(191 days)
Not Found
No
The description focuses on the physical characteristics and materials of a catheter, with no mention of AI or ML capabilities. Performance studies are limited to bench testing and biocompatibility, not algorithmic performance.
No
The device, a catheter, is used for vascular access to perform therapies such as hemodialysis, hemoperfusion, or apheresis, but it does not intrinsically perform a therapeutic function itself.
No
The device is a catheter used for vascular access during therapies like hemodialysis, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical catheter made of polyurethane with hardware components like lumens, luer connectors, and a suture wing. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing vascular access for hemodialysis, hemoperfusion, or apheresis therapy. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter designed to be inserted into a vein.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) 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 treatment.
N/A
Intended Use / Indications for Use
"The Vas-Cath Soft-Cell dual lumen hemodialysis cutheter 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. "
Product codes (comma separated list FDA assigned to the subject device)
78 MSD
Device Description
Soft-Cell Dual Lumen Catheters as currently distributed by BAS are available in straight and precurved configurations, in multiple insertion lengths. Catheters are made of polyurethane containing barium sulfate to provide radiopacity. Colored luer connectors identify the arterial (red) and venous (blue) lumens. Each extension has an atraumatic occlusion clamp, which closes the catheter. A fixed suture wing is located at the bifurcation.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed according to the above referenced standards and guidance document recommendations. The test results met the requirements.
Only those tests applicable to the luer connection were conducted: Dimensions; Tensile strength of catheter body to hub attachment [For this project, extension leg to hub attachment]; Leakage at hub; Catheter burst pressure (positive internal pressure).
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.
0
Page 1 of 3
Soft-Cell Catheter Connector Change Abbr. 510(k)
AUG - 6 2003
Soft-Cell Dual Lumen Catheter Luer Connector Change 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a).
General Information:
| Submitter Name: | Bard Access Systems, Inc.
[Wholly owned Subsidiary of C. R. Bard, Inc.]
[Distributor for Vas-Cath, Inc.] |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| Address: | 5425 W. Amelia Earhart Drive
Salt Lake City, UT 84116 |
| Telephone Number: | (801) 595-0700 ext. 5525 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Glenn Norton |
| Date of Preparation: | January 24, 2003 |
Device Information:
| Device Name: | Soft-CellTM Dual Lumen Catheter |
|---|---|
| Trade Name: | Soft-CellTM |
| Common/Usual Name: | Long-Term Hemodialysis Catheter |
| Classification Name: | 78 MSD -- Catheter, Hemodialysis, Implanted |
| 21 CFR 876.5540(b)(1) - Class III | |
| Blood Access Device | |
| Classification Panel: | Gastroenterology and Renal |
Class III -- No effective date has been established for the requirement for premarket approval for the device described in paragraph (b)(1).
Predicate Device:
(As described above)
K871488 Soft-Cell Dual Lumen Catheter
Summary of Change:
The modification to the Short-Term Dialysis Catheters is a change of material and design for the luer connectors.
Device Description:
Soft-Cell Dual Lumen Catheters as currently distributed by BAS are available in straight and precurved configurations, in multiple insertion lengths. Catheters are made of polyurethane containing barium sulfate to provide radiopacity. Colored luer connectors identify the arterial (red) and venous (blue) lumens. Each extension has an atraumatic occlusion clamp, which closes the catheter. A fixed suture wing is located at the bifurcation.
Intended Use of Device:
The intended use of the Soft-Cell Dual Lumen Catheter is for use in attaining short term or long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein.
Image /page/0/Picture/19 description: The image shows a sequence of numbers, specifically "0007". The numbers are printed in a bold, sans-serif font, and they appear to be slightly distressed or aged, with some imperfections and variations in the thickness of the lines. The numbers are arranged horizontally, with each digit clearly visible.
1
K030277 Page 2 of 3
Soft-Cell Catheter Connector Change Abbr. 510(k)
Technological Comparison to Predicate Device:
The technological characteristics of the modified Soft-Cell Dual Lumen Catheters are substantially equivalent to those of the predicate Soft-Cell catheters in terms of intended use, application, user population, design, performance, labeling, packaging, and sterilization method. The modification raises no new concerns of safety or effectiveness.
All aspects of the modified devices are identical to the predicate devices except for the luer connector hub material and design. All performance testing conducted focused on the qualification of the new connector only.
510(k) Substantial Equivalence Decision Tree:
New device is compared to Marketed Device
Yes.
