(121 days)
Not Found
No
The summary describes a physical medical device (a catheter) and its performance based on standard testing and comparison to a predicate device. There is no mention of software, algorithms, image processing, AI, or ML.
Yes
The device is a hemodialysis catheter, which is a medical device used to perform hemodialysis. Hemodialysis is a therapeutic treatment for kidney failure, making the device a therapeutic device.
No
Explanation: The device is a chronic hemodialysis catheter used for treatment (hemodialysis and apheresis), not for diagnosing a condition.
No
The device description clearly states it is a "chronic hemodialysis catheter," which is a physical medical device, not software. The performance studies also focus on functional and material testing of a physical catheter.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "chronic hemodialysis and apheresis." These are procedures performed on a patient's body to filter blood or remove specific components from blood.
- Device Description: The description clearly states it's a "chronic hemodialysis catheter," which is a physical device implanted into the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. IVDs are typically reagents, instruments, or systems used for diagnostic testing.
This device is a medical device used for a therapeutic procedure (hemodialysis/apheresis), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The UltraStream Chronic Hemodialysis Catheter is designed for chronic hemodialysis and apheresis.
Product codes
MSD
Device Description
The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures.
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
Comparative functional testing to the predicated devices was performed based on ISO 10555-1 and the FDA's Reviewer Guidance for Long Term and Short Term Intravascular Catheters. Material testing also included ISO 10993 Biocompatibility Testing. Testing results revealed the subject device to be substantially equivalent to the predicate device.
Key Metrics
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
Exhibit 1
Special 510(k): Device Modification UltraStream Chronic Hemodialysis Catheter
Image /page/0/Picture/3 description: The image shows the logo for REX MEDICAL. The logo is in black and white. The word "REX MEDICAL" is written in a bold, sans-serif font. There is a curved line above and below the word "REX MEDICAL".
pg 10f3
1100 East Hector Street, Suite 245, Conshohocken, PA 19428
510(K) SUMMARY
NOV 1 8 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
1. Submitter's Identification:
Rex Medical, LP 1100 East Hector Street Suite 245 Conshohocken, PA 19428
Contact: Mr. Walter H. Peters Quality Manager
Date Summary Prepared: July 6, 2010
2. Name of the Device:
UltraStream Chronic Hemodialysis Catheter
3. Predicate Device Information:
- K071422, Hemo-Stream™ True Over the Wire Dialysis Catheter
4. Device Description:
The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures.
The device is used in the same manner as the predicate device and other substantially equivalent 510(k) cleared devices.
5. Intended Use:
The UltraStream Chronic Hemodialysis Catheter Set is designed for chronic hemodialysis and apheresis,
6. Comparison to Predicate Devices:
See next page
1
| Attribute | Rex Medical UltraStream Chronic
Hemodialysis Catheter (Subject
Device) | Rex Medical Hemo-Stream™
True Over the Wire Dialysis
Catheter (K071422 - Predicate) |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Catheter Type | Implanted Vascular Access | Implanted Vascular Access |
| Intended Use | Hemodialysis and Apheresis | Hemodialysis and Apheresis |
| Lumen Configuration | 2 Kidney Shaped Arterial Lumens, 1
Round Venous Lumen | 3 Kidney Shaped Arterial
Lumens, 1 Round Venous
Lumen |
| Catheter O.D. | 15.5F | 15.5F |
| Arterial/Venous Access
Lumens | Yes | Yes |
| Color Coded Female
Luers | Red: Arterial, Blue: Venous | Red: Arterial, Blue: Venous |
| Color Coded Clamp on
Extensions | No | No |
| Rotating Suture Wing on
Cath. Hub | No | No |
| Catheter Cuff for Tissue
In-Growth | Yes | Yes |
| Radiopaque Catheter
Lumen | 20% Barium Sulfate | 20% Barium Sulfate |
| Offset Tip for Arterial /
Venous Separation | 1.125" Separation | 1.125" Separation |
| Hub junction for catheter
lumen / extension tubing | Injection Molded, One Piece Hub | Injection Molded, One Piece
Hub |
| Dilator Provided for
Catheter Insertion | 16F Rex Dilator | 16F Rex Dilator |
| Tunneling Tool provided
for Catheter Insertion | Tunneling Tool | Tunneling Tool |
| Injection Sites supplied
with Catheter | Qty. 2: Latex Free Injection Sites
Provided | Qty. 2: Latex Free Injection Sites
Provided |
| Priming Volume Printed
on Female Luers | No | No |
| Catheter Identification
and Reference size
printed on Catheter Hub | No | No |
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:
Comparative functional testing to the predicated devices was performed based on ISO 10555-1 and the FDA's Reviewer Guidance for Long Term and Short Term Intravascular Catheters. Material testing also included ISO 10993 Biocompatibility Testing. Testing results revealed the subject device to be substantially equivalent to the predicate device.
8. Discussion of Clinical Tests Performed:
Not applicable as there are no new indications for use which must be supported by clinical data.
2
Exhibit 1
20 Special 510(k): Device Modification UltraStream Chronic Hemodialysis Catheter
9. Conclusions:
The subject device, the UltraStream Chronic Hemodialysis Catheter, has the same intended use as the predicate device, the 15.5F Hemo-Stream™ True Over the Wire Hemodialysis Catheter (K071422). Bench testing and non-clinical testing supplied within our submission demonstrates that there are not any differences in their technological characteristics thereby not raising any new questions of safety and effectiveness. Therefore, the UltraStream Chrynic Hemodialysis Catheter is substantially equivalent to the predicate device, the Hemo-Stream™ True Over the Wire Hemodialysis Catheter (K071422).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird with its wings spread, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
REX Medical c/o Ms. Susan D. Goldstein-Falk Official Correspondent for REX Medical MDI Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021
NOV 1 8 2010
Re: K102043
Trade/Device Name: UltraStream Chronic Hemodialysis Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: October 25, 2010 Received: October 26, 2010
Dear Ms. Goldstein-Falk:
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 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). You may, therefore, market the device, subject to the general controls provisions of the 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 legally 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, and 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.
4
Page 2 - Ms. Susan D. Goldstein-Falk
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Hebert Leuner
Herbert P. Lerner, MD, Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Exhibit D
Special 510(k): Device Modification UltraStream Chronic Hemodialysis Catheter
NOV 1 8 2010
Indications For Use
KID2043
Page _ 1 of
510(k) Number (if known):
Device Name: UltraStream Chronic Hemodialysis Catheter
Indications For Use:
The UltraStream Chronic Hemodialysis Catheter is designed for chronic hemodialysis and apheresis.
Prescription Use × (Per 21 CFR 801.109)
OR ﺮ
Over-The Counter Use_ (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K102043 |