(197 days)
No
The document describes a physical catheter device and its intended use and performance characteristics. There is no mention of software, algorithms, or any form of artificial intelligence or machine learning.
No.
The device is indicated for long-term vascular access, which is a supportive function for medical treatments like hemodialysis and apheresis, rather than directly providing therapy itself.
No
Explanation: The device is described as a catheter used for attaining long-term vascular access for hemodialysis and apheresis, which are therapeutic procedures, not diagnostic ones. Its function involves removing and returning blood for treatment.
No
The device description clearly details a physical catheter made of polyurethane with lumens, tips, side holes, a cuff, and connectors, indicating 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 in the adult patient." This is a therapeutic and access procedure performed directly on the patient's body.
- Device Description: The description details a catheter designed for insertion into blood vessels to remove and return blood. This is an invasive medical device used for treatment and access, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for direct patient treatment and access.
N/A
Intended Use / Indications for Use
THE MEDCOMP SPLIT CATH® II IS INDICATED FOR USE IN ATTAINING FONG-TERM VASCULAR ACCESS FOR HEMODIALYSIS AND APHERESIS IN THE ADULT PATIENT. IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN. Alternate insertion site is the subclavian vein or inferior vena cava as required. Catheters greater than 40cm are intended for femoral insertion or inferior vena cava insertion. Translumbar insertion via inferior vena cava is indicated only when all other access sites are identified as non-viable.
Product codes
MSD
Device Description
The Medcomp Split Cath® II is a polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, tapered at the distal tip, with three side holes on each tip. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term 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. The side holes are orientated to allow 360-degree arterial uptake and venous return. The lumens are connected to the extensions via a soft pliable hub with suture wing. Red and blue luer connectors and clamps identify the arterial and venous extensions. Priming volume information is printed an identification ring housed within the extension line clamp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, subclavian vein, inferior vena cava, 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)
In Vitro performance data for the legally cleared Medcomp Ash Split Cath® II, included tensile strength, joint strength, leakage, recirculation, flow performance, and flexural apply to the Split Cath® II since there are no significant material or design changes. Performance data is submitted for peel testing and force @ break only due to a change in solvent from the predicate device (solvent was cleared under K972207). Chemical testing is submitted for recent ointment testing performed by Medcomp.
Biocompatibility testing on the Ash Split Cath® II demonstrates the lumen materials meet the requirements of ISO 10993 for a permanent contact device. Biocompatibility data on the Split Cath® II was not deemed necessary since substantial equivalence is addressed by way of comparison to a legally marketed device.
Clinical data is based on numerous published clinical papers on the need for and presently used translumbar technique for catheter insertion. Due to criteria stressed in the published clinical papers this technique is for a very small patient population as an absolute last resort when all other traditional access sites have been exhausted. Properly inserted catheters via the translumbar technique do not have a detrimental affect on the clinical outcome as to catheter function.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 3 0 2005
510(k) SUMMARY
Submitter Information: A.
Submitter:
MEDCOMP® 1499 Delp Drive Harleysville, PA 19438 (215) 256-4201 Telephone (215) 256-9191 Fax Jean Callow May 11, 2005
Contact: Date Prepared:
Predicate Device:
- B. Trade Name: Common Name: Classification: C.F.R. Section:
Medcomp Split Cath® II Hemodialysis Catheter, Implanted MSD 876.5540
K020465 Medcomp® Ash Split Cath® II K884375 Argon Medical Corp. Translumbar Aortography Needle Catheter.
D. Device Description:
The Medcomp Split Cath® II is a polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, tapered at the distal tip, with three side holes on each tip. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term 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. The side holes are orientated to allow 360-degree arterial uptake and venous return. The lumens are connected to the extensions via a soft pliable hub with suture wing. Red and blue luer connectors and clamps identify the arterial and venous extensions. Priming volume information is printed an identification ring housed within the extension line clamp.
intended Use: E.
The Medcomp Split Cath® II is indicated for use in attaining fong-term vascular access for hemodialysis and apheresis in the adult patient. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion site is the subclavian vein or inferior vena cava as required.
ﺎ ﻓﻲ ﺍﻟﻤﺴﺘﻘ
Medcomp Split Cath II Translumbar 510(k) Summary Page 1 of 2
C.
1
K051280 Page 2 of 2
Catheters greater than 40cm are intended for femoral insertion or inferior vena cava insertion. Translumbar insertion via inferior vena cava is indicated only when all other access sites are identified as non-viable.
