(266 days)
Not Found
No
The device description focuses solely on the physical components and materials of a vascular access catheter and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is a vascular access catheter used to facilitate therapies (hemodialysis, hemoperfusion, apheresis) but does not directly perform a therapeutic function on the patient.
No
Explanation: The device is a catheter used for short-term vascular access for therapies like hemodialysis, hemoperfusion, and apheresis. Its function is to facilitate these treatments, not to diagnose a medical condition.
No
The device description clearly details a physical catheter made of polyurethane with lumens, extension lines, clamps, and a stylet. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "attaining short-term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein." This describes a procedure performed on the patient's body to access their vascular system.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. It talks about lumens, materials, lengths, and connectors – all components of a device used for direct intervention on the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for therapeutic procedures.
N/A
Intended Use / Indications for Use
GamCath® catheters are indicated for use in attaining short-term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein. Not for pediatric use.
Product codes (comma separated list FDA assigned to the subject device)
78 MPB
Device Description
The catheter is a device, which can be used for short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion and apheresis via the jugular, subclavian or femoral veins. The catheter is available in 13 French (4,3 mm / 0,169") straight configuration with the following insertion length: 125mm (4,921"), 150mm (5,906"), 175mm (6,900"), 200mm (7,874") and 250mm (9,843"). The catheter body and hub (bifurcation) is made from aliphatic polyurethane. The catheter body and hub is radiopaque (filled with Barium Sulfate). The catheter body has two lumens positioned side by side. The cross section of the venous lumen is elliptical and the cross section of the arterial lumen is kidnev-shaped. The arterial lumen is beveled. The venous lumen extends beyond the arterial lumen with a rounded tip. The arterial and venous extension line is made from transparent aliphatic polyurethane, which is connected to the hub. On each extension line there is a clamp with safety insert. The clamps are color coded to indicate the arterial lumen (red) and venous lumen (blue). The insertion length, diameter and priming volume are printed on the safety inserts. The Luer-Lock connectors are made from rigid PVC connected to the extension line. The Luer-Lock connector is protected with a Luer-Lock protection cap. A stylet made of FEP is provided in the venous lumen for insertion. A rotary suture ring is assembled with the hub (bifurcation) for fixation of the device. The brand name of the device is printed on the hub (bifurcation).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jugular, subclavian or femoral vein
Indicated Patient Age Range
Not for pediatric use.
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)
The performance data demonstrate that the GamCath® High Flow Catheter is substantially equivalent to the predicate devices currently available on the market. The tests were performed per Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 03/16/95. Testing performed on the GamCath® High Flow Catheter indicates that they are safe, effective and perform as well as the predicate devices, when used in accordance with the instruction for use.
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
NOV - 1 2004
510(k) SUMMARY
| SUBMITTER: | Gambro Renal Products 10810 West Collins Avenue Lakewood, CO 80215 |
|---|---|
| ------------------- | ---------------------------------------------------------------------- |
CONTACT: Thomas B. Dowell, Manager Regulatory Affairs
Phone: (303) 231-4094 Fax: (303) 542-5138
February 6, 2004 DATE PREPARED:
DEVICE NAME: GamCath® High Flow Catheter
13 French 12.5 cm 13 French 15 cm 13 French 17.5 cm 13 French 20 cm 13 French 25 cm
COMMON/UNUSUAL NAME: Short-Term Hemodialysis Catheter
CLASSIFICATION NAMES: MPB - Catheter, Hemodialysis, Non Implanted [21 CFR 876.5540(b)(2)] - Non Implanted Blood Access Device
CLASSIFICATION: Class II per 21 CFR 876.5540(b)(2)
PREDICATE DEVICE: Niagara™ Slim-Cath™
Straight: 12 French, 15, 20 and 24 cm Precurved: 12 French, 12.5, 15 and 20 cm
K010778; April 13, 2001
DEVICE DESCRIPTION:
The catheter is a device, which can be used for short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion and apheresis via the jugular, subclavian or femoral veins.
The catheter is available in 13 French (4,3 mm / 0,169") straight configuration with the following insertion length: 125mm (4,921"), 150mm (5,906"), 175mm (6,900"), 200mm (7,874") and 250mm (9,843").
The catheter body and hub (bifurcation) is made from aliphatic polyurethane. The catheter body and hub is radiopaque (filled with Barium Sulfate).
1
The catheter body has two lumens positioned side by side. The cross section of the venous lumen is elliptical and the cross section of the arterial lumen is kidnev-shaped. The arterial lumen is beveled. The venous lumen extends beyond the arterial lumen with a rounded tip.
The arterial and venous extension line is made from transparent aliphatic polyurethane, which is connected to the hub. On each extension line there is a clamp with safety insert. The clamps are color coded to indicate the arterial lumen (red) and venous lumen (blue).
The insertion length, diameter and priming volume are printed on the safety inserts.
The Luer-Lock connectors are made from rigid PVC connected to the extension line. The Luer-Lock connector is protected with a Luer-Lock protection cap.
A stylet made of FEP is provided in the venous lumen for insertion. A rotary suture ring is assembled with the hub (bifurcation) for fixation of the device.
The brand name of the device is printed on the hub (bifurcation).
INTENDED USE:
GamCath® catheters are indicated for use in attaining short-term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein. Not for pediatric use.
Technological Characteristics:
The proposed device configurations have the same technological characteristics and are similar in design, function, composition, and operation, to the currently marketed devices on the market.
Performance Data:
The performance data demonstrate that the GamCath® High Flow Catheter is substantially equivalent to the predicate devices currently available on the market.
The tests were performed per Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 03/16/95.
Conclusions:
Testing performed on the GamCath® High Flow Catheter indicates that they are safe, effective and perform as well as the predicate devices, when used in accordance with the instruction for use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 2004
Mr. Thomas B. Dowell Manager Regulatory Affairs Gambro® Renal Products 10810 W. Collins Avenue LAKEWOOD CO 80215
Re: K040301
Trade/Device Name: GamCath® High Flow Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: 78 MPB Dated: September 24, 2004 Received: September 27, 2004
Dear Mr. Dowell:
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). 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.
3
Page 2 - Mr. Thomas Dowell
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 (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.
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 vours,
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
K040301 - Page / of GamCath® High Flow Catheter
SECTION XII
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K040301
Device Name: GamCath® High Flow Catheter
Indications For Use:
GamCath® catheters are indicated for use in attaining short-term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein. Not for pediatric use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Nancy C. Brogdon
(Division Sign Division of Reproductive, Abdomin and Radiological Devi 510(k) Number