(205 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, material properties, and basic functionality of a hemodialysis catheter. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
This device is intended for short-term central venous access for hemodialysis, apheresis, and infusion, which are all therapeutic interventions for medical conditions.
No
This device is a catheter intended for short-term central venous access for therapies like hemodialysis, apheresis, and infusion. It is used for access rather than for diagnosing a medical condition.
No
The device description clearly describes a physical catheter with lumens, adapters, and various sizes and configurations. The performance studies focus on physical properties and biocompatibility, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "short-term central venous access for hemodialysis, apheresis, and infusion." This describes a device used in vivo (within the body) to facilitate medical procedures.
- Device Description: The description details a catheter designed to be inserted into a vein for direct access to the bloodstream. This is a medical device used for treatment and access, not for testing samples in vitro (outside the body).
- Anatomical Site: The anatomical site is "Central venous access (Subclavian, jugular or femoral)," which are locations within the human body.
- Performance Studies: The performance studies focus on the physical and biological compatibility of the device for insertion and use within the body (e.g., tensile force, flow, biocompatibility). IVD performance studies would focus on the accuracy and reliability of tests performed on biological samples.
An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This catheter is used to access the body for treatment and procedures, not to test samples.
N/A
Intended Use / Indications for Use
The Duo-Flow Side x Side Double Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.
Product codes
MPB
Device Description
The Duo-Flow Side x Side Double Lumen Catheter has a Red Adapter for the proximal lumen and a Blue Adapter for the distal lumen. The proximal lumen provides "arterial" outflow from the patient; the distal lumen provides "venous" return. The catheter comes in a variety of sizes and is offered with curved or straight extensions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Central venous access, Insertion Site: Subclavian, jugular or femoral
Indicated Patient Age Range
Adult
Intended User / Care Setting
The operating room is the preferred location for insertion; however, bedside insertion is acceptable if sterile technique is followed.
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)
Bench/Performance Data/ Non-Clinical Testing was conducted based on various ISO and ISTA standards.
Key Performance Testing included:
- Air Leak, Liquid Leak, Peak Tensile Force, Gravity Flow (based on ISO 10555-1)
- Transit and Shelf Life testing (based on ISO 11607-1, ISO 11607-2)
- Transit Testing (based on ISTA 3A)
- Gauging (based on ISO 594-1)
- Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking (based on ISO 594-2)
Biocompatibility evaluation was conducted in accordance with FDA guidance and ISO 10993 standards. The device met biocompatibility requirements for externally communicating medical devices intended to be in contact with circulating blood for a prolonged duration (>24 hours to less than 30 days). The following biological endpoints were met:
- CYTOTOXICITY (ISO 10993-5:2009)
- SENSITIZATION (ISO 10993-10:2010)
- IRRITATION OR INTRACUTANEOUS REACTIVITY (ISO 10993-10:2010)
- SYSTEMIC TOXICITY (ISO 10993-11:2006)
- PYROGENICITY (ISO 10993-11:2006, Annex F)
- SUBACUTE TOXICITY (ISO 10993-11:2006)
- GENOTOXICITY (ISO 10993-3:2014)
- IMPLANTATION (ISO 10993-6:2016)
- HEMOCOMPATIBILITY (ASTM F576:2017, ISO 10993-4:2002/A1:2006, ISO 10993-4:2017)
- OTHER: Chemical Characterization of Materials (ISO 10993-18, 2005)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
April 23, 2020
Medical Components Inc. (dba MedComp) Courtney Nix Regulatory Affairs Director, North America and Europe 1499 Delp Drive Harleysville, PA 19438
Re: K192807
Trade/Device Name: Duo-Flow Side x Side Double Lumen Catheter Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: MPB Dated: March 13, 2020 Received: March 16, 2020
Dear Courtney Nix:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192807
Device Name
Duo-Flow Side x Side Double Lumen Catheter
Indications for Use (Describe)
The Duo-Flow Side x Side Double Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/15 description: The image shows the logo for medCOMP. The logo features a red geometric shape that resembles a stylized house or building. The word "med" is in red, while "COMP" is in black. The logo is simple and modern, with a focus on the company name and a memorable visual element.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter
| Section 6 | 510(k) SUMMARY | Traditional 510K | |
|---|---|---|---|
| A. Submitter Information | |||
| Submitter Name: | Medical Components Inc. | ||
| (dba Medcomp®) | |||
| 1499 Delp Drive | |||
| Harleysville, PA 19438 | |||
| Address: | 2518902 | ||
| Registration Number: | Courtney Nix | ||
| Regulatory Affairs Director, | |||
| North America and EU | |||
| Contact Person: | 09/27/2019 | ||
| Date of Preparation: | |||
| B. Subject Device | |||
| Trade Name: | Duo-Flow® Side x Side Double Lumen Catheter | ||
| Device: | Catheter, Hemodialysis, Non-Implanted | ||
| Blood access device and accessories | |||
| Regulation Description: | MPB | ||
| Product Code: | 876.5540 | ||
| Regulation Number: | II | ||
| Class: | Gastroenterology/Urology | ||
| Review Panel: | |||
| C. Predicate Device | |||
| Predicate Trade Name: | Mahurkar™ Acute Dual Lumen Catheter | ||
| 510(k) Number: | K955002 | ||
| 510(k) Holder: | Quinton, Inc. | ||
| Device: | Catheter, Hemodialysis, Non-Implanted | ||
| Blood access device and accessories | |||
| Regulation Description: | MPB | ||
| Product Code: | 876.5540 | ||
| Regulation Number: | II | ||
| Class: | Gastroenterology/Urology | ||
| Review Panel: | |||
| D. Device Description: |
- Red Adapter = proximal lumen O
- O Blue Adapter = distal lumen
The proximal lumen provides "arterial" outflow from the patient; the distal lumen provides "venous" return.
Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter Section 6: 510(k) Site Summary
6-1
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Image /page/4/Picture/1 description: The image shows the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "C" or an incomplete square with rounded corners. Below the geometric shape, the word "medCOMP" is written in a stylized font, with "med" in red and "COMP" in black.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter
The catheter comes in a variety of sizes and is offered with curved or straight extensions.
E. Indications for Use:
The Duo-Flow® Side x Side Double Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.
F. Comparison to Predicate Device(s):
Table 6.1: 510(k) Summary Design Comparison Matrix
| Attribute | Subject Device
Duo-Flow® Side x Side Double Lumen Catheter | Predicate Device
Mahurkar™ Acute Dual Lumen Catheter (K955002) | | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------------------------------------------------------------------------------------------|
| Prescription
Indications
for Use | Prescription Use
The Duo-Flow® Side x Side Double Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion | Prescription Use
The catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion. | | |
| Definition
(From
Product
Code) | Short-term (24 hours to less than 30 days). The biological endpoints that were met as are follows:
CYTOTOXICITY
- o ISO 10993-5:2009, Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity
SENSITIZATION
- o ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization
IRRITATION OR INTRACUTANEOUS REACTIVITY
- · ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization
SYSTEMIC TOXICITY
- o ISO 10993-11:2006, Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity
PYROGENICITY
- ISO 10993-11:2006, Biological Evaluation of Medical Devices Part 11: 0 Tests for Systemic Toxicity, Annex F
SUBACUTE TOXICITY
Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter Section 6: 510(k) Site Summary
6-4
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Image /page/7/Picture/1 description: The image contains the logo for medCOMP. The logo consists of a red geometric shape that resembles a stylized letter "M" or an abstract building. Below the geometric shape, the word "med" is written in red, lowercase letters, while "COMP" is written in black, uppercase letters. The overall design is clean and modern.
Harleysville, PA 19438
Tel: 215-256-4201
Fax. 215-256-1787
Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter
- O ISO 10993-11:2006, Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity
GENOTOXICITY
- o ISO 10993-3:2014, Biological Evaluation of Medical Devices Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity
IMPLANTATION
- · ISO 10993-6:2016, Biological Evaluation of Medical Devices Part 6: Test for Local Effects After Implantation
HEMOCOMPATIBILITY
- 0 ASTM F576:2017, Standard Practice for Assessment of Hemolytic Properties of Materials
- · ISO 10993-4:2002/A1:2006, Biological Evaluation of Medical Devices Part 4: Selection of Tests for Interactions with Blood
- ISO 10993-4:2017, Biological Evaluation of Medical Devices Part 4: O Selection of Tests for Interactions with Blood
OTHER
- ISO 10993-18, 2005, Biological Evaluation of Medical Devices, Part 18: O Chemical Characterization of Materials
ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ Summary of Substantial Equivalence
Based on the indications for use, design, safety and performance testing. the proposed device, Duo-Flow® Side x Side Double Lumen Catheter, raises no new questions of effectiveness compared to the predicate device and is substantially equivalent to the predicate device, Mahurkar™ Acute Dual Lumen Catheter (K955002).
Medcomp®: Duo-Flow® Side x Side Double Lumen Catheter Section 6: 510(k) Site Summary