(307 days)
Not Found
No
The document describes a physical medical device (catheter) and its material properties and performance characteristics. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for hemodialysis, hemoperfusion, and apheresis therapy, which are treatments for medical conditions.
No
Explanation: The device is indicated for short term vascular access for therapies like hemodialysis, hemoperfusion, and apheresis therapy, which are treatments, not diagnostic procedures. The device description also focuses on its physical characteristics and materials for providing access to the vascular system.
No
The device description clearly details a physical catheter with various material components, coatings, and accessories, indicating it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "attaining short term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein." This describes a device used in vivo (within the body) for therapeutic procedures, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like lumens, extension lines, connectors, and a coating. This aligns with a device used for accessing the vascular system, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen for diagnostic information. The device facilitates a medical procedure (hemodialysis, etc.), it doesn't perform a diagnostic test.
Therefore, the GamCath® High Flow Dolphin® Catheter is a medical device used for vascular access in therapeutic procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
GamCath® High Flow Dolphin® catheters are indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular. subclavian or femoral vein. GamCath® High Flow Dolphin® Catheter is not intended for use in pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
MPB
Device Description
The GamCath® High Flow Dolphin® Catheters are single use medical devices for short term use to obtain vascular access in patients with acute or chronic renal failure. The GamCath® High Flow Dolphin® Catheter combines the GamCath® High Flow Catheter with an additional coating based on a block copolymer. The polymer layer results in a surface structure that locks in barium sulfate particles. The coated catheter is free of heparin, therefore the use of the catheter is not contraindicated in patients with HIT syndrome.
Catheters made of Polyurethane are equipped with small rotatable Polypropylene suture rings, still allowing rotation of catheter when sutured to skin. Polyurethane Extension lines, present on each lumen, are equipped with PVC luer-lock connectors according to ISO 594-1 with Polyethylene protection caps and are provided with clamps which may be color coded to indicate the venous (blue), arterial (red). Clamp inserts bear easily legible and permanently fixed imprints indicating usable catheter length and outer diameter of catheter shaft (in French calibration) as well as priming volumes. The Catheter is available in 13 French and 11.5 French straight and curved extension line configuration. An inner dilator made of FEP is provided in the venous lumen for insertion. The insertion length is available in range from 150 mm (5.906") up to 250 mm (9.843"). The Dolphin coating is a co-polymer film which is applied over the catheter surface to form a continuous surface that has a smoother surface morphology than an untreated catheter. The copolymer film is formed by providing a hydrophobic polymer block, such as polydimethylsiloxan (PDMS) with functional -OH end groups.
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 intended for use in pediatric patients.
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 non-clinical tests submitted included biocompatibility data as per ISO 10993-1 (including Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic toxicity, Genotoxicity, and Hemolysis). Ethylene Oxide sterilization was validated as per ISO 11135-1 and 10993-7. Package integrity testing was done successfully.
Substantial equivalence versus the predicate device was shown by the following tests: Integrity of the catheter was shown by testing for air leakage and liquid leakage as per ISO 10555-1. Clamping tests up to 300 cvcles were done to prove absence of visible delamination or visible detachable particles. Pressure in the catheter was measured over the range of flow rates. Performance data was collected to verify tensile strength according ISO 10555-1 of Connector to extension line, Extension line to hub (bifurcation), Hub to catheter shaft, and Catheter shaft to tip.
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
K100451 Page 177
DEC 2 1 2010
برت
GamCath® High Flow Dolphin® Catheter
| Submitter's Name | Gambro Renal Products, Inc. |
|---|---|
| Address | 14143 Denver West Parkway, Suite 400 |
| Lakewood, Colorado 80401 | |
| Establishment Registration Number | 2087532 |
| Contact Person | Kae Miller, Regulatory Affairs Manager |
| Telephone Number | 303.222.6724 |
| Fax Number | 303.222.6916 |
| Date Summary Was Prepared | December 02, 2010 |
510(k) SUMMARY
| Device Information | |
|---|---|
| Name of the Device | GamCath® High Flow Dolphin® Catheter |
| Common or Usual Name | Short-Term Hemodialysis Catheter |
| Classification Name | Catheter Hemodialysis Non-Implanted |
| Device Class | II |
| Product Code | MPB |
| Regulation Number | 21 CFR 876.5540 |
| Predicate Device Information (1) | |
|---|---|
| Name of the Device | GamCath® High Flow Catheter |
| 510(k) Number | K040301 |
| Classification Name | Catheter Hemodialysis Non-Implanted |
| Device Class | II |
| Product Code | MPB |
| Regulation Number | 21 CFR 876.5540 |
1
(100457) Regs
GamCath® High Flow Dolphin® Catheter
| Predicate Device Information (2) | |
|---|---|
| Name of the Device | Medcomp Duo-Flow II Catheter with |
| Lubricious Heparin | |
| 510(k) Number | K991320 |
| Classification Name | Catheter Hemodialysis Non-Implanted |
| Device Class | II |
| Product Code | MPB |
| Regulation Number | 21 CFR 876.5540 |
DEVICE DESCRIPTION
The GamCath® High Flow Dolphin® Catheters are single use medical devices for short term use to obtain vascular access in patients with acute or chronic renal failure. The GamCath® High Flow Dolphin® Catheter combines the GamCath® High Flow Catheter with an additional coating based on a block copolymer. The polymer layer results in a surface structure that locks in barium sulfate particles. The coated catheter is free of heparin, therefore the use of the catheter is not contraindicated in patients with HIT syndrome.
