(196 days)
No
The device description and performance studies focus on the physical characteristics and in-vitro performance of a hemodialysis catheter, with no mention of AI or ML technology.
Yes
The device is indicated for use in attaining long-term vascular access for hemodialysis and apheresis, which are medical treatments for kidney failure and blood disorders, respectively. These are therapeutic procedures.
No
This device is a hemodialysis catheter used for vascular access, specifically for removing and returning blood for treatment, not for diagnosing a condition.
No
The device description clearly describes a physical catheter made of polyurethane with lumens, a cuff, and a suture wing hub. It is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "attaining long-term vascular access for hemodialysis and apheresis." This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a physical catheter designed to remove and return blood. It does not describe any components or functions related to analyzing samples in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of analyzing blood or other bodily fluids for diagnostic purposes. The device facilitates the process of hemodialysis and apheresis, which are treatments.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) to access the vascular system for therapeutic procedures.
N/A
Intended Use / Indications for Use
THE MEDCOMP SC4 HEMODIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN. CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION. THE SC4 EXTENSION SET IS INTENDED TO REPAIR THE SC4 HEMODIALYSIS CATHETER.
Product codes (comma separated list FDA assigned to the subject device)
78 MSD, 78 NFK
Device Description
The Medcomp SC4 is a 16F polyurethane, double lumen catheter used to remove and return blood through two-secregated lumen passages. Both lumens are "D" shaped, tapered at the distal tip, each with a series of side holes. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement. A removable suture wing hub is provided for securing the catheter after initial placement. The arterial and venous lumens are designed to be split, or peeled apart, prior to insertion to provide two free-floating lumens within the vessel. After the catheter has been positioned the catheter lumens can be trimmed and an extension set is assembled on the proximal end of the catheter. Red and blue luer connectors and clamps identify the arterial and venous extensions set. Priming volume information is printed on the catheter lumen.
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
Not Found
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)
In-vitro performance data for the Medcomp SC4, including tensile strength, joint strength, leakage, recirculation, flow performance, and lumen peel demonstrate that this device is substantially equivalent to the legally marketed predicate devices. Clinical data was not deemed necessary since substantial equivalence is addressed by way of comparison to a legally marketed device.
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.
K020465 Medcomp Ash Split-Cath™ II
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.
K971925 Medcomp Bio-Flex™ CS
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
K02 2678
page 1 of 2
FFB 2 4 2003
510(k) SUMMARY
MEDCOMP®
A. Submitter Information:
Submitter:
| | | 1499 Delp Drive
Harleysville, PA 19438
(215) 256-4201 Telephone |
|--|-----------------|-----------------------------------------------------------------------|
| | | (215) 256-1787 Fax |
| | Contact: | Florence A. Caikoski |
| | Date Prepared: | November 19, 2002 |
| | Trade Name: | Medcomp SC4 |
| | Common Name: | Hemodialysis Catheter, Implanted |
| | Classification: | 78 MSD |
| | C.F.R. Section: | 876.5540 |
C. Predicate Device:
B.
K020465 Medcomp Ash Split-Cath™ II K971925 Medcomp Bio-Flex™ CS
D. Device Description:
The Medcomp SC4 is a 16F polyurethane, double lumen catheter used to remove and return blood through two-secregated lumen passages. Both lumens are "D" shaped, tapered at the distal tip, each with a series of side holes. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement. A removable suture wing hub is provided for securing the catheter after initial placement.
The arterial and venous lumens are designed to be split, or peeled apart, prior to insertion to provide two free-floating lumens within the vessel. After the catheter has been positioned the catheter lumens can be trimmed and an extension set is assembled on the proximal end of the catheter. Red and blue luer connectors and clamps identify the arterial and venous extensions set. Priming volume information is printed on the catheter lumen.
E. Intended Use:
The Medcomp SC4 is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion site is the subclavian vein.
Catheters greater than 40cm are intended for femoral vein insertion.
The SC4 Extension Set is intended to repair the SC4 Hemodialysis Catheter.
F. Comparison to Predicate Device:
The technological characteristics of the Medcomp SC4 are substantially equivalent to the predicate devices in terms of intended use, materials, design, insertion method, anatomical location, performance, labeling, manufacturing process, and method of sterilization.
Medcomp SC4 510(k) Summary Page 1 of 2
1
G. Performance Data:
In-vitro performance data for the Medcomp SC4, including tensile strength, joint strength, leakage, recirculation, flow performance, and lumen peel demonstrate that this device is substantially equivalent to the legally marketed predicate devices.
Clinical data was not deemed necessary since substantial equivalence is addressed by way of comparison to a legally marketed device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2003
Ms. Florence A. Caikoski Regulatory Affairs Associate MedCOMP® 1499 Delp Drive HARLEYSVILLE PA 19438
Re: K022678
Trade/Device Name: MedCOMP 16F Split-Stream SC4 Hemodialysis Catheters: 24, 28, 32, 36, and 55cm and Repair Kit Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Regulatory Class: II Product Code: 78 NFK Dated: December 6, 2002 Received: December 9, 2002
Dear Ms. Caikoski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found
3
Page 2 - Ms. Florence Caikoski
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation, please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
David A. Siggman
Hancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number: KO222678
Device Name: MEDCOMP SC4 HEMODIALYSIS CATHETER
Indications for use:
THE MEDCOMP SC4 HEMODIALYSIS CATHETER IS INDICATED FOR USE IN ATTAINING LONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS.
IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN. ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN.
CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN INSERTION.
THE SC4 EXTENSION SET IS INTENDED TO REPAIR THE SC4 HEMODIALYSIS CATHETER.
(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
Evinth le. deyon
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number