(90 days)
THE MEDCOMP ULTRA-FLOW™ HEMODIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING ECHE TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN OF AN ADULT PATIENT. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.
The Medcomp Ultra-Flow™ Catheter is a 14.5F polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, open at the distal tip, with two side holes. The distal venous lumen is tapered and extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement. The lumens are connected to the extensions via a soft pliable hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on the clamps for ease in identification. The proposed device is a product line extension to the legally marketed device, ar identical in design and materials. The modifications include: 55cm length, Femoral insertion instructions for use.
Here's a summary of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance Study Summary
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Recirculation Performance | "demonstrate that this device is substantially equivalent to legally marketed devices" |
| Flow Performance | "demonstrate that this device is substantially equivalent to legally marketed devices" |
Note: The document does not provide specific quantitative acceptance criteria (e.g., "recirculation rate < X%"). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices for recirculation and flow performance.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "In-Vitro performance data for the proposed device."
- Data Provenance: In-vitro testing. No country of origin is mentioned, and it's not applicable as it's an in-vitro study, not clinical. The study is prospective in the sense that it was conducted for the purpose of this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This was an in-vitro performance study, not a study requiring expert readers or ground truth established by medical professionals.
4. Adjudication Method for the Test Set:
Not applicable. No expert adjudication was involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was performed, though not an "algorithm" in the AI sense. The "device" (catheter) was tested in-vitro in a standalone manner to assess its physical performance characteristics (recirculation and flow).
7. Type of Ground Truth Used:
For this in-vitro study, the "ground truth" was established by measured physical performance characteristics (recirculation and flow rates) as compared to the performance of legally marketed predicate devices.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device where a "training set" would be used in the traditional sense. The design and materials are stated to be "unchanged" from the predicate device, implying that the "learning" for the design was derived from the predicate's established performance.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the context of an AI/ML device. The "ground truth" for the device's design implicitly comes from the established safety and effectiveness of the predicate devices.
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AUG 2 7 2002
/C21759 Page / of.
510(k) SUMMARY
A. Submitter Information:
Submitter:
Contact:
Date Prepared:
- B. Trade Name: Common Name: Classification: C.F.R. Section:
MEDCOMP® 1499 Delp Drive Harleysville, PA 19438 (215) 256-4201 Telephone (215) 256-0818 Fax Florence A. Caikoski Regulatory Affairs Associate May 20, 2002
Medcomp Ultra-Flow™ Catheter Hemodialysis Catheter, Implanted 78 MSD 876.5540
C. Predicate Device: K003207 Medcomp Ultra-Flow™ Catheter K012562 Medcomp 14.5F Double Lumen Hemodialysis Catheter
D. Device Description:
The Medcomp Ultra-Flow™ Catheter is a 14.5F polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, open at the distal tip, with two side holes. The distal venous lumen is tapered and extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement.
The lumens are connected to the extensions via a soft pliable hub with suture wing. The arterial and venous extensions are identified by red and blue luer connectors and clamps. Priming volume information is printed on the clamps for ease in identification.
E. Intended Use:
The Medcomp Ultra-Flow™ Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site is the subclavian vein as required. Catheters greater than 40cm are intended for femoral vein insertion.
Medcomp Ultra-Flow™ Catheter Summary Page 1 of 2
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. 2 ° F2
The proposed device is a product line extension to the legally marketed device, ar identical in design and materials.
The modifications include:
- 55cm length .
- Femoral insertion instructions for use .
G. Performance Data:
In-Vitro performance data for the proposed device including recirculation and flow performance demonstrate that this device is substantially equivalent to legally marketed devices intended for hemodialysis and apheresis treatments.
Since the design and materials remain unchanged additional performance testing or supporting documentation is not deemed necessary and is not included in this submission.
Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices.
Medcomp Ultra-Flow™ Catheter Summary
Page 2 of 2
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT. HUMAN SERVICES. USA.", which is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2002
Ms. Florence A. Caikoski Regulatory Affairs Associate MEDCOMP® 1499 Delo Drive HARLEYSVILLE PA 19438
Re: K021759
Trade/Device Name: MEDCOMP® 14F X 55CM Ultra-Flow™ Catheter, UFS55 and UFT55 Regulation Number: 21 CFR 8876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: May 20, 2002 Received: May 29, 2002
Dear Ms. Caikoski:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of 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 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, 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 vour 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); good manufacturing practice requirements as set forth in the quality
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Page 2 - Ms. Florence A. Caikoski
systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
In addition, we have determined that your device kit contains Povidone Iodine Ointment and Swabsticks and Lidocaine HCI 1%, which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug component[s] of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component|s]. For information on applicable Agency requirements for marketing this [these] drug[s], we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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 our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act. may be obtained 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/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
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KO21759/A1
INDICATIONS FOR USE
510(k) Number:
Device Name: MEDCOMP ULTRA-FLOW™ CATHETER
Indications for use:
THE MEDCOMP ULTRA-FLOW™ HEMODIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING ECHE TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS.
IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN OF AN ADULT PATIENT.
ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AS REQUIRED.
CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K021759
§ 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.