Catheters made of Polyurethane are equipped with small rotatable Polypropylene suture rings, still allowing rotation of catheter when sutured to skin. Polyurethane Extension lines, present on each lumen, are equipped with PVC luer-lock connectors according to ISO 594-1 with Polyethylene protection caps and are provided with clamps which may be color coded to indicate the venous (blue), arterial (red). Clamp inserts bear easily legible and permanently fixed imprints indicating usable catheter length and outer diameter of catheter shaft (in French calibration) as well as priming volumes. The Catheter is available in 13 French and 11.5 French straight and curved extension line configuration. An inner dilator made of FEP is provided in the venous lumen for insertion. The insertion length is available in range from 150 mm (5.906") up to 250 mm (9.843"). The Dolphin coating is a co-polymer film which is applied over the catheter surface to form a continuous surface that has a smoother surface morphology than an untreated catheter. The copolymer film is formed by providing a hydrophobic polymer block, such as polydimethylsiloxan (PDMS) with functional -OH end groups.
2
INDICATIONS FOR USE
GamCath® High Flow Dolphin® catheters are indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular. subclavian or femoral vein. GamCath® High Flow Dolphin® Catheter is not intended for use in pediatric patients.
TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE
The GamCath® High Flow Dolphin® Catheter is substantially equivalent to the GamCath® High Flow Catheter, K040301 and the MedComp Duo-Flow II Catheter with · Lubricious Heparin manufactured by Medical Components, Inc. K991320.
Substantial equivalency was shown by detailed comparisons of Intended Use, Patient Population, Mode of Operation, Labeling and Catheter Type. Technological characteristics showed substantial equivalency with respect to material of the catheter (Connector, Catheters Tube, Extension Line), position of insertion of the catheter, sizes of the catheter, design/physical characteristics (number of lumens, sterility, distal end configuration, intended anatomical location of distal end, proximal end configuration).
Both GamCath® High Flow Dolphin® Catheter and MedComp Duo-Flow II Catheter are having a coating. The materials used differ. MedComp Duo-Flow II Catheter uses a lubricious heparin coating whereas GamCath® High Flow Dolphin® Catheter uses the Dolphin® coating. The Dolphin coating is a co-polymer film which is applied over the catheter surface to form a continuous surface. In general the copolymer film is formed by providing a hydrophobic polymer block, such as polydimethylsiloxan (PDMS) with functional -OH end groups. The reliance of Dolphin coating was placed on testing against recognized standards to evaluate safety and performance (see section non-clinical performance data below). GamCath® High Flow Dolphin® catheter coating is free of heparin; therefore the use of the catheter is not contraindicated in patients with HIT syndrome.
NON-CLINICAL PERFORMANCE DATA
The non-clinical tests submitted included biocompatibility data as per ISO 10993-1 (including Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute Systemic toxicity, Genotoxicity, and Hemolysis). Ethylene Oxide sterilization was validated as per ISO 11135-1 and 10993-7. Package integrity testing was done successfully.
Substantial equivalence versus the predicate device was shown by the following tests: Integrity of the catheter was shown by testing for air leakage and liquid leakage as per ISO 10555-1. Clamping tests up to 300 cvcles were done to prove absence of visible delamination or visible detachable particles. Pressure in the catheter was measured over the range of flow rates. Performance data was collected to verify tensile strength according ISO 10555-1 of Connector to extension line, Extension line to hub (bifurcation), Hub to catheter shaft, and Catheter shaft to tip.
3
K/0045/
GAMBRO Renal Products GamCath® High Flow Dolphin® Catheter
CONCLUSION OF SAFETY AND EFFECTIVENESS
The comparison of technological characteristics demonstrated that GamCath® High Flow Dolphin® Catheters are substantially equivalent to the predicate devices. The GamCath® High Flow Dolphin® Catheters met all performance criteria of the test performed and is safe and effective when used as intended.
4
Image /page/4/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 or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Kae Miller Regulatory Affairs Manager Gambro Renal Products. Inc. 14143 Denver West Pkwy, Suite 400 LAKEWOOD CO 80401
DEC 2 1 2010
Re: K100451
Trade/Device Name: GamCath® High Flow Dolphin® Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: MPB Dated: December 6, 2010 Received: December 7, 2010
Dear Ms. Miller:
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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. Please note: CDRH does not evaluate information related to contract liability " warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 the Act's requirements, including, but not limited to: registration and listing (21 CFR.Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
5
Page 2
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.html 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Huker Lemun md
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
6
GAMBRO.Renal Products Traditional 510(k) for GamCath® High Flow Dolphin® Catheter
Indications for Use Statement
| 510(k) Number (if known): | K100451 |
|---|---|
| Device Name: | GamCath® High Flow Dolphin® Catheter |
DEC 21 2010## Indications for Use Statement:
GamCath® High Flow Dolphin® catheters are indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein. GamCath® High Flow Dolphin® Catheter is not intended for use in pediatric patients.
Prescription Use X (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, Gastro-Renal, and
Urological Devices
510(k) Number K100451
Page 1 of 1
Attachment 1, Page 1