(90 days)
Not Found
No
The device description and intended use focus on mechanical components and their function within a blood tubing set. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device components are accessories used as part of an extracorporeal blood circuit for hemodialysis, facilitating the procedure rather than directly providing a therapeutic effect. Their function is to connect or redirect blood flow within the circuit.
No
Explanation: The device is described as accessories for an extracorporeal blood circuit for hemodialysis, used for functions like reversing blood flow, connecting bloodlines, and interconnecting dialyzers. While the "Reverso" accessory can facilitate "certain common diagnostic procedures," its primary function and the overall purpose of the product line are for managing blood flow during hemodialysis treatment, not for diagnosing conditions.
No
The device description clearly details physical components such as valves, gaskets, tubing, and Luer connectors, indicating it is a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these accessories are "indicated for use as a part of an extracorporeal blood circuit for hemodialysis." Hemodialysis is a treatment that filters blood outside the body.
- Device Description: The descriptions detail components used to manage blood flow and connect equipment within this extracorporeal circuit.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to test blood, urine, tissue, etc., to detect diseases, conditions, or measure substances.
These accessories are components of a therapeutic system (hemodialysis) rather than a diagnostic one.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
78 KOC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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."
2
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)
3
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) |