(90 days)
Medisystems Blood Tubing Set Accessories are indicated for use as a part of an extracorporeal blood circuit for hemodialysis. The specific indications for use each accessory are as follows:
a. The Reverso™ is indicated for use as an access flow reversing valve to reverse the blood flow to and from the arterial and venous access devices during hemodialysis procedures without the need to clamp and disconnect bloodlines.
b. The Recirculation Connector is indicated for use as a male to male Luer adaptor.
c. The Parallel Dialyzer Connector is indicated for use to interconnect two hemodialyzers in parallel as prescribed by the physician as part of the extracorporeal blood system.
d. The Series Dialyzer Connector is indicated for use to interconnect two hemodialyzers in series as prescribed by the physician as part of the extracorporeal blood system.
A series of blood tubing set accessories to be used as part of the extracorporeal circuit.
A. Medisystems Blood Tubing Set Accessory, Access Flow Reversing Valve, (Reverso): The technical characteristics of the device consist of a manually operated valve with a gasket to prevent leakage. The device is also equipped with tubing and Luer connectors to allow it to interconnect between the blood tubing set and the blood access devices. The device allows reversal to the arterial and venous blood access without the need to disconnect the blood tubing set from the access devices. The reversal of the arterial and venous accesses is necessary to facilitate certain common diagnostic procedures and can be used to reverse flow in central venous or femoral catheters that have patency problems.
B. Medisystems Blood Tubing Set Accessory, Recirculation Connector: The device is a singly packed recirculation connector (male-to male Luer adaptor) used to interconnect the arterial and venous bloodlines.
C. Medisystems Blood Tubing Set Accessory, Parallel Dialyzer Interconnector: The device is used with a standard blood tubing set to provide a means to connect two dialyzers in parallel into the extracorporeal circuit.
D. Medisystems Blood Tubing Set Accessory, Series Dialyzer Interconnector: The device is used with a standard blood tubing set to provide a means to connect two dialyzers in series into the extracorporeal circuit.
The provided text describes a 510(k) submission for "Blood Tubing Set Accessories" by Medisystems Corporation. The document outlines the device's intended use and technological characteristics but does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or similar measures typically found in AI/ML device submissions.
Instead, the submission focuses on establishing substantial equivalence to a legally marketed predicate device (Medisystems' Blood Tubing Sets described in K953823) and details the safety and effectiveness measures in terms of manufacturing processes and quality control.
Here's a breakdown of the requested information based on the provided text, highlighting what is missing:
Acceptance Criteria and Device Performance Study for K994306 (Medisystems Blood Tubing Set Accessories)
Given the nature of the device (blood tubing set accessories for hemodialysis) and the regulatory context (510(k) submission from 2000), the testing described is primarily for manufacturing quality assurance and functional integrity rather than AI/ML performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Manufacturing/Quality Control | Sterility | "all finished products are tested and must meet all required release specifications before distribution" |
| Pyrogenicity | "all finished products are tested and must meet all required release specifications before distribution" | |
| Physical Testing | "all finished products are tested and must meet all required release specifications before distribution" | |
| Visual Examination (in-process and finished product) | "all finished products are tested and must meet all required release specifications before distribution" | |
| Functional Integrity | Gasket to prevent leakage (for Reverso™ valve) | The device description states it has a "gasket to prevent leakage," implying this is a design feature meant to be met. The general statement about meeting release specifications would cover this. |
| Ability to interconnect between blood tubing set and access devices (for Reverso™) | The device description states it is "equipped with tubing and Luer connectors to allow it to interconnect..." Implied to be met through design and quality checks. | |
| Ability to reverse arterial and venous access without disconnection (for Reverso™) | This is the intended function. No specific performance metric is given beyond the description of functionality. | |
| Proper interconnection as male-to-male Luer adaptor (Recirculation Connector) | Implied through design and quality checks. Functionality as described is the performance. | |
| Ability to connect two dialyzers in parallel (Parallel Dialyzer Interconnector) | Implied through design and quality checks. Functionality as described is the performance. | |
| Ability to connect two dialyzers in series (Series Dialyzer Interconnector) | Implied through design and quality checks. Functionality as described is the performance. |
Missing Information: The document does not specify quantitative acceptance criteria for device performance (e.g., "leakage rate must be < X%," or "reversal mechanism must operate smoothly for Y cycles"). The "acceptance criteria" are implied by the necessity to conform to "product design specifications" and "required release specifications" through general quality control tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "all finished products are tested," which implies 100% inspection or batch testing based on internal procedures, but no specific sample size for a "test set" in a clinical/performance study context is mentioned.
- Data Provenance: Not applicable in the context of clinical/performance data. The testing described is part of the manufacturing process and quality control, not from patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a mechanical accessory, not an AI/ML diagnostic or prognostic device that requires expert-established ground truth from images or clinical data. The "ground truth" for this device's safety and effectiveness relies on meeting engineering specifications and quality control parameters.
4. Adjudication Method for the Test Set
- Not Applicable. There is no "adjudication method" described as it relates to expert review of output or clinical outcomes. Testing is physical and functional.
