(99 days)
The Reprocessing Products Corporation (RPC) E-Z Chek® Blood Leak Test Strips are designed to indicate the presence or absence of blood in dialysate during the hemodialysis procedure. The test strips will measure equal to 0 mg HGB/dL and 0.25 mg HGB/dL in dialysate.
The Reprocessing Product Corporation (RPC) E-Z Chek® Blood Leak Test Strips are indicated for detecting the presence or absence of blood in dialysate during hemodialysis treatments.
Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with blood in dialysate. The pad is attached to a plastic strip for handling.
The provided document describes the Reprocessing Products Corporation (RPC) E-Z Chek® Blood Leak Test Strips. Here's an analysis of the acceptance criteria and the study outlined:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative pass/fail format typical for medical device verification. Instead, it describes the intended performance and the study's findings regarding that performance.
| Acceptance Criteria (Implied from Intended Use) | Reported Device Performance |
|---|---|
| Indicate the presence or absence of blood in dialysate. | The product consistently generates color change which meets the color block for the reference solution concentration. |
| Measure equal to 0 mg HGB/dL (no blood). | Reference solutions were used to evaluate performance between 0 mg HGB/dL and 0.25 mg HGB/dL Bicarbonate/Acetate dialysate. The data confirm the product meets the color block for this concentration. |
| Measure 0.25 mg HGB/dL (presence of blood at a specific detectable threshold). | Reference solutions were used to evaluate performance between 0 mg HGB/dL and 0.25 mg HGB/dL Bicarbonate/Acetate dialysate. The data confirm the product meets the color block for this concentration. |
| Appropriate performance for use in hemodialysis dialysate during treatment. | These data demonstrate appropriate performance for use in hemodialysis dialysate used in treatment. |
| Technological characteristics: Detection based on pseudoperoxidative activity of hemoglobin and myoglobin, catalyzing oxidation of an indicator by an organic hydroperoxide, producing a color change consistent with color blocks. | Confirmed through the performance study where the device generates color change that meets the color block for reference solutions, implying the underlying technological principle is functional and produces the expected visual outcome. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Reference solutions" were used, and "data confirm the product consistently generates color change," but it doesn't quantify the number of tests performed or the sample size of distinct reference solutions/concentrations tested.
- Data Provenance: Not explicitly stated. The study appears to be a laboratory-based performance evaluation using reference solutions, rather than human clinical data from a specific country. It is almost certainly retrospective in the sense that the test strips were manufactured and then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device is established by the known concentrations of hemoglobin (HGB) in the prepared reference solutions, not by expert human interpretation. The "color block" comparison itself would be a visual assessment, but the ground truth is the chemical concentration.
4. Adjudication Method for the Test Set
Not applicable. The performance is evaluated by observing a color change and comparing it to a visual "color block" corresponding to known HGB concentrations. There is no mention of human adjudication for the results beyond this direct comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a diagnostic test strip where performance is assessed by comparison to reference color blocks, not by interpretation by multiple human readers. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this appears to be a standalone performance evaluation. The device's performance is determined by its inherent color-changing reaction to blood in dialysate, and its comparison to established color blocks. There is no "human-in-the-loop" aspect to its fundamental operation or the evaluation method described beyond visually comparing the strip's color to a reference.
7. The Type of Ground Truth Used
The ground truth used is known concentrations of hemoglobin (HGB) in prepared reference solutions. These solutions serve as the objective standard against which the test strip's color-changing reaction is evaluated.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical reagent test strip, not an AI or machine learning algorithm that requires a "training set." Its chemical formulation dictates its performance, which is then verified.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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510(k) SUMMARY
MAR 20 2013
Page 1 of 2
| Prepared: | November 30, 2012 |
|---|---|
| Submitter: | Reprocessing Products Corporation (RPC) |
| Address: | 1643 W. Modern CourtTucson, AZ 85705 |
| Phone: | 520-888-5551 |
| Fax: | (Fax) 520-888-5557 |
| Contact: | Michael Honstein, Chief Operating Officer |
| Device Trade Name: | E-Z Chek® Blood Leak Test Strips K100-0114 |
| Common or Usual Name: | Blood Leak Test Strips |
| Device Classification Name: | Strip, Dialysate, Hemodialysis Water,Blood Leak indicator |
| Product Code: | FJD |
| Class: | II |
| Regulation Number: | 875.5665, 876.5820 |
| Substantial Equivalence: | The Reprocessing Products Corporation(RPC) E-Z Chek® Blood Leak Test Stripsare substantially equivalent to the Serim®Blood Leak Test Strips. |
| Device Description: | Device is semi-quantitative, reagent teststrip comprised of a pad impregnated withchemicals which change color upon contactwith blood in dialysate. The pad is attachedto a plastic strip for handling. |
| Intended Use: | The Reprocessing Products Corporation(RPC) E-Z Chek® Blood Leak Test Stripsare designed to indicate the presence orabsence of blood in dialysate during thehemodialysis procedure. The test strips willmeasure equal to 0 mg HGB/dL and 0.25mg HGB/dL in dialysate. |
| Technological Characteristics: | The detection is based on thepseudoperoxidative activity of hemoglobinand myoglobin, which catalyze theoxidation of an indicator by an organichydroperoxide producing a color changeconsistent with the color blocks provided inthe labeling. |
| Performance: | The data confirm the product consistentlygenerates color change which meets thecolor block for the reference solutionconcentration. Reference solutions wereused to evaluate performance between 0mg HGB/dL and 0.25 mg HGB/dLBicarbonate/Acetate dialysate used forhemodialysis treatment. These datademonstrate appropriate performance foruse in hemodialysis dialysate used intreatment. |
| Conclusion: | The Reprocessing Products Corporation(RPC) E-Z Chek® Blood Leak Test Stripshave the same intended use as the predicatedevice. Both test strips are designed todetect the presence or absence of blood indialysate during hemodialysis treatments.The Reprocessing Products Corporation(RPC) E-Z Chek® Blood Leak Test Stripshas no characteristics which raise newtypes of safety and effectiveness questions.The Reprocessing Products Corporation(RPC) E-Z Chek® Blood Leak Test Stripscan be used to detect the presence orabsence of blood in dialysate duringhemodialysis treatment. |
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Traditional 510k Premarket Notification E-Z Chek® Blood Leak Test Strips 22805
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2013
Reprocessing Products Corporation % Mr. Ted Williams Quality Assurance/Regulatory Affairs Director P.O. Box 35849 TUCSON AZ 85740
Re: K123805
Trade/Device Name: E-Z Chek® Blood Leak Test Strips (K100-0114) Regulation Number: 21 CFR& 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJD Dated: January 29, 2013 Received: February 7, 2013
Dear Mr. Williams:
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.
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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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Herbert P.Lerner -S
for 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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Traditional 510k Premarket Notification E-Z Chek® Blood Leak Test Strips
Page 1 of 1
Statement of Indications for Use: 4.
510k Number (if known): K123805
E-Z Chek® Blood Leak (K100-0114) Device Name:
Indications for Use: The Reprocessing Product Corporation (RPC) E-Z Chek® Blood Leak Test Strips are indicated for detecting the presence or absence of blood in dialysate during hemodialysis treatments.
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)
Herbert Lerner -S
dve. Gastro-Renal, and
§ 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.