(87 days)
No
The summary describes a physical catheter device and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a catheter used for vascular access during therapies like hemodialysis, hemoperfusion, or apheresis. It does not perform any therapeutic function itself; it is a tool for delivering or performing these therapies.
No
This device is a catheter used for vascular access in therapies like hemodialysis, hemoperfusion, or apheresis. It does not perform any diagnostic functions such as detecting, diagnosing, or monitoring a disease or condition. Its purpose is to facilitate treatment by providing access to the vascular system.
No
The device description clearly details a physical catheter made of polyurethane with lumens, connectors, clamps, and a cuff. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "attaining short term or long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein." This describes a device used in vivo (within the body) for therapeutic purposes (dialysis, hemoperfusion, apheresis).
- Device Description: The description details a catheter designed to be inserted into a blood vessel. This is consistent with an in vivo device.
- Anatomical Site: The specified anatomical site is the "jugular or subclavian vein," which are blood vessels within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes.
IVD devices are used to test samples like blood, urine, or tissue to diagnose diseases or conditions. This device is used to directly access the bloodstream for therapeutic treatments.
N/A
Intended Use / Indications for Use
The Opti-Flow Dual Lumcn Catheter is indicated for use in attaining short or long term vascular access for hemodialysis, hemoperfusion or aphercsis therapy via the jugular or subclavian vein.
Product codes
78 MSD
Device Description
The Vas-Cath Opti-Flow catheter is a polyurethane catheter which allows for dialysis. hemoperfusion or apheresis. It has two clear polyurethane clamping extensions with luer connectors at the ends and atraumatic clamps. The arterial and venous extensions are identified with red and blue luer connectors. The two extensions merge into a tapered bifurcation joint or hub molded to the catheter body tubing. A removable suture wing is available for securing the catheter after initial placement. The fixed retention cuff on the shaft provides an anchoring site for tissue ingrowth during longer term placement.
The cross-section of the shaft consists of two "D"-shaped arterial and venous lumens, separated by the straight part of the "D". The venous lumen extends beyond the arterial lumen and ends with a 45 degree beveled tip. The Opti-Flow catheters are available in 19 cm, 23 cm, 27 cm, and 35 cm insertion lengths. The Opti-Flow catheter is also available with a VitaCuff® antimicrobial cuff which helps to provide protection against catheter related infections and helps anchor the catheter during the initial fow weeks of placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jugular or subclavian 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
In vitro performance data show that the Opti-Flow catheter has comparable results to the predicate catheter in regard to elongation to failure, tensile strength of molded joints, flexibility, leakage, recirculation, as well as maximum pressure and vacuum. The flow rates of the Opti-Flow catheter are greater than the Soft-Cell catheter as determined by bench testing.
In vitro test results support the labeling change of incorporating a warning against use of ointments with the catheter and the new dressing change protocol in the revised IFUs, Dressing Change Protocol, Nursing Procedure Manual and Patient Guide.
Under certain conditions, the interaction between the polyurethane tubing, PEG and moisture can lower the burst and/or radial tensile strength of the tubing, thereby increasing its susceptibility to cracking or splitting.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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K981994
p. 1/3
Bard Access Systems. I 425 W. Amelia Earhart D alt Lake City, UT 84116 hone: 801-595-0700 ax: 801-595-4969
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510(K) Summary of Safety and Effectiveness
Vas-Cath Opti-Flow® Long Term Dual Lumen Hemodialysis Catheter
Submitter information 1.
| Submitter's Name: | Bard Access Systems | |
|---|---|---|
| Address: | 5425 W. Amelia Earhart Dr. | |
| Salt Lake City, Utah 84116 | ||
| Telephone Number | 801-595-0700 | |
| Fax Number | 801-595-7156 | |
| Contact Person: | Peggy Keiffer | |
| Date of Preparation: | May 29, 1998 | |
| 2. | Device Name: | Vas-Cath Long Term Dual Lumen Hemodialysis |
| Catheter | ||
| Trade Name: | Opti-Flow® | |
| Common/Usual Name: | Hemodialysis Catheter | |
| Classification Name | Implanted hemodialysis catheter | |
| 3. | Predicate Device Name: | Vas-Cath Permanent Dual Lumen Catheter |
| Trade name | Soft-Cell® |
Device Description: 4.
The Vas-Cath Opti-Flow catheter is a polyurethane catheter which allows for dialysis. hemoperfusion or apheresis. It has two clear polyurethane clamping extensions with luer connectors at the ends and atraumatic clamps. The arterial and venous extensions are identified with red and blue luer connectors. The two extensions merge into a tapered bifurcation joint or hub molded to the catheter body tubing. A removable suture wing is available for securing the catheter after initial placement. The fixed retention cuff on the shaft provides an anchoring site for tissue ingrowth during longer term placement.
