(28 days)
Not Found.
No
The summary describes a simple medical device (an extension set) with material and connector changes, and bench testing focused on flow rates. There is no mention of AI, ML, or any computational analysis of data for diagnosis, treatment, or decision support.
No
The device is described as an "extension set" to connect a filter circuit to an access catheter for blood return. It facilitates the function of another system (System 100) but does not itself provide a therapeutic effect.
No
Explanation: The device is described as an "extension set" for connecting a "System 100 circuit outflow line to the access catheter for filtered blood return into the patient." This describes a function related to fluid delivery or return, not diagnostic measurement or analysis.
No
The device description clearly indicates it is a physical medical device (extension set with connectors) used to connect components of a blood filtration system. It discusses materials, packaging, sterilization, and bench testing related to flow rates, which are all characteristics of hardware, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect an extracorporeal filter circuit (System 100) to an access catheter for filtered blood return into the patient. This is a direct connection for fluid transfer within the body, not for analyzing samples outside the body.
- Device Description: The description focuses on materials, packaging, sterilization, and connecting fluid pathways. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The text does not contain any keywords or descriptions typically associated with IVD devices, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases
- Reagents, calibrators, or controls
The device is clearly intended for use in a medical procedure involving blood filtration and return to the patient, which falls under the category of medical devices used for treatment or support, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
For use with System 100.
Extension set male connector is specifically designed to secure the extension set to the Statock securement device. Connect luer extension fitting directly to the infusion catheter hub only.
Product codes
KDI
Device Description
Not Found.
Mentions image processing
No
Mentions AI, DNN, or ML
No
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
Bench testing was performed on a variety of access catheters with specified dimensional characteristics for lumen diameter and length. Data generated demonstrated access catheters meeting or falling with these dimensional criteria result in flow rates acceptable for use with the System 100.
Key Metrics
Not Found.
Predicate Device(s)
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 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.”
0
OCT 2 5 2002
20.324
510(k) Summarv
| Product Name: | Infusion Catheter Extension, Model 1513 |
|---|---|
| Common Name: | Catheter Extension / Accessory |
| Submitter's Name: | Chf Solutions, Inc. |
| Suite 170 – 7601 Northland Drive | |
| Brooklyn Park, MN 55428 | |
| Official Contact: | Amy Peterson |
| Vice President, RA/QA/CR | |
| Telephone: 763-463-4620 | |
| Fax: 763-463-4606 |
Summary Preparation Date: September 9, 2002
This summary is provide in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission.
The System 100 cleared under K013733 was classified as a high permeability hemodialysis system. 876.5860 which includes accessories. The extension catheter is considered an accessory and is substantially equivalent to that contained in the original clearance.
Class: Il Panel: Gastroenterology -Urology
Product code: KDI Classification: 876.5860
The device has identical materials of construction, packaging and sterilization. It is provided sterile and the fluid pathway is nonpyrogenic. The intended use is to connect the System 100 circuit outflow line to the access catheter for filtered blood return into the patient. Two changes are reflected in this submission for an alternate catheter extension and do not change the intended use.
-
- One of the two proprietary connectors was replaced with a standard male luer connector.
-
- Labeling was updated to allow use of the alternate extension catheter on the outflow side of the System 100, UF 500 extracorporeal filter circuit.
Bench testing was performed on a variety of access catheters with specified dimensional characteristics for lumen diameter and length. Data generated demonstrated access catheters meeting or falling with these dimensional criteria result in flow rates acceptable for use with the System 100. The acceptable dimensional characteristics have been incorporated into the directions for use leaflet.
This product is substantially equivalent to the predicate device and considered acceptable for the intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, human services, and well-being. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Public Health Service
OCT 2 5 200Z
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Amy Peterson Official Correspondent and Vice President, RA/QA/CR CHF Solutions, Inc. Suite 170 7601 Northland Drive BROOKLYN PARK MN 55428 Re: K023224 Trade/Device Name: Infusion Catheter Extension, Model A1513 Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: September 26, 2002 Received: September 27, 2002
Dear Ms. Peterson:
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 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.
2
Page 2
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
3
510(k) Number (if know): K023224
Device Name:
Infusion Catheter Extension Set with Securement Device & Male Luer, Model A1513
FDA's Statement of the Indication For Use for device:
For use with System 100.
Extension set male connector is specifically designed to secure the extension set to the Statock securement device. Connect luer extension fitting directly to the infusion catheter hub only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
larind li. Leyen
CHF Solutions, Inc.
(Division Sign-Off) (Division Sign of Reproductive, Abdominal, and Radiological Devices 510(k) Number --