(174 days)
Minntech Corporation's RenaClean™ SH Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers, prior to being reprocessed on a Renatron® Dialyzer Reprocessing System.
The Renaclean SH Dialyzer Cleaning System facilitates the cleaning and removal of blood and other debris from multiple-use hollow fiber dialyzers prior to reprocessing on a Renatron® Dialyzer Reprocessing System. The stand-alone countertop system utilizes ANSI/AAMI quality water and a pre-diluted sodium hypochlorite solution.
The operator, through the use of a membrane switch front panel, controls the Renaclean SH Dialyzer Cleaning System. Operators have the following cycle choices: High Flux dialyzer clean, Low Flux dialyzer clean and System Sanitize.
This device, the RENACLEAN™ SH Dialyzer Cleaning System, is a medical device used to pre-clean dialyzers. The provided text is a 510(k) summary for this device, outlining its description, intended use, and a comparison to a predicate device, as well as the FDA's clearance letter. However, the provided text does not contain detailed acceptance criteria or a comprehensive study plan with specific performance metrics, sample sizes, or ground truth establishment methods typical for AI/ML device evaluations. This submission predates the widespread use of advanced AI/ML in medical devices, and the evaluation relies on functional testing and material compatibility, rather than AI-specific performance metrics.
Based on the information provided, here's a structured response addressing the requested points to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "Minntech Corporation has performed functional testing to show the Renaclean Dialyzer Cleaning System is safe and has equivalent performance with respect to the predicate device." It also mentions "All materials have been tested for material compatibility with the chemicals used in the system as specified in the labeling."
Given the nature of the device (a dialyzer pre-cleaning system) and the submission type (510(k) summary from 2004), the "acceptance criteria" appear to be centered around functional equivalence and material compatibility with the predicate device and specified chemicals. Specific quantitative acceptance criteria are not detailed in the provided documents.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety | Demonstrated through functional testing and material compatibility. |
| Equivalent performance to predicate device (Renatron II pre-clean cycle) in cleaning blood/debris from dialyzers prior to reprocessing. | Functional testing performed to show equivalent performance. |
| Material compatibility with chemicals used in the system (ANSI/AAMI quality water and pre-diluted sodium hypochlorite solution). | All materials tested for compatibility as specified in labeling. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the functional testing or material compatibility tests.
The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that this is a functional device (a cleaning system) rather than an image analysis or diagnostic AI, the concept of "ground truth established by experts" in the typical AI sense does not directly apply. The evaluation would likely involve engineering and quality control specialists assessing cleaning efficacy and material integrity, but no specific number or qualifications of experts are provided.
4. Adjudication Method for the Test Set
Not applicable to this type of device and evaluation as described. There's no mention of expert review or adjudication in the context of diagnostic performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided information does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted. This type of study is typically associated with diagnostic or image analysis AI/ML devices where human readers interpret data with and without AI assistance. This device is a pre-cleaning system for dialyzers, not a diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
While the device operates "standalone" in the sense that it performs a pre-cleaning cycle automatically, the concept of "algorithm only without human-in-the-loop performance" as typically discussed for AI/ML devices is not directly applicable. The device's performance is intrinsically linked to its mechanical and chemical processes, not an AI algorithm that makes diagnostic or treatment recommendations. The mentioned "functional testing" would represent the standalone performance of the physical system.
7. Type of Ground Truth Used
For functional testing of a cleaning device, "ground truth" would likely involve objective measurements of cleaning efficacy (e.g., residual blood/debris levels) on dialyzers after the cleaning cycle, compared against established benchmarks or the performance of the predicate device. For material compatibility, it would be material integrity assessments after exposure to chemicals. The specific methodologies are not detailed in the summary.
8. Sample Size for the Training Set
Not applicable. The device is a physical cleaning system, not an AI/ML algorithm that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
{0}------------------------------------------------
RENACLEAN™ SH DIALYZER CLEANING SYSTEM
510(k) Summary of Safety and Effectiveness
| Manufacturer: | Minntech Corporation |
|---|---|
| Address: | 14605 28th Avenue NorthMpls, MN 55447USA |
| Official Contact: | Craig SmithVice President, Regulatory Affairs and Quality Assurance |
Minntech Corporation has supplied the following information to the U.S. Food and Drug Administration to support substantial equivalency of the Renaclean™ SH Dialyzer Cleaning System to other dialyzer pre-cleaning cycles in automated dialyzer reprocessing systems currently in distribution in the United States.
1. Device Description
The Renaclean SH Dialyzer Cleaning System facilitates the cleaning and removal of blood and other debris from multiple-use hollow fiber dialyzers prior to reprocessing on a Renatron® Dialyzer Reprocessing System. The stand-alone countertop system utilizes ANSI/AAMI quality water and a pre-diluted sodium hypochlorite solution.
The operator, through the use of a membrane switch front panel, controls the Renaclean SH Dialyzer Cleaning System. Operators have the following cycle choices: High Flux dialyzer clean, Low Flux dialyzer clean and System Sanitize.
-
- Intended Use
Minntech Corporation's Renaclean SH Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers, prior to being reprocessed on a Renatron Dialyzer Reprocessing System.
- Intended Use
-
- Comparison to Another Device in Commercial Distribution Within the United States
The Renaclean SH Dialyzer Cleaning System is equivalent to other dialyzer precleaning cycles in automated dialyzer reprocessing systems currently in distribution in the United States. The Renatron II Dialyzer Reprocessing System (K904210) pre-clean cycle is intended to pre-clean multiple-use dialyzers prior to testing and sterilization.
- Comparison to Another Device in Commercial Distribution Within the United States
{1}------------------------------------------------
Page 2/2
Summary 4.
- 4.1 Minntech Corporation has performed functional testing to show the Renaclean Dialyzer Cleaning System is safe and has equivalent performance with respect to the predicate device.
- All materials have been tested for material compatibility with the chemicals 4.2 used in the system as specified in the labeling.
- ડ. Summary of Substantial Equivalence
Minntech Corporation has provided the above information within the 510(k) to support the claim that the Renaclean Dialyzer Cleaning System is safe and effective when used in accordance with the device labeling.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2004
Mr. Richard M. Ormsbee Senior Regulatory Affairs Specialist MINNTECH® 14605 28th Avenue, N. MINNEAPOLIS MN 55447
Re: K033505
Trade/Device Name: Renaclean™ SH Dialyzer Cleaning System Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LIF Dated: February 4, 2004 Received: April 5, 2004
Dear Mr. Ormsbee:
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 cither 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to cognituding of substantial equivalence of your device to a legally premairce noticated on: "The 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 It you desire spoolite activery at one of the following numbers, based on the regulation number at the top of the 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 Additionally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other or other warket notification" (21CFR Part 807.97) you may obtain. Other general of release to promation of your responsibilities under the Act may be obtained from the Division of Small mioritation on your velpenal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrf/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
{4}------------------------------------------------
Indications for Use
510(k) Number (if Known):
Device Name:
RenaClean™ SH Dialyzer Cleaning System
Indications for Use:
Minntech Corporation's RenaClean™ SH Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers, prior to being reprocessed on a Renatron® Dialyzer Reprocessing System.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use v (Per21 CFR 801.109) OR
Over-the Counter-use (Optional Format 1-1-96)
Nancy C. Braydon
(Division Sign-Off) Division of Reproductive, Abdo minal and Radiological De 510(k) Number
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.