metrics like sensitivity, specificity, or reader agreement.
Since the document focuses on substantial equivalence for a physical medical device, not an AI/algorithm-based diagnostic tool, most of the requested information (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable or not provided in this specific type of regulatory filing.
However, I can extract the relevant information that is present:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Functional Performance | Acceptable results (implied by substantial equivalence claim) |
| Biocompatibility | Acceptable results (implied by substantial equivalence claim) |
| Design Comparison | Substantially equivalent to predicate device |
| Materials Comparison | Substantially equivalent to predicate device |
| Intended Use Comparison | Expanded indications, but substantially equivalent to predicate device |
2. Sample size used for the test set and the data provenance:
- Not Applicable/Not Provided. The submission relies on functional performance and biocompatibility testing and substantial equivalence to a predicate device, not clinical performance data from a patient test set in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided. This information is relevant for diagnostic accuracy studies, which are not detailed in this 510(k) summary for a physical irrigation system.
4. Adjudication method for the test set:
- Not Applicable/Not Provided.
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 not an AI-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/algorithm-based diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For functional performance and biocompatibility testing, the ground truth would typically be established by established engineering standards, material science testing protocols, and biological safety evaluations.
- For substantial equivalence, the ground truth is the performance, design, and indications for use of the predicate device.
8. The sample size for the training set:
- Not Applicable/Not Provided. This information is relevant for AI models, not for a physical medical device like the Peristeen™ Anal Irrigation System.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided.
Summary of the "study" that proves the device meets acceptance criteria:
The "study" referenced in the document is a comparison to a legally marketed predicate device (K083770) combined with functional performance and biocompatibility testing.
- Comparison to Predicate: The report states: "Substantial equivalence of the Peristeen™ Anal Irrigation System is supported by a comparison of the design, materials, and intended use compared to the predicate..." This comparison essentially serves as the primary "study" for establishing regulatory acceptance based on the 510(k) pathway. If the new device is sufficiently similar to an already cleared device in terms of safety and effectiveness, it can be cleared.
- Functional Performance and Biocompatibility Testing: The document mentions "acceptable results from functional performance and biocompatibility testing." While the details of these tests are not provided in this summary, they would involve engineering tests to ensure the device operates as intended (e.g., proper water flow, balloon inflation/deflation, pressure control) and material tests to ensure the components are safe for human contact (e.g., ISO 10993 series of standards). The "acceptance criteria" for these would be specific engineering and biocompatibility thresholds defined prior to testing.
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0325 JAN 3 1 201
3. 510(K) SUMMARY
510(K) Owner's Name: Coloplast A/S Holtedam 1 Address: 3050 Humlebaek, Denmark Establishment Registration: 9610694 Owner/Operator: 8010144 (612) 302-4987 Office: Phone/Fax/Email: (612) 968-9567 Mobile: Fax: (612) 287-4138 usbes@coloplast.com email: Brian Schmidt Name of Contact Person: Regulatory Affairs Manager 1601 West River Road Address/Contact: Minneapolis, MN 55411 November 2, 2010 Date Prepared: Peristeen™ Anal Irrigation System Trade Name: Rectal Catheter and accessories and Common Name: Enema kit 876.5980 Gastrointestinal tube & accessories Classification Name: Class II and 876.5210 Enema kit Class I (Exempt) KNT and FCE Product Code:
Legally Marketed Devices To Which Your Firm Is Claiming Equivalence:
The Peristeen™ Anal Irrigation System is substantially equivalent in performance, indications, The Persion - Than Irrigation System Anal Irrigation System cleared on November 23, 2009 under premarket notification 510(k) number K083770.
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Description Of The Device:
The Peristeen™ Anal Irrigation system consists of a single-use irrigation catheter with a balloon for retention; a control unit with a manual switch to add pressure to the water bag, inflate and deflate the balloon on the catheter; a bag with a lid to hold water or isotonic saline solution, leg straps that may be used to fasten the control unit and tubing to the thigh, and tubes with connectors. The system may be purchased with a carrying case (toilet bag). The rectal catheter is single-use, but the other components may be used multiple times. Accessory kits are available for the components. The PAI system does not contain natural rubber latex components.
(103254
page 20f 2
Intended Use Of The Device:
The Peristeen™ Anal Irrigation (PAI) System is intended to instill water into the colon through a rectal catheter-which incorporates an inflatable balloon-inserted into the rectum to promote revacuation of the contents of the lower colon. The PAI System is indicated for use by Children (2 years - < 12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - <21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.
Technological Characteristics Compared To Predicate Device:
The proposed Peristeen™ Anal Irrigation System (expanded indications for use) is substantially equivalent to the Peristeen™ Anal Irrigation System.
Summary and Conclusions from the Nonclinical Tests Submitted:
Substantial equivalence of the Peristeen™ Anal Irrigation System is supported by a comparison of the design, materials, and intended use compared to the predicate, as well as acceptable results from functional performance and biocompatibility testing.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, depicted with three curved lines forming the body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Coloplast A/S c/o Mr. Brian Schmidt Regulatory Affairs Manager Coloplast Manufacturing US, LLC 1601 West River Road North MINNEAPOLIS MN 55411
JAN 3 1 2511
Re: K103254
Trade/Device Name: Peristeen™ Anal Irrigation System Regulation Number: 21 CFR $876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Codes: KNT and FCE Dated: November 2, 2010 Received: November 3, 2010
Dear Mr. Schmidt:
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. 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. 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
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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/CDRHOffices/ucm1118001, places the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 30) min iss note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR), Paul 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/Resourcesfor You/Industry/default:htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely vours.
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
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2. STATEMENT OF INDICATIONS FOR USE
Indications for Use
510(k) Number (if known): 1033
Device Name: Peristeen™ Anal Irrigation System
Indications for Use:
The Peristeen™ Anal Irrigation (PAI) System is intended to instill water into the colon through a rectal catheter-which incorporates an inflatable balloon-inserted into the rectum to promote evacuation of the contents of the lower colon. The PAI System is indicated for use by Children (2 years - <12 years old), adolescent (12 years - < 18 years old), transitional adolescent (18 - < 21 years old) and adult patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or timeconsuming bowel management procedures.
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)
Aoyn Th Thn
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K103254
§ 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.