(162 days)
K#012365
Not Found
No
The description focuses on the physical characteristics and materials of a hemodialysis catheter, with no mention of AI or ML capabilities.
Yes.
The device is a hemodialysis catheter, which is used for chronic hemodialysis, a therapeutic procedure that removes waste products from the blood of patients with kidney failure.
No
Explanation: The device is a hemodialysis catheter, which is used for treatment (delivering fluids and removing waste products during dialysis) rather than for diagnosing a condition.
No
The device description clearly describes a physical catheter made of polyurethane with a polyester cuff and luer locking adapters. It is a hardware device used for hemodialysis.
Based on the provided information, the Hemo-Stream™ Hemodialysis Catheter Set 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 the patient's body to filter blood or remove specific blood components.
- Device Description: The description details a catheter designed to be inserted into the body (intravascular) for the purpose of accessing the bloodstream. It describes physical components like lumens, a cuff, and luer locking adapters, all related to the physical connection to the patient's circulatory system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Hemo-Stream™ catheter does not perform any such analysis or testing of specimens outside the body.
The Hemo-Stream™ Hemodialysis Catheter is a medical device used for a therapeutic procedure (hemodialysis/apheresis), not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Hemo-Stream™ Hemodialysis Catheter Set is designed for chronic hemodialysis and apheresis.
Product codes
78 MSD
Device Description
The Rex Medical Hemo-Stream™ Hemodialysis Catheter is a 16F chronic, multilumen, radiopaque, polyurethane catheter with a polyester cuff and two female luer locking adapters. The cuff promotes tissue in-growth for fixation of the catheter in a subcutaneous tunnel. The luer locking adapters, as well as the tubing clamps, are colored to differentiate the arterial and venous lumens. Four arterial intake lumens are located 360º around a central venous lumen. The catheter intended purpose is identical to the predicate device with the exception that the Hemo-Stream™ Catheter does not facilitate the use of a tear-away sheath during the insertion procedure. The catheter will be manufactured in useable lengths, or the length from the distal catheter tip to the hub junction, of 24cm, 28cm, 32cm, 36cm, and 40cm.
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)
Comparative Functional testing to the predicate 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#012365
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.
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KO23847
Page 1 of 3
APR 3 0 2003
EXHIBIT #1
510(K) SUMMARY
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 585 County Line Road Radnor, PA 19087
Date Summary Prepared:
November 15, 2002
ર્યુ Name of the Device:
Hemo-Stream™ Hemodialysis Catheter Set
3. Predicate Device Information:
K#012365, Vaxcel Dialysis Catheter, Boston Scientific Corporation, Natick, MA.
4. Device Description:
The Rex Medical Hemo-Stream™ Hemodialysis Catheter is a 16F chronic, multilumen, radiopaque, polyurethane catheter with a polyester cuff and two female luer locking adapters. The cuff promotes tissue in-growth for fixation of the catheter in a subcutaneous tunnel. The luer locking adapters, as well as the tubing clamps, are colored to differentiate the arterial and venous lumens. Four arterial intake lumens are located 360º around a central venous lumen. The catheter intended purpose is identical to the predicate device with the exception that the Hemo-Stream™ Catheter does not facilitate the use of a tear-away sheath during the insertion procedure. The catheter will be manufactured in useable lengths, or the length from the distal catheter tip to the hub junction, of 24cm, 28cm, 32cm, 36cm, and 40cm.
1
5. Intended Use:
The Hemo-Stream™ Hemodialysis Catheter Set is designed for chronic hemodialysis and apheresis.
Comparison to Predicate Devices: 6.
Discussion of Similarities:
The Hemo-Stream™ Hemodialysis Catheter is similar to the Vaxcel Catheter in that they both provide access for hemodialysis. Both Catheters offer a colorcoded female luer adapter, red for arterial and blue for venous, to attach to a dialysis tubing set. The female luers for both catheters offer the corresponding lumen primina volume to insure the catheter receives the proper heparin lock between treatments. Both catheters offer a fixed polyester felt cuff located on the catheter lumen to stimulate tissue in-growth which will anchor the catheter in place as well as form an infection barrier. Proximal to the catheter lumens for both catheters is an integrated hub that encapsulates the catheter tubing and extension tubing junctions. On this hub is a rotating suture wing that may be used to anchor the catheter to the patient until the tissue in-growth around the catheter cuff is matured. Both catheters are made of a polyurethane material and have an adequate offset distance on the distal tip between the arterial intake lumen and the venous return lumen to reduce the effects of arterial/venous blood re-circulation.
Discussion of Differences
The outer diameter of the Hemo-Stream™ Hemodialysis Catheter is approximately 16F. The proximal portion of the Vaxcel Catheter has an outer diameter of 16F that tapers down to 14F distally. The Hemo-Stream™ Hemodialysis Catheter has four independent lumens for arterial intake and one lumen for venous return. The Vaxcel Catheter has one arterial intake lumen and one venous lumen. The Vaxcel utilized a tear-away sheath for catheter insertion while the Hemo-Stream™ Hemodialysis Catheter provides a catheter stiffener that allows the catheter to be introduced over the guidewire.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Comparative Functional testing to the predicate 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.
2
KC23847-
r
Rage 30f 3
8. Discussion of Clinical Tests Performed:
Not applicable, as there are no new indications for use which must be supported by clinical data.
Conclusions: 9.
The subject device, Hemo-Stream™ Hemodialysis Catheter, has the same intended use as the predicate device, the Boston Scientific Vaxcel Catheter. Moreover, bench testing contained in our submission and non-clinical testing supplied demonstrates that there are no differences in their technological characteristics, thereby not raising any new questions of safety and effectiveness. Thus, the Hemo-Stream™ Hemodialysis Catheter is substantially equivalent to the predicate device, the Vaxcel Catheter.
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2003
Rex Medical c/o Ms. Susan Goldstein-Falk Official Correspondent MDI Consultants, Inc. 55 Northern Blvd. Suite 200 GREAT NECK NY 11021
Re: K023847
Trade/Device Name: Hemo-Stream™ Hemodialysis Catheter Set Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: February 28, 2003 Received: May 5, 2003
Dear Ms. Goldstein-Falk:
We have reviewed vour 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). 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 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 (21 CFR Part 807); 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 the labeling regulation, please contact the Office of Compliance at (301) 594-4616. 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 (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
David A. Dyarman
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Exhibit B
Page 1
510(k) Number (if known): _ KO2 3847
Device Name: Hemo-Stream™ Hemodialysis Catheter Set
Indications For Use:
The Hemo-Stream™ Hemodialysis Catheter Set is designed for chronic hemodialysis and apheresis.
(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 (Optional Format 1-2-96)
David R. Legnon
(Division Sign-Off)
Division of Reproductive, and Radiological Dev 510(k) Number