(107 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a catheter, with no mention of AI or ML capabilities.
Yes.
The device is indicated for use in hemodialysis or apheresis therapy, which are therapeutic interventions.
No
Explanation: The device description and intended use indicate it is a catheter for vascular access for hemodialysis or apheresis therapy, which are treatment procedures, not diagnostic ones. There is no mention of it being used to gather information for diagnosis.
No
The device description clearly describes a physical catheter made of radiopaque silicone with lumens and a Dacron cuff, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- HemoCath Function: The HemoCath is a catheter designed for direct access to the vascular system (veins) for the purpose of removing and returning blood during hemodialysis or apheresis. It is a therapeutic device used to facilitate a medical procedure, not to analyze a sample outside the body.
The description clearly indicates it's a device for vascular access and blood handling during treatment, not for diagnostic testing of a sample.
N/A
Intended Use / Indications for Use
The HemoCath Hemodialysis/Apheresis Catheter is indicated for use in attaining long term vascular access for hemodialysis or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.
Product codes (comma separated list FDA assigned to the subject device)
78 MSD
Device Description
The HemoCath is a radiopaque silicone, double lumen catheter used to remove and return blood through two segregated circular lumen passages. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed Dacron cuff allows for tissue ingrowth for long-term placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jugular 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Information submitted in this premarket notification includes in vitro performance data for the HemoCath including flow rate and tensile strength that is substantially equivalent to the legally marketed devices. Clinical data was not deemed necessary since in vitro testing was sufficient to demonstrate safety and efficacy by way of comparison to legally marketed predicate device intended for hemodialysis and apheresis treatments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR 1 6 7005
510(k) Summary
SPONSOR 1.
Med-Conduit Inc. 18 Derby Lane Tyngsboro, MA 01879
Contact: Robert W. Cunningham
March 7, 2005 Date Prepared:
DEVICE NAME 2.
| Proprietary Name: | HemoCath Hemodialysis/Apheresis Catheter |
|---|---|
| Common/Usual Name: | Central Venous Catheter |
| Classification Name: | Long-Term Intravascular Catheter |
| Classification: | 78 MSD |
PREDICATE DEVICES ri
DermaPort DermaPort™ Access Device--K894131
Pourchez RetrO™ Catheter--K022000
DEVICE DESCRIPTION 4.
The HemoCath is a radiopaque silicone, double lumen catheter used to remove and return blood through two segregated circular lumen passages. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed Dacron cuff allows for tissue ingrowth for long-term placement.
INTENDED USE 5.
The HemoCath Hemodialysis/Apheresis Catheter is indicated for use in attaining long term vascular access for hemodialysis or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.
1
SUBSTANTIAL EQUIVALENCE 6.
The HemoCath is substantially equivalent to a combination of its predicate devices in terms of intended use, design, material type, performance, and method of sterilization.
PERFORMANCE TESTING 7.
Information submitted in this premarket notification includes in vitro performance data for the HemoCath including flow rate and tensile strength that is substantially equivalent to the legally marketed devices.
Clinical data was not deemed necessary since in vitro testing was sufficient to demonstrate safety and efficacy by way of comparison to legally marketed predicate device intended for hemodialysis and apheresis treatments.
2
Image /page/2/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 forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2005
Mr. Robert W. Cunningham Director, Regulatory Affairs Med-Conduit, Inc. 18 Derby Lane TYNGSBORO MA 10879
Re: K043292
K043292
Trade/Device Name: HemoCath Hemodialysis/Apheresis Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: February 9, 2005 Received: February 10, 2005
Dear Mr. Cunningham:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section >10(x) prematics is substantially equivalent (for the indications
referenced above and have determined the device is substant devices marketed i referenced above and have decimined the arrased predicate devices marketed in interstate for use stated in the enclosure) to regarly markets of the Medical Device Amendments or to commerce prior to May 28, 1976, the encentralie with the provisions of the Federal Food, Drug, devices that have been reclassified in accordation that the device, subject to the general controls and Cosmetic Act (ACC). You may, meterere, market one that the medical devices your provisions of the Act. Trowever, you are reaponsors in the last and one legally and the market prior use as components in the Kit have citiler of the act), or were legally on the market prior to
premarket notification process (Section 510(k) of the act), or were note: [[ xoy premarket notification process (Section 910(x) of the Medical Device Amendments. If your May 28, 1970, the enactlifen date of the Mea. Be shed and further process (s.g., sterilize)
purchase your device components in bulk (i.e., unfinished) and further . The seppe purchase your device components in bank (first and components in your kit. The general you must submit a new JT6(K) octore menaling and registration, listing of devices,
controls provisions of the Act include requirements for annual registration and controls provisions of the Fet mendale requirement.
good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into entire reason regilations affecting your device can be
it may be subject to additional controls. Existing major resultions affe it may be subject to additional controls. Extrolling major solo to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In additio found in the Code of I caeral 105 meeting your device in the Federal Register.
3
Page 2 - Mr. Robert Cunningham
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 8 issualles over device complies with other requirements of the Act that I DX has made a actuations administered by other federal agencies. You must or any I cacial suttates and regarments, including, but not limited to: registration (21 CFR Part comply with an the Fee of equilibeling (21 CFR Part 801); good manufacturing practice 807), instillE (21 CFR Part 007), systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in and quanty is novisions (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) I mis letter will unow you to organizating of substantial equivalence of your device to a legally premarket notificate device results in a classification for your device and thus, permits your marketed proceed to the market. If you desire specific advice for your device on the labeling device to proceed to the mancer ice of Compliance at (240) 276-0115. Also, please note the regulation, premo contact and one by reference to premarket notification" (21 CFR Part 807.97). regulation other general information on your responsibilities under the Act from the Tou may oodain other geleral meeting 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/industry/support/index.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
4
Indications for Use
510(k) Number (if known): K043292
HemoCath Hemodialysis/Apheresis Catheter Device Name:
Indications For Use: The HemoCath Hemodialysis/Apheresis Catheter is indicated for cmoodiff formoung term vascular access for hemodialysis ase in attaining via the jugular or subclavian vein. The or uphersels intended for implantation dwell time of greater than 30 days.
× Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. bowdon
510kl Nur
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