Comparison to Predicate Device: F.
The technological characteristics of the Split Cath® II are identical to the predicate device in terms of design, design specifications, performance, manufacturing process and method of sterilization.
The difference between the proposed device and the predicate is the inclusion of inferior vena cava as insertion site. Labeling indicating translumbar placement instructions and indicating that translumbar placement of the catheter is a useful and reliable alternative for patients that require long-term hemodialysis but all other access sites are identified as non-viable.
Performance Data: G.
In Vitro performance data for the legally cleared Medcomp Ash Split Cath® II, included tensile strength, joint strength, leakage, recirculation, flow performance, and flexural apply to the Split Cath® II since there are no significant material or design changes. Performance data is submitted for peel testing and force @ break only due to a change in solvent from the predicate device (solvent was cleared under K972207). Chemical testing is submitted for recent ointment testing performed by Medcomp.
Biocompatibility testing on the Ash Split Cath® II demonstrates the lumen materials meet the requirements of ISO 10993 for a permanent contact device. Biocompatibility data on the Split Cath® II was not deemed necessary since substantial equivalence is addressed by way of comparison to a legally marketed device.
Clinical data is based on numerous published clinical papers on the need for and presently used translumbar technique for catheter insertion. Due to criteria stressed in the published clinical papers this technique is for a very small patient population as an absolute last resort when all other traditional access sites have been exhausted. Properly inserted catheters via the translumbar technique do not have a detrimental affect on the clinical outcome as to catheter function.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
NOV 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Jean Callow Regulatory Specialist MedComp® 1499 Delp Drive HARLEYSVILLE PA 19438
Re: K051280
KUS I 280
Trade/Device Name: MedComp 14F Split Cath II for Translumbar Insertion Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: November 9, 2005 Received: November 28, 2005
Dear Ms. Callow:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section > rotty premained is substantially equivalent (for the indications felerenced above and nave decembed by marketed predicate devices marketed in interstate for use stated in the enciosale) to regars atment date of the Medical Device Amendments or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reclusined in accesses in a creat the device, subject to the general controls and Cosment Act (Fict). Totalina), are responsible to determine that the medical devices you provisions of the Act. "However, you de reap determined as substantially equivalent under the use as components in the Kir nave etater 500k) of the act), or were legally on the market prior to premarket notifeation process (Section of Secure in endments. Please note: If you May 20, 1970, the chacinent and 07 thel (i.e., unfinished) and further process (e.g., sterilize) purchase your device components in luding these components in your kit. The general you must submit a new 9 regis oread equirements for annual registration, listing of devices, controls provisions of the or use 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 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.
3
Page 2 - Ms. Jean Callow
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease of advised hat I Dri 3 issualite or our device complies with other requirements of the Act that I DA has made a actoring administered by other federal agencies. You must of any it cach sundles and regulanents, 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) I mis letter will anow you to oegn mainer of substantial equivalence of your device to a legally premative lieutification " - e results in a classification for your device and thus, permits your marketed proceed to the market. If you desire specific advice for your device on the labeling device to proceed to the mance in Joa Compliance at (240) 276-0115. Also, please note the regulation, prease contact anding by reference to premarket notification"(21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may oounn other generational 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/industry/support/index.html.
Sincerely yours,
Edmund Ch. Huyckson
for
Nancy 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: KO5 1280
Device Name: SPLIT CATH® II CATH® II CATHETER
Indications for use:
THE MEDCOMP SPLIT CATH® II CATHETER IS INDICATED FOR USE IN ATTAINING LONG TERM THE MEDICOME OF EFF ORTHO'!! SKULTION SPHERESIS IN THE ADULT PATIENT.
IT MAY BE INSERTED PERCUTANEOUSLY AND IS PRIMARILY PLACED IN THE INTERNAL JUGULAR VEIN.
ALTERNATE INSERTION SITES INCLUDE THE SUBCLAVIAN VEIN AND INFERIOR VENA CAVA AS REQUIRED.
CATHETERS GREATER THAN 40CM ARE INTENDED FOR FEMORAL VEIN OR INFERIOR VENA CAVA INSERTION. TRANSLUMBAR INSERTION VIA INFERIOR VENA CAVA IS INDICATED WHEN ALL OTHER ACCESS SITES ARE IDENTIFIED AS NON-VIABLE.
(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__________ |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K051280 |
(Optional Format 1-2-96)