(70 days)
No
The summary describes a physical catheter and its compatibility with a system that uses software for blood flow rate adjustment. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a peripheral venous access catheter that facilitates blood removal and return for ultrafiltration, which is a treatment for fluid overload. The indication for use explicitly states it's for use with the Aquadex System 100, which is indicated for "temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload." This describes a therapeutic purpose.
No
The device is a catheter used for ultrafiltration treatment of fluid overload, facilitating blood removal and return. It is not intended for diagnostic purposes like laboratory sampling.
No
The device description clearly details a physical catheter made of polyurethane and stainless steel, intended for peripheral venous access. While it is used with a system that utilizes software, the device itself is a hardware component.
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 the catheter is for "peripheral venous access" and specifically for use with the Aquadex™ System 100 for "ultrafiltration treatment of patients with fluid overload." It explicitly states it is "not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs." IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's purpose is to facilitate a physical treatment (ultrafiltration) by providing access to the bloodstream, not to analyze bodily fluids for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics of the catheter and its function in facilitating blood removal and return for ultrafiltration. There is no mention of any components or processes related to analyzing biological samples.
- Lack of IVD-related information: The document does not contain any information typically associated with IVD devices, such as:
- Analysis of biological samples.
- Measurement of analytes.
- Diagnostic claims.
- Performance metrics like sensitivity, specificity, etc., in the context of diagnostic testing.
The device is a medical device used for a therapeutic procedure (ultrafiltration), not a diagnostic test.
N/A
Intended Use / Indications for Use
The 5.2F dELC catheter is a peripheral venous access catheter, inserted preferably in the basilic vein (arm) and antecubital region respectively and specifically for use with the Aquadex™ System 100 when the blood flow rate is set at ≤20ml/minute.
The catheter not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.
The Aquadex System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
Product codes
KDI, MPB
Device Description
The 5.2F dELC is a 16 gauge, polyurethane, dual lumen extended-length catheter. It is intended to provide short-term peripheral venous access to facilitate blood removal and return for the purposes of ultrafiltration. The catheter has a low profile, flexible hub with suture wings for securement to the skin. The dual lumen tubing in the proximal portion of the catheter shaft is a double-D configuration and is fused to a single lumen tube for the distal portion. The catheter shaft construction includes a 304 stainless steel coil to minimize kinking from bending. The blood is drawn up through the single lumen tubing, and infused back into the vessel through the short proximal dual lumen section of the catheter shaft. The catheter will connect directly to the UF circuit of the Aquadex System 100 to conduct blood to and from the patient for the purposes of ultrafiltration. The 5.2F dELC is compatible with the Aquadex System 100 which utilizes software allowing blood flow rate adjustment as this catheters' optimal blood flow rate is at ≤20ml/minute.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
basilic vein (arm) and antecubital region
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)
Bench tests demonstrate the dELC is compatible with the Aquadex System 100 which utilizes software allowing blood flow rate adjustment to ≤20ml/minute.
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
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
K041791 Page 1 of 1
| SEP 1 0 2004 | 510(k) Summary
Prepared on July 1, 2004 | |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| This 510(k) Summary is submitted in accordance with 21 CFR 807.92. | | |
| Trade Name: | 5.2F Dual-Lumen Extended Length Catheter (dELC) | |
| Manufacturer: | CHF Solutions, Inc., Suite 170 – 7601 Northland Drive, Brooklyn Park, MN 55428 | |
| Official
Contact: | Amy Peterson
Vice President, RA & QA | Telephone: 763-463-4620
Fax: 763-463-4606 |
| Generic Name: | Short-term/non-implanted blood access device | |
| Classification: | Aquadex™ System 100 - Accessory
• Class: II (21 CFR 876.5860)
• Panel: Gastroenterology-Urology
• Product code: KDI | Non-implanted Blood Access Device
• Class: II (21 CFR 876.5540 (b)(2))
• Panel: Gastroenterology-Urology
• Product code: MPB |
| Predicate
Devices: | • CHF Solutions, 6F dELC (K031869)
• CHF Solutions, Extended Length Catheter (K013733) | |
| Device
Description: | The 5.2F dELC is a 16 gauge, polyurethane, dual lumen extended-length catheter. It is
intended to provide short-term peripheral venous access to facilitate blood removal and return
for the purposes of ultrafiltration. The catheter has a low profile, flexible hub with suture wings
for securement to the skin. The dual lumen tubing in the proximal portion of the catheter shaft
is a double-D configuration and is fused to a single lumen tube for the distal portion. The
catheter shaft construction includes a 304 stainless steel coil to minimize kinking from
bending. The blood is drawn up through the single lumen tubing, and infused back into the
vessel through the short proximal dual lumen section of the catheter shaft. The catheter will
connect directly to the UF circuit of the Aquadex System 100 to conduct blood to and from the
patient for the purposes of ultrafiltration. The 5.2F dELC is compatible with the Aquadex
System 100 which utilizes software allowing blood flow rate adjustment as this catheters'
optimal blood flow rate is at ≤20ml/minute. | |
| Indication
for Use: | The 5.2F dELC catheter is a peripheral venous access catheter, inserted preferably in the
basilic vein (arm) and antecubital region respectively and specifically for use with the
Aquadex™ System 100 when the blood flow rate is set at ≤20ml/minute.
The catheter not intended for the infusion of medications or fluids, for laboratory sampling, or
other venous access needs.
The Aquadex System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of
patients with fluid overload. | |
| Safety &
Performance: | The 5.2F dELC and predicate devices are similar in materials of construction and identical for
packaging and sterilization. The dELC is provided sterile and nonpyrogenic. Bench tests
demonstrate the dELC is compatible with the Aquadex System 100 which utilizes software
allowing blood flow rate adjustment to ≤20ml/minute. | |
| Conclusion: | Based on the intended use, technology characteristics and bench testing, the new access
catheter has been shown to be safe and effective for its intended use. This product is
substantially equivalent10 and considered acceptable for the intended use. | |
10 This document uses the term "substantial equivalent" as intended in 21 CFR 807.87 and not as defined in Title 36 of the U.S. Code.
1
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2004
Mr. Steve Bernard Director, Disposable Development CHF Solutions, Inc. Suite 170 7601 Northland Drive BROOKLYN PARK MN 55428
Re: K041791
Trade/Device Name: Aquadex™ System 100 – 5.2F/16G Dual Lumen Extended Length Catheter (dELC), Model A1562 Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: 78 NQJ Dated: July 1, 2004 Received: July 6, 2004
Dear Mr. Bernard:
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
This letter will allow you to begin marketing your device as described in your Section 5 (and This letter will allow you to begin marketing of substantial equivalence of your device to a legally premarket nothication - The F17A miom, or samulation or 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 If you desire specific advice for your dones on one of the following numbers, based on the regulation number at the top of the 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 Additionally, 101 questions of the promotion ................................................................................................................................. Other of Compliance at (301) 57 - 1059. 1205. 1204 ( by reference to premarket nonitation (DTC) of the Act may be obtained from the Division of Small information on your responsionalities and consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octuberther and Collectives and Schamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT (Page 1 of 1)
510(k) Number (if know): ____K04_179 l
Device Name: 5.2F Dual Lumen Extended Length Catheter (dELC)
Indication For Use for device:
The 5.2F dELC catheter is a peripheral venous access catheter, inserted preferably in the I ne 0.2. Lear cantecubital region respectively and specifically for use with the Aquadex™ System 100 when the blood flow rate is set at ≤20ml/minute.
The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs.
The Aquadex System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use