(103 days)
The TCx-I-DV Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, NxStage System One Hemo Dialysis system, and weight scale upon the prescription of a licensed physician or healthcare provider. The TCx-I-DV Remote Care Management system serves as the communication link between the compatible devices and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center.
The purpose of the system is to collect and transmit medical information such as weight, blood pressure and pulse rate, and dialysis data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
TCx-I-DV Remote Care Management system collects and transmits measurement information such as weight, blood pressure and pulse rate, and dialysis data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
The provided text is a 510(k) submission summary for the "TCx-I-DV Remote Care Management system." This device is a telemedicine system designed to collect and transmit medical information (weight, blood pressure, pulse rate, dialysis data) from patients remotely to their healthcare providers.
The document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy or clinical effectiveness. Instead, the submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices.
Here's a breakdown based on your request, highlighting what is (and isn't) present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided. The document does not specify quantitative acceptance criteria (e.g., accuracy percentages, precision metrics) for the device's performance in collecting or transmitting medical data. | Not provided. The document states "Verification activities including substantial equivalence testing demonstrates that this system is substantially equivalent to the predicate devices in terms of functionality and intended use," but does not present specific performance metrics or data. It emphasizes that the device functions to "collect and transmit measurement information." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "Verification activities including substantial equivalence testing," but provides no details on the sample size used for this testing.
- Data Provenance: Not specified. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable/not provided in this submission. The device is a data transmission system, not a diagnostic or interpretive device requiring expert ground truth for its performance evaluation in the context of this 510(k). The document notes, "Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional," implying that the device itself is not making interpretations that would need expert ground truth for its own validation.
4. Adjudication method for the test set
- Not applicable/Not provided. As stated above, the submission focuses on functional equivalence rather than clinical performance adjudication.
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, an MRMC comparative effectiveness study was not done. This device is a data transmission system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. The device's primary function is to collect and transmit data; it is not presented as an algorithmic diagnostic tool that would have standalone performance measured in this context. Its function is to facilitate communication, with interpretation explicitly stated to require a human experienced medical professional.
7. The type of ground truth used
- Not applicable/Not provided. Given the nature of the device (data transmission), the concept of "ground truth" for clinical outcomes or diagnostic accuracy is not directly relevant to this 510(k) submission, which focuses on functional equivalence and safe transmission of data.
8. The sample size for the training set
- Not applicable/Not provided. This device is not described as utilizing a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no mention of a machine learning algorithm or training set, this information is not relevant to the provided text.
In summary: The provided 510(k) document emphasizes the functional equivalence of the TCx-I-DV Remote Care Management system to existing predicate devices. It clearly states the device's purpose is to collect and transmit data and that interpretation requires clinical judgment. It does not present a study with specific acceptance criteria, performance metrics, or ground truth establishment as would be seen for a diagnostic or AI-powered device. The "study" referenced is "Verification activities including substantial equivalence testing," which confirmed its functionality and intended use were comparable to predicate devices.
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K09 3379
BL Healthcare Inc 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirement of 21 CFR 807.92
Submitter: Michael Mathur BL Healthcare, Inc 33 Commercial Street, Suite #3 Foxboro, MA 02035 Phone: (508) 543-4150 Fax: (508) 543-6150
Contact Person: Michael Mathur President and CEO Mmathur@BLHealthcare.com
Date Prepared: 10 Oct 2009
Regulation Number: Section 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: II Product Code: KDI Trade Name: TCx-I-DV Remote Care Management system Common Name: Telemedicine systems
Legally Marketed Predicate Device(s):
BL Healthcare Remote Care Management system (K051470) Telephone Based TCx-I-DV Remote Care Management system (RCMS) (K052608) MedApps' Remote Patient Monitoring System (K062377) Exalis software 1.15 (K083158)
Submission Device Description:
TCx-I-DV Remote Care Management system collects and transmits measurement information such as weight, blood pressure and pulse rate, and dialysis data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
Intended use and indications for use:
The TCx-I-DV Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, NxStage System One Hemo Dialysis system and weight scale upon the prescription of a licensed physician or healthcare provider. The TCx-I-DV Remote Care Management system serves as the communication link between the compatible devices and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center.
FDA 510(k) Page 15
FEB - 9 2010
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Image /page/1/Picture/1 description: The image contains the logo for BL Healthcare Inc. The logo consists of a black geometric shape resembling a plus sign made of squares, followed by the text "BL Healthcare Inc" in a simple, sans-serif font. The text is aligned to the right of the geometric shape.
The purpose of the system is to collect and transmit medical information such as weight, blood pressure and pulse rate, and dialysis data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
This system is installed by or with support from trained professionals.
This device is not intended to provide time sensitive data or alarms. This system may not be used as a substitute for direct medical intervention or emergency care.
Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.
Substantial Equivalence Summary
The TCx-I-DV Remote Care Management system has the same fundamental technology as the predicate devices. Verification activities including substantial equivalence testing demonstrates that this system is substantially equivalent to the predicate devices in terms of functionality and intended use.
Conclusion:
The TCx-I-DV system is substantially equivalent to the predicate devices.
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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 it. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three wing-like extensions.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G66 Silver Spring, MD 20993-0002
BL Healthcare, Inc. c/o Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Rd. Unit B7 TWINSBURG, OH 44087
FEB - 9 2010
Re: K093379
Trade/Device Name: TCx-I-DV Remote Care Management System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: January 26, 2010 Received: January 27, 2010
Dear Mr. Lehtonen:
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/CDRH/CDRHQffices/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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BL Healthcare Inc Statement of Indication of Use
The TCx-I-DV Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, NxStage System One Hemo Dialysis system, and weight scale upon the prescription of a licensed physician or healthcare provider. The TCx-I-DV Remote Care Management system serves as the communication link between the compatible devices and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center.
The purpose of the system is to collect and transmit medical information such as weight, blood pressure and pulse rate, and dialysis data from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.
This system is installed by or with support from trained professionals.
This device is not intended to provide time sensitive data or alarms. This system may not be used as a substitute for direct medical intervention or emergency care.
Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ x (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Saul R. Morin
(Division Sign-On)
Division of Reproductive, Abdominal, and
Radiological Deviceş
510(k) Number K093379
FDA 510(k) Page 9
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”