The cross-section of the shaft consists of two "D"-shaped arterial and venous lumens, separated by the straight part of the "D". The venous lumen extends beyond the arterial lumen and ends with a 45 degree beveled tip. The Opti-Flow catheters are available in 19 cm, 23 cm, 27 cm, and 35 cm insertion lengths. The
Opti-Flow 510(k)
1
catheter is also available with a VitaCuff& antimicrobial cuff which helps to provide protection against catheter related infections and helps anchor the catheter during the initial fow weeks of placement.
Intended Use: ર.
The Opti-Flow Dual Lumcn Catheter is indicated for use in attaining short or long term vascular access for hemodialysis, hemoperfusion or aphercsis therapy via the jugular or subclavian vein.
6. Technological Charactcristics
| Characteristic | Subject Device
Vas-Cath Opti-Flow Catheter | Predicate Device
Vas-Cath Soft-Cell Catheter
(K871488) |
|---------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Shaft diameter | 15 French | 12.5 French |
| Materials | polyurethane body and extensions, PVC connectors | polyurethane body and extensions, PVC connectors |
| Priming Volume (arterial lumen) | 19 cm: 1.8 cc
23 cm: 2.1 cc
27 cm: 2.2 cc
35 cm: 2.5 cc | 12 cm: 1.3 cc
19 cm: 1.5 cc
23 cm: 1.7 cc |
| Priming Volume (venous lumen) | 19 cm: 2.0 cc
23 cm: 2.2 cc
27 cm: 2.4 cc
35 cm: 2.7 cc | 12 cm: 1.4 cc
19 cm: 1.6 cc
23 cm: 1.8 cc |
| Shape of arterial/venous lumens | "Double D" | "Double D" |
| Indications | hemodialysis, hemoperfusion, apheresis | hemodialysis, hemoporfusion, apheresis |
| Catheter Insertion Lengths | 19cm, 23cm, 27cm, 35cm | 12cm, 19cm, 23cm |
| Tip Characteristics | 45°beveled tip | 45°beveled tip |
| Manufacturing Process | Injection molded bifurcation onto body and extensions. Catheter is one piece. | Injection molded bifurcation onto body and extensions. Catheter is one piece. |
Opti-Flow 510(k)
000621
1981994
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Performance Data: 7.
In vitro performance data show that the Opti-Flow catheter has comparable results to the predicate catheter in regard to elongation to failure, tensile strength of molded joints, flexibility, leakage, recirculation, as well as maximum pressure and vacuum. The flow rates of the Opti-Flow catheter are greater than the Soft-Cell catheter as determined by bench testing.
In vitro test results support the labeling change of incorporating a warning against use of ointments with the catheter and the new dressing change protocol in the revised IFUs, Dressing Change Protocol, Nursing Procedure Manual and Patient Guide.
Under certain conditions, the interaction between the polyurethane tubing, PEG and moisture can lower the burst and/or radial tensile strength of the tubing, thereby increasing its susceptibility to cracking or splitting.
Since clinical personnel and/or patients cannot readily determine each ointment's formulation, the Instructions for Use instructs users to avoid all ointments and apply the dressing in such a way that the extension legs are not under the dressing.
Opti-Flow 510(k)
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3
Image /page/3/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three overlapping, abstract shapes resembling bird wings or stylized human figures. The emblem is black, and the text is arranged to follow the curve of the circle.
3 1698 SEP
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Peggy Keiffer Regulatory Affairs Manager Bard Access Systems, Inc. 5425 W. Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K981994
Vas-Cath Opti-Flow® Long-Term Dual Lumen Hemodialysis Catheter Regulatory Class: III 21 CFR 876.5540/Product Code: 78 MSD Dated: May 29, 1998 Received: June 8, 1998
Dear Ms. Keiffer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might
4
Page 2 - Ms. Peggy Keiffer
have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
In addition, we have determined that your device kit contains xylocaine and povidone iodine swabsticks which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, 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 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 809 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 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers 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.
William, Ph.D.
Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 1 - D
INDICATION(S) STATEMENT
I state in my capacity as Regulatory Affairs Manager of Bard Access Systems that this 1 state in my capacity as regulars - Opti-Flow ® Dual Lumen Catheter is indicated for the following:
The Opti-Flow Dual Lumen Catheter is indicated for use in attaining short term or long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein.
Signature of 5100k; Submitter
Peggy Keiffer Regulatory Affairs Manager (Printed Name of Submitter)
Date: 5,13.58
Suggested language and format to meet the requirements of sections 513(k) of the Federal Food, Drug and Cosmetic act, as amended, and section 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.
CONCURRENCE OF OFFICE OF DEVICE EVALUATION
K P81994
510(K) number
Division Sign-off, Office of Device Evaluation
Kilian Yi
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number
Opti-Flow 510(k)
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