(119 days)
No
The device description and intended use clearly define the device as blood tubing sets for hemodialysis, which are passive components and do not incorporate AI/ML technology. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
The device facilitates hemodialysis by connecting blood access devices to a hemodialyzer, but it does not directly treat or manage a medical condition itself.
No
Explanation: The device description clearly states its purpose is to connect blood access devices to a hemodialysis machine and a hemodialyzer. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly outlines physical components like tubing, chambers, filters, and injection sites, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the blood tubing sets as being used with a hemodialyzer for extracorporeal procedures (hemodialysis or hemofiltration). This involves processing blood outside the body for treatment, not for diagnostic purposes.
- Device Description: The description details components like air trap chambers, filters, injection sites, pump segments, etc., all of which are consistent with a system for circulating and treating blood externally. There is no mention of analyzing blood or other biological samples for diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (e.g., glucose, enzymes, antibodies)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly intended for therapeutic use in conjunction with a hemodialysis or hemofiltration machine and a hemodialyzer/hemofilter.
N/A
Intended Use / Indications for Use
The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.
Product codes
FJK, KOC
Device Description
Medisystems/NxStage blood tubing sets consist of a family of products which are used during extracorporeal procedures to provide a means to connect blood access devices to a hemodialysis or hemofiltration machine and a hemodialyzer or hemofilter. To facilitate a hemodialysis procedure, for example, the arterial and/or venous blood tubing sets may contain features such as air trap chambers, filters, injection sites, pump segments, heparin infusion lines, saline administration lines, pressure pillows, priming sets, and pressure monitoring lines with or without transducer protectors. Numerous product codes are produced to accommodate various manufacturer's dialysis machines, as well as differing clinical preferences and clinical procedures.
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)
Performance, verification and validation testing was conducted to characterize performance of the subject blood tubing sets to provide a basis of comparison to the predicate device as all features are not identical. Results of this testing have documented that the subject blood tubing sets are substantially equivalent to the predicate device and are suitable for the labeled indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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K080807
Page 1 of 3
NxStage Medical, Inc. Blood Tubing Sets Special 510(k) Device Modification
9045797
Michael Doyle
(978) 687-4746
(978) 687-4750
9616074
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter's Information:
Name:
NxStage Medical Inc.
JUL 1 8 2008
Address:
439 South Union Street, 5th Floor Lawrence, MA 01843
Manager, Regulatory Affairs
Av. Valle imperial No. 10523 Parque industrial Valle Sur Tijuana, B.C., Mexico 22180
FDA Establishment Owner/Operator Number:
Contact Person:
Phone: Fax:
Manufacturing Site:
FDA Establishment Registration Number:
Manufacturing/Sterilization Site:
Kawasumi Laboratories Co. Ltd. 55/26-27 m-13 Phaholyothin Rd. Km-46 Klong Nueng, Klong Luang Pratumtanee, Thailand
MEDIMEXICO, S. DE R.L. DE C.V.
FDA Establishment Registration Number:
Manufacturing/Sterilization Site:
Kawasumi Laboratories Co. Ltd. 48 Moo 8 Ratchasima-Chokchai Rd., Tambon Tha-ang, Amphur Chokchai, Nakhorn Rachasima, Thailand
FDA Establishment Registration Number: 9615908
9680437
Sterilization Site:
Steris Corporation Isomedix Services, Inc. 1000 S. Sarah Place Ontario, CA 91761
1
K080807
Page 2 of 3
| FDA Establishment
| Registration Number: | Contract sterilizer |
|---|---|
| Sterilization Site: | STERIS Corporation |
| Isomedix Service, Inc. | |
| 7685 St. Andrews Ave. | |
| San Diego, CA 92154 | |
| FDA Establishment | |
| Registration Number: | Contract sterilizer |
| B. Device Name: | |
| Trade/Proprietary Name: | Blood Tubing Sets |
| Common/Usual Name: | Tubing sets |
| Classification Name: | Sets, Tubing, Blood, With and Without Anti- |
| Regurgitation Valve | |
| Regulation Number: | 876.5820 |
| Product Code: | FJK |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology/Urology |
C. Substantial Equivalence/Predicate Devices:
The subject blood tubing sets are substantially equivalent to the following legally marketed predicate device, previously cleared by the FDA:
- · Arterial-Venous Blood Tubing Sets, K953823, September 23, 1996
D. Device Description/Indications for Use:
Medisystems/NxStage blood tubing sets consist of a family of products which are used during extracorporeal procedures to provide a means to connect blood access devices to a hemodialysis or hemofiltration machine and a hemodialyzer or hemofilter. To facilitate a hemodialysis procedure, for example, the arterial and/or venous blood tubing sets may contain features such as air trap chambers, filters, injection sites, pump segments, heparin infusion lines, saline administration lines, pressure pillows, priming sets, and pressure monitoring lines with or without transducer protectors. Numerous product codes are produced to accommodate various manufacturer's dialysis machines, as well as differing clinical preferences and clinical procedures.
Indications for use:
The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.
2
K080807
Page 3 of 3
NxStage Medical, Inc. Blood Tubing Sets Special 510(k) Device Modification
E. Technological Characteristics:
The subject device has the same technological characteristics and is similar in design and configuration as compared to the predicate device. The subject device is designed with similar components and features also used in the predicate device.
F. Summary of Non-Clinical Test/Performance Testing - Bench
NxStage Medical, Inc. believes that the information and data provided in this submission clearly describes the subject device and demonstrates that the device is adequately designed for the labeled indications for use. Performance, verification and validation testing was conducted to characterize performance of the subject blood tubing sets to provide a basis of comparison to the predicate device as all features are not identical. Results of this testing have documented that the subject blood tubing sets are substantially equivalent to the predicate device and are suitable for the labeled indications for use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael J. Doyle Manager, Regulatory Affairs NxStage Medical, Inc. 439 South Union Street 5th Floor LAWRENCE MA 01843
K080807 Re:
Trade/Device Name: Blood Tubing Sets (Sterile Fluid Path) Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Codes: FJK and KOC Dated: July 10, 2008 Received: July 11, 2008
Dear Mr. Doyle:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: Blood Tubing Sets (Sterile Fluid Path)
Indications for Use:
The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices.
| 510(k) Number | K080807 |
|---|---|
| --------------- | --------- |
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