(90 days)
Not Found
No
The summary describes a set of tubing and an injection port for use with a hemodialysis system, focusing on physical components and their function in flow measurement. There is no mention of AI, ML, or any computational analysis beyond standard measurement techniques.
No
The device is described as an extension set for hemodialysis circuits that allows for measurements (access flow, recirculation, cardiac output) to be made during treatment, rather than providing therapy itself.
No
The device description indicates it is a set of tubing for hemodialysis circuits used in conjunction with a separate system (HD01) to make measurements. It serves as a component of a larger system that performs diagnostic functions, but the set itself is a conduit rather than a diagnostic device.
No
The device description explicitly states it is a "Hemodialysis extension set" which is a physical tubing component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as part of an extracorporeal blood circuit for hemodialysis, used in conjunction with the Transonic HD01 System to make measurements during the patient's hemodialysis treatment. This involves interacting with the patient's blood flow within the circuit, not analyzing samples in vitro (outside the body).
- Device Description: The description confirms it's a hemodialysis extension set for connection into standard hemodialysis circuits. It facilitates measurements within the circuit.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) outside the body to provide diagnostic information. The measurements are related to the flow dynamics within the hemodialysis circuit.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Transonic Flow-QC Set is indicated for use as part of an extracorporeal blood circuit for hemodialysis when the Transonic HD01 System will be use to make access flow, recirculation, and/or cardiac output measurements during the patient's hemodialysis treatment.
Product codes
78KOC, 78MQS
Device Description
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic Flow-QC® Sets which are Hemodialysis extension sets for connection into standard Hemodialysis circuits. These sets provide tubing segments of consistent material and wall thickness to which our HD01 Hemodialysis system can be calibrated. They also provide an injection port for making cardiac output measurements with the HD01 system.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Transonic Flow-QC® Sets
510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
April 17, 2002
Transonic Systems Inc.
| 34 Dutch Mill Rd |
|---|
| Ithaca, NY |
| Telephone: (607) 257-5300 |
| Fax: (607) 257-7256 |
| Contact: | Mark S. Alsberge |
|---|---|
| Product Name: | Transonic Flow-QC® Set |
| Classification name: | Hemodialysis Accessories, Blood Circuit |
| Gastroenterology and Urology | |
| Class II, 78KOC | |
| 21 CFR §876.5820 |
SUBSTANTIAL EQUIVALENCE1 TO:
| 510 (k) Number | Name | Applicant |
|---|---|---|
| K002816 | Transonic Hemodialysis Flow | |
| Reverser | Transonic Systems Inc. |
Device Description:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic Flow-QC® Sets which are Hemodialysis extension sets for connection into standard Hemodialysis circuits. These sets provide tubing segments of consistent material and wall thickness to which our HD01 Hemodialysis system can be calibrated. They also provide an injection port for making cardiac output measurements with the HD01 system.
1 The term "substantially equivalent" as use herein is intended to be a delermination of substantial equivalence from an FDA regulatory point of view under the Federal Food, Drug, and Cosmelic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and diminish any patent daims related to this product or the technology used to manufacture the product.
1
Material:
The Transonic Flow-QC® Sets are made of materials which have been tested in accordance with the ISO Standard 10993 and therefore suitable for the intended use of this product.
Substantial equivalence:
The Transonic Flow-QC® Sets is similar in materials, form and intended use to the Transonic Hemodialysis Flow Reverser currently marketed by Transonic Systems Inc. and cleared under K002816. The minor difference between Flow-QC Sets and the Transonic Hemodialysis Flow Reverser are that the Flow-QC Sets do not have a Flow reversing valve present in the Flow Reverser. This difference does not raise any new issues of safety or effectiveness regarding the Transonic Flow-QC® Sets.
Safety and Effectiveness:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product). The ANSVAAMI standard "American National Standard for Hemodialyzer Blood Tubing" RD17- 1994 was followed for the design and will continue to be followed for the production and quality assurance testing of this device.
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures that ensure the products performance parameters conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control cGMP"s.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest the bird's head and wings. The bird is positioned to the right of the text, which is arranged in a circular pattern around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 2002
Mr. Mark S. Alsberge VP Medical and Regulatory Affairs Transonic Systems, Inc. 34 Dutch Mill Road ITHACA NY 14850-9787
Re: K021571
Trade/Device Name: Transonic Flow-QC® Sets Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 MQS Dated: May 8, 2002
Received: May 14, 2002
Dear Mr. Alsberge:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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); 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.
3
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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy Crozdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): Device Name: Transonic Flow-QC® Sets Indications for Use:
The Transonic Flow-QC Set is indicated for use as part of an extracorporeal blood circuit for hemodialysis when the Transonic HD01 System will be use to make access flow, recirculation, and/or cardiac output measurements during the patient's hemodialysis treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
Prescription Use
David A. Ingram
(Optional Format 3-10-98)
(Posted July 1, 1998)