(288 days)
Not Found
No
The device description and intended use focus solely on the physical characteristics and function of a hemodialysis/apheresis catheter, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a hemodialysis/apheresis catheter, which is used for medical therapy (hemodialysis and apheresis).
No.
The CASCADE™ Hemodialysis/Apheresis Catheter is an invasive device designed for long-term vascular access to facilitate hemodialysis and apheresis therapies. It is a therapeutic device used for treatment, not for diagnosing conditions or diseases.
No
The device description clearly states it is a physical catheter made from silicone material and includes introduction components, indicating it is a hardware device.
Based on the provided information, the CASCADE™ Hemodialysis/Apheresis Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The CASCADE™ Hemodialysis/Apheresis Catheter is a device that is inserted into the body (specifically veins) to provide vascular access for medical procedures (Hemodialysis and Apheresis). It is a therapeutic and access device, not a device used to analyze specimens outside the body.
- Intended Use: The intended use clearly states it's for "attaining long-term vascular access" for specific therapies. It does not mention any analysis of biological samples.
Therefore, the CASCADE™ Hemodialysis/Apheresis Catheter falls under the category of an invasive medical device used for therapeutic and access purposes, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CASCADE™ Hemodialysis/Apheresis Catheter is intended for use in attaining long-term vascular access for Hemodialysis therapy and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and femoral vein, as required.
Indications For Use:
- The CASCADE™ Hemodialysis/Apheresis Catheter is indicated for use in attaining . Long-Term (greater than 30 days) vascular access for Hemodialysis therapy and Apheresis.
- It may be inserted percutaneously and is primarily placed in the internal jugular vein ● of an adult patient.
- Alternate insertion sites include subclavian vein as required. .
- Catheters greater than 40 cm are intended for femoral vein insertion. .
- . The curved CASCADE™ Hemodialysis/Apheresis Catheter is intended for internal jugular vein insertion.
Product codes (comma separated list FDA assigned to the subject device)
MSD
Device Description
The CASCADE™ Hemodialysis/Apheresis Catheter is a family of percutaneously inserted catheters designed to perform Hemodialysis therapy and Apheresis. The catheters are manufactured from medical grade radiopaque silicone material, which provides increased patient comfort while offering excellent biocompatibility. The CASCADE™ Hemodialysis/Apheresis Catheter Kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
The CASCADE™ Hemodialysis/Apheresis Catheter is indicated for dwell times greater than 30 days. The CASCADE™ Hemodialysis/Apheresis Catheter product line has catheters in 12.5 Fr dual lumen sizes. Catheters range from approximately 13 - 55 cm long and are offered in straight or curved catheter configurations with cuffs for long-term implantation. The catheters are attached to an injection-molded silicone hub that has a suture wing and extension legs with Luer lock fittings for access attachment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, subclavian vein, femoral vein
Indicated Patient Age Range
adult patient
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)
Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards.
Performance data gathered in design verification testing demonstrated that the CASCADE™ Hemodialysis/Apheresis Catheter is substantially equivalent to the noted predicate device.
The CASCADE™ Hemodialysis/Apheresis Catheter met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the CASCADE™ Hemodialysis/Apheresis Catheter is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate device: Medcomp Hemo-Cath (K113487).
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.
Hemo-Cath® (K113487)
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
Health Line International Corporation
Page 15 of 161
510(k) Premarket Notification Submission: CASCADE™ Hemodialysis/Apheresis Catheter
KI 30851
SECTION 5.0
JAN - 9 2014
に
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for the CASCADE™ Hemodialysis/Apheresis Catheter (21 CFR 807.92)
(See Following Page)
1
Health Line International Corporation
510(k) Premarket Notification Submission: CASCADE™ Hemodialysis/Apheresis Catheter
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for CASCADE™ Hemodialysis/Apheresis Catheter
SUBMITTER:
Health Line International Corporation 803 N. 1250 W. - STE 1 Centerville, Utah 84014
ESTABLISHMENT REGISTRATION NUMBER: 3006097687
CONTACT:
Nola Benstog QA/RA Director Telephone: 801-773-7798 X 107 Fax: 855-228-1336 Email: nbenstog@hlic.net
DATE PREPARED:
March 21, 2013
NAME OF MEDICAL DEVICE:
Proprietary Name: CASCADE™ Hemodialysis/Apheresis Catheter Blood access device and accessories Regulation Name: Common/Usual Name: Hemodialysis Catheter, Implanted ·
DEVICE CLASSIFICATION:
Classification Panel: Regulatory Class: Product Code: Regulation Number: Gastroenterology / Urology Class III MSD 21 CFR 876.5540
PREDICATE DEVICE:
Proprietary Name: Regulation Name: Common/Usual Name: Classification Panel: Regulatory Class: Product Code: Regulation Number:
Hemo-Cath® (K113487)
Blood access device and accessories Hemodialysis Catheter, Implanted Gastroenterology / Urology Class III MSD 21 CFR 876.5540
2
DEVICE DESCRIPTION:
The CASCADE™ Hemodialysis/Apheresis Catheter is a family of percutaneously inserted catheters designed to perform Hemodialysis therapy and Apheresis. The catheters are manufactured from medical grade radiopaque silicone material, which provides increased patient comfort while offering excellent biocompatibility. The CASCADE™ Hemodialysis/Apheresis Catheter Kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
Page 17 of 161
The CASCADE™ Hemodialysis/Apheresis Catheter is indicated for dwell times greater than 30 days. The CASCADE™ Hemodialysis/Apheresis Catheter product line has catheters in 12.5 Fr dual lumen sizes. Catheters range from approximately 13 - 55 cm long and are offered in straight or curved catheter configurations with cuffs for long-term implantation. The catheters are attached to an injection-molded silicone hub that has a suture wing and extension legs with Luer lock fittings for access attachment.