Does the new device have the same indication statement as the predicate?
Yes.
Does the new device have the same technological characteristics, eg. design, material, etc. ?
Not in all respects. The principles of operation and basic design are the same. The old blue and red luer connectors are being replaced with blue and red polycarbonate luer connectors made of a new material/design. The PC luer connectors are made of a different material, have a modified design, and use a different bonding process. The catheter remains the same in all other respects.
Could the new characteristics affect safety or effectiveness?
Yes. The new material and design of the connector and the extension tubing/connector bond integrity could affect the safety or effectiveness of the device.
Do the new characteristics raise new types of safety and effectiveness questions?
No. There are no new types of safety and effectiveness questions. The safety and effectiveness questions are the same for all long-term dialysis catheters.
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. Reliance on recognized standards, ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General Requirements, ISO 594-2:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock Fittings, and FDA's Guidance on Premarket Notification [510]k]] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95, and corresponding ISO Standards were used to evaluate the device's performance.
Biocompatibility met the requirements of ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing and the FDA Modified ISO 10993 Test Profile for externally communicating blood contacting long term devices.
Are performance data available to assess effects of new characteristics?
Yes. Bench testing was performed according to the above referenced standards and guidance document recommendations. The test results met the requirements.
2
Page 3 of 3
Soft-Cell Catheter Connector Change Abbr. 510(k)
I)o performance data demonstrate equivalence?
Yes. Performance data demonstrate that the Soft-Cell catheters with new luer connectors are substantially equivalent to the predicate Soft-Cell catheters.
Non-Clinical Performance Data
As this change is being submitted via Abbreviated 510(k), the modification of the luer connector was done with conformance to a recognized standard:
ISO 594-2:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings.
In addition, design verification testing was conducted in conformance of FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term Intravascular Catheters, dated 3/16/95, to in-house protocols, and performed or evaluated based on the following FDA Guidances and recognized standards:
- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95
- ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General requirements .
- ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters ●
- ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other ● medical equipment - Part 1 : General Requirements
- . AAMI/ANSI/ISO-10993-1: 1997. Biological evaluation of medical devices - Part 1: Evaluation and testing, and the FDA Modified ISO 10993 Test Profile
- . AAMI/ANSI/ISO 11135:1994, Medical devices - Validation and routine control of ethylene oxide sterilization
Only those tests applicable to the luer connection were conducted: Dimensions; Tensile strength of catheter body to hub attachment [For this project, extension leg to hub attachment]; Leakage at hub; Catheter burst pressure (positive internal pressure).
Biocompatibility testing results met the requirements of ISO-10993, " Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" and the FDA Modified ISO 10993 Test Profile for externally communicating blood contacting long term devices.
All test results confirm the modified device to be substantially equivalent to the predicate device.
Conclusions:
Soft-Cell Dual Lumen Catheters met all the performance criteria of the testing performed and, based on FDA 's decision tree, are substantially equivalent to the predicate device, the Soft-Cell Dual Lumen Catheter, K871488, concurrence date June 12, 1987.
3
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2003
Mr. Glenn Norton Sr. Regulatory Affairs Specialist Bard Access Systems, Inc. C. R. Bard, Inc. 5425 W. Amelia Earhart Drive SALT LAKE CITY UT 84116
Re: K030277
Trade/Device Name: Vas-Cath Soft-Cell™ Dual Lumen Catheters Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: May 29, 2003 Received: May 30, 2003
Dear Mr. Glenn Norton:
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). 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 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.
4
Page 2 - Mr. Glenn Norton
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,
Daniel R. Seymore
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KO302 77
Soft-Cell Catheter Connector Change Abbr. 510(k)
Section 1-B
Luer Connector Change for Soft-Cell Catheters Abbreviated 510(k)
INDICATION(S) FOR USE STATEMENT*
I state in my capacity as Senior Regulatory Affairs Specialist of Bard Access Systems, that this notification [510(k)] for the following devices, Soft-Cell Dual Lumen Catheters, are indicated for the following:
"The Vas-Cath Soft-Cell dual lumen hemodialysis cutheter 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 510(k) Submitter:
Printed Name of Submitter:
Date:
Glenn Norton
1-24-2003
*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.
Concurrence of Office of Device Evaluation
510(k) Number
Division Sign-Off Office of Device Evaluation
David A. Legener
Division Sign-099) Division of Reprometive, Abdominal, and Radiological Devic
510(k) Number K030277
Prescription Use (Per 21 CFR 801.109)