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
- Not Applicable. This device is a mechanical medical accessory, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
- The "ground truth" for this device's safety and effectiveness is based on engineering specifications, manufacturing standards, and quality control procedures (e.g., demonstration of sterility, lack of pyrogens, physical integrity, and functional performance as designed). There is no "expert consensus," "pathology," or "outcomes data" ground truth described for its basic functional performance.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is not an AI/ML device that requires a training set and associated ground truth.
Summary Conclusion:
The K994306 submission describes a mechanical medical device designed to facilitate hemodialysis. The "safety and effectiveness" section focuses entirely on standard manufacturing quality control and adherence to design specifications (sterility, pyrogenicity, physical testing, visual examination). It establishes substantial equivalence based on its intended use and technological characteristics being comparable to previously cleared predicate devices, rather than through performance metrics derived from clinical studies or AI/ML evaluation. Therefore, most of the requested information (related to AI/ML device evaluation) is not present in this document.
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K99.4306
PAGE 1 of 2
MAR 2 0 2000
Section I
510(k) Summary Required by 21 CFR §807.92
I. Submitter:
A. Name: Medisystems Corporation
1201 Third Avenue B. Address: Seattle, WA 98101-3016
C. Phone and Fax Numbers: Phone: 206-621-6500 Fax 206-621-6501
D. Contact Person: Mr. Fredric Swindler
II. Date of preparation of this Summary: December 17, 1999.
III. Trade name: The access flow reversing valve will have the trade name, Reverso"*
IV. Common name: Blood Tubing Set Accessories
V. Classification name: Set, Tubing, Blood, with and without Antiregurgitation Valve
VI. The marketed device(s) to which equivalence is claimed The Medisystems Blood Tubing Set Accessories that are the subject of this submission are substantially equivalent to Blood Tubing Sets marketed by Medisystems and described in Medisystems' Premarket Clearance number K953823.
VII. Product description: A series of blood tubing set accessories to be used as part of the extracorporeal circuit.
VIII. Statement of intended use compared to currently marketed predicate device: Medisystems Blood Tubing Set Accessories are intended for use as part of an extracorporeal blood circuit for hemodialysis. This is identical to the intended use of the legally marketed predicate device. Medisystems Blood Tubing Sets.
IX. Discussion of technological characteristics:
A. Medisystems Blood Tubing Set Accessory, Access Flow Reversing Valve, (Reverso): The technical characteristics of the device consist of a manually operated valve with a gasket to prevent leakage. The device is also equipped with tubing and Luer connectors to allow it to interconnect between the blood tubing set and the blood access devices
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The device allows reversal to the arterial and venous blood access without the need to disconnect the blood tubing set from the access devices. The reversal of the arterial and venous accesses is necessary to facilitate certain common diagnostic procedures and can be used to reverse flow in central venous or femoral catheters that have patency problems.
B. Medisystems Blood Tubing Set Accessory, Recirculation Connector: The device is a singly packed recirculation connector (male-to male Luer adaptor) used to interconnect the arterial and venous bloodlines.
C. Medisystems Blood Tubing Set Accessory, Parallel Dialyzer Interconnector: The device is used with a standard blood tubing set to provide a means to connect two dialyzers in parallel into the extracorporeal circuit.
D. Medisystems Blood Tubing Set Accessory, Series Dialyzer Interconnector: The device is used with a standard blood tubing set to provide a means to connect two dialyzers in series into the extracorporeal circuit.
X. Safety and effectiveness: To assure that the devices are safe and effective, all finished products are tested and must meet all required release specifications before distribution. The testing required for release includes, but is not limited to; sterility, pyrogenicity, physical testing, and visual examination of both in-process and finished product.
The required testing is defined by written and approved procedures that conform to the product design specifications. This testing for the Medisystems Blood Tubing Set Accessories is defined in detail in the "Device Master Records."
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2000
Mr. Fredric G. Swindler Vice President Quality Assurance and Regulatory Affairs Medisystems Corporation 1201 Third Avenue, 39th Floor Seattle, Washington 98101
Re: K994306 Blood Tubing Set Accessories (ReversoTM, Recirculation Connector, Parallel Dialyzer Interconnector, and Series Dialyzer Interconnector) Dated: December 17, 1999 Received: December 21, 1999 Regulatory Class: II 21 CFR §876.5820/Procode: 78 KOC
Dear Mr. Swindler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 pror 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). 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulator, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-5597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Daniel C. Schultz, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Section A
510(k) Number (if known): K994306
Device Name: Blood Tubing Set Accessories
Indications For Use:
Medisystems Blood Tubing Set Accessories are indicated for use as a part of an extracorporeal blood circuit for hemodialysis. The specific indications for use each accessory are as follows:
a. The Reverso™ is indicated for use as an access flow reversing valve to reverse the blood flow to and from the arterial and venous access devices during hemodialysis procedures without the need to clamp and disconnect bloodlines.
b. The Recirculation Connector is indicated for use as a male to male Luer adaptor.
c. The Parallel Dialyzer Connector is indicated for use to interconnect two hemodialyzers in parallel as prescribed by the physician as part of the extracorporeal blood system.
d. The Series Dialyzer Connector is indicated for use to interconnect two hemodialyzers in series as prescribed by the physician as part of the extracorporeal blood system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use | (Division Sign-Off) | Over-The-Counter Use | |
|---|---|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |||
| 510(k) Number | K994306 | (Optional Format 1-2-96) |
§ 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.