(98 days)
Not Found
No
The 510(k) summary describes a physical medical device (a catheter) and its intended use for vascular access. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated for providing vascular access for hemodialysis, hemoperfusion, and apheresis treatments, which are all therapeutic procedures.
No
The device is described as a "Short-Term Dialysis Catheter" for "attaining short-term vascular access for hemodialysis, hemoperfusion, and apheresis treatments" and for "power injection of contrast media, and central venous pressure monitoring." These are therapeutic and monitoring functions, not diagnostic functions that identify a disease or condition.
No
The 510(k) summary describes a physical catheter device, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The Power-Trialysis™ Short-Term Dialysis Catheter is a device that is inserted into the body (in vivo) to provide vascular access for medical treatments like hemodialysis. It is a medical device used for direct patient care and treatment, not for analyzing samples outside the body.
The intended use clearly describes a device for accessing the vascular system for therapeutic purposes, which is the domain of in vivo medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Power-Trialysis™ Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media.
Product codes
NIE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jugular, femoral, or subclavian vein
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)
K020089, K010778, K053501, K051991
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
K083675 page lot 2
MAR 1 9 2009
510(k) Summary 21 CFR 807.92(a)
March 5, 2009
Submitter of 510(k)
Power-Trialysis™ Short Term Dialysis Catheter Family
Premarket Notification: Phone: (801) 595-0700, Ext. 5651 Fax: (801) 595-5425 Contact Person: Jessica Agnello Regulatory Affairs Specialist Power-Trialysis™ Device Trade Name: Device Generic Name: Short Term Dialysis Catheter Niagara® Slim-Cath® Catheters Trade Name: Common/Usual Name: Short-Term Hemodialysis Catheter Classification Name: 78 MPB-Catheter, Hemodialysis, Non-Implanted CFR Reference: 21 CFR §876.5540(b)(2), Class II Classification Panel: Gastroenterology and Urology Premarket Notification: See below
| Predicate Device Name | 510(k) | Concurrence Date |
|---|---|---|
| Niagara® Slim-Cath® Short | ||
| Term Dialysis Catheters | K010778 | April 13, 2001 |
PowerPICC® Catheters Trade Name: Common/Usual Name: Peripherally Inserted Central Catheter (PICC) Classification Name: 80 LJS- Long Term Intravascular Catheter CFR Reference: 21 CFR §880.5970, Class II Classification Panel: General Hospital Premarket Notification: See below
| Predicate Device Name | 510(k) | Concurrence Date |
|---|---|---|
| 6 Fr Triple Lumen (TL) | ||
| PowerPICC® catheter | K053501 | January 13, 2006 |
| Central Venous Pressure | ||
| Monitoring - PICCs and CVC | ||
| Catheters | K051991 | October 20, 2005 |
| Trade Name: | Mahurkar® Triple Lumen Catheter |
|---|---|
| Common/Usual Name: | Catheter, Hemodialysis, Triple-Lumen, |
| Non-implanted | |
| Classification Name: | 78 NIE |
| CFR Reference: | 21 CFR §876.5540, Class II |
| Classification Panel: | Gastroenterology and Urology |
| Premarket Notification: | See below |
General Provisions Bard Access Systems, Inc. (BAS) [Subsidiary of C.R. Bard, Inc.] Salt Lake City, Utah 84116
Predicate Devices
1
| Predicate Device Name | 510(k) | Concurrence Date |
|---|---|---|
| Mahurkar® Triple Lumen | ||
| Catheter | K020089 | January 9, 2002 |
| Classification | 21 CFR §876.5540(b)(2), Class II, | |
| 78 NIE-Catheter, Hemodialysis, Triple Lumen, Non-Implanted | ||
| Performance | ||
| Standards | Performance standards have not been established by FDA under section 514 | |
| of the Federal Food, Drug and Cosmetic Act. | ||
| Intended Use | The Power-Trialysis™ Short-Term Dialysis Catheter, with a third internal | |
| lumen for intravenous therapy, power injection of contrast media, and central | ||
| venous pressure monitoring, is indicated for use in attaining short-term (less | ||
| than 30 days) vascular access for hemodialysis, hemoperfusion, and | ||
| apheresis treatments. The catheter is intended to be inserted in the jugular, | ||
| femoral, or subclavian vein as required. The maximum recommended | ||
| infusion rate is 5 ml/sec for power injection of contrast media. | ||
| Indications for | ||
| Use | The Power-Trialysis™ Short-Term Dialysis Catheter, with a third internal | |
| lumen for intravenous therapy, power injection of contrast media, and central | ||
| venous pressure monitoring, is indicated for use in attaining short-term (less | ||
| than 30 days) vascular access for hemodialysis, hemoperfusion, and | ||
| apheresis treatments. The catheter is intended to be inserted in the jugular, | ||
| femoral, or subclavian vein as required. The maximum recommended | ||
| infusion rate is 5 ml/sec for power injection of contrast media. | ||
| Technological | ||
| Characteristics | Technological similarities between the subject Power-Trialysis™ catheters | |
| and the predicate devices remain identical. There are no new questions | ||
| raised regarding safety or efficacy of the Power-Trialysis™ catheters. | ||
| Summary of | ||
| Substantial | ||
| Equivalence | Based on the indications for use, technological characteristics, and safety and | |
| performance testing, the subject Power-Trialysis™ catheters met the | ||
| minimum requirements that are considered adequate for its intended use and | ||
| is substantially equivalent in design, materials, sterilization, principles of | ||
| operation and indications for use to current commercially available | ||
| catheters/cited predicates. |
K083675 page 2082
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
MAR 1 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jessica Agnello Regulatory Affairs Specialist C.R. Bard, Inc. Bard Access Systems, Inc. 605 North 5600 West SALT LAKE CITY UT 84116
Re: K083675
Trade/Device Name: Power-Trialysis™ Short-Term Dialysis Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: NIE Dated: March 9, 2009 Received: March 10, 2009
Dear Ms. Agnello:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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
3
Page 2 - Ms. Jessica Agnello
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.
In addition, we have determined that your device kit contains Chloraprep Applicator, Sodium Chloride Solution, and Lidocaine, 1%, which are subject to regulation as drugs,
Our substantially equivalent determination does not apply to the drug component[s] of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification''(21 CFR Part 807.97). 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 yours,
Herbert Remen
ine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K013675 page 101
510(k) Number (if known):
Device Name:
Indications for Use:
The Power-Trialysis™ Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media.
Dialysis Catheter
Power-Trialysis™ Short-Term
Prescription Use V (Part 21 CFR §801 Subpart D)
AND/OR
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, |
| Radiological Devices |
| K083675 | |
|---|---|
| -- | --------- |