3
INTENDED USE:
The CASCADE™ Hemodialysis/Apheresis Catheter is intended for use in attaining long-term vascular access for Hemodialysis therapy and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and femoral vein, as required.
INDICATIONS FOR USE:
- The CASCADE™ Hemodialysis/Apheresis Catheter is indicated for use in attaining . Long-Term (greater than 30 days) vascular access for Hemodialysis therapy and Apheresis.
- It may be inserted percutaneously and is primarily placed in the internal jugular vein ● of an adult patient.
- Alternate insertion sites include subclavian vein as required. .
- Catheters greater than 40 cm are intended for femoral vein insertion. .
- . The curved CASCADE™ Hemodialysis/Apheresis Catheter is intended for internal jugular vein insertion.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
New device is compared to Marketed Device? Yes. It is compared to a legally marketed predicate device.
Does the new device have the same indication statements? Yes, the CASCADE™ Hemodialysis/Apheresis Catheter indications are substantially equivalent to the predicate device. Differences include limiting the access to long term (removal of temporary access) and removal of hemoperfusion. Additionally, Health Line includes a statement that the curved catheter is intended for internal jugular vein insertion (consistent with the primary placement site).
Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness}? No, the differences do not alter the intended effect of the device.
Does the new device have the same technological characteristics, e.g. design, material, etc.? Yes. The CASCADE™ Hemodialysis/Apheresis Catheter technological characteristics are identical to the Medcomp Hemo-Cath® (K113487). The basic fundamental technological characteristics of the device have not changed. There may be minor variations in the size of lumen. Additionally, the CASCADE™ Hemodialysis/Apheresis Catheter is made from a silicone material, which is identical to Medcomp Hemo-Cath® (K113487). These differences have no negative impact on the device performance, safety or efficacy.
4
Could the new characteristics affect safety or effectiveness? No.
Do the new characteristics raise new types of safety and effectiveness questions? No. There are no new types of safety and effectiveness questions.
Do accepted scientific methods exist for assessing effects of the new characteristics? Yes.
The FDA's Draft Guidance, Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis, dated June 28, 2013 was used as a guide to determine the appropriate methods for evaluating the device's performance characteristics.
Sterilization requirements of ISO 11135:2007, Sterilization of Health Care Products -Requirements for Validation and Routine Control -- Ethylene Oxide Sterilization.
Biocompatibility requirements according to ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. Test profiles for externally communicating, circulating blood, permanent contact devices will be met.
These and other standards were used to determine the appropriate methods for evaluating the device's performance.
Are performance data available to assess effects of new characteristics? Yes. Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards.
Do performance data demonstrate equivalence? Yes. Performance data gathered in design verification testing demonstrated that the CASCADE™ Hemodialysis/Apheresis Catheter is substantially equivalent to the noted predicate device.
Additionally, consideration was given to the Draft Guidance for Industry and Food and Drug Administration Staff, Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis issued on June 20, 2012 throughout this submission, as it pertains to the safety and effectiveness of the device.
CONCLUSION
The CASCADE™ Hemodialysis/Apheresis Catheter met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the CASCADE™ Hemodialysis/Apheresis Catheter is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate device: Medcomp Hemo-Cath (K113487).
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human form or a caduceus, rendered in a bold, black color.
Food and Drug Administration 1903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2014
Nola Bentsog OARA Director Health Line International Corporation 803 N. 1250 West - Suite 1 Centerville, UT 89014
Re: K130851
Trade/Device Name: CASCADE™ Hemodialysis/Apheresis Catheter Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: November 11, 2013 Received: November 13, 2014
Dear Nola Bentsog,
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. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] 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/tray. 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. 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.
6
Page 2 - Nola Benstog
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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K130851
Device Name
CASCADE™ Hemodialysis/Apheresis Catheter
Indications for Use (Describe)
Indications For Use:
· The CASCADE™ Hemodialysis/Apheresis Catheter is indicated for use in attaining Long-Term (greater than 30 days) vascular access for Hemodialysis therapy and Apheresis.
· It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
· Alternate insertion sites include subclavian vein as required.
· Catheters greater than 40 cm are intended for femoral vein insertion.
· The curved CASCADE™ Hemodialysis/Apheresis Catheter is internal jugular vein insertion.
Type of Use (Select one or both, as applicable)
[ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
・・・
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FDA USE ONLY
中国在线路 .. : Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Herbert P. Lerner 2014.01.09 07:36
FORM FDA 3881 (9/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.