(199 days)
The Reprocessing Products Corporation Test Strips are intended for use in the monitoring of pH in Dialysate and Water.
The Reprocessing Product Corporation (RPC) pH Test Strips are indicated for determining the pH of acid dialysates, bicarbonate dialysates, or water. These Test Strips are indicated for testing acid/bicarbonate dialysates and water.
pH Test Strips are comprised of two different pH ranges:
pH = 6.8-8.5 (K100-0117) is for acid/bicarbonate dialysate, bicarbonate concentrate and water
pH = 0-14 (K100-0104) is for water used to make up dialysate.
Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with Dialysate or Water respectively. The pad is attached to a plastic strip for handling.
Here's an analysis of the acceptance criteria and study information for the Reprocessing Products Corporation pH Test Strips, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific quantitative metrics like sensitivity or accuracy percentages. Instead, the performance is described qualitatively.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accurate pH determination (correlation to Hydrogen ion concentration) | "The test strip contains a specialized chemical formulation that reacts with the Hydrogen ion concentration in solutions of dialysate and water. The reaction results in a color change which is correlatable to the concentration of Hydrogen ions in the solution." |
| Consistent and correct color changes across the specified pH ranges | "The data confirm that the product consistently generates color changes which match the color blocks for the Reference solution pH. Reference solutions were used to evaluate pH performance between 6.8 and 8.5 in acid/bicarbonate dialysate, bicarbonate concentrate and water, and the pH performance between 0 and 14 in water used to prepare dialysate." |
| Appropriate performance for intended use (hemodialysis dialysate and water) | "These data demonstrate appropriate performance for use in hemodialysis dialysate and water." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set. It mentions "Reference solutions were used to evaluate pH performance." This implies a series of solutions at various pH levels within the specified ranges, but the exact number is not provided.
- Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the testing was conducted by the manufacturer, Reprocessing Products Corporation, based in Tucson, AZ, USA. The data appears to be prospective, as it describes the evaluation of the product's performance against reference solutions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be established by the reference solutions themselves, whose pH values are presumably known through independent, calibrated means (e.g., pH meters).
4. Adjudication Method for the Test Set
No adjudication method is described or implied, as the ground truth is established by reference solutions and the device's color changes are matched against these.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This device is a test strip with a visual color change, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done. The "Performance" section explicitly states: "The data confirm that the product consistently generates color changes which match the color blocks for the Reference solution pH." This refers to the device's inherent ability to produce accurate results independent of human interpretation or assistance, by visually matching the color to a provided chart.
7. Type of Ground Truth Used
The ground truth used was reference solutions with known pH values. The device's color changes were compared to the color blocks corresponding to these reference pH values.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here in the context of machine learning. This device is a chemical reagent test strip, not a machine learning algorithm. Its performance is based on chemical reactions, not trained data.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" in the machine learning sense for this type of device. The chemical formulation of the test strip is designed to react in a specific way to different pH levels, and its performance is evaluated against chemically prepared reference solutions.
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K101750 Page 1 of 2
510(k) SUMMARY
JAN - 7 2011
| Prepared: | December 14, 2010 | |
|---|---|---|
| Submitter: | Reprocessing Products Corporation | |
| Address: | 3655 N. Oracle RoadTucson, AZ 85705 | |
| Phone: | 520-888-5551 | |
| Fax: | (Fax) 520-888-5557 | |
| Contact: | Michael Honstein, Chief Operating Officer | |
| Device Trade Name: | Two ranges:0-14 pH Test Strips (K100-0104) and 6.8-8.5 pH Test Strips (K100-0117) | |
| Common or Usual Name: | pH Test Strips | |
| Device Classification Name: | Strip, Test, Reagent, Dialysate, Water | |
| Product Code: | MSY | |
| Class: | II | |
| Regulation Number: | 876.5665 | |
| Substantial Equivalence: | The Reprocessing Products CorporationpH Test Strips are substantially equivalentto the SERIM® BICARB PH REAGENTSTRIPS | |
| Device Description: | Device is semi-quantitative, reagent teststrip comprised of a pad impregnated withchemicals which change color uponcontact with Dialysate or Waterrespectively. The pad is attached to aplastic strip for handling. | |
| Intended Use: | The Reprocessing Products CorporationTest Strips are intended for use in themonitoring of pH in Dialysate and Water. | |
| Technological Characteristics: | pH test strips are comprised of twodifferent pH ranges: The K100-0117 testStrips will determine the pH in the rangeof 6.8 -8.5 for acid/bicarbonate dialysate,bicarbonate concentrate and water used toprepare dialysate. The K100-0104 teststrips will determine the in the range of 0-14 pH for water used to prepare dialysate.The test strip contains a specializedchemical formulation that reacts with theHydrogen ion concentration in solutions ofdialysate and water. The reaction results ina color change which is correlatable to theconcentration of Hydrogen ions in the | |
| solution.The color change is interpreted by the useof color blocks on two separate (ranges)color charts. Gradations for 6.8-8.5 pHTest Strips (K100-0117) include 6.8, 7.0,7.2, 7.4, 7.6, 7.8, 8.0, and 8.5. Gradationsfor the 0-14 pH test strips (K100-0104)include 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 13, and 14. | JAN - 7 | |
| Performance: | The data confirm that the productconsistently generates color changes whichmatch the color blocks for the Referencesolution pH. Reference solutions wereused to evaluate pH performance between6.8 and 8.5 in acid/bicarbonate dialysate,bicarbonate concentrate and water, and thepH performance between 0 and 14 in waterused to prepare dialysate. These datademonstrate appropriate performance foruse in hemodialysis dialysate and water. | |
| Conclusion: | The Reprocessing Products CorporationpH test strips have the same intended useas the predicate device. Test strips measurethe hydrogen ion concentration inacid/bicarbonate dialysate or water. TheReprocessing Products Corporation pHTest Strips have no characteristics whichraise new types of safety and effectivenessquestions. The Reprocessing ProductsCorporation pH Test Strips can be used tomonitor the pH (hydrogen ionconcentration) present in water and/ordialysate. |
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K101750 Page 2 of 2
2011
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
7 2011 JAN
Reprocessing Products Corp. c/o Mr. Walter B. Jansen MedReg Consulting 8662 Comstock Lane N. . MAPLE GROVE MN 55311-1436
Re: K101750
Trade/Device Name: RPC E-Z CHEK® pH TEST STRIPS Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: MNV Dated: January 5, 2011 Received: January 5, 2011
Dear Mr. Jansen:
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 v 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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Page 2
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,
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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Image /page/4/Picture/0 description: The image shows the letters "RPC" in a bold, sans-serif font. The letters are black and stand out against a white background. To the left of the letters "RPC" is the letters "RP" inside of a square. There is an arrow pointing up between the letters "R" and "P".
4 Statement of Indications for Use:
Indications for Use
JAN - 7 2011
510(k) Number (if known): K101750
RPC E-Z CHEK® pH TEST STRIPS Device Name: Indications for Use: The Reprocessing Product Corporation (RPC) pH Test Strips are indicated for determining the pH of acid dialysates, bicarbonate dialysates, or water. These Test Strips are indicated for testing acid/bicarbonate dialysates and water.
- pH Test Strips are comprised of two different pH . ranges:
- . pH = 6.8-8.5 (K100-0117) is for acid/bicarbonate dialysate, bicarbonate concentrate and water
- pH = 0-14 (K100-0104) is for water used to . make up dialysate.
Prescription Use X AND/OR Over the Counter Use (Part 21 CFR 801 Subpart D) (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
form m Nha
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K101756
